chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Myalgia, Rash vesicular, Varicella
Clinical narrative: Rash with vesicles, myalgias, arthralgias and mild cough (mild chickenpox).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Fever - 102.7 with chills no other sx only tx. Fever protocol.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Back pain, Discomfort, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: 3/12/13 Left arm very sore also soreness in up in neck and in back. That evening, at injection site knot in arm red & swollen. Took Ibuprofen - low grade fever. 3/13/13 Arm & pain the same and continued Ibuprofen. Started BENADRYL in the evening with moist heating pad. 3/14/13 Injection site swelling decreased "little uncomfortable" continues BENADRYL & Ibuprofen. 3/15/13 No S & S per pt.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: 3/12/13 Left arm very sore also soreness in up in neck and in back. That evening, at injection site knot in arm red & swollen. Took Ibuprofen - low grade fever. 3/13/13 Arm & pain the same and continued Ibuprofen. Started BENADRYL in the evening with moist heating pad. 3/14/13 Injection site swelling decreased "little uncomfortable" continues BENADRYL & Ibuprofen. 3/15/13 No S & S per pt.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Back pain, Chills, Erythema, Mobility decreased
Clinical narrative: Chills, fever, stomach pains, back pain, leg pain, severe redness, swelling of arm. Severe pain in arm - inability to raise etc.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, stomach pains, back pain, leg pain, severe redness, swelling of arm. Severe pain in arm - inability to raise etc.
Age: 41.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Angina pectoris, Back pain, Bone pain, Burning sensation, Chest pain
Clinical narrative: Pain, itching, burning at injection sites on arms, same symptoms spreading within 2 months to other parts of body. Pain and burning in liver after 2 months spread to neck, arms, penis, anus, face, back, itchy dry eyes, chest pains, heart pains, aches in bones, tingling in fingertips.
Age: 41.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Dry eye, Eye pruritus, Facial pain, Genital pain, Injection site pain
Clinical narrative: Pain, itching, burning at injection sites on arms, same symptoms spreading within 2 months to other parts of body. Pain and burning in liver after 2 months spread to neck, arms, penis, anus, face, back, itchy dry eyes, chest pains, heart pains, aches in bones, tingling in fingertips.
Age: 41.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Injection site pruritus, Neck pain, Pain in extremity, Paraesthesia, Proctalgia
Clinical narrative: Pain, itching, burning at injection sites on arms, same symptoms spreading within 2 months to other parts of body. Pain and burning in liver after 2 months spread to neck, arms, penis, anus, face, back, itchy dry eyes, chest pains, heart pains, aches in bones, tingling in fingertips.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Redness/rash on both arms and torso. Patient prescribed Prednisone taper.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis secondary on (L) deltoid, given ROCEPHIN 1 gm 03/06/13.
Age: 27.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 27 year old patient (gender not reported). On 18-JAN-2013 the patient was vaccinated with VAQTA , the dose number, route of administration, anatomical location, lot number and expiry date were not reported. On 01-MAR-2013 the patient was vaccinated with VAQTA., the dose number, route of administration, anatomical location, lot number and expiry date were not reported. No adverse event was reported. Treatment information was not reported. Additional information has been requested.
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Varicella #2 on 3/14/13. Pt developed redness & significant swelling & warmth on (L) arm from mid deltoid to elbow. Pt was evaluated in clinic on 3/16/13.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Employee was approximately 4 weeks pregnant at the time of immunization.  Did not realize patient was pregnant at the time until reviewing records and then checking with patient for when she got pregnant.  She said she realized it later, but did not report it back to employee health nurse.  Employee has been advised to alert her OB provider.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Asthenia, Dyskinesia, Loss of consciousness, Muscular weakness
Clinical narrative: Syncopal episode with sudden onset upper abdominal pain ten minutes prior, loss of consciousness for approximately 60 seconds accompanied by tonic movements. Alert and oriented upon waking, weakness and tingling in hands lasted ten minutes after syncopal episode.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Paraesthesia, Syncope
Clinical narrative: Syncopal episode with sudden onset upper abdominal pain ten minutes prior, loss of consciousness for approximately 60 seconds accompanied by tonic movements. Alert and oriented upon waking, weakness and tingling in hands lasted ten minutes after syncopal episode.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Ultrasound scan normal
Clinical narrative: Pain and weakness in legs, L>R, starting in feet going to knees. Seen in ER on 10/25/2012. US venous duplex-no acute changes. On 3/12/2013 pt still has a little residual pain in muscle/cords in his legs. Question possible Guillain-Barre Syndrome.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Malaise, Oedema, Pain, Pyrexia
Clinical narrative: 03/13/13 7 pm: General malaise; 03/14/13 6 am: febrile and body aches; 03/14/13 5 pm: slight axillary lymphadenopathy; 03/15/13 6 pm: axillary edema.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Muscle swelling, Neck pain, Oedema peripheral
Clinical narrative: Swollen muscles, high fever of 101.5 to 102.2, Brachial neuritis, joint pain, swollen back, arms, neck pain, headache on and off.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Radiculitis brachial, Swelling
Clinical narrative: Swollen muscles, high fever of 101.5 to 102.2, Brachial neuritis, joint pain, swollen back, arms, neck pain, headache on and off.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pruritus, Skin warm
Clinical narrative: Patient complaints the area on her left arm red, warm to touch and itchy. This redness was 1" X 1", this is in a lighter red area that is 2" X 4". The Lighter red area appeared on Sunday. The redness is at the site of the injection. Patient used a Calming cream on the reaction which has helped the itching. We discussed the use of Claritin and or Zyrtec to help with the itchiness as patient is taking blood pressure medication.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vision blurred, Vomiting
Clinical narrative: Headache, dizziness, vomiting, blurred vision.
Age: 49.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: SMALL RED DOTS.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pain, Rash erythematous, Rash maculo-papular, Tenderness
Clinical narrative: About 8-10 small red maculopapular rash with one vesicle.  Vesicle painful and very tender if touched.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Cough, Dyspnoea, Heart rate increased, Pharyngeal oedema
Clinical narrative: Swelling of the throat, rapid heart beat, shortness of breath, coughing.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient states she noticed the area around the injection site was swollen and red. Patient was seen in provider office on 3/19/13 and given antibiotic therapy.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Discomfort, Erythema, Hyperaesthesia, Injection site pruritus, Skin warm
Clinical narrative: Redness at back of left arm about 5 inches in length and 4 inches across, warm to the touch, sensitive to the touch, "felt bumpy" large hive in the center of the redness approximately 3" x 1 1/2".  Itching at site.  Discomfort and some swelling at axillary. Symptoms lasting until 03/17/2013 approximately 9:00. By morning on 3/18/2013. Redness began to lessen. Axillary became less tender.  Into HD on 03/18/2013. Pictures taken. Referred to PMD. if any further symptoms or if symptoms do not continue to decline.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Swelling, Tenderness, Urticaria
Clinical narrative: Redness at back of left arm about 5 inches in length and 4 inches across, warm to the touch, sensitive to the touch, "felt bumpy" large hive in the center of the redness approximately 3" x 1 1/2".  Itching at site.  Discomfort and some swelling at axillary. Symptoms lasting until 03/17/2013 approximately 9:00. By morning on 3/18/2013. Redness began to lessen. Axillary became less tender.  Into HD on 03/18/2013. Pictures taken. Referred to PMD. if any further symptoms or if symptoms do not continue to decline.
Age: 15.0
Sex: F
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Chest discomfort, Dyspnoea, Erythema, General physical health deterioration, Oedema peripheral
Clinical narrative: Approx: 4:00PM- Received phone call client's mother-reporting that they had to rush adolescent to ER due to reaction from vaccines given. Mom reported that on way home, client compliant of scratchy throat, chest tightness, itching, rash developing around neck. Parent immediately return to town to take to nearest hospital stopping at local Fire Department to have child assessed due to developing reaction. On assessment, increase resperation, chest tightness,  O2 sat at 96%, family headed on the ER approx. 9 miles away. Child's condition deteriorating with increacing difficulty breathing. Child in distress on arrival- O2 sat down to 84%. Breathing treatments started, child given Benadryl, was placed on steroids and release after stable. Mom reports, child returned to ER the following day with respiratory distress. Was given breathing treatments, steroid injection and oral steroids to take. Follow up on 3-07-13-mom reported that lower arms developed bilateral redness and swelling approx 4 inches in width (area MMR and Varicella were give). Teen was slowing improving. On 03-12-13, spoke with mom and child was back to normal.
Age: 15.0
Sex: F
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Pruritus, Rash, Respiratory distress, Respiratory rate increased, Throat irritation
Clinical narrative: Approx: 4:00PM- Received phone call client's mother-reporting that they had to rush adolescent to ER due to reaction from vaccines given. Mom reported that on way home, client compliant of scratchy throat, chest tightness, itching, rash developing around neck. Parent immediately return to town to take to nearest hospital stopping at local Fire Department to have child assessed due to developing reaction. On assessment, increase resperation, chest tightness,  O2 sat at 96%, family headed on the ER approx. 9 miles away. Child's condition deteriorating with increacing difficulty breathing. Child in distress on arrival- O2 sat down to 84%. Breathing treatments started, child given Benadryl, was placed on steroids and release after stable. Mom reports, child returned to ER the following day with respiratory distress. Was given breathing treatments, steroid injection and oral steroids to take. Follow up on 3-07-13-mom reported that lower arms developed bilateral redness and swelling approx 4 inches in width (area MMR and Varicella were give). Teen was slowing improving. On 03-12-13, spoke with mom and child was back to normal.
Age: 25.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Pt says the area has itched for about 3 days and today she noticed a red area on her left deltoid that is 2.75 inches wide by 3.5 inches long.  She says she had the same type reaction to a flu shot in Jan 2013.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain
Clinical narrative: Immediate shoulder pain.  Pain and loss of motion continue to today, 6 months later.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Per mother of the pt - pt given flu shot and feeling ok afterwards. They started walking out of the pharmacy / store, pt and sister was talking about needles & blood when she began to feel queasy because of the talk (pt has history of fainting when.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Patient developed a 5x6 cm irregularly shaped erythematous welt 2 days after injection, to her left thigh.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient received Tdap to (L) dt IM at 1106. Immediately after administering vaccine, pt stood up, walked a couple steps and fainted. Pt fell sideways and hit wall. Immediately RN was called and MD was notified legs were elevated. Transferred to a room via wheelchair for close monitoring on exam table. Regained consciousness within seconds. Discharged home at 11:30 am. Last BP 90/60. Parent was present the whole time.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling, Rash papular
Clinical narrative: Developed papular rash & swelling injection site.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Auricular swelling, Rash, Rash macular, Swelling face, Urticaria
Clinical narrative: 1 1/2 hours after immunizations patient had red blotches on face. 10 minutes later mother states his face and ears appeared swollen and he had hives all over his body. Mother took him to the emergency room where they gave him BENADRYL. The emergency room monitored him until swelling and hives were gone.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Convulsion, Injection site rash, Pyrexia
Clinical narrative: Pt developed 102.4 fever approx 12 hours s/p vaccination (PREVNAR, varicella, MMR); pt had seizure activity approx 2 hrs prior to febrile start, acting well in office circumferential rash at vaccine sites also.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Bruxism, Dyskinesia, Tic
Clinical narrative: Patient developed motor tic; jaw clenching; hand movement (involuntary) for approx. a one week period post vaccines.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope. Tx lifted his legs.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certificated medical assistant referring an unspecified number of patients whom on an unknown date, were vaccinated with a dose of VAQTA, the reporter was unable to provide lot #/expiration dates and administrations dates for the vaccine. It was reported that the vaccine was exposed to 1 F for 3 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant referring an unspecified number of patients whom on an unknown date, were vaccinated with a dose of GARDASIL the reporter was unable to provide lot #/expiration dates and administrations dates for the vaccine. It was reported that the vaccine was exposed to 1 F for 3 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient currently 64 years old (unknown gender). The pharmacist reported that on 26-SEP-2012 the patient was vaccinated with ZOSTAVAX (lot# and expiration date unspecified), standard dose, subcutaneous injection in the arm (dose unspecified). The pharmacist reported that in September 2012 the patient developed wide spread bruising after received ZOSTAVAX. The bruising spanned from the injection site to the underarm to the near shoulder which persisted for a few days and then dissipated. At the time of the report the outcome of wide spread bruising was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and a Licensed practical nurse (LPN) refers to a patient of unknown age and gender who on 27-FEB-2013 received one dose of (Merck) VARIVAX injection (Lot # reported as H015951, expiration date 23-AUG-2014) (dose, route and site of administration not reported) that was exposed to refrigerator temperatures not greater than 46 F for 60 days. (Merck) VARIVAX was placed in the refrigerator of 5 C on 08-NOV-2012 and discovered on 06-MAR-2013 (also reported as for a few months). No adverse effect reported. This is one of two cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and a Licensed practical nurse (LPN) refers to a patient of unknown age and gender who on 27-DEC-2012 received one dose of (merck) VARIVAX injection (Lot # reported as H015951, expiration date 23-AUG-2014) (dose, route and site of administration not reported) that was exposed to refrigerator temperatures not greater than 46 F for 60 day. (merck) VARIVAX was placed in the refrigerator of 5 C on 08-NOV-2012 and discovered on 06-MAR-2013 (also reported as a few months). No adverse effect reported. This is one of two cases from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous was received from a health worker for VARIVAX, a Pregnancy Registry product, regarding a 37 year old female patient. On an unknown date, the patient was vaccinated with (merck) VARIVAX and M-M-R II while she was pregnant. Concomitant medications were not reported. The last menstrual period (LMP) was reported as 10-JUL-2012 and an estimated delivery date (EDD) of 16-APR-13. Ultrasound was done. The patient sought unspecified medical attention. Follow up information has been received from a health care professional regarding a 37 year old female patient. Patient with 3 previous pregnancies and 1 full term deliveries, in the previous pregnancies did not occur a birth defect or still birth or any miscarriage..On 18-JULY-2012, the patient was vaccinated with (merck) VARIVAX. The patient was not test for varicella antibodies before vaccination with varicella zoster virus containing vaccine. Prenatal testing were performed: ultrasound (29-JAN-2013) negative, the reasons to performed this tests were gestational diabetes and fetal growth. Maternal Serum Alpha Fetoprotein was performed on 29-OCT-2013 negative. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event, Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender and the majority were hospitalized, with pre-existing unspecified medical issues. It was reported that on an unknown date, the majority of patients were vaccinated during hospitalization with PNEUMOVAX23 (lot numbers and expiration date not reported) (dose 0.5 ml, intramuscular route). Other co suspect or concomitant medications were not reported. On an unknown date, an unspecified Emergency Room (ER) doctor stated that he had seen 3 or 4 unspecified reactions after administration of PNEUMOVAX23. Some of those unspecified patients required administered intravenous (IV) of unspecified antibiotics as a result of an adverse event, specifically cellulitis, after the PNEUMOVAX23 was given. It was unspecified if the patients needed a prolonged hospitalization. The reporter stated that there were multiple lot numbers of PNEUMOVAX23 involved, although, she could not provided any lot number at the time of the report. The outcome of the multiple patients for the cellulitis, the unspecified reactions and the adverse event was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age, with no known drug reactions/allergies and no other pertinent medical history. On 11-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, and route not reported) (lot # H019040). There was no concomitant medication. On an unknown date the patient experienced pain, redness, swelling, warmth and itching at the injection site following the administration of ZOSTAVAX. The pharmacy doctor reported that the size of the affected area around the injection site was approximately 1.5 inches by 3 inches. The reported also mentioned that the patient stated she had difficulty moving her arm. The patient sought unspecified medical attention. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age, with no known drug reactions/allergies and no other pertinent medical history. On 11-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, and route not reported) (lot # H019040). There was no concomitant medication. On an unknown date the patient experienced pain, redness, swelling, warmth and itching at the injection site following the administration of ZOSTAVAX. The pharmacy doctor reported that the size of the affected area around the injection site was approximately 1.5 inches by 3 inches. The reported also mentioned that the patient stated she had difficulty moving her arm. The patient sought unspecified medical attention. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certificated medical assistant referring an unspecified number of patients whom on an unknown date, were vaccinated with a dose of RECOMBIVAX HB, the reporter was unable to provide lot #/expiration dates and administrations dates for the vaccine. It was reported that the vaccine was exposed to 1 F for 3 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test normal, Rash
Clinical narrative: This spontaneous report as received from a 91 years old female patient reporting on herself. The patient reported allergy to penicillin and none other pertinent medical history. In 2008 the patient was vaccinated with a standard dose of ZOSTAVAX injection (lot number were not specified), for prevention of shingles. There were none concomitant medications. The patient reported she has developed a mild case of shingles a few weeks ago (date unspecified0, and she was treated with prednisone, and a medication that began with a V "(possible Valcyclovir)" both prescribed for one week. She also received an over the counter (OTC) eye drops reported as "Octiva" to protect her eyes because the rash had developed very near the eye. Glaucoma tests were performed to assess the rashes effect on patient's eyes. All tests results were normal. The patient sought medical attention. The outcome of developed a mild case of shingles was unknown. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Decreased vibratory sense, Encephalitis, Encephalopathy, Headache, Mycoplasma infection
Clinical narrative: Initial report was received from the scientific literature on 26 November 2012. A 12-year-old male patient developed severe headache, optic neuritis, Bell's palsy, and decreased vibratory sense in the left lower extremity 16 days after receiving a dose of MENACTRA (lot number, route, site and date of administration not reported) and a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer, lot number, route, site and date not reported). He was hospitalized twice with a primary diagnosis of encephalitis and secondary diagnoses of optic neuritis, encephalopathy, facial palsy, and Mycoplasma infection. Outcome was not reported. This case is linked to 2012-11398, 2012-11399, 2012-11400, 2012-11401, 2012-11402, 2012-11403, 2012-11404, 2012-11405, 2006-01981, 2007-00580 and 2007-00581. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Optic neuritis, VIIth nerve paralysis
Clinical narrative: Initial report was received from the scientific literature on 26 November 2012. A 12-year-old male patient developed severe headache, optic neuritis, Bell's palsy, and decreased vibratory sense in the left lower extremity 16 days after receiving a dose of MENACTRA (lot number, route, site and date of administration not reported) and a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer, lot number, route, site and date not reported). He was hospitalized twice with a primary diagnosis of encephalitis and secondary diagnoses of optic neuritis, encephalopathy, facial palsy, and Mycoplasma infection. Outcome was not reported. This case is linked to 2012-11398, 2012-11399, 2012-11400, 2012-11401, 2012-11402, 2012-11403, 2012-11404, 2012-11405, 2006-01981, 2007-00580 and 2007-00581. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, Asthenia, CSF cell count increased, Headache, Lethargy
Clinical narrative: Initial report was received from the scientific literature on 26 November 2012. A 16-year-old male patient developed headache, photophobia, progressive weakness, decreased sensation, and urinary retention 15 days after receiving a dose of MENACTRA (lot number, route, site and date not reported) and a dose of diphtheria, tetanus and acellular pertussis vaccine (manufacturer, lot number, route, site and date not reported), followed by loss of consciousness and lethargy. Laboratory studies revealed CSF pleocytosis and an abnormal MRI of the brain identified diffuse parenchymal signal changes above and below the tentorium, compatible with acute disseminated encephalomyelitis (ADEM). His symptoms resolved approximately 7 weeks after vaccination. Outcome was recovered. This case is linked to 2012-11398, 2012-11399, 2012-11400, 2012-11401, 2012-11402, 2012-11404, 2012-11405, 2012-11406, 2006-01981, 2007-00580 and 2007-00581. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging brain abnormal, Photophobia, Pleocytosis, Sensory disturbance
Clinical narrative: Initial report was received from the scientific literature on 26 November 2012. A 16-year-old male patient developed headache, photophobia, progressive weakness, decreased sensation, and urinary retention 15 days after receiving a dose of MENACTRA (lot number, route, site and date not reported) and a dose of diphtheria, tetanus and acellular pertussis vaccine (manufacturer, lot number, route, site and date not reported), followed by loss of consciousness and lethargy. Laboratory studies revealed CSF pleocytosis and an abnormal MRI of the brain identified diffuse parenchymal signal changes above and below the tentorium, compatible with acute disseminated encephalomyelitis (ADEM). His symptoms resolved approximately 7 weeks after vaccination. Outcome was recovered. This case is linked to 2012-11398, 2012-11399, 2012-11400, 2012-11401, 2012-11402, 2012-11404, 2012-11405, 2012-11406, 2006-01981, 2007-00580 and 2007-00581. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urinary retention
Clinical narrative: Initial report was received from the scientific literature on 26 November 2012. A 16-year-old male patient developed headache, photophobia, progressive weakness, decreased sensation, and urinary retention 15 days after receiving a dose of MENACTRA (lot number, route, site and date not reported) and a dose of diphtheria, tetanus and acellular pertussis vaccine (manufacturer, lot number, route, site and date not reported), followed by loss of consciousness and lethargy. Laboratory studies revealed CSF pleocytosis and an abnormal MRI of the brain identified diffuse parenchymal signal changes above and below the tentorium, compatible with acute disseminated encephalomyelitis (ADEM). His symptoms resolved approximately 7 weeks after vaccination. Outcome was recovered. This case is linked to 2012-11398, 2012-11399, 2012-11400, 2012-11401, 2012-11402, 2012-11404, 2012-11405, 2012-11406, 2006-01981, 2007-00580 and 2007-00581. Documents held by sender: None.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, Musculoskeletal stiffness
Clinical narrative: Initial report received from a Health Care Professional on 13 June 2012. A 10-year-old female patient, who had no known allergies and concomitant medications, received an intramuscular dose of ADACEL (Lot number: C3475AA, expiry date: 16 June 2012) and MENACTRA vaccine (lot number: U4074BA, expiry date: 05 July 2012) on 12 June 2012. (Site of administration was not reported for both the vaccines). It was reported that the patient received ADACEL for Tdap vaccine instead of BOOSTRIX. The child was vaccinated with ADACEL at an inappropriate age. On the same visit i.e. on 12 June 2012, the patient also received MENACTRA. On 12 June 2012 midnight (13th June 2012) patient complained of stiffneck. It was reported that patient required ER/ doctor's visit. Treatment details and laboratory investigations were not reported. As of 13 June 2012, the outcome was reported as not recovered. Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Tremor, Urticaria, Vomiting
Clinical narrative: This case is a part of cluster report of 2 cases and is linked with the case# 2012-07269, (same reporter, ADACEL vaccine (lot no: U4329AA), MENACTRA (lot number: 4244AA) and Varicella (lot no: 0591AE)). Initial information received from a Health care professional on 26 July 2012. Local reference no: 12-0426. The 14-year-old male patient whose medical history and concomitant drugs not reported received dose of MENACTRA vaccine (lot no: U4244AA) intramuscular in right arm, ADACEL vaccine (lot no: U4329AA) intramuscular in left arm and Varicella (lot no: 0591AE, Manufacturer is Merck) subcutaneous in left arm on 23 July 2012. The patient experienced fever hives, shaking and vomiting for 2 days. Laboratory test was not reported. Corrective treatment included the patient was treated with TYLENOL, MOTRIN and BENADRYL. The events recovered on unknown date. Documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Papule, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of skin rash on face and neck in a 9-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 13 December 2012 at 14:30 the subject received 1st dose of HAVRIX (.5 ml, unknown route, right deltoid). On 14 December 2012, 1 day after vaccination with HAVRIX, the subject experienced skin rash on face and neck, skin papules, hive and possible contact dermatitis. The nurse described the papules as "raised papules with a hive component." The nurse reported that the subject's physician believed the rash "was contact dermatitis, but could not rule out yet that the rash was from the vaccine." The subject was treated with BENADRYL. At the time of reporting the events were improved.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Headache, Urticaria
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of headache in an 18-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination included hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on an unspecified date. On 18 June 2012 the subject received 1st dose of HAVRIX (unknown route, left arm). On 18 June 2012, less than one day after vaccination with HAVRIX, the subject experienced headache and tiredness. At the time of reporting the events had been ongoing for four days and were still unresolved. The mother reported another event for her son with Hepatitis B vaccine. She explained that the subject experienced hives following first dose of Hepatitis B vaccine as a child. See case A0982384B for details on the Hepatitis B vaccine case. Denied permission to contact physician.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Headache
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of headache in an 18-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination included hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on an unspecified date. On 18 June 2012 the subject received 1st dose of HAVRIX (unknown route, left arm). On 18 June 2012, less than one day after vaccination with HAVRIX, the subject experienced headache and tiredness. At the time of reporting the events had been ongoing for four days and were still unresolved. The mother reported another event for her son with Hepatitis B vaccine. She explained that the subject experienced hives following first dose of Hepatitis B vaccine as a child. See case A0982384B for details on the Hepatitis B vaccine case. Denied permission to contact physician.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain, Muscle tightness, Musculoskeletal pain, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. On 11-Jan-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, no pertinent medical history and no drug allergy. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in his shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. On 11-Jan-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, no pertinent medical history and no drug allergy. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in his shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. On 11-Jan-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, no pertinent medical history and no drug allergy. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in his shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. On 11-Jan-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, no pertinent medical history and no drug allergy. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in his shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Muscle tightness, Musculoskeletal pain, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with DEMEROL allergy, sulfa allergy, penicillin allergy and erythromycin allergy. On 11-JAN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, and no pertinent medical history. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in her shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with DEMEROL allergy, sulfa allergy, penicillin allergy and erythromycin allergy. On 11-JAN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, and no pertinent medical history. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in her shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with DEMEROL allergy, sulfa allergy, penicillin allergy and erythromycin allergy. On 11-JAN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot# was unspecified. The patient had no concomitant medication, and no pertinent medical history. On 13-JAN-2013, 2 days after receiving ZOSTAVAX, the patient developed arthralgias in her shoulders, back of legs and glutes maximum. No treatment was given. No lab test was done. The outcome of event was reported as not recovered/not resolved. The patient contacted pharmacist to seek medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Chills, Eosinophil percentage decreased, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old male patient with high cholesterol and none drug allergies. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # reported as H015749,exp 08-JUN-2014, 0.5 ml, subcutaneous). Concomitant therapy included simvastatin (manufacturer unknown). On 02-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local emergency room and was diagnosed with cellulitis. The patient was treated with KEFLEX. The outcome of cellulitis was reported as recovered/resolved on an unknown date. This is one of the two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site swelling, Lymphocyte percentage decreased, Neutrophil percentage increased, Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old male patient with high cholesterol and none drug allergies. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # reported as H015749,exp 08-JUN-2014, 0.5 ml, subcutaneous). Concomitant therapy included simvastatin (manufacturer unknown). On 02-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local emergency room and was diagnosed with cellulitis. The patient was treated with KEFLEX. The outcome of cellulitis was reported as recovered/resolved on an unknown date. This is one of the two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old male patient with high cholesterol and none drug allergies. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # reported as H015749,exp 08-JUN-2014, 0.5 ml, subcutaneous). Concomitant therapy included simvastatin (manufacturer unknown). On 02-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local emergency room and was diagnosed with cellulitis. The patient was treated with KEFLEX. The outcome of cellulitis was reported as recovered/resolved on an unknown date. This is one of the two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Full blood count abnormal, Injection site induration, Injection site swelling, White blood cell count increased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old male patient with high cholesterol and none drug allergies. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # reported as H015749,exp 08-JUN-2014, 0.5 ml, subcutaneous). Concomitant therapy included simvastatin (manufacturer unknown). On 02-MAR-2013 the patient developed redness and swelling at the injection site. The patient was evaluated at a local emergency room and was diagnosed with cellulitis. The patient was treated with KEFLEX. The outcome of cellulitis was reported as recovered/resolved on an unknown date. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 12-MAR-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot # 670513/0543AA, EXP Date 11-MAR-2013). The nurse reported that the first dose of oral, ROTATEQ was administered on 01/03/2013. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 12-MAR-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot # 670513/0543AA, EXP Date 11-MAR-2013). The nurse reported that the first dose of oral, ROTATEQ was administered on 01/03/2013. No adverse event reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse, for ZOSTAVAX, a Pregnancy Registry product, refers to a 30 year old female patient. The patient had past "allergic" experience of having nausea with furosemide and having jittery with PAXIL. The patient had no pertinent medical history and no concomitant medication. On 02-NOV-2012 the 30 year old patient who was nursing a baby was vaccinated with ZOSTAVAX (lot # 0071AE, expiry date 03-APR-2013) due to a human error. Lot # and vaccination route was unspecified. Later the patient became pregnant. At reporting time (12-MAR-2013), the patient's gestation was 8 weeks pregnant. Estimated last menstrual period (LMP) (calculated as 8 weeks prior to reporting time) was on 15-JAN-2013 and estimated due date (EDD) was on 22-OCt-2013. The pregnancy outcome was pending. The patient's gravida and para was unspecified. No lab test was done. No adverse effect reported. The patient saw the physician to seek medical attention. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Exposure during breast feeding, Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse, for ZOSTAVAX, a Pregnancy Registry product, refers to a 30 year old female patient. The patient had past "allergic" experience of having nausea with furosemide and having jittery with PAXIL. The patient had no pertinent medical history and no concomitant medication. On 02-NOV-2012 the 30 year old patient who was nursing a baby was vaccinated with ZOSTAVAX (lot # 0071AE, expiry date 03-APR-2013) due to a human error. Lot # and vaccination route was unspecified. Later the patient became pregnant. At reporting time (12-MAR-2013), the patient's gestation was 8 weeks pregnant. Estimated last menstrual period (LMP) (calculated as 8 weeks prior to reporting time) was on 15-JAN-2013 and estimated due date (EDD) was on 22-OCt-2013. The pregnancy outcome was pending. The patient's gravida and para was unspecified. No lab test was done. No adverse effect reported. The patient saw the physician to seek medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Secretion discharge, Skin discolouration, Skin lesion
Clinical narrative: Pink bump on right shoulder.  Noted a weeping lesion on base of neck on 3/19/2013 at 11:00 AM and third non-weeping lesion noted at 7:00 PM.