chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: CSF white blood cell count negative, Chest X-ray normal, Culture urine negative, Fontanelle bulging, Haemoglobin normal
Clinical narrative: Developed fever up to 102 degrees along with bulging of anterior fontanelle. Was seen in ER next day where labs done and L.P. done. Was admitted on antibiotics pending cultures. Did well at the hospital, culture negative.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Lymphocyte percentage, Neutrophil percentage, Pyrexia, Red blood cells CSF positive, Urine analysis normal
Clinical narrative: Developed fever up to 102 degrees along with bulging of anterior fontanelle. Was seen in ER next day where labs done and L.P. done. Was admitted on antibiotics pending cultures. Did well at the hospital, culture negative.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: White blood cell count decreased
Clinical narrative: Developed fever up to 102 degrees along with bulging of anterior fontanelle. Was seen in ER next day where labs done and L.P. done. Was admitted on antibiotics pending cultures. Did well at the hospital, culture negative.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Fatigue, Infantile spasms, Lethargy, Pyrexia
Clinical narrative: 10/25 Immunizations -> followed by 1-2 days of fever 1 week later restarted fever to 102 fatigue & diarrhea (seen 11/2). 11/4 Became more lethargic. Lost milestone, then started infantile spasms. Diagnosed by neurologist.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness started at noon today, hot to touch and painful.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 24 hours after injection pt developed large red area up his arm. Area is red, raised and hard underneath. Counseled pt to apply ice and call us tomorrow with condition of red area.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: Started 10.5 x 9.5 cm area of tenderness and erythema. No fever. (L) arm suppcare treatment.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Atrial fibrillation, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Tdap & MENACTRA given in (L) arm at CP on 8/24/12, mom calls next day, site red, hot to touch, hard painful, no streaks. Limited ROM. Afib. Referred to ED for eval. By 8/27/12 arm better & good ROM.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Tdap & MENACTRA given in (L) arm at CP on 8/24/12, mom calls next day, site red, hot to touch, hard painful, no streaks. Limited ROM. Afib. Referred to ED for eval. By 8/27/12 arm better & good ROM.
Age: 25.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Fatigue, Headache, Neck pain, Pain in jaw
Clinical narrative: Fatigue; Left jaw pain; Pain in temples; Posterior cervical pain.
Age: 25.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Arthralgia, Blood test normal, Dizziness, Fatigue, Full blood count
Clinical narrative: Fatigue; Left jaw pain; Pain in temples; Posterior cervical pain.
Age: 25.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Headache, Hypersomnia, Muscle tightness, Neck pain, Red blood cell sedimentation rate increased
Clinical narrative: Fatigue; Left jaw pain; Pain in temples; Posterior cervical pain.
Age: 25.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Sinusitis
Clinical narrative: Fatigue; Left jaw pain; Pain in temples; Posterior cervical pain.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Left thigh injection sites measure 15 cm x 11.5 cm with erythematous firm cellulitis/indurated.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effects & no treatment. Pharmacist administered FLUZONE ID to pediatric patient but it is only indicated for patients 18-64 years of age. The advertising of it being painless & good for anyone who is afraid, prompted pharmacist to administer it.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Redness, blister, itching, numbness at site of injection.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Pt fainted within 5 minutes of receiving vaccine.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Dizziness, Nausea
Clinical narrative: After receiving FLUZONE HIGH DOSE vaccine, the patient became very dizzy & complained of severe nausea. She was checked at nearby PCP office for BP, temp, & blood sugar, then sent home on fluids & bland diet.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: Area is red, swollen (5 x 4 area), tender, & warm to touch. Pt told to take BENADRYL, ibuprofen, & ice affected area.
Age: 0.02
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Erythematous partially generalized rash.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Paralysis
Clinical narrative: Weak, sick, can't use his right hand, feels like "it's paralyzed"
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 11 years old female patient with no preexisting allergies, birth defects or medical conditions. The patient was vaccinated with lot # (669796/0840AA) dose 1 GARDASIL, right deltoid on 27-DEC-2011 at 16:48. No other co-suspects were reported. Concomitant medications included MENACTRA (lot # U4055AA), BOOSTRIX (lot # AC52B073CA) and FLUMIST (lot # YL2068). It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 years old male patient. The patient was vaccinated intramuscularly into the right arm with first dose of 0.5 ml GARDASIL (lot number not reported) in 2010 and the second dose was administered today on 14-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age who received GARDASIL series "off schedule". The patient was vaccinated on 23-DEC-2011, 29-MAY-2012 and 27-JUL-2012, with the first, second and third dose of GARDASIL respectively (doses, routes and lot numbers not reported). No symptoms were reported, Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a patient of unknown age and gender. On 21-AUG-2012, the patient was vaccinated with a dose of oral ROTATEQ Lot 0517Z that expired on 22-APR-2012. No adverse effect was reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46 F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #3 was a 2 month old female who on 10-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at her next visit. This is one of several reported received from the same source. No further information is available.
Age: 1.3
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #4 was a 15 month old female who on 11-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at her next visit. This is one of several reports received from the same source. No further information is available.
Age: 0.7
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #5 was a 8 month old female who on 16-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at her next visit. This is one of several reports received from the same source. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 62 year old female patient who on 21-AUG-2012 was vaccinated with a single dose 0.65 ml subcutaneous in her right deltoid with ZOSTAVAX (lot number 671663/1159AA, expiration date 18-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the next day post vaccination, on 22-AUG-2012, the patient's injection site was really itchy in an area two inches wide. No treatment information was reported. The outcome of injection site was really itchy recovering. This is one of several reports received from the same source (other case number 1208USA011817 and 1208USA011818). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 patients of unknown age. The patients were vaccinated with 0.65 ml ZOSTAVAX (lot number 0564AE, expired date 21-MAR-2013) subcutaneous on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients were given ZOSTAVAX and had a similar reaction with "redness, swelling, pain and warmth at the injection site and the reaction was about 3" in diameter". It took about 2-3 weeks for their reactions to go away. The patients were recovered at the time of report. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pustular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 26 month old patient who on 28-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# unspecified). The nurse mentioned that on 17-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. Follow-up information from the registered nurse revealed that on 28-FEB-2011, the 26 month old female patient with wheezing and no illness at time of vaccination received the first dose of (Merck) VARIVAX (lot# unspecified) (dose, route and lot # not provided). On 17-MAY-2012, the patient went to the clinic with a rash described as a diffuse varied sized pustules throughout her body and was diagnosed with varicella. No relevant diagnostic and laboratory tests were performed. On 06-JUL-2012, the patient recovered from the event, the patient had no rash. The patient did not seek medical attention. This was one of the several reports from the same source. A lot check has been initiated.
Age: 0.2
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 5 patients of unknown age and gender. On an unknown date in 2012 the patients were vaccinated with a dose of RECOMBIVAX HB (dose, route not reported) (lot # 671326/1522AA, exp date 21-APR-2014) which was stored in a refrigerator reading 36-46 F, but in a section of the refrigerator with intermittent excursion to 30 F since 11-JUN-2012. No adverse effect reported. Follow-up information has been received from the nurse reporting that patient #2 was a 3 month old male who on 09-JUL-2012 was vaccinated with the dose of RECOMBIVAX HB. The reporter also noted that the patient would be re-vaccinated at his next visit. This is one of several reports received from the same source. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 77 years old female patient with unknown medical history. The patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported) (lot#0366AE, exp. date 23-MAR-2013) on 02-AUG-2012. Concomitant medications were unknown. On 04-AUG-2012 the patient noticed redness and swelling of about 4 inches in diameter around the injection site. There was no laboratory data. The pharmacist recommended that the patient seek medical attention and as of 04-AUG-2012 the patient continued to experience redness and swelling. It was unknown if the patient would continue on the ZOSTAVAX. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 53 year old female patient who on 10-AUG-2012 was vaccinated with a single dose 0.65 ml subcutaneous in her left arm with ZOSTAVAX (lot number 671663/1159AA, expiration date 18-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an unspecified injection site reaction. No treatment information was reported. The outcome of injection site reaction was reported as recovering/resolving. This is one of several reports received from the same source (other cases number 1208USA011817, 1208USA010432). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 76 years old female patient. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number 0564AE, expired date 21-MAR-2013) subcutaneous on 15-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. Within 24 hours of getting the shot, on approximately 15-AUG-2012 the patient developed redness, swelling, pain and warmth at the injection site and the reaction was about 3" in diameter. Treatments TYLENOL and ice were given for adverse events. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from a 75 years old female consumer with pain, high blood pressure, high cholesterol and no drug reaction/allergies refers to herself. The patient stated that she think she was vaccinated SQ with a dose of ZOSTAVAX (dose and lot# not reported) in 2006. Concomitant medications included PREDNISONE, acetaminophen, LORTAB, PROTONA blood pressure medicine, and cholesterol. The patient stated that in December 2010 she experienced shingles, which was lasting for 3-4 weeks at the time with rash and then it healed. The patient was still suffering from post herpetic neuralgic (PHN). It was reported that the patient sought unspecified medical attention. It was treated with different antivirals. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 65 year old male patient who on 10-AUG-2012 was vaccinated with a single dose 0.65 ml subcutaneous in her left deltoid ZOSTAVAX (lot number 671018/0748AA, expiration date 18-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient reported an area of an inch and a half of itching, redness and a big round raised welt at the injection site of administration. No treatment information was reported. At the time of the report, the patient was recovering from the event. This is one of several report received from the same source (other case numbers 1208USA011818, 1208USA010432). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a currently 62 year old female patient with many allergies. The patient was vaccinated with lot # (672608/1715AA) expiration date 02-FEB-2013, 0.65 ml ZOSTAVAX subcutaneously in the left arm on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient was vaccinated with ZOSTAVAX and developed an adverse reaction. The pharmacist reported that the patient went into the pharmacy with warm, itchy red rash, (about 8 inches) at the injection site of the left arm. The patient was treated with BENADRYL (OTC) and cold compress laboratory and diagnostics were not performed. At the time of the report, the patient had not recovered from warm, itchy red rash, (about 8 inches) at the injection site of the left arm. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia, Hypoaesthesia oral, Vision blurred
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 82 year old male patient with penicillin allergy. On 21-AUG-2012 the patient was vaccinated with a single dose of 0.65 ml ZOSTAVAX subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 21-AUG-2012, moments after she administered ZOSTAVAX, the patient complained of tongue numbness, and a sensation of "funny taste on his tongue". The patient went to the bathroom, and when he returned a few minutes later he reported that he had also experienced blurry vision but that all three symptoms had resolved while he was in the bathroom. No treatment was given. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Gastrooesophageal reflux disease, Maternal exposure during pregnancy, Urinary tract infection
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 36 year old female. The patient has a history of 1 previous pregnancy, it was unknown if a birth defect or stillbirth or miscarriage occur in any previous pregnancy. On 14-MAY-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). No other co-suspects were reported. It was noted that the patient did not experienced local reaction at the vaccination site, varicella (chickenpox) symptoms or Herpes Zoster (shingles) symptoms post vaccination. Subsequently, the patient became pregnant with a last menstrual period (LMP) of 11-MAY-2012 and an estimated delivery date (EDD) of 15-FEB-12. On an unspecified date the patient experienced urinary tract infection treated with MACROBID and reflux treated with PROTONIX. It was also reported that the patient was tested for varicella antibodies before vaccination with VARIVAX (Merck) (in an approximately 2012) with result reported as "negative". At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.98
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 11 month old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot # unspecified). The nurse mentioned that on 31-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HIBV
Symptoms: Antibody test negative, Antimicrobial susceptibility test
Clinical narrative: This spontaneous report as received from a physician refers to currently 11 years old male patient with low Immunoglobulin A (IgA). On unknown date (as infant), the patient was vaccinated with a dose of haemophilus b conjugate vaccine (manufacturer unknown) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. Physician reported that the patient received a complete haemophilus b conjugate vaccine (manufacturer unknown) series as infant and "now" (July of 2012) had a low "hib" titer of 0.21 (units not reported). No treatment information was reported. At the time of report, the patient's outcome was reported as not recovered/not resolved. The relatedness for the patient's event was not reported for Haemohilus b Conjugate Vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number, route, dose and injection site were not known) on 21-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient received a dose of ZOSTAVAX which was expired on 18-AUG-2012, and the patient received the dose on 21-AUG-2012. No adverse effect reported. It was unspecified  if the patient had sought medical attention. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Herpes zoster, Pain, Pruritus, Pyrexia
Clinical narrative: Information has been received from a 58 years old male patient reporting on himself. There was no medical history and concurrent conditions reported. On 26-JUN-2012, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On 27-JUN-2012, the patient developed shingles after received ZOSTAVAX. The area of the rash was about the size of two hands on his back with some pain and itchiness. The patient experienced dizziness and fever while taking VALTREX to treat the shingles. The patient was recovering from the adverse events. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 58 years old male patient reporting on himself. There was no medical history and concurrent conditions reported. On 26-JUN-2012, the patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On 27-JUN-2012, the patient developed shingles after received ZOSTAVAX. The area of the rash was about the size of two hands on his back with some pain and itchiness. The patient experienced dizziness and fever while taking VALTREX to treat the shingles. The patient was recovering from the adverse events. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from an allergist refers to a 73 years old female patient with penicillin allergy, hypertension and hyperlipidemia. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 04-JUN-2012. No other co-suspect were reported. No concomitant medications were reported. The allergist was attending the patient for pruritus two days after receiving the vaccination on 06-JUN-2012. The patient was experiencing itching bilaterally on her mid back and on her popliteal region and the itching was responding to antihistamine therapy. The allergist stated that the patient was taking cetirizine, diphenhydramine and SINGULAIR (related case # 1208USA011923) in unspecified dosages. The outcome of pruritus/itching bilaterally on her mid back and no her popliteal region was reported as not recovered. The relatedness for pruritus/itching bilaterally on her mid back and no her popliteal region was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to an about eight patients of an unknown age, who on an unknown date were vaccinated with a dose of ZOSTAVAX (doses, routes and lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that out of the twenty ZOSTAVAX injections that she had administered about eight patients had had injections site reaction of red, swelling of about one inch radius and two inches in diameter, no rash. The pharmacist reported that two patients had come in to show her the injection site reaction, but there had been about eight people in total who had the injection site reaction. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for injection site reaction of red and swelling of about 1 inch radius and 2 inches in diameter was unknown for ZOSTAVAX. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Abasia, Blood test normal, Convulsion, Dysstasia, Nuclear magnetic resonance imaging normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with attention deficit hyperactivity disorder was vaccinated on 19-JUN-2012 with the second dose of GARDASIL, (lot # 0101AC), in the right arm (dose and route not reported). Concomitant vaccine given on the same date included the first dose of HAVRIX, (lot # AHAVB550AC), in the left arm, (dose and route not reported). Concomitant medication included VYVANSE, (which was not taken by the patient on vaccination day). On 19-JUN-2012, the patient had a seizure about 15 seconds after the second of two vaccinations. The patient had upper body tremors for approximately 10 hours and could not stand or walk for 7 hours (paralyzed). On an unspecified date MRI and Blood test were performed and were normal. At the time of the report, patient's outcome for tremor and paralysis was reported as recovered, outcome for abasia, dysstasia and convulsion was not reported. This report was considered non-serious by the agency, it required ER visit. Upon internal review, paralysis and seizure were considered to be an other important medical events. The original reporting source was not provided. The VAERS ID # is 457871. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Paralysis, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient with attention deficit hyperactivity disorder was vaccinated on 19-JUN-2012 with the second dose of GARDASIL, (lot # 0101AC), in the right arm (dose and route not reported). Concomitant vaccine given on the same date included the first dose of HAVRIX, (lot # AHAVB550AC), in the left arm, (dose and route not reported). Concomitant medication included VYVANSE, (which was not taken by the patient on vaccination day). On 19-JUN-2012, the patient had a seizure about 15 seconds after the second of two vaccinations. The patient had upper body tremors for approximately 10 hours and could not stand or walk for 7 hours (paralyzed). On an unspecified date MRI and Blood test were performed and were normal. At the time of the report, patient's outcome for tremor and paralysis was reported as recovered, outcome for abasia, dysstasia and convulsion was not reported. This report was considered non-serious by the agency, it required ER visit. Upon internal review, paralysis and seizure were considered to be an other important medical events. The original reporting source was not provided. The VAERS ID # is 457871. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from registered nurse concerning a 60 years old female patient who is also a nurse with no pertinent history and no drug reactions/allergies who on 01-AUG-2012, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (lot # 670820/0660AA, exp 04-AUG-2012). No concomitant medications were reported. On 02-AUG-2012 the patient experienced at the injection site tender to touch, warm, redness that was 9 cm x 6 cm, painful to touch, hardness in middle and slight itch that started first before the reactions occurred. The patient had no temperature, no headache, and no rash. The patient had no treatment given. There was no lab diagnostics studies performed. At the time of the report, the patient had not recovered. The patient called the physician. The relatedness for tender to touch at the injection site, slight itch at the injection site that started first before the reactions occurred, harness at the injection site in middle, painful to touch at the injection site and redness at injection site that is 9cmx6cm is unknown for ZOSTAVAX. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Joint swelling, Rash
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 21 August 2012. A six-year-old male patient had received an injection of DAPTACEL (lot number not reported), IPOL (lot number not reported) and MMR (manufacturer unknown) (routes and sites not reported) on 14 August 2012. An unspecified amount of time later, the patient had a very bad reaction and had to be taken to the doctor three times. All of his joints were swollen, he was not able to move his fingers and had trouble walking. His face and body were very swollen and he was very uncomfortable. At the time of the report, he had hives covering all of his body. The patient received "treatment to detox his system" and "medication to counter act the adverse reactions". The patient's outcome was not recovered. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Discomfort, Gait disturbance, Joint swelling, Mobility decreased, Swelling
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 21 August 2012. A six-year-old male patient had received an injection of DAPTACEL (lot number not reported), IPOL (lot number not reported) and MMR (manufacturer unknown) (routes and sites not reported) on 14 August 2012. An unspecified amount of time later, the patient had a very bad reaction and had to be taken to the doctor three times. All of his joints were swollen, he was not able to move his fingers and had trouble walking. His face and body were very swollen and he was very uncomfortable. At the time of the report, he had hives covering all of his body. The patient received "treatment to detox his system" and "medication to counter act the adverse reactions". The patient's outcome was not recovered. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 21 August 2012. A six-year-old male patient had received an injection of DAPTACEL (lot number not reported), IPOL (lot number not reported) and MMR (manufacturer unknown) (routes and sites not reported) on 14 August 2012. An unspecified amount of time later, the patient had a very bad reaction and had to be taken to the doctor three times. All of his joints were swollen, he was not able to move his fingers and had trouble walking. His face and body were very swollen and he was very uncomfortable. At the time of the report, he had hives covering all of his body. The patient received "treatment to detox his system" and "medication to counter act the adverse reactions". The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Paraesthesia, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with lot # (672675/0068AE), 0.65 ml ZOSTAVAX on 15-AUG-2012. Expiration date 13-APR-2013. No other co-suspects were reported. Concomitant medication included trazodone, spironolactone, buspirone and simvastatin *manufacture unknown. The pharmacist reported that the patient developed a mild site reaction about 1 to 1 and 1/2 inches in size that was reddish, tingly and itchy one hour after received ZOSTAVAX. At the time of the report, the patient was recovering from mild site reaction about 1 to 1 and 1/2 inches in size that was reddish, tingly and itchy. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with lot # (672675/0068AE), 0.65 ml ZOSTAVAX on 15-AUG-2012. Expiration date 13-APR-2013. No other co-suspects were reported. Concomitant medication included trazodone, spironolactone, buspirone and simvastatin *manufacture unknown. The pharmacist reported that the patient developed a mild site reaction about 1 to 1 and 1/2 inches in size that was reddish, tingly and itchy one hour after received ZOSTAVAX. At the time of the report, the patient was recovering from mild site reaction about 1 to 1 and 1/2 inches in size that was reddish, tingly and itchy. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain lower, Blood test abnormal, Dehydration, Drug intolerance, Gastroenteritis
Clinical narrative: Twenty four hours after Hep A vaccine pt had temp of 102. Forty eight hours after Hep A vaccine pt began w/ emesis. Hx of fever for 7 days w/ tmax of 104 on dy # 7 - No fever thereafter. Hx of emesis of all po intake for 6 days. ER visit on day # 6 secondary dehydration. Hosp admit on dy #7 due to dehydration. Increasing LFTs (pt D/Ced home on 8/22/12).
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inflammation, Malaise, Nausea, Pyrexia, Urine analysis
Clinical narrative: Twenty four hours after Hep A vaccine pt had temp of 102. Forty eight hours after Hep A vaccine pt began w/ emesis. Hx of fever for 7 days w/ tmax of 104 on dy # 7 - No fever thereafter. Hx of emesis of all po intake for 6 days. ER visit on day # 6 secondary dehydration. Hosp admit on dy #7 due to dehydration. Increasing LFTs (pt D/Ced home on 8/22/12).
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Vomiting
Clinical narrative: Twenty four hours after Hep A vaccine pt had temp of 102. Forty eight hours after Hep A vaccine pt began w/ emesis. Hx of fever for 7 days w/ tmax of 104 on dy # 7 - No fever thereafter. Hx of emesis of all po intake for 6 days. ER visit on day # 6 secondary dehydration. Hosp admit on dy #7 due to dehydration. Increasing LFTs (pt D/Ced home on 8/22/12).
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Liver function test abnormal, Pyrexia
Clinical narrative: Twenty four hours after Hep A vaccine pt had temp of 102. Forty eight hours after Hep A vaccine pt began w/ emesis. Hx of fever for 7 days w/ tmax of 104 on dy # 7 - No fever thereafter. Hx of emesis of all po intake for 6 days. ER visit on day # 6 secondary dehydration. Hosp admit on dy #7 due to dehydration. Increasing LFTs (pt D/Ced home on 8/22/12).
Age: 86.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around site & itching told to ice & BENADRYL crm. Called Dr.- spoke w/ they will call pt if needed.
Age: 86.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness around site & itching told to ice & BENADRYL crm. Called Dr.- spoke w/ they will call pt if needed.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Burning sensation, Computerised tomogram normal, Dizziness
Clinical narrative: The second the shot was administered there was intense pain at the injection site on the left shoulder but no redness or swelling. Immediately after completion the pain traveled down my arm, quickly spreading up my neck to part of the my face and down my left leg. The pain stayed localized to left side, the side of the injection. It was a gnawing, near-tingling-but-not-quite sensation. Within a 2 minutes I was feeling woozy. Within 5 I began to grey out while sitting, quickly plunging my head below my heart. A nurse provided a soda. It kept the passing out at bay. I then sat for close to an hour slowly, barely resolving to a point where upon they could draw blood. About an hour after the injection I was slightly improved from a fainting spell, but hardly. My vein blew when they were going to draw blood (I was already in a lying position). They decided against the blood draw. I laid there possibly for 15 minutes, was move to a sitting position. 2 hours + after injection I was still light headed, slightly weak, and still experiencing left side pain, fatigue, slight numbness. 3 hours after I ate a meal comprised of eggs and toast, immediately feeling lethargic and increasingly fatigued. I ended up napping on and off for 2 hours before forcing myself to get up and call a medical professional. At 7 pm, an hour after waking, my legs were heavy and shaky, I remain lightheaded, weak as ever. Left side heaviness had increased. Drove to ER. Was administered Benadryl and steroids nearly 10 hours after initial injection. Shook furiously from the Benadryl. Saw no real change in symptoms, although leg heaviness slightly slightly decreased. Was sent home after a clear CT scan and was in a weakened state for nearly 6 days, unable to work. It is now the 7th day from injection and still not 100% and only some minor improvements. Now beginning to experience joint pain in both sides of body-arms, legs, back, neck. Still have lighthead spells and an overall 'humming to my body almost like one has when experiencing a fever. No recorded fever as of yet. Left side weakness has severely decreased but am still experiencing random points of intermittent tingling and bouts of nerve burning sensations.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Facial pain, Fatigue, Feeling abnormal, Hemiparesis, Hypoaesthesia
Clinical narrative: The second the shot was administered there was intense pain at the injection site on the left shoulder but no redness or swelling. Immediately after completion the pain traveled down my arm, quickly spreading up my neck to part of the my face and down my left leg. The pain stayed localized to left side, the side of the injection. It was a gnawing, near-tingling-but-not-quite sensation. Within a 2 minutes I was feeling woozy. Within 5 I began to grey out while sitting, quickly plunging my head below my heart. A nurse provided a soda. It kept the passing out at bay. I then sat for close to an hour slowly, barely resolving to a point where upon they could draw blood. About an hour after the injection I was slightly improved from a fainting spell, but hardly. My vein blew when they were going to draw blood (I was already in a lying position). They decided against the blood draw. I laid there possibly for 15 minutes, was move to a sitting position. 2 hours + after injection I was still light headed, slightly weak, and still experiencing left side pain, fatigue, slight numbness. 3 hours after I ate a meal comprised of eggs and toast, immediately feeling lethargic and increasingly fatigued. I ended up napping on and off for 2 hours before forcing myself to get up and call a medical professional. At 7 pm, an hour after waking, my legs were heavy and shaky, I remain lightheaded, weak as ever. Left side heaviness had increased. Drove to ER. Was administered Benadryl and steroids nearly 10 hours after initial injection. Shook furiously from the Benadryl. Saw no real change in symptoms, although leg heaviness slightly slightly decreased. Was sent home after a clear CT scan and was in a weakened state for nearly 6 days, unable to work. It is now the 7th day from injection and still not 100% and only some minor improvements. Now beginning to experience joint pain in both sides of body-arms, legs, back, neck. Still have lighthead spells and an overall 'humming to my body almost like one has when experiencing a fever. No recorded fever as of yet. Left side weakness has severely decreased but am still experiencing random points of intermittent tingling and bouts of nerve burning sensations.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Impaired work ability, Injection site joint pain, Lethargy, Neck pain
Clinical narrative: The second the shot was administered there was intense pain at the injection site on the left shoulder but no redness or swelling. Immediately after completion the pain traveled down my arm, quickly spreading up my neck to part of the my face and down my left leg. The pain stayed localized to left side, the side of the injection. It was a gnawing, near-tingling-but-not-quite sensation. Within a 2 minutes I was feeling woozy. Within 5 I began to grey out while sitting, quickly plunging my head below my heart. A nurse provided a soda. It kept the passing out at bay. I then sat for close to an hour slowly, barely resolving to a point where upon they could draw blood. About an hour after the injection I was slightly improved from a fainting spell, but hardly. My vein blew when they were going to draw blood (I was already in a lying position). They decided against the blood draw. I laid there possibly for 15 minutes, was move to a sitting position. 2 hours + after injection I was still light headed, slightly weak, and still experiencing left side pain, fatigue, slight numbness. 3 hours after I ate a meal comprised of eggs and toast, immediately feeling lethargic and increasingly fatigued. I ended up napping on and off for 2 hours before forcing myself to get up and call a medical professional. At 7 pm, an hour after waking, my legs were heavy and shaky, I remain lightheaded, weak as ever. Left side heaviness had increased. Drove to ER. Was administered Benadryl and steroids nearly 10 hours after initial injection. Shook furiously from the Benadryl. Saw no real change in symptoms, although leg heaviness slightly slightly decreased. Was sent home after a clear CT scan and was in a weakened state for nearly 6 days, unable to work. It is now the 7th day from injection and still not 100% and only some minor improvements. Now beginning to experience joint pain in both sides of body-arms, legs, back, neck. Still have lighthead spells and an overall 'humming to my body almost like one has when experiencing a fever. No recorded fever as of yet. Left side weakness has severely decreased but am still experiencing random points of intermittent tingling and bouts of nerve burning sensations.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Paraesthesia, Sensation of heaviness, Tremor
Clinical narrative: The second the shot was administered there was intense pain at the injection site on the left shoulder but no redness or swelling. Immediately after completion the pain traveled down my arm, quickly spreading up my neck to part of the my face and down my left leg. The pain stayed localized to left side, the side of the injection. It was a gnawing, near-tingling-but-not-quite sensation. Within a 2 minutes I was feeling woozy. Within 5 I began to grey out while sitting, quickly plunging my head below my heart. A nurse provided a soda. It kept the passing out at bay. I then sat for close to an hour slowly, barely resolving to a point where upon they could draw blood. About an hour after the injection I was slightly improved from a fainting spell, but hardly. My vein blew when they were going to draw blood (I was already in a lying position). They decided against the blood draw. I laid there possibly for 15 minutes, was move to a sitting position. 2 hours + after injection I was still light headed, slightly weak, and still experiencing left side pain, fatigue, slight numbness. 3 hours after I ate a meal comprised of eggs and toast, immediately feeling lethargic and increasingly fatigued. I ended up napping on and off for 2 hours before forcing myself to get up and call a medical professional. At 7 pm, an hour after waking, my legs were heavy and shaky, I remain lightheaded, weak as ever. Left side heaviness had increased. Drove to ER. Was administered Benadryl and steroids nearly 10 hours after initial injection. Shook furiously from the Benadryl. Saw no real change in symptoms, although leg heaviness slightly slightly decreased. Was sent home after a clear CT scan and was in a weakened state for nearly 6 days, unable to work. It is now the 7th day from injection and still not 100% and only some minor improvements. Now beginning to experience joint pain in both sides of body-arms, legs, back, neck. Still have lighthead spells and an overall 'humming to my body almost like one has when experiencing a fever. No recorded fever as of yet. Left side weakness has severely decreased but am still experiencing random points of intermittent tingling and bouts of nerve burning sensations.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: Progressively worsening chest pain for several weeks after receiving the Smallpox vaccine. Admitted to hospital. Discharge diagnosis was myocarditis.