chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patient received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed 10 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also MMR II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that one dose of GARDASIL (Lot# reported as J010305, expiration date reported as 20-APR-2016, dose not reported) that was exposed to highest temperature of 9C for 7 hours from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that one dose of GARDASIL (Lot#J011960, expiration date 06-AUG-2015, dose not reported) that was exposed for 4 hours to highest temperature of 8.5C from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
Age: 1.03
Sex: U
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 12 month old patient of unknown gender. On 20-JUN-2014 the patient was vaccinated with first dose of VARIVAX (Merck) 0.5 ml once, subcutaneous in the left leg (lot # J014228 and expiry date 08-NOV-2015). Concomitant therapies included PREVNAR 13 and fourth dose of ACTHIB given on the same day (20-JUN-2014). On 30-JUN-2014 the patient experienced raised, large area, red, 1.5 inch by .75 inch wide evaluated at the time of the report so treatment was not yet determined. There was no Lab Diagnostic Studies Performed. The patient sought medical attention by visiting doctor's office. At the time of the report the patient did not recovered from adverse events. The relatedness between the events and VARIVAX (Merck) was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Feeling hot, Flushing, Paraesthesia oral
Clinical narrative: Pt returned to pharmacy approx. 25 minutes after receiving vaccination saying that her "tongue felt full," difficulty swallowing, and she "felt warm/flushed." Epipen 0.3 mg administered at 7:01 om on 7/21/14. 911 called and EMS arrived within 5 minutes. EMS transported to local hospital.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that three doses of GARDASIL (Lot#J003727, expiration date 7-NOV-2015, dose not reported) that were improperly stored from 28-AUG-2013 to June 2014 were administered to unspecified patients (unknown age and gender) on an unknown dates (2 doses were exposed for 269 hours to highest temperature of 9C and one dose for 271 hours to 10C). Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of MMR II. The medical assistant reported that a male patient had negative antibody titers to measles (date unspecified). The patient did not have access to vaccination records, but was thought to have received one or two doses of MMR II on unspecified dates in the past. The patient sought medical attention via office visit. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old patient of unknown gender. There were none pertinent medical history and none drug reactions/allergies. On 02-JUL-2014 the patient was vaccinated with a dose of MMR II, 0.5 ml, subcutaneously. There were none concomitant medication. On approximately 12-JUL-2014, reported as about 10 days after the MMRI II injection the patient developed an injection site rash. The outcome of injection site rash was reported as recovered/resolved on 14-JUL-2014. There was no treatment given. There were no lab tests performed. The patient sought medical attention by contacting the nurse. The relatedness beween MMR II and adverse event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (healthcare worker) refers to a patient of unknown age. Office manager reported that a patient received Dose 2 of VAQTA (lot #, expiration date, dose, frequency, and route not reported) late (on 05-FEB-2014). Dose 1 was administered on 01-MAR-2006 and Dose 2 was administered on 05-FEB-2014. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse practitioner to unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). The reporter stated that many patients had received the GARDASIL series off schedule. Information for those many patients were unknown. This is one of several reports from the same reporter. Additional information is not expected because the reported did not wish for follow up.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Pruritus, Sensory disturbance
Clinical narrative: About 16 hours after receiving vaccine, pt developed red palms, itchy palms, swollen hands and when seen at clinic had same sensation around temples, but had no rash - given CLARITIN 10 mg po.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report as received from a nurse practitioner to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (0.5 ml, intramuscular, anatomical location, lot number were not reported). The reporter stated that a patient on an unknown date developed abdominal pain on the same day after receiving a dose of GARDASIL years ago. The reporter stated that the patient went to unspecified emergency room for the abdominal pain. She reported that the patient was not admitted to the hospital. The outcome of abdominal pain was reported as recovered/resolved (date unspecified). The relatedness between reported adverse event and GARDASIL was not reported. This is one of several reports from the same reporter. Additional information is not expected because the reported did not wish for follow up.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash maculo-papular, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old female patient. On 09-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot#J016235, Expiry date: 19-DEC-2015, 0.5 ml, subcutaneous). Pertinent medical history and concomitant medications were reported as none. The reporter stated that on 11-JUL-2014 treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No additional information provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female, non pregnant patient. The patient had none pertinent medical history and developed none drug reactions or allergies. On 12-JUN-2014 the patient was vaccinated with PROQUAD (Merck) 0.5ml (lot # K004418, expiration date: 25-SEP-2015) (route of administration was not reported) due to the patients titer being negative rubeola and negative varicella. Concomitant therapy included unspecified asthma medications. The patient did not seek medical attention. This case is linked with MARRS # 1407USA001571 and 1407USA001009 (same reporter links). Additional information had been requested.
Age: 0.3
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health care student refers to a 3 month old patient of unknown gender. No relevant medical history of the patient was reported. On 16-JUL-2014 the patient was vaccinated with PNEUMOVAX23 (strength, dose, route of administration, site of administration, lot number and expiration dates were not reported). There was no concomitant medications reported. It was reported that the patient received PNEUMOVAX23 instead of PREVNAR on 16-JUL-2014. There were no adverse symptoms reported. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. The outcome of received PNEUMOVAX23 instead of PREVNAR was unknown. Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Large hives appeared on his face, mostly on the left side. I took him back to dr that day. I was told although there was no other hypothesis, that it could not be vaccines. I asked about information about others having similar reactions and was told I can't believe anything I find on the internet. I was told to keep giving him Zyrtec and applying ice when the hives appear. They kept showing up once per day on both sides of face and under his chin, for about 5-6 days. I asked for a medical vaccine waiver for school and the dr said I wouldn't get one. That he would never attribute this to the vaccine. That his reaction was  an 'enigma'... I provided several photographs of his face swollen up with the hives.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Patient developed a rash.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same source. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014. The nurse stated that one dose of GARDASIL (Lot#H020901, expiration date 05-JUL-2014, dose not reported) that was exposed for 8 hours to highest temperature of 9C from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Injection site is edematous, warm, erythematous at subcutaneous are of (L) arm. Pt had 2 injections place on same arm (one IM, one Sub Q). Tx: ice to area, BENADRYL.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to over 40 unspecified patients of unknown age (no patient information provided). On an unknown date, the patient was vaccinated with, improperly stored outside temperature conditions listed in the product insert, liquid PEDVAXHIB, (dosage regimen and indication were not provided). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ
Symptoms: Erythema, Fall, Feeling cold, Headache, Hunger
Clinical narrative: Had finished giving client vaccines, mother walked out with daughter to have her sit in waiting room so she could bring her other child in for shots 2 approx 9:40 AM. At 9:50 AM, after giving the other child shots was called to the front because the first client I had done had fallen out of the chair. RNs were assisting to get her legs elevated and place a cold pack on back of neck. Client was alert and talking. B/P 120/78. Mom stated that she gets dizzy with shots, but had never fainted and she had not eaten this morning. 10:00 AM complains of being cold. Pt was covered with jacket. B/P now 118/75. Glucose given by RN. Pupils checked, normal reaction. Client complains of headache, redness noted around (L) eye at outer browbone and cheekbone. No bruising or swelling noted at this time. 10:10 AM B/P now 110/70. Client was helped to a sitting position on floor and then helped to feet and sat in chair. Client states she is feeling better and was answering questions about school. Verbalized her name and stated she was hungry. RN asked mother if she wanted EMS called and mother declined. She stated she would take her daughter to clinic and would call RN after the assessment. RN called the mother at 1PM on her cell phone as a courtesy to inquire about the daughter's condition. Mother stated the Dr looked her over and said that she was OK and did not need any further treatment and no meds were prescribed. Mother states the daughter has no more complaint.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Left leg broke out in rash within 2 hours of receiving shots and spread over entire body in the next few days.  On 6/22/2014 child had rash over entire body with exception of back. Child was given Benadryl and taken to MD. On 6/23/2014 MD told mother that he did not think it was due to the immunizations.
Age: 52.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Headache, Joint swelling, Nausea, Pruritus, Rash generalised
Clinical narrative: First dose Vivotif taken 7/14/14 AM, awoke during night of 7/14/14 with nausea, headache. Second dose Vivotif taken 7/16/14 AM, rash to shoulders began 7/17/14. Third dose Vivotif taken 7/18/14, progressed to full body rash with itching, hot to touch. No swelling to tongue, throat or difficulty breathing. On morning of 7/19/14, pt awoke to disseminated joint swelling, skin rash diminished. Fourth dose Vivotif taken 7/20/14 - Rash disappeared, joint swelling persisted. On 7/21/14, Pt took 40 mg Prednisone PO. Symptoms improved. On 7/22/14, Pt saw primary care physician for evaluation; Joint swelling much improved.
Age: 52.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Skin warm
Clinical narrative: First dose Vivotif taken 7/14/14 AM, awoke during night of 7/14/14 with nausea, headache. Second dose Vivotif taken 7/16/14 AM, rash to shoulders began 7/17/14. Third dose Vivotif taken 7/18/14, progressed to full body rash with itching, hot to touch. No swelling to tongue, throat or difficulty breathing. On morning of 7/19/14, pt awoke to disseminated joint swelling, skin rash diminished. Fourth dose Vivotif taken 7/20/14 - Rash disappeared, joint swelling persisted. On 7/21/14, Pt took 40 mg Prednisone PO. Symptoms improved. On 7/22/14, Pt saw primary care physician for evaluation; Joint swelling much improved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Headache, Mass
Clinical narrative: 1. Chills, low grade fever, light-headed: duration approximately one hour. 2. Headache: duration one day. 3. Redness, warmth and lump with extreme soreness started on 07/15/2014 and lasted 5 days with daily improvement. 4. Pins and needles feeling on very small area of back behind right shoulder started on 07/18/2014 and is still there but improved and currently very slight--noticed while taking a shower--felt when water touched area--very strange sensation but no break out.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia, Skin warm
Clinical narrative: 1. Chills, low grade fever, light-headed: duration approximately one hour. 2. Headache: duration one day. 3. Redness, warmth and lump with extreme soreness started on 07/15/2014 and lasted 5 days with daily improvement. 4. Pins and needles feeling on very small area of back behind right shoulder started on 07/18/2014 and is still there but improved and currently very slight--noticed while taking a shower--felt when water touched area--very strange sensation but no break out.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Postictal state
Clinical narrative: 2 hours after vaccines were administered baby had seizure at home last about 5 minutes with a 30-40 minute postictal period.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid erythema, warmth, tenderness. Treated for non-purulent cellulitis with KEFLEX and BACTRIM.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Marked erythema on right thigh approx 12 cm. circular around injection sight - swollen.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Moaning
Clinical narrative: Was fine in office but about 20 minutes after getting home patient started to have difficulty breathing, dizziness, lightheadedness. The injection site is fine with no local reaction noted. While on the phone I could hear patient moaning in the background and "panting" almost: after speaking with mother she said that the breathing got so bad that she called 911.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Patient came in to clinic the morning of July 18th 2014 with cc of redness on right thigh. Patient had dollar sized red raised rash on upper right thigh in the area where the vaccine was given. Child did c/o some itchy. No pain or tenderness, no fever noted per mother.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Injection site rash, Local reaction, Pruritus, Rash
Clinical narrative: On 7/16 and 7/17 had mild localized rash to left upper arm (site of vaccine), treated with Benadryl Cream.  On 7/19 noticed spreading rash to upper thighs, stomach, top of right foot.  Rash red and papular.  Went to Urgent Care about 1:30 PM and Dr. told her that she was allergic to Varicella Vaccine.  Given Prednisone 20 mg, two tablets once a day for 5 days.  Today on 7/22 rash is faint, pale and almost gone. States it still itches but is better.  Localized reaction to left upper arm is gone completely.  Did not have a fever during this time.  No other problems other than rash.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: On 7/16 and 7/17 had mild localized rash to left upper arm (site of vaccine), treated with Benadryl Cream.  On 7/19 noticed spreading rash to upper thighs, stomach, top of right foot.  Rash red and papular.  Went to Urgent Care about 1:30 PM and Dr. told her that she was allergic to Varicella Vaccine.  Given Prednisone 20 mg, two tablets once a day for 5 days.  Today on 7/22 rash is faint, pale and almost gone. States it still itches but is better.  Localized reaction to left upper arm is gone completely.  Did not have a fever during this time.  No other problems other than rash.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Fontanelle bulging, Pyrexia
Clinical narrative: Fever and bulging fontanelle.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Had a seizure at daycare and was febrile.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episode lasting less than 1 minute.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Blistering rash at injection site.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Basophil percentage, Bradycardia, C-reactive protein increased, Eosinophil percentage
Clinical narrative: Increasing frequency and severity of bradycardia and desaturation events. Eventually progressing to apnea and requiring vigorous tactile stimulation and place back on nasal cannula 0.5LPM up to 35% FiO2. Was previously on room air.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Haematocrit decreased, Haemoglobin decreased, Lymphocyte percentage, Monocyte percentage, Myelocyte count
Clinical narrative: Increasing frequency and severity of bradycardia and desaturation events. Eventually progressing to apnea and requiring vigorous tactile stimulation and place back on nasal cannula 0.5LPM up to 35% FiO2. Was previously on room air.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Neutrophil percentage, Oxygen saturation decreased, Platelet count normal, White blood cell count normal
Clinical narrative: Increasing frequency and severity of bradycardia and desaturation events. Eventually progressing to apnea and requiring vigorous tactile stimulation and place back on nasal cannula 0.5LPM up to 35% FiO2. Was previously on room air.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Zostavax was administered about 9:00 am. by 9:30 am had developed extremely itchy palms, then feet. 25 mg Diphenylhydramine HCL taken at 9:45 am and another at 11:30 am. Symptoms of itchiness resolved. On 7/22/2014 noted skin around injection site raised and red. Another 25 mg. diphenhydramine HCL take at 8:00 pm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Diplegia, Paralysis, Respiratory disorder
Clinical narrative: Received flu vaccine on 10-1-13. On 10-7-13 I had an adverse reaction from the flu vaccine which caused paralysis in my legs, feet, arms and hands. It also caused respiratory issues.
Sex: F
Vaccine: HEP
Symptoms: Erythema, Headache, Irritability, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date (also reported as many years ago) the patient was vaccinated with the first dose of RECOMBIVAX HB (injection, dose1, in the arm, strength, route, lot # and expiration date not reported). Concomitant medications were not reported. The reporter informed that the patient experienced fever, headache and irritability, as well as soreness, redness, heat and swelling of the arm in which she received the first dose of RECOMBIVAX HB. The physician reported that the patient had no received further doses of RECOMBIVAX HB or any other Hepatitis B virus vaccine and wanted to know whether it was safe to attempt revaccination. The outcome of the events was reported as recovered/resolved (also reported as the symptoms lasted about 1 week). Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date (also reported as many years ago) the patient was vaccinated with the first dose of RECOMBIVAX HB (injection, dose1, in the arm, strength, route, lot # and expiration date not reported). Concomitant medications were not reported. The reporter informed that the patient experienced fever, headache and irritability, as well as soreness, redness, heat and swelling of the arm in which she received the first dose of RECOMBIVAX HB. The physician reported that the patient had no received further doses of RECOMBIVAX HB or any other Hepatitis B virus vaccine and wanted to know whether it was safe to attempt revaccination. The outcome of the events was reported as recovered/resolved (also reported as the symptoms lasted about 1 week). Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash macular
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. On 18-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The physician reported that on 18-JUL-2014, the patient felt light headed. The patient layed down in the office for a while and that was when they noticed a red/blotchiness mark on her neck when she left the office. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via sales representative refers to a 74 year old female patient. Medical history was not reported. In July 2014 the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 plaque forming units (PFU) lot number, expiration date, route and dosage were not reported. Concomitant therapy was not reported. The reporter informed that the patient transported ZOSTAVAX from the pharmacy to the office to be administered. Also mentioned that she called the pharmacy when she noticed an expired product was dispensed an the pharmacist told her that the vaccine was safe to administer because ZOSTAVAX retains potency past the indicated shelf life. No adverse symptoms were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Large red welt at injection site.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Chest discomfort, Dizziness, Dysphonia, Erythema, Urticaria
Clinical narrative: Pt developed hoarseness voice one hour after flu shot. Then got hives from head to toe. Pt took 2 tabs of diphenhydramine 25mg. Redness getting subside but developed dizziness and chest tightness. Ambulance came and brought her to ER.
Age: 27.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: 7/22/14 - Reporting a med error. On 7/18/14: Without checking patient's record (relying on memory, bad idea) I was certain he was due for HPV #3. HPV #3 was admn. 4/29/14. Patient had a sore arm that resolved 7/20/14. He states he feels well on 7/22/14.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Head injury, Syncope
Clinical narrative: Collapsed after 10 minutes of receiving Tdap and MENVEO. Px hit back of head on wall. Per mom, Px appeared to have a seizure.
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a register nurse refers to a male adult patient of unspecified age. Concomitant medication and pertinent medical history were not provided. The nurse reported that the adult patient said he hd received two doses of M-M-R II (lot #, dose and route were not provided) when he was a child on unspecified dates. However, because he would be entering pharmacy school he was required to have his titers checked and it was found that his rubella titers were negative. Because of the negative rubella titers, he was given a third dose of M-M-R II (lot #, dose and route were not provided) in June 2014. The outcome of the events was not provided. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Nausea, Paraesthesia
Clinical narrative: Lightheaded, nausea, unable to breathe, tingling in hands 2 days after vaccine. Dr. could not find problems but pt still having symptoms.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 21-JUL-2014 the patient was vaccinated with a dose of PNEUMPVAX23 (dose, route, lot number and expiration date were unknown). On 11-JUL-2014, the patient was vaccinated with a dose of PENUMOVAX23 (dose, route, lot number and expiration date were unknown). No adverse event was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Local swelling
Clinical narrative: Right hand and joints swelled 2 days after vaccine. Pt tried multiple therapies no relief.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site induration, Pruritus, Rash
Clinical narrative: Large indurated redness 1" at injection site on 6/17. 5x5 cm redness on 6/19/14. Lower back pain x2 days 6/20. Rash-hives with pruritus 6/23/14. No pain in area. Delayed and prolong reaction (used BENADRYL 1x once).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Large indurated redness 1" at injection site on 6/17. 5x5 cm redness on 6/19/14. Lower back pain x2 days 6/20. Rash-hives with pruritus 6/23/14. No pain in area. Delayed and prolong reaction (used BENADRYL 1x once).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Paraesthesia, Pruritus
Clinical narrative: 7/18/14 1300 3 x 5 cm redness, sl induration; redness started 7/17/14 pm. 7/20/14 had large redness at site of injection with tingling down (R) hand w/itching. BENADRYL 25 mg. Had taken TYLENOL qd first 3 days. 7/22/14, 0830 sl. redness 1/2 cm, no induration, no itching, without pain.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 79 year old patient of unknown gender. On 15-JUL-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J002242, expiration date 21-MAY-2014, 0.65 ml, subcutaneous). Concomitant therapy was not reported. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner  refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. Since 01-APR-2014 the patients were vaccinated with M-M-R II (lot number, expiration date, route and dosage were not reported). That was improperly stored. No adverse events were reported. Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. Since 01-APR-2014 the patients were vaccinated with GARDASIL (injection), (lot number, expiration date, route and dosage were not reported). That was improperly stored. No adverse events were reported. Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose one, dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date, 24 hours after vaccination, the patient experienced syncope while in the shower. The outcome of th syncope and relatedness between reported adverse event and GARDASIL was not reported. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, drug reactions and allergies were reported. On 18-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II, 0.5 ml, expiration date 29-JUN-2014 (strength, route, dose number and lot number were not reported). No adverse effects reported. Concomitant therapies were not reported. The outcome of received an expired dose of M-M-R II was unknown. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional concerning a 4 month old patient, of an unknown gender. Medical history and concurrent conditions were not reported. On 10-JUL-2014 the patient was vaccinated with the first dose of ROTATEQ (lot number, expiration date and strength were not reported), 2ml, oral. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that a patient received their first dose of ROTATEQ on 10-JUL-2014 and then accidentally received another dose of 15-JUL-2014. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date, "as a child (recently)" the patient was vaccinated with M-M-R II (dose, route, lot number and albumin status were not reported). Concomitant medications were not reported. On an unknown date, patient had titers drawn for measles, mumps and rubella for entrance into school, and the patient's titers were "lower than required". The patient's physician wrote a prescription for another dose of M-M-R II as treatment. The outcome of the event was  not reported.  The relationship between M-M-R II and the event was not reported. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red area around site 3 inches x 4 inches in size. Afebrile. Site warm to touch.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Measles antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient had none pertinent medical history and developed none drug reactions or allergies. On 15-SEP-1999, the patient received first dose of M-M-R II HSA (dose, route of administration, lot # and expiration date were not provided). On 21-OCT-1999, the patient received her first dose of (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not provided). On 09-SEP-2003, the patient received a second dose of M-M-R II (dose, route of administration, lot # and expiration date were not provided). On 03-JUL-2008, the patient received a second dose of (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not provided). On 09-JUN-2014, the patient had titers drawn on and the results of the titers showed that the patient was negative rubeola and negative varicella. The reporter stated that the patient was administered a dose of (Oka/Merck) PROQUAD on 12-JUN-2014 due to the patient was negative rubeola and negative varicella. The outcome of the events was unknown. The relatedness between the event and the vaccination with suspect vaccines was unknown. This case is linked with MARRS#1407USA005462 and 1407USA001009 (same reporter linked). Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Deafness unilateral, Hypoacusis, Nuclear magnetic resonance imaging
Clinical narrative: Patient on the next day after receiving vaccine experienced hear loss. He is MD and has been seen by specialists since then and he has lost 60% of his hearing in one ear.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Diet refusal, Emotional distress, Screaming
Clinical narrative: Screaming inconsolable refusing to nurse hysterical one dose of Tylenol.
Age: 0.6
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea
Clinical narrative: After 4 month vaccines had a gasping episodes resulting in ER visit today, only DTAP given and later in day had another gasping episode.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Chest X-ray abnormal, Culture urine, Cyanosis, Differential white blood cell count, Electrocardiogram
Clinical narrative: Patient and parents returned home approx 8pm from doctor office. Pt had vomited in his car seat. He appeared blue and limp to parents. He did not stop breathing per parents. Parents removed from car seat. Symptoms resolved. Parents took him to hospital and was admitted. Fever 101.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Full blood count, Hypotonia, Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Patient and parents returned home approx 8pm from doctor office. Pt had vomited in his car seat. He appeared blue and limp to parents. He did not stop breathing per parents. Parents removed from car seat. Symptoms resolved. Parents took him to hospital and was admitted. Fever 101.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient and parents returned home approx 8pm from doctor office. Pt had vomited in his car seat. He appeared blue and limp to parents. He did not stop breathing per parents. Parents removed from car seat. Symptoms resolved. Parents took him to hospital and was admitted. Fever 101.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Excessive local redness/warmth/induration 2.75 in. in diameter.
Age: 5.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Irritability, Pain
Clinical narrative: Patient developed fever of 102 degrees 4 hours after the vaccine, significant rash, induration and erythema at the sites of BOTH inoculations (Deltoids), with swelling that extended over the anterior chest wall on the left side. She also complained of localized pain bilaterally and has been fussy.
Age: 5.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient developed fever of 102 degrees 4 hours after the vaccine, significant rash, induration and erythema at the sites of BOTH inoculations (Deltoids), with swelling that extended over the anterior chest wall on the left side. She also complained of localized pain bilaterally and has been fussy.
Sex: U
Vaccine: HPV4, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL and VARIVAX (Merck) (dose and route unspecified). The nurse reported that since an unknown date the 4 patient have ben administered both GARDASIL and VARIVAX (Merck) which reached a temperature outside the prescribing information. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This spontaneous report as received from a consumer (patient's husband) refers to a 68 year old female patient. The patient's pertinent medical history and drug reaction/allergies were none. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX (lot number, expiration date unspecified, route reported as injection, dose/frequency reported as directed). Concomitant medication was none. The patient developed a breakout that looked like chicken pox between 20-JUN-2014 and 22-JUN-2014. The patient visited office for seeking medical attention.The patient was still itching and stated that the unspecified salve that she was prescribed as a treatment was not working to address the itching. No diagnostics studies were performed. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administration error, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical technician refers to a 27 year old female patient. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. ON 15-JUL-2014 the patient was seen in the office, at which time she was mistakenly vaccinated with a dose of (Oka/Merck) VARIVAX (injection, lot # J011125, expiration date 05-SEP-2015, 0.5 ml, subcutaneous). The medical technician stated 'we took a pregnancy test after the vaccine was given and it was positive". No treatment was given for the adverse events. The last menstrual period (LMP) and expected date of deliver (EDD) were not provided. The outcome of the events was unknown. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 59 year old patient. On 17-JUL-2014, the patient was vaccinated with PNEUMOVAX23 lot# H022280 expiration date on 16-JUL-2014 0.5 ml, once, intramuscular. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as VFC employee) regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On an unknown date, an unknown number of patients was vaccinated with COMVAX (dose, route, product lot and expiry date was not reported), that had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as VFC employee) regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical  history and drug reaction or allergies of the patients reported. On an unknown date, an unknown number of patients was vaccinated with ROTATEQ (product lot and expiry date was not reported) orally that had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same source.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site papule
Clinical narrative: Seen in office for 12 mo WCE on 07-11-14; Rec'd all 12 mo vaccinations. Developed redness at site (RA); Now with 1 1/2 x 2 cm area erythema with 2-3 (+) papules; No induration or tenderness on exam 7/22/14. Afebrile 7/22/14; Max (T) = 100 F; Tx with ibuprofen q 6-8 hours.