chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H019998, expired date 02-FEB-2014, subcutaneous. Concomitant therapies included Omeprazole, Lorazepam, Estazolam and Sertraline hydrochloride. On 18-JUL-2013, the patient experienced dizziness and soreness at the injection site. From 19-JUL-2013 through 21-JUL-2013 the patient experienced swelling the size of a "fried egg" at the injection site, arm swelling, itchiness, soreness, head and body aches, pain and a bright red injection site that was hot to the touch. On 22-JUL-2013 the patient stated the arm swelling and redness subsided but the itchiness, head and body aches continued and she was still sensitive to touch. On 23-JUL-2013 the patient stated her arm was sore to the touch, she had a slight rash, her skin started "tickling and prickling" and her itchiness continued. The patient called her unspecified primary care provider and described the reaction to him. The unspecified primary care provider prescribed oral BENADRYL (manufacturer unspecified) and an unspecified cortisone cream. On the same day, the patient came into the pharmacy to explain her reaction to the pharmacist. Pharmacist stated the rash was gone and what remained did not look like shingles. Pharmacist stated the patient called in on 24-JUL-2013 stating the soreness and itchiness had subsided. No lab diagnostics studies were performed. At the time of reporting, the outcome of AEs except arm swelling, redness, soreness and itchiness was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H019998, expired date 02-FEB-2014, subcutaneous. Concomitant therapies included Omeprazole, Lorazepam, Estazolam and Sertraline hydrochloride. On 18-JUL-2013, the patient experienced dizziness and soreness at the injection site. From 19-JUL-2013 through 21-JUL-2013 the patient experienced swelling the size of a "fried egg" at the injection site, arm swelling, itchiness, soreness, head and body aches, pain and a bright red injection site that was hot to the touch. On 22-JUL-2013 the patient stated the arm swelling and redness subsided but the itchiness, head and body aches continued and she was still sensitive to touch. On 23-JUL-2013 the patient stated her arm was sore to the touch, she had a slight rash, her skin started "tickling and prickling" and her itchiness continued. The patient called her unspecified primary care provider and described the reaction to him. The unspecified primary care provider prescribed oral BENADRYL (manufacturer unspecified) and an unspecified cortisone cream. On the same day, the patient came into the pharmacy to explain her reaction to the pharmacist. Pharmacist stated the rash was gone and what remained did not look like shingles. Pharmacist stated the patient called in on 24-JUL-2013 stating the soreness and itchiness had subsided. No lab diagnostics studies were performed. At the time of reporting, the outcome of AEs except arm swelling, redness, soreness and itchiness was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Tenderness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H019998, expired date 02-FEB-2014, subcutaneous. Concomitant therapies included Omeprazole, Lorazepam, Estazolam and Sertraline hydrochloride. On 18-JUL-2013, the patient experienced dizziness and soreness at the injection site. From 19-JUL-2013 through 21-JUL-2013 the patient experienced swelling the size of a "fried egg" at the injection site, arm swelling, itchiness, soreness, head and body aches, pain and a bright red injection site that was hot to the touch. On 22-JUL-2013 the patient stated the arm swelling and redness subsided but the itchiness, head and body aches continued and she was still sensitive to touch. On 23-JUL-2013 the patient stated her arm was sore to the touch, she had a slight rash, her skin started "tickling and prickling" and her itchiness continued. The patient called her unspecified primary care provider and described the reaction to him. The unspecified primary care provider prescribed oral BENADRYL (manufacturer unspecified) and an unspecified cortisone cream. On the same day, the patient came into the pharmacy to explain her reaction to the pharmacist. Pharmacist stated the rash was gone and what remained did not look like shingles. Pharmacist stated the patient called in on 24-JUL-2013 stating the soreness and itchiness had subsided. No lab diagnostics studies were performed. At the time of reporting, the outcome of AEs except arm swelling, redness, soreness and itchiness was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H019998, expired date 02-FEB-2014, subcutaneous. Concomitant therapies included Omeprazole, Lorazepam, Estazolam and Sertraline hydrochloride. On 18-JUL-2013, the patient experienced dizziness and soreness at the injection site. From 19-JUL-2013 through 21-JUL-2013 the patient experienced swelling the size of a "fried egg" at the injection site, arm swelling, itchiness, soreness, head and body aches, pain and a bright red injection site that was hot to the touch. On 22-JUL-2013 the patient stated the arm swelling and redness subsided but the itchiness, head and body aches continued and she was still sensitive to touch. On 23-JUL-2013 the patient stated her arm was sore to the touch, she had a slight rash, her skin started "tickling and prickling" and her itchiness continued. The patient called her unspecified primary care provider and described the reaction to him. The unspecified primary care provider prescribed oral BENADRYL (manufacturer unspecified) and an unspecified cortisone cream. On the same day, the patient came into the pharmacy to explain her reaction to the pharmacist. Pharmacist stated the rash was gone and what remained did not look like shingles. Pharmacist stated the patient called in on 24-JUL-2013 stating the soreness and itchiness had subsided. No lab diagnostics studies were performed. At the time of reporting, the outcome of AEs except arm swelling, redness, soreness and itchiness was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H019998, expired date 02-FEB-2014, subcutaneous. Concomitant therapies included Omeprazole, Lorazepam, Estazolam and Sertraline hydrochloride. On 18-JUL-2013, the patient experienced dizziness and soreness at the injection site. From 19-JUL-2013 through 21-JUL-2013 the patient experienced swelling the size of a "fried egg" at the injection site, arm swelling, itchiness, soreness, head and body aches, pain and a bright red injection site that was hot to the touch. On 22-JUL-2013 the patient stated the arm swelling and redness subsided but the itchiness, head and body aches continued and she was still sensitive to touch. On 23-JUL-2013 the patient stated her arm was sore to the touch, she had a slight rash, her skin started "tickling and prickling" and her itchiness continued. The patient called her unspecified primary care provider and described the reaction to him. The unspecified primary care provider prescribed oral BENADRYL (manufacturer unspecified) and an unspecified cortisone cream. On the same day, the patient came into the pharmacy to explain her reaction to the pharmacist. Pharmacist stated the rash was gone and what remained did not look like shingles. Pharmacist stated the patient called in on 24-JUL-2013 stating the soreness and itchiness had subsided. No lab diagnostics studies were performed. At the time of reporting, the outcome of AEs except arm swelling, redness, soreness and itchiness was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, blotchy rash over all extremities and face.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Rash macular, Streptococcus test, Streptococcus test negative
Clinical narrative: Red, blotchy rash over all extremities and face.
Age: 0.12
Sex: F
Vaccine: HEP, RV5
Symptoms: Crying, Diarrhoea, Haematochezia, Irritability
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no medical history. The patient had multiple allergies. On 09-JUL-2007 the patient was vaccinated with the first dose of ROTATEQ (lot # unspecified) oral. Other suspect therapies included RECOMBIVAX HB (lot # unspecified). On an unknown date the patient developed irritability, crying, loose and bloody stools after vaccination. The outcome of bloody stools, loose stools, crying and irritability was reported as recovered on an unknown date. No treatment was given. No lab tests were performed. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, also reported as a health care worker, refers to a female patient of unknown age. On 18-MAY-2013 the patient was vaccinated with dose 1 of GARDASIL. Lot number, expiry date, route of administration, anatomical location and prophylaxis were not reported. On 03-APR-2013 the patient was vaccinated with dose 2 of GARDASIL. Lot number, expiry date, route of administration, anatomical location and prophylaxis were not reported. No adverse event was reported, no PQC was involved. The outcome and treatment information were not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old female patient, who in 1994 was vaccinated with series of RECOMBIVAX HB (lot # and doses not reported), "on school", as a child. At an unspecified time in 2013 the patient had titers drawn for Hepatitis B and the results were negative. The patient sought medical attention by consulted office. The outcome of patient and causality was not reported.  Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Erythema, Headache, Local swelling, Tuberculin test positive
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 13 year old son. On 28-JUN-2013, the patient was vaccinated with GARDASIL dose 1 in the left arm for prophylaxis. Concomitant therapies included TUBERCULIN performed on the lower portion of the patient's left arm. This was the patient's first tuberculin skin test. The licensed practical nurse reports that on the evening of 28-JUN-2013, the site where the tuberculin test was administered was "red and swollen". On 29-JUN-2013, the patient developed a headache and recovered from it the same day, 29-JUN-2013. When the patient went to his unspecified physician's office on 01-JUL-2013 the site where the tuberculin skin test was administered on the patient's arm was "a 13 millimeter, raised, red area" and because of that the patient "tested positive for tuberculosis. No treatment has been given at this time for tuberculosis, however the nurse reports that the patient's doctor scheduled him to have a chest x-ray performed and will begin medication therapy to treat tuberculosis soon. On an unknown date, unspecified "blood work" was performed. The outcome of headache was reported as recovered/resolved. The outcome of the site where the tuberculin test was administered was "red and swollen" was unknown. The action taken with GARDASIL was not applicable. The reporter did not assess the relationship between the events and GARDASIL. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Tuberculosis
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 13 year old son. On 28-JUN-2013, the patient was vaccinated with GARDASIL dose 1 in the left arm for prophylaxis. Concomitant therapies included TUBERCULIN performed on the lower portion of the patient's left arm. This was the patient's first tuberculin skin test. The licensed practical nurse reports that on the evening of 28-JUN-2013, the site where the tuberculin test was administered was "red and swollen". On 29-JUN-2013, the patient developed a headache and recovered from it the same day, 29-JUN-2013. When the patient went to his unspecified physician's office on 01-JUL-2013 the site where the tuberculin skin test was administered on the patient's arm was "a 13 millimeter, raised, red area" and because of that the patient "tested positive for tuberculosis. No treatment has been given at this time for tuberculosis, however the nurse reports that the patient's doctor scheduled him to have a chest x-ray performed and will begin medication therapy to treat tuberculosis soon. On an unknown date, unspecified "blood work" was performed. The outcome of headache was reported as recovered/resolved. The outcome of the site where the tuberculin test was administered was "red and swollen" was unknown. The action taken with GARDASIL was not applicable. The reporter did not assess the relationship between the events and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 17-JUN-2013 and 25-JUL-2013 the patient was vaccinated with the second and third doses of GARDASIL (lot # not reported, dose, route not reported) for vaccination. No adverse effects reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old female patient with no drug allergies. Current condition included rheumatoid arthritis. On 12-JUL-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot # J000435 and expiration date 10-APR-2014, route not reported) in the left arm. Concomitant therapies included METHOTREXATE 15 milligram (mg) weekly by mouth (orally), AMARYL and SIMVASTATIN tablets, USP. Pharmacist stated that patient reported developing redness at the time of injection and on 29-JUL-2013 patient reported back to the pharmacy with redness "about the size of a quarter" at site where ZOSTAVAX was administered. Pharmacist stated that there was no heat at the site of injection, "did not appear infected, just red". No treatment was provided for the event. No laboratory diagnostic studies were performed. The outcome of redness at the site of injection was unknown. Causality was not reported. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative refers to a female patient in her early 70's. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). On an unknown date the patient experienced local reaction to the injection site. The outcome of the event was unknown. Treatment information, lab diagnostic studies performed were unspecified by the reporter. Unspecified medical attention was sought for the event. Causality was not reported. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 72 year old male patient with no pertinent medical history and no drug reactions/allergies. On 21-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). Approximately on 21-OCT-2012 (reported as about 30 days after receiving ZOSTAVAX the patient experienced hives. The hives reappeared at times and have not ever fully gone away. The event did not resolve at the time of the report. The patient was given ranitidine 150 milligram (mg) once daily, fexofenadine hydrochloride (reported as fexofenadine) 180 mg once daily and hydroxyzine 25 mg as treatment for the event. Laboratory diagnostic studies were not performed. The patient saw the physician and sought medical attention. Causality was not reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Swelling face
Clinical narrative: This spontaneous report as received from an 78 year old female patient with high cholesterol, high blood pressure and allergies to sulfa. On 21-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # and route were not reported) in the left arm. Concomitant therapies included NEXIUM and unspecified cholesterol blood pressure medications. On 12-JUL-2013, the patient experienced right eye swollen and right side of the face was also red and swollen. The patient wanted to know if the events could be a side effect of the ZOSTAVAX vaccination given on 21-JUN-2013. Blood work up was performed in June 2013. The patient did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 29-APR-2002 and on 02-JUL-2013 the patient was vaccinated with the first dose and the second dose of VARIVAX (Merck) (lot # H020249, expire date unspecified), injection, subcutaneously. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). On 10-JUL-2013, the patient developed rash and was diagnosed with shingles after received the second dose of VARIVAX (Merck). On 10-JUL-2013, the patient noticed the rash on left hand and it spread to her arm. The patient saw the physician on 12-JUL-2013 and prescribed the triamcinolone cream 0.1%. But the next day she developed vesicular rash and was diagnosed with shingles. She was prescribed acyclovir. The event outcome was reported as recovered/resolved, but the date was unspecified. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 62 year old male patient. On 14-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000447, expire date 11-APR-2014), 0.65 ml injection. Concomitant therapies included T-DAP (unspecified), which was given on 14-MAY-2013. The patient experienced injection site redness (but no rash) after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. On 01-JUL-2013, the patient was vaccinated with a dose 1 of PROQUAD (lot #, expiry not reported). on 12-JUL-2013, the patient experienced chicken pox after receiving the first shot of the PROQUAD vaccine. Patient sought medical attention: saw the doctor. The outcome of chicken pox was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB strength reported as: 10 mcg/ml, lot # J001183, (exp. date unspecified). On an unknown date, the seven doses of RECOMBIVAX HB, from lot # J001183, subject to the June 2013 product recall, were administered to patients. No adverse effect reported. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Abasia, Balance disorder, Decreased appetite, Hypersomnia
Clinical narrative: 3 months after receiving vaccines child developed balance issues. Would not walk, sleeping more, appetite decreased.
Age: 1.34
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered nurse refers to a 16 month old patient (gender unknown). On 22-MAY-2013 the patient was vaccinated with the first dose of VARIVAX (Merck)(INJ)(route, lot number and expiration date not reported). There was no concomitant medication reported. On 23-JUL-2013, the patient was vaccinated with the second dose of VARIVAX (Merck)(route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Age: 1.37
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Balance disorder, Decreased appetite, Gait disturbance, Somnolence
Clinical narrative: 3 months after receiving vaccines child developed balance issues, would not walk, sleeping more, appetite decreased.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Urticaria
Clinical narrative: Received Dtap and MMR on 7/30. Mother called on 7/31 at 8:30 am to report to child awoke with "hives" on extremities. Spoke to dr-told to give BENADRYL and report back if no change or worse.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Chills, Crying, Exaggerated startle response, Hypertonia, Irritability
Clinical narrative: Patient was fussy in the afternoon (received shots in AM) with two periods of 30 seconds each of stiffening and shaking of the whole body while crying. Since that day, she has had an increased startle reflex - Starting frequently. MOC very worried. Exam unremarkable.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Tremor
Clinical narrative: Patient was fussy in the afternoon (received shots in AM) with two periods of 30 seconds each of stiffening and shaking of the whole body while crying. Since that day, she has had an increased startle reflex - Starting frequently. MOC very worried. Exam unremarkable.
Age: 1.45
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Body temperature increased, Injection site induration, Injection site rash, Injection site swelling, Irritability
Clinical narrative: Rash to immunization site - 7 days after vaccination, also having low grade temps -99-100: unusual fussiness. Area is raised and hardened.
Age: 1.49
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash pustular, Vaccination site pustule
Clinical narrative: Pt had pustule form 10 days after VARIVAX given. One pustule at vaccination site, one on forehead, (L) shoulder, and ankle. No other symptoms. Pt's mother was advised to use anti-itch cream (BENADRYL) and antibiotic cream.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Mother called in 7/29/13 that her son had possible reaction from vaccine given 7/25/13. Developed hives one day after vaccination 7/26/13. Hives lasted for one day. Given antihistamine by the mother.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Fatigue, Hypoaesthesia, Lumbar puncture, Muscular weakness
Clinical narrative: Mid Nov. and Dec. pain in calves, increased tiredness, fatigue with 100 grade fever, decreased balance by end of December with numbness of feet at times. Jan 2013 (R) leg gave out. March 28th hospitalized.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Pyrexia
Clinical narrative: Mid Nov. and Dec. pain in calves, increased tiredness, fatigue with 100 grade fever, decreased balance by end of December with numbness of feet at times. Jan 2013 (R) leg gave out. March 28th hospitalized.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Woke up 7-28-13 with red, swollen, hot skin around injection site. Felt tired aching pain in both shoulders.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Woke up 7-28-13 with red, swollen, hot skin around injection site. Felt tired aching pain in both shoulders.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 64 year old patient (gender unknown). On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number and expiration date not reported), subcutaneous. There was no concomitant medication reported. It was reported that on an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) instead of the intended ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Hepatitis B antibody negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old patient. On unknown date (as a child) the patient received 2 doses of VARIVAX (Merck) and 3 doses of RECOMBIVAX HB. The reporter stated that the patient recently had titer's drawn for varicella and hepatitis B (reported in MARRS# 1307USA006271) both of which came back negative. Treatment for this consisted of booster doses of VARIVAX (Merck) and RECOMBIVAX HB. The outcome was not reported. The relatedness between VARIVAX (Merck) and the event was not reported. Some patient link MARRS#1307USA006271. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Cold sweat, Vision blurred
Clinical narrative: The pt was given HPV #2.  She c/o blurred vision, clammy and blood pressure dropped to 80/54.  Paramedics were called to the health center.  When paramedics arrived, pt was feeling better. She refused to go to the hospital.  She stayed in the health center and was monitored by the nurses until her blood pressure was 112/70.
Age: 0.42
Sex: F
Vaccine: DTPIHI
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Terrible swelling at injection site, warm to the touch, fever, rash around injection site. Swelling lasted for 2 weeks. A bump at injection site lasted 2 months.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased, Neuralgia, Periarthritis
Clinical narrative: Extreme deltoid soreness following vaccination after a couple days.  At least 12 days later following vaccine, patient saw physician and was diagnosed with a 'frozen shoulder.' Extreme somatic pain accompanied with nerve pain sensations limiting patient's range of motion.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Depressed mood
Clinical narrative: Around 7:00 AM he became despondent, crying inconsolably.  This has never happened in his life.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Full blood count, Irritability
Clinical narrative: Intermittent inconsolable fussiness about two weeks after vaccine was given.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Anti-SS-A antibody negative, Anti-SS-B antibody negative, Antibody test negative, Antinuclear antibody negative, Arthralgia
Clinical narrative: Left knee full of pain and swelling above knee, shoulder, hip, knee and wrist joints stiff and painful.  Shoulder and neck muscles tense and full of knots.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Blood heavy metal normal, Blood thyroid stimulating hormone normal, C-reactive protein increased, DNA antibody negative, Inflammation
Clinical narrative: Left knee full of pain and swelling above knee, shoulder, hip, knee and wrist joints stiff and painful.  Shoulder and neck muscles tense and full of knots.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Joint stiffness, Joint swelling, Muscle tightness, Nodule, Nuclear magnetic resonance imaging normal
Clinical narrative: Left knee full of pain and swelling above knee, shoulder, hip, knee and wrist joints stiff and painful.  Shoulder and neck muscles tense and full of knots.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate increased, Reverse tri-iodothyronine, Thyroid function test normal, Tri-iodothyronine free normal, Tri-iodothyronine normal
Clinical narrative: Left knee full of pain and swelling above knee, shoulder, hip, knee and wrist joints stiff and painful.  Shoulder and neck muscles tense and full of knots.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray limb
Clinical narrative: Left knee full of pain and swelling above knee, shoulder, hip, knee and wrist joints stiff and painful.  Shoulder and neck muscles tense and full of knots.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Blepharospasm, Staring
Clinical narrative: Mother stated "child started staring into space and eyes were twitching, child would not answer any questions".
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Fainted after administration. Placed her supine and allowed her to rest and recover.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Pain in extremity, Pyrexia
Clinical narrative: Whole arm sore, excessive whining/crying, low grade fever.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Joint swelling, Lymphadenopathy, Oropharyngeal pain, Pain, Pharyngeal oedema
Clinical narrative: Pt reports starting to feel tender around 8pm the night she received vaccines. Later that night and the next morning she developed body aches, joint swelling, swollen glands, sore throat with mild swelling, mild fever, red spots on body, vomiting. Tx with diphenhydramine, changed antibiotic pt was using, given vicodin for pain.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pyrexia, Rash erythematous, Tenderness, Vomiting
Clinical narrative: Pt reports starting to feel tender around 8pm the night she received vaccines. Later that night and the next morning she developed body aches, joint swelling, swollen glands, sore throat with mild swelling, mild fever, red spots on body, vomiting. Tx with diphenhydramine, changed antibiotic pt was using, given vicodin for pain.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given.  5 yr old was given Gardasil.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: Wrong vaccine given.  5 yr old was given Gardasil.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented in clinic by mother, another nurse evaluated the patient and the nurses stated that the patient complains of injection site being swollen, red, warm, and itchy. Also states that child complained of itching. Mother denies that patient has been scratching injection site, but patient is noted scratching the site with a magazine. Measurments of the injection site are 3"x 3", redness noted, it is warm and hot to touch. Patient's mother was instructed to take patient to an urgent care or private provider for assessment. The patient's mother was also informed that if she does not take the patient for assessment to continue applying cool towels and administer Motrin to help decrease the inflammation. Mother voiced understanding.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus
Clinical narrative: Patient presented in clinic by mother, another nurse evaluated the patient and the nurses stated that the patient complains of injection site being swollen, red, warm, and itchy. Also states that child complained of itching. Mother denies that patient has been scratching injection site, but patient is noted scratching the site with a magazine. Measurments of the injection site are 3"x 3", redness noted, it is warm and hot to touch. Patient's mother was instructed to take patient to an urgent care or private provider for assessment. The patient's mother was also informed that if she does not take the patient for assessment to continue applying cool towels and administer Motrin to help decrease the inflammation. Mother voiced understanding.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site movement impairment, Injection site pain, Pyrexia
Clinical narrative: Gait disturbance in right leg where shot was administered, fever of 102, after motrin fever reduced to 100. Pain in right leg where shot was given and child not wanting to walk.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Incoherent, Malaise, VIIth nerve paralysis, Vomiting
Clinical narrative: Patient injected with Gardisil Vaccine, on L deltoid at 01:15 PM shortly after patient verbalized "I'm not feeling well" skin color on face was pale, patient was slightly coherent, perspire and vomiting. This nurse helped patient to sit back in chair and cold wet cloth applied on back of neck. Patient had vomited all milk that had consumed per mom. Requested mother to give her a well balanced meal before next appointment, with plenty of fluids. Instructed mother to verbalized the nursing staff to lay patient down for following injections. Mother verbalized understanding. Mother stated" all of her sisters do the same thing when getting vaccination".
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Erythema covering 1/3 of upper arm, warm and itchy.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning a 32 year old female pregnant patient non pertinent medical history who on 05-NOV-2011 ("the patient thinks") was vaccinated with her first dose of VARIVAX (Merck) (lot# not reported) at approximately 5 weeks gestation. The patient became pregnant with a LMP approximately of 05-OCT-2011 (at the time of the report the patient was approximately 19 weeks gestation) and estimated delivery date (EDD) of 11-JUL-2012. There was no concomitant medication. The patient had received the dose from an unknown facility. The patient had sought medical attention via office visiting. None treatment was given. The patient had an ultrasound on 15-FEB-2012 but this was the last time the physician would be seeing her. The patient was being referred to Obstetrics and Gynecology (OB/GYN). The pregnancy outcome was unknown. Case lost to follow up. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: CSF test normal, Cardiac function test normal, Chest pain, Headache, Rash
Clinical narrative: Pt received anthrax and smallpox vaccines on Jul 18 and 20.  Presented to facility on 30 Jul brought in by ambulance.  Developed chest pain (cardiac pain ruled out with cardiac studies), papular rash on flexural areas of upper and lower extremities and headache.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Rash papular, White blood cell count normal
Clinical narrative: Pt received anthrax and smallpox vaccines on Jul 18 and 20.  Presented to facility on 30 Jul brought in by ambulance.  Developed chest pain (cardiac pain ruled out with cardiac studies), papular rash on flexural areas of upper and lower extremities and headache.
Age: 1.08
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Erythema, Herpes virus infection, Localised infection, Pain in extremity
Clinical narrative: By the date of 7/23/2011 on my sons left thumb was a very large pus filled area around the knuckle also very red and visibly painful. We went to the urgent care since it was a Saturday and had only gotten bigger. She thought it was from an infection but there was no puncture area, it looked as if it's coming from the inside out. She popped it and gave an antibiotic and bandaged it. This was the first of 4 events I believe. Each time in the exact same area. The last time, at our physicians office, she said it looked herpetic and gave him acyclovir which withered it almost instantly.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Fainting episode with head trauma.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hemiplegia, Hypoaesthesia
Clinical narrative: Numbness and spastic paralysis on entire left side of body.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Mother states that on top of her son's arm where he had gotten his vaccines his arm is now red and warm to the touch with 2 small bumps that look like pimples and it is itchy. Consulted with someone and advised mother to use a cool compress, 15 minute on and 15 mins off, until redness and itching went down. Advised mother to use childrens Tylenol for pain. Advised mother to seek medical attention if redness and itching do not get better or get worse over the next 1-2 days. Advised mother to seek mediacal attention STAT if child begins to get worse or have trouble breathing. Mother stated that pt does have a local latex reaction to bandaids but latex-free used at HD.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in right arm, which is the arm vaccine was administered.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, itchiness, induration and warmth to left upper arm.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Chills, Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: Chills, numbness in legs, weakness in legs, pain at injection site, inability to walk.
Age: 1.31
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ear haemorrhage, Epistaxis, Idiopathic thrombocytopenic purpura, Intensive care, Mouth haemorrhage
Clinical narrative: Looking back the initial onset date was 09/20/10 as ITP could be seen near her left elbow. It wasn't until 10/01/10 that her pedi saw ITP in numerous areas and also blood leaking from ear, nose and mouth. On this date blood was drawn and platelets were less than 1,000 and was admitted to ICU.
Age: 1.31
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Platelet count decreased
Clinical narrative: Looking back the initial onset date was 09/20/10 as ITP could be seen near her left elbow. It wasn't until 10/01/10 that her pedi saw ITP in numerous areas and also blood leaking from ear, nose and mouth. On this date blood was drawn and platelets were less than 1,000 and was admitted to ICU.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Crying, Erythema, Feeding disorder neonatal, Lethargy, Tremor
Clinical narrative: Newborn has continuous, high-pitched, inconsolable screaming/crying, not feeding, lethargic, very ruddy and plethoric, tremors.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Redness, swelling and tenderness at injection site of Proquad vaccine in right thigh. Suspect large local reaction, but bacterial cellulitis is possible.
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Confusional state, Incoherent, Pyrexia, Somnolence
Clinical narrative: Pt was driving home and had overwhelming need to fall asleep. She called a family member who told her she wasn't making sense and was concerned that she was drunk or drugged. Pt went directly home and had taken no meds that day. She felt feverish and took her temp which peaked at 101 at 6pm. When she woke up at 7mp she was in and unusual position and believed that the health care provider she had seen earlier in the day was in her home and had been interviewing her at her home. When she woke up at 7 pm the fever was gone and she felt totally normal again.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 11:07AM CLIENT'S MOTHER PHONED TO C/O REDNESS AND SWELLING TO ARM AREA OF INJECTION. STATES SHE HAD GIVEN MOTRIN. ALSO STATED CHILD HAD NEVER HAD REACTION BEFORE.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea, no other symptoms.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE. TDAP GIVEN TO UNDER 7 YEAR OLD.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Started with just what looked to be a normal zoster reaction, but the redness and swelling continued throughout the day into the night, and increased even with Benadryl. A 4in circ reaction emerged by noon 7/31/2013 when patient went in.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Woke up the morning after IZ on 5/29/13 with stiffness and pain in the R. arm, breast, underarm and neck. 5/30/13 a little better.  Since the IZ 5/28/13 I have weakness with my R arm.  Pain is worse at night better during the day.  I have not seen my primary care giver as I hope each day it will get better. OTC anti-inflammatory gives no relief nor does heat or ice. ... wondering if IZ was given too high above deltoid and hit a nerve ?
Age: 42.0
Sex: M
Vaccine: MEA
Symptoms: Injection site swelling, Oedema peripheral, Pain, Skin warm
Clinical narrative: Severe swelling at injection point. Entire arm and bicep area 2 1/2 times its original size. Area red and hot to the touch 24 hours later. Extremely painful the 24 hours later.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Oedema peripheral, Seizure like phenomena, Sensation of heaviness
Clinical narrative: Flashes of dizziness, heaviness feeling in my arm, slight swelling, and seizure like movements in my arm.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 04-JUL-2013 the patient was vaccinated with an expired dose of ZOSTAVAX lot # 0168AE, expiration date 06-MAR-2013, (strength, route, dose number were not reported). No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from the patient's mother refers to a female patient of unknown age. It was reported that the patient was just vaccinated with the second dose of GARDASIL on 19-JUL-2013, (lot number and expiration date unknown), (dose, route and anatomical location unspecified) for prophylaxis. The patient had received her first dose on an unspecified date in 2008 and has not yet received her third dose. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 71 year old male patient with allergy to cephalexin and no pertinent medical history refers to the patient himself. On 12-JUL-2013 the patient was vaccinated with ZOSTAVAX for prevent shingles (dose, route and lot # not reported). Concomitant therapies included VALTREX. The patient reported that on approximately 12-JUL-2013 ("within 24 hours" of receiving ZOSTAVAX he developed redness at the injection site. He also reported that at an unspecified time after developing the redness at the injection site, he developed tenderness. The patient did not seek medical attention. The patient reported that he put ice on his injection site and took ibuprofen. No lab diagnostics studies were performed. The outcome of tenderness and redness at the injection site was reported as recovered at least five days ago. Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin lesion, Varicella
Clinical narrative: Pt received vaccine 06-4-13, was out of town 7-5-13 - 7-7-13. On 7-8-12 9 y/o grandson has mild case of chicken pox. He had received vaccine at age 1. 7-23-13 pt broke out with rash on thighs, buttock, stomach. Approx 100 lesions. Also, 10 m/o grandson broke out on 7-29-13.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: Pt received vaccine 06-4-13, was out of town 7-5-13 - 7-7-13. On 7-8-12 9 y/o grandson has mild case of chicken pox. He had received vaccine at age 1. 7-23-13 pt broke out with rash on thighs, buttock, stomach. Approx 100 lesions. Also, 10 m/o grandson broke out on 7-29-13.
Age: 1.29
Sex: M
Vaccine: HEPA, DTAP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.29
Sex: M
Vaccine: HEPA, DTAP, HEPA
Symptoms: Convulsion, Laboratory test normal, Pyrexia
Clinical narrative: None stated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: Gave extra dose of Hep B, employee error due to verbal orders and not verifying chart.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Local swelling
Clinical narrative: 2 days after vaccine, patient had swelling and pain in axillary area.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to three patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX, 19400 PFU, 0.65 ml, subcutaneously for doctor recommendation. Healthcare worker reported that three unspecified patient developed redness and itchiness at the injection site after receiving ZOSTAVAX (2-3 days after receiving ZOSTAVAX). She thinks that the all three of the patients received lot # H021291 and expiration February 2014 of the ZOSTAVAX. Healthcare worker reported that the unspecified patients were instructed by pharmacist to apply an ice pack to the injection site. On an unspecified date, the patients recovered from events. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Skin reaction
Clinical narrative: Localized skin reaction after Tdap - not immediate, not anaphylaxic.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder, unable to lift arm up over head, to the side.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm
Clinical narrative: Warm to touch, redness.