chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Blood thyroid stimulating hormone normal, Full blood count, Metabolic function test
Clinical narrative: Vaccine given 5:30 pm 1/10. Patient experienced arrhythmias the following morning. She already is treated for this with beta blockers but has been symptom free. She was monitored by her physician & he eventually directed her to ER on 1/13.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Blood glucose abnormal, Delivery, Exposure during pregnancy, Laboratory test normal, Live birth
Clinical narrative: Information has been received from a healthcare worker, for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 32 year old female patient who on 02-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 671085/0829AA, expiry date 02-JUN-2013) (dose and route not reported). Secondary suspect therapy included M-M-R II (lot number 670892/0872AA, expiry date 06-JUN-2013) (dose and route not reported) on 02-MAR-2012. It was reported, that the patient came to the immunization clinic (connected to immigration office), received and filled out questionnaire and checked no to being pregnant. Then she received both the VARIVAX (Merck) and M-M-R II that day. Then, the family practice called and reported to the immunization office that the patient was 23-weeks pregnant. The patient's LMP was approximately on 06-OCT-2011. Expected date of delivery was 12-JUL-2012. The patient sought medical attention for pregnancy and her first prenatal visit was scheduled for next week. Follow up information has been received from a Licensed Practice Nurse (LPN), for VARIVAX (Merck), a Pregnancy Registry Product, concerning the 32 year old patient who on 02-MAR-2012 was vaccinated with a dose of VARIVAX (Merck). Other concomitant therapy included Tdap (manufacturer unknown) vaccinated on the same day. The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The patient's Date of last menstrual period was 05-OCT-2011, estimated delivery date was 02-JUL-2012. On 29-MAR-2012, the patient did ultrasound, the result was OK except for hydronephrosis. The patient had 5 previous pregnancies. Full term deliveries was 4 times. There was no  pre-term births. No birth defect occurred in previous pregnancy. The patient had a stillbirth or miscarriage in the previous pregnancy of 4-6 weeks. The patient did not have local reaction at vaccination site and did not have varicella and herpes zoster symptoms post vaccination. Follow up information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry Product concerning a female patient with no infections or illness during pregnancy and no concurrent medical conditions, who on 03-JUL-2012 delivered a live normal male baby at her 40 weeks from LMP. None congenital anomalies and other complications or abnormalities were reported, The infant did not experience adverse event. During pregnancy the patient had gestational diabetes. Concomitant therapy included prenatal vitamins  (name reported as Prenatal), used most of pregnancy, 1 daily, uncertain number of doses taken for nutrition. The patient experienced post partum hemorrhage during labor/delivery. Ultrasound was performed on 29-MAR-2012, 09-MAY-2012 and 26-JUN-2012 and showed hydronephrosis. On 26-JUN-2012 hydronephrosis resolved. On an unknown date, prenatal lab profile was performed with a result of normal. On an unknown date, glucose screening tests were performed with a result of abnormal. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Postpartum haemorrhage, Pregnancy test positive, Prenatal screening test, Ultrasound scan abnormal
Clinical narrative: Information has been received from a healthcare worker, for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 32 year old female patient who on 02-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot number 671085/0829AA, expiry date 02-JUN-2013) (dose and route not reported). Secondary suspect therapy included M-M-R II (lot number 670892/0872AA, expiry date 06-JUN-2013) (dose and route not reported) on 02-MAR-2012. It was reported, that the patient came to the immunization clinic (connected to immigration office), received and filled out questionnaire and checked no to being pregnant. Then she received both the VARIVAX (Merck) and M-M-R II that day. Then, the family practice called and reported to the immunization office that the patient was 23-weeks pregnant. The patient's LMP was approximately on 06-OCT-2011. Expected date of delivery was 12-JUL-2012. The patient sought medical attention for pregnancy and her first prenatal visit was scheduled for next week. Follow up information has been received from a Licensed Practice Nurse (LPN), for VARIVAX (Merck), a Pregnancy Registry Product, concerning the 32 year old patient who on 02-MAR-2012 was vaccinated with a dose of VARIVAX (Merck). Other concomitant therapy included Tdap (manufacturer unknown) vaccinated on the same day. The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. The patient's Date of last menstrual period was 05-OCT-2011, estimated delivery date was 02-JUL-2012. On 29-MAR-2012, the patient did ultrasound, the result was OK except for hydronephrosis. The patient had 5 previous pregnancies. Full term deliveries was 4 times. There was no  pre-term births. No birth defect occurred in previous pregnancy. The patient had a stillbirth or miscarriage in the previous pregnancy of 4-6 weeks. The patient did not have local reaction at vaccination site and did not have varicella and herpes zoster symptoms post vaccination. Follow up information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry Product concerning a female patient with no infections or illness during pregnancy and no concurrent medical conditions, who on 03-JUL-2012 delivered a live normal male baby at her 40 weeks from LMP. None congenital anomalies and other complications or abnormalities were reported, The infant did not experience adverse event. During pregnancy the patient had gestational diabetes. Concomitant therapy included prenatal vitamins  (name reported as Prenatal), used most of pregnancy, 1 daily, uncertain number of doses taken for nutrition. The patient experienced post partum hemorrhage during labor/delivery. Ultrasound was performed on 29-MAR-2012, 09-MAY-2012 and 26-JUN-2012 and showed hydronephrosis. On 26-JUN-2012 hydronephrosis resolved. On an unknown date, prenatal lab profile was performed with a result of normal. On an unknown date, glucose screening tests were performed with a result of abnormal. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient said dizzy after received shot 1-9-13 4:30pm, ok at night, then dizzy again when woke up this morning 1-10-13. Had 1st flu shot 2012 and no reaction.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Dizziness, Feeling drunk, Pyrexia
Clinical narrative: Pt received vaccine Friday (1/10/13), on Sat pt describes feeling of lightheadedness.  Patient went to ER and was treated for fever and dehydration. Symptoms of feeling drunk or intoxicated continued through Wednesday (1/15/13).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 years old female patient. The patient's medical history included hyperparathyroidism and drug reactions/allergies to terramycin (not further specified). On 11-JAN-2013 the patient was vaccinated subcutaneously with ZOSTAVAX from a pharmacy (dose number lot number, dose not reported). No other co-suspects were reported. The patient was concomitantly using unspecified thyroid medications. On 12-JAN-2013 the patient experienced itching at the injection site. On 13-JAN-2013 the patient experienced a lump and erythema below the injection site. The affected area was about 5 inches. The patient received a moist compress as treatment. On 14-JAN-2013 the lump was decreasing in size. No relevant tests were performed and the patient did not seek medical attention. The outcome of the events was reported as recovering/resolving. A reporter causality for itching at the injection site, and for lump and erythema below the injection site was not reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified group of children of unknown age and gender. At an unknown date, the patients were vaccinated with VARIVAX (Merck) injection. Route, dose and frequency were not reported. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that in the past she has heard about an unspecified number of cases where children received VARIVAX and developed generalized varicella-like lesions. These were not her patients and she had no other information. No other details. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a 69 year old male patient. Patient's relevant medical history included heart disease. No drug allergies reported. On 16-JAN-2013 the patient received dose 2 PNEUMOVAX23 0.5 mL (route not reported). He had already had PNEUMOVAX23 on 07-NOV-2010 and did not experience an adverse reaction after receiving the first dose. Concomitant medications included CRESTOR, amlodipine, metoprolol and PLAVIX. On 16-JAN-2013, the patient's arm at the injection site was extremely painful after receiving the second dose of vaccine. No treatment was given, no lab test was performed. Patient did not seek medical attention. At the time of reporting the patient did not recovered from the event. Additional information has been requested. The consumer also reported AE regarding herself (captured in Case # 1301USA009248).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with VARIVAX (Merck). Other suspect therapies included PROQUAD (Merck). No concomitant medications were reported. Nurse reported that a patient received a dose of VARIVAX (Merck). and a dose of PROQUAD (Merck) during the same visit at an unknown date. No symptoms reported. No other details. No treatment information was reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Blister, Feeling hot
Clinical narrative: Body on fire went to emergency rm - after 2 hrs blisters all over arms and crotch/legs! Admitted in isolation for what they thought was Steven Johnson Syndrome - Blisters for 3 weeks and still have a skin issue.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema
Clinical narrative: Body on fire went to emergency rm - after 2 hrs blisters all over arms and crotch/legs! Admitted in isolation for what they thought was Steven Johnson Syndrome - Blisters for 3 weeks and still have a skin issue.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Patient has itching at injection site as well as hives on injection arm and trunk.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient (consumer's daughter) of unknown age. On an unspecified date the patient was vaccinated with "chickenpox vaccine" (manufacturer unknown). On an unknown date the patient got the shingles from the chickenpox vaccine. No treatment information was reported. The outcome of shingles is unknown. Reporter disconnected without providing further information. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Child had swollen/hard bump at injection site and fever of 103.5. Child given 130 mg ADVIL and 750 mg of ROCEPHIN/Ceftriaxone. Child observed 1 1/2 hrs and temp down to 100.5, pt give TYLENOL/ADVIL for home. Child came back in on 1-16-13 for follow up with no fever, pain, redness or swelling.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown sex and age. The patient was vaccinated with dose 1 GARDASIL (lot number not provided) in August 2012. No other co-suspects were reported. No concomitant medications were reported. On 08-JAN-2013 the patient came in the office to receive the second dose of GARDASIL. No adverse event was reported. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Following IM injection flu vaccine - FLUVIRIN, Lot # 1206901, Exp date 06/30/2013- I developed pain and persistent soreness at injection site. The pain still persists more than one month following injection. No erythema seen, mild swelling present.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: At wellcheck visit, influenza 0.5ml IM administered in pt's left arm and a pneumococcal vaccine 0.5ml IM high in her right arm on 1/15/13 -12N. No complaints until -1600 when she began having pain in right arm. At 2000, pt called MD to report symptoms and MD referred pt to urgent care or ED. Pt declined and self-medicated with unknown dose of ibuprofen at 2015 and again at 0145 1/16 and again at breakfast 1/16. Presented to clinic 1/16 and was found to have severe pain -10/10- when moving arm. Right shoulder diffusely tender with very limited ROM. Significant guarding. Cannot externally rotate arm. Appeared to have normal strength of elbow, fingers, wrist. Pulses: 2+ and symmetric. Pt was seen and evaluated and referred to orthopedics to evaluate.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Flu shot area swelled to size of silver dollar pain went under arm to opposite side and down toward breast. Could not use left arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Neck pain, Pain
Clinical narrative: I went into a pharmacy to get a flu shot. I was told that for anyone over 65 the more high powered flu shot was better. I questioned whether I would have a bad reaction to this shot. I have had flu shots for many years and never had any reaction at all. I was assured no, no, there would be no reaction. That night I was wakened by a dreadfully sore arm-into which the shot had been given. It wasn't so terribly sore at the insertion point, the entire area throbbed and felt as if it has been beaten with a stick. The pain went up into my neck. I didn't feel as if I had the flu although I did have a bit of a headache. The pain has never completely left that arm. It will seem ok during the day, but then when I am sleeping the pain will come again. I can live with it but I will NEVER have the stronger flu shot again. I went back into pharmacy just to report my reaction. I don't know if they reported it. They didn't have me fill anything out or sign anything.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Ear pain, Fatigue, Lymphadenopathy, Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: Feeling tired and ear ache on right side, sore throat on right side.  By 12/4/12, I was getting worst.  I had swollen lymph node behind right ear and /right tonsil was swollen.  Went to ER 12-27-12.  No throat cultures or labs.  Received 10 days of amoxicilin. Still tired, sore throat and ear pain. I went to the doctors, last week and the week before.  New doctors at facility.  Labs draw last week and in ER three days ago reveal low white count.  I'm still sick.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count decreased
Clinical narrative: Feeling tired and ear ache on right side, sore throat on right side.  By 12/4/12, I was getting worst.  I had swollen lymph node behind right ear and /right tonsil was swollen.  Went to ER 12-27-12.  No throat cultures or labs.  Received 10 days of amoxicilin. Still tired, sore throat and ear pain. I went to the doctors, last week and the week before.  New doctors at facility.  Labs draw last week and in ER three days ago reveal low white count.  I'm still sick.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Muscle spasms, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain/stiffness in arm, shoulder & neck. Muscle spasms in those areas.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Pain/stiffness in arm, shoulder & neck. Muscle spasms in those areas.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Injected with ZOSTAVAX and months later broke out with shingles. This happened in 10-1-12 and to date I still have them 1-7-13. I have two friends who have had same experience. Merck should go back and review their research,
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral
Clinical narrative: Patient stated she lost her hearing in one ear within 2 weeks of receiving vaccine. She was seen by an ENT doctor who gave her a prescription but it did not help her hearing.
Age: 20.0
Sex: F
Vaccine: HEP, HPV4, TDAP, VARCEL
Symptoms: Rash, Rash erythematous, Swelling face
Clinical narrative: Small red bumps to facial area/chin. Some swelling to nose and facial area.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Pain/soreness of upper left arm starting 12/2/12 progressing to weakness, difficulty lifting, numbness radiating down the left arm to the hand. Pain of left index finger.
Age: 53.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a 53 years old male clinical supervisor with no pertinent medical history and no drug reactions allergies. On an unknown date the patient was vaccinated with M-M-R II (dose, lot number, dose and route unknown). No other co-suspects were reported. No concomitant medications were reported. The reporter thinks he received M-M-R II as a child (unspecified number of doses) and currently (on an unknown date) his measles antibody titer is "low". The reporter does not have a vaccination record from when he was a child so he is not positive if he received M-M-R II in the past. There was no treatment given for the event. At the time of the report, the outcome of measles titer antibody is low is not recovered. The reporters relatedness for measles titer antibody is low is unknown for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age. The patient was vaccinated with (Merck) VARIVAX (lot number not provided) on 24-SEP-2012. This vaccination was within 28 days of the M-M-R II vaccination (07-sep2012). No adverse event was reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelled to baseball size is red and warm - advised to take BENADRYL as directed and apply cold compress.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received concerning a female patient of unknown age from her mother. The patient was vaccinated with a first, second and third dose of GARDASIL (lot number, expiry date, dose and route unspecified) on 21-DEC-2009, 17-JULY-2012 and on 21-NOV-2012 respectively. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant health care student regarding to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX (merck) (dose, route and lot number were not provided) instead of ZOSTAVAX. Staff error only. No adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: 3 cm x 2.5 cm induration with minimal erythema advised to apply ice.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness
Clinical narrative: Tightness in her throat on & off since receiving the GARDASIL vaccine on 1/8/13.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Erythema, Skin warm
Clinical narrative: Local area red, warm no induration no swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Atrophy, Fat necrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tender red & swollen about 6 inches wide in her right upper arm. On examination 1/13 there is fat necrosis & atrophy.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect drug dosage form administered
Clinical narrative: I was to administer ACTHIB, but I only gave the diluent. TC to return my phone call. Will follow. 11/21/2012 - 10:38 TC I instruct that the Hib will need to be re-administered because I only gave the diluent. This will be at next immunization clinic. 1/18/2012 HIB given 1/2/2013.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 on 19-OCT-2012 at a doctor's office. On 15-JAN-2013 the patient was vaccinated with another dose of PNEUMOVAX23 at a different doctor's office. No AE was reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, warmth, swollen (slightly) mild pain.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Developed urticaria 2-3 d after receiving MENACTRA & GARDASIL vaccines.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Skin warm
Clinical narrative: Pt came in with hot, swollen arm. Sent to ER 1/10/13. Abx treatment. Saw ER again 1/11/13 & rec'd more meds. Saw us 1/14/13 - no s/s of cellulitis anymore.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pyrexia
Clinical narrative: Information has been received from a pharmacist regarding to a 63 years old female patient with depression and with no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX vial 19,400 pfu 10 vials of 1 (subcutaneous, lot number was not provided) (Product circular number 9989115). Other suspect therapies included AFLURIA 0.5 mL intramuscular on 14-JAN-2013. No concomitant medications were reported. On 15-JAN-2013, after the patient received ZOSTAVAX and AFLURIA in the same arm at the same time, the patient now developed fever and redness (no rash). The patient received TYLENOL as treatment for the adverse events. Laboratory test was not performed. The patient sought medical attention, contacted pharmacist. At the time of the report, the patient did not recover from the adverse events. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Pt received pneumococcal vaccine 01/14/13. Sun 01/15/13 for c/o redness to left shoulder area. C/o occasional cough no SOB or swelling state feels hot on side of injection. Mild erythema to left shoulder and axilla orders for loratadine and ranitidine.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Generalised erythema, Pain in extremity, Pruritus generalised, Rash
Clinical narrative: A day after receiving the shingles vaccine Pt experienced hot, and painful arm. Around Dec 6th Pt went into see her doctor complaining of a red rash on her stomach. Pt was given Ceftriaxone 1g in the right buttock. Pt. was given LEVAQUIN 500 mg for 5 days. The following day was worse, and went back to the doctor where she was given prednisone. Pt was also given a Rx for a cream for the itching. On Dec 10th Pt. seen CNA, patient was red & itchy from head to toe.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: A day after receiving the shingles vaccine Pt experienced hot, and painful arm. Around Dec 6th Pt went into see her doctor complaining of a red rash on her stomach. Pt was given Ceftriaxone 1g in the right buttock. Pt. was given LEVAQUIN 500 mg for 5 days. The following day was worse, and went back to the doctor where she was given prednisone. Pt was also given a Rx for a cream for the itching. On Dec 10th Pt. seen CNA, patient was red & itchy from head to toe.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blister, Erythema, Eye swelling, Heat rash
Clinical narrative: A day after receiving the shingles vaccine Pt experienced hot, and painful arm. Around Dec 6th Pt went into see her doctor complaining of a red rash on her stomach. Pt was given Ceftriaxone 1g in the right buttock. Pt. was given LEVAQUIN 500 mg for 5 days. The following day was worse, and went back to the doctor where she was given prednisone. Pt was also given a Rx for a cream for the itching. On Dec 10th Pt. seen CNA, patient was red & itchy from head to toe.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nail disorder, Oedema peripheral, Rash, Rash generalised, Sensation of foreign body
Clinical narrative: A day after receiving the shingles vaccine Pt experienced hot, and painful arm. Around Dec 6th Pt went into see her doctor complaining of a red rash on her stomach. Pt was given Ceftriaxone 1g in the right buttock. Pt. was given LEVAQUIN 500 mg for 5 days. The following day was worse, and went back to the doctor where she was given prednisone. Pt was also given a Rx for a cream for the itching. On Dec 10th Pt. seen CNA, patient was red & itchy from head to toe.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin burning sensation, Skin exfoliation, Skin warm, Urticaria
Clinical narrative: A day after receiving the shingles vaccine Pt experienced hot, and painful arm. Around Dec 6th Pt went into see her doctor complaining of a red rash on her stomach. Pt was given Ceftriaxone 1g in the right buttock. Pt. was given LEVAQUIN 500 mg for 5 days. The following day was worse, and went back to the doctor where she was given prednisone. Pt was also given a Rx for a cream for the itching. On Dec 10th Pt. seen CNA, patient was red & itchy from head to toe.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Lymphadenopathy, Nausea, Pruritus, Urticaria
Clinical narrative: Hives, nausea, shortness of breath, itching, swollen lymph nodes. Tx. ATARAX 50 mg HS MEDROL dose pack.
Age: 13.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Injection given (R) arm SQ. Mom stated area became red and raised. Issue resolved. Area was painful to the touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cardiac disorder, Laboratory test, Pain in extremity
Clinical narrative: This spontaneous report as received from a 69 years old consumer refers to herself with high blood pressure, who on 19-DEC-2011, was vaccinated with a dose of PNEUMOVAX23 (lot number reported as 1138AA, expiration date: 27-APR-2013) (route and dose were not reported). No other co-suspects were reported. Concomitant medications included SYNTHROID, hydrochlorothiazide, KLOR-CON, NORVASC, metoprolol tartrate, fenofibrate, CRESTOR and PROTONIX. The consumer reported that she was administered the PNEUMOVAX23 vaccination and her arms hurt ever since getting the shot. In January 2012, the patient experienced some heart related issues. The consumer sought medical attention, she had overnight hospital stay for some heart related issues. Lab diagnostics studies were performed, a blood work was done for several weeks ago. Unspecified treatment was given for the adverse events. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Rash
Clinical narrative: Rash & swelling on left arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling on (R) delt at site of MENACTRA - 9 cm reaction red, warm to touch. Swelling on (L) delt at site of tdap - 6.5 cm reaction red warm to touch. Prescribed BACTRIM oral suspension 10 ml bid x 7 days.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site rash, Oedema, Pruritus
Clinical narrative: Red, raised 2 inch x 1 inch area surrounding injection area. C/o puritis. Mild edema noted, mild discomfort to touch. Referred to physician. Patient took Claritin on 1/15/13. Patient called to report on 1/16/13 that her arm had increased redness, puritis, edema and pain. Physician scheduled to see patient and on 1/17/13, patient was prescribed methylprednisolone 4mg dose pack disp 21 tabs. On 1/22/13 at 0930 patient notified the clinic that all symptoms of the reaction were resolved with the exception of a darkish mark to the left arm where the injection was given.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Skin discolouration
Clinical narrative: Red, raised 2 inch x 1 inch area surrounding injection area. C/o puritis. Mild edema noted, mild discomfort to touch. Referred to physician. Patient took Claritin on 1/15/13. Patient called to report on 1/16/13 that her arm had increased redness, puritis, edema and pain. Physician scheduled to see patient and on 1/17/13, patient was prescribed methylprednisolone 4mg dose pack disp 21 tabs. On 1/22/13 at 0930 patient notified the clinic that all symptoms of the reaction were resolved with the exception of a darkish mark to the left arm where the injection was given.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: States this morning she started itching on face, right forearm and back and had rash at those areas, 110 mm by 45 mm reddened area left deltoid area at injection site.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness below injection site from entire tricep to shoulder on outer aspect of child's arm. Appeared hot, red, swollen. No white areas noted. High temperature noted throughout reaction was 99.2 orally. Child did not complain of pain. Mom medicated with Benadryl throughout the reaction until resolved on 1/14/2013 in the night hours but realized resolved at 0630 when child awoke for school.
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Large hives on extremities followed by itching sensation. Mainly in shoulder, elbow, wrist, knees went away in a.m. reappeared at p.m. the next evening that was present on torso and extremities, itching kept him awake. We put itching cream on to make more comfortable. Most gone by a.m. Reappeared on injection shoulder encompassing whole shoulder, gone within an hour.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness below injection site from entire tricep to shoulder on outer aspect of child's arm. Appeared hot, red, swollen. No white areas noted. High temperature noted throughout reaction was 99.2 orally. Child did not complain of pain. Mom medicated with Benadryl throughout the reaction until resolved on 1/14/2013 in the night hours but realized resolved at 0630 when child awoke for school.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Atrial fibrillation, Blood glucose increased, Blood pressure increased, Chills, Cough
Clinical narrative: COUGH, CHILLS, HEADACHE, FATIGUE, DROWSINESS, SLURRED SPEECH, WHEEZING, O2 LEVEL LOWER, BP SLIGHTLY ELEVATED GLUCOSE HIGHER THAN NORMAL.  ON 01/20/2013 + TROUBLE CONCENTRATING, AF, SHORTNRSS OF BREATH. ON 01/21/2013 + DIARRHEA.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Disturbance in attention, Dysarthria, Dyspnoea, Fatigue
Clinical narrative: COUGH, CHILLS, HEADACHE, FATIGUE, DROWSINESS, SLURRED SPEECH, WHEEZING, O2 LEVEL LOWER, BP SLIGHTLY ELEVATED GLUCOSE HIGHER THAN NORMAL.  ON 01/20/2013 + TROUBLE CONCENTRATING, AF, SHORTNRSS OF BREATH. ON 01/21/2013 + DIARRHEA.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Laboratory test, Oxygen saturation decreased, Somnolence, Wheezing
Clinical narrative: COUGH, CHILLS, HEADACHE, FATIGUE, DROWSINESS, SLURRED SPEECH, WHEEZING, O2 LEVEL LOWER, BP SLIGHTLY ELEVATED GLUCOSE HIGHER THAN NORMAL.  ON 01/20/2013 + TROUBLE CONCENTRATING, AF, SHORTNRSS OF BREATH. ON 01/21/2013 + DIARRHEA.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Client received Tdap vaccine in her right thigh at hospital; came for WIC appt and c/o pain in right leg; right leg red, swollen, and warm to touch; client referred to Dr. (to see him after leaving health dept).
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: Seizure.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching soon after receiving vaccine.  Advised to take Benadryl and see doctor. Took 25 mg Benadryl.  Said that she could not afford to see doctor, but itchiness and rash subsided after taking Benadryl.  Went back to work.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Convulsion, Diarrhoea, Upper respiratory tract infection
Clinical narrative: Non-febrile seizure lasting for 10 seconds with URI symptoms and nonbloody loose stool.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Dizziness, Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Intense pain in arm. Limited mobility. Unable to sleep on left side. Pain is worse at night and in the mornings. Also, experiencing dizziness and loss of balance at times.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Dizziness, Insomnia, Mobility decreased, Pain
Clinical narrative: Intense pain in arm. Limited mobility. Unable to sleep on left side. Pain is worse at night and in the mornings. Also, experiencing dizziness and loss of balance at times.
Age: 53.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Discomfort, Feeling hot, Paraesthesia, Rash, Rash erythematous
Clinical narrative: Had both shingles and DTaP vaccine on 1-18-13. Got a raised bumpy red rash on face from bottom of nose down neck to thyroid area...prickly, uncomfortable and warm feeling. Taking antihistamine tablets and applying antihistamine ointment helps some. Three days later (today) I still have rash with no improvement in condition. I think this is caused by the shingles vaccine. I have not had shingles before but I had chickenpox at age 6.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Gaze palsy, Haemorrhage, Unresponsive to stimuli
Clinical narrative: Patient received HPV vaccine in (L) deltoid following by Hepatitis A. Pt observed blood on arm, eyes rolled back Pt assisted from sitting to lying position with feet elevated BP 126/80 - Pulse 86, O2 Saturation 98%. Initially unable to answer questions but within 1 minute, pt responsive, alert & oriented to person, place, time provided juice, Pt kept in supine position.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Skin warm
Clinical narrative: Patient noticed itching and redness at injection site few hours after vaccination. Continued throughout next 24 hours itching, swelling, redness, warm to touch. Patient showed arm to pharmacist 830AM 1/11/13, contacted primary MD. Advised to ice area & take oral antihistamine product. Diarrhea reported 1/11/13.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Acute herpes zoster left 7th thoracic level, severe.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Acute herpes zoster left 7th thoracic level, severe.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Body temperature increased, Hypotonia, Pain, Screaming, Weight bearing difficulty
Clinical narrative: Vaccines administered 01/22/13. On 01/22/13, woke from nap "screaming". Would not bear weight on left leg. 1/23/13 - Walking today, but with a limp. Won't play due to pain. Temp 100.4 deg F.
Age: 1.44
Sex: F
Vaccine: FLU3, HIBV, PNC13
Symptoms: Otitis media, Pyrexia
Clinical narrative: Vaccines given 11-30-2012. Parents went to ER 12-7-12 for high fever (104 degrees Rectal) - otitis media noted at time of ER visit.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Patient stated she had swelling under her left arm the size of an apple.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Starting within 24 hours after shot pt experienced a "huge outflow of mucous"; no fever & no other symptoms; pt. came back 1 week after shot to report symptoms and RPh did not seem to think vaccine related; pt. as of 1/23/13 still some mucous.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy type reaction - (R) sided facial paralysis. Currently being treated w/ MEDROL Dose pak.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Bell's palsy type reaction - (R) sided facial paralysis. Currently being treated w/ MEDROL Dose pak.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Left arm Dtap & MMR same arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 years old female patient with penicillin allergy, sulfa allergy, morphine allergy, unspecified pain and blood pressure. On 18-JAN-20 the patient was vaccinated with a dose of ZOSTAVAX 19.000 PFU in her left arm subcutaneously (lot number H019038, expiration date 17-JAN-2014). No other co-suspects were reported. Concomitant medications included unspecified medications for pain and blood pressure. On 18-JAN-2013, the patient had a local reaction to ZOSTAVAX at the injection site. On 20-JAN-2013, the patient presented at the pharmacist with a local reaction that had spread at and around the injection site on the left arm. This reaction included redness, itching, warmth and swelling. The area was stated to be 5 inches long by 5 inches wide. Relevant lab data was unknown. No treatment information was reported. As of 20-JAN-2013, the patient had not recovered from the event. This is one of several reports received from the same source (other case number 1301USA010850). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 years old female patient with penicillin allergy, sulfa allergy, morphine allergy, unspecified pain and blood pressure. On 18-JAN-20 the patient was vaccinated with a dose of ZOSTAVAX 19.000 PFU in her left arm subcutaneously (lot number H019038, expiration date 17-JAN-2014). No other co-suspects were reported. Concomitant medications included unspecified medications for pain and blood pressure. On 18-JAN-2013, the patient had a local reaction to ZOSTAVAX at the injection site. On 20-JAN-2013, the patient presented at the pharmacist with a local reaction that had spread at and around the injection site on the left arm. This reaction included redness, itching, warmth and swelling. The area was stated to be 5 inches long by 5 inches wide. Relevant lab data was unknown. No treatment information was reported. As of 20-JAN-2013, the patient had not recovered from the event. This is one of several reports received from the same source (other case number 1301USA010850). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Loss of consciousness, Malaise, Nausea, Pallor
Clinical narrative: Syncopal episode 2 plus hrs post FLUMIST. Jan 23 2013 12:34PM Spoke with mom, patient was in for FLUMIST this am. She states he is at school now and they have called to say he isn't feeling well. He c/o nausea and is weak, no fever. Encouraged her to have him eat and drink something. Mom is on her way to pick him up and will call back with an update. Jan 23 2013 1:27 PM Mom called back to give update. Regarding Hx of today's episode, mom states that this am, he ate cereal went to a dental appt, came here for FLUMIST, ate a donut, & proceeded to class. She states that he passed out in the classroom about 15 minutes after arriving this morning and 2 hours after receiving the FLUMIST. He was seated at his desk, appeared pale/white then slumped causing his desk to tip over and pt was briefly unresponsive to teacher/classmates. He was eventually given some apple juice. Thereafter, mom was able to check his pulse and  BP (at home) and his HR was 68 and seated BPs were: 113/51. 101/48/ 106/44. Currently acting ok, alert, still pale w/ cold extremities. No emesis, though recalls nausea prior to syncope. Currently resting at home. Disc Sx c/w a vagal episode. Reassured mom this is uncommon with FLUMIST, but we would submit a VAERS report. Mom is confident that his episode was due to the vaccine. Rec update call in am. Mom agreeable.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Peripheral coldness, Presyncope, Syncope, Unresponsive to stimuli
Clinical narrative: Syncopal episode 2 plus hrs post FLUMIST. Jan 23 2013 12:34PM Spoke with mom, patient was in for FLUMIST this am. She states he is at school now and they have called to say he isn't feeling well. He c/o nausea and is weak, no fever. Encouraged her to have him eat and drink something. Mom is on her way to pick him up and will call back with an update. Jan 23 2013 1:27 PM Mom called back to give update. Regarding Hx of today's episode, mom states that this am, he ate cereal went to a dental appt, came here for FLUMIST, ate a donut, & proceeded to class. She states that he passed out in the classroom about 15 minutes after arriving this morning and 2 hours after receiving the FLUMIST. He was seated at his desk, appeared pale/white then slumped causing his desk to tip over and pt was briefly unresponsive to teacher/classmates. He was eventually given some apple juice. Thereafter, mom was able to check his pulse and  BP (at home) and his HR was 68 and seated BPs were: 113/51. 101/48/ 106/44. Currently acting ok, alert, still pale w/ cold extremities. No emesis, though recalls nausea prior to syncope. Currently resting at home. Disc Sx c/w a vagal episode. Reassured mom this is uncommon with FLUMIST, but we would submit a VAERS report. Mom is confident that his episode was due to the vaccine. Rec update call in am. Mom agreeable.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received via social media refers to a female patient of unknown age, who on an unspecified date was vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The other reported that the patient died after vaccination. The relatedness for the adverse event was unknown for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified number of patient who on unknown dates were vaccinated with a dose of live ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patients had experienced responses to live ZOSTAVAX such as local reaction to live ZOSTAVAX at the injection site. This reaction included redness, itching, warmth and swelling. No treatment information was provided. At the time of the report, the patients outcome was not provided. This is one of several reports received from the same source (other MAARS number 1301USA010850). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified number of patient who on unknown dates were vaccinated with a dose of live ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patients had experienced responses to live ZOSTAVAX such as local reaction to live ZOSTAVAX at the injection site. This reaction included redness, itching, warmth and swelling. No treatment information was provided. At the time of the report, the patients outcome was not provided. This is one of several reports received from the same source (other MAARS number 1301USA010850). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received via social media who reported multiple patients (unknown age and gender) who on an unspecified date were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unspecified date, the patients were severely affected from the vaccine. No treatment information was reported. At the time of the report, the patients outcome for the adverse event was unknown. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Heat rash, Oedema peripheral, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 11 years old concerns to her daughter with no known allergies. On 17-JAN-2013, the patient was vaccinated with GARDASIL intramuscular, left deltoid (dose and lot not reported). No other co-suspects were reported. No concomitant medications were reported. On 17-JAN-2013, within a few hours after vaccination, the patient's left hand and wrist developed hives. That morning, the patient's hand was swollen and looked as if it had a "prickly heat" rash, in addition to the right hand appearing red around the wrist as well. On 17-JAN-2013, the pharmacist called an unspecified physician to determine how to treat the hives. The patient was treated with ibuprofen and ALLEGRA. At the time of the report, the outcome of the patient's left hand and wrist developed hives was unknown. The relatedness for the patient's left hand and wrist developed hives was unknown for GARDASIL. Additional information is not expected.