chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Thi spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The healthcare worker reports that an improperly stored GARDASIL (lot #, expiry not reported) that was exposed to a temperature of 27F for 1 hour may have been administered. The healthcare worker did not have patient or physician details available at the time of the call since it was unknown to her whether or not the vaccine had been administered. No adverse effect reported. The healthcare worker also reported that the vaccine were stored as low as 33 F for up to 225 hours. This excursion was supported so there was no adverse event. This is 1 of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Patient received shingles vaccines on Tuesday 9/3/13 site swollen that night and progressively got larger. Complaints of itching.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 21 year old female patient. The nurse stated that after reviewing a patient's vaccination history, the patient only received 1 dose of VARIVAX (Merck), injection (dose and route not reported) administered on 23-AUG-2007. Patient was in the office and would be receiving the second dose of VARIVAX (Merck) on 12-AUG-2013. No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin ulcer
Clinical narrative: Sores on palms of hands, some rash at inner thigh.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to consumer's friend an 65 year old patient on an unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX, injection (strength, dose, route not provided) got very sick and had to go home from work. The outcome of event was unknown. This report is one of 2 reports from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 76 year old male patient with no drug reactions/allergies, who on 28-AUG-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously in the right arm (dose and lot # reported). Concomitant therapies included: atenolol 50 mg daily "Worphren" 1 mg; lisinopril (manufacturer unknown) 5 mg daily, and tamsulosin 0.4 mg daily. On 29-AUG-2013, the patient had a reaction to ZOSTAVAX. He was sore at the injection site on his right arm, and it was itchy. No treatment was given for the events. The outcome of the events was reported as recovering.  The relatedness of the events to therapy with ZOSTAVAX was not reported. The patient did not seek medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Local arm redness, itching, induration at 24 hours with extension of redness to elbow mostly resolved by 4th day.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Redness and swelling of left arm.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Redness, swelling, warmth and tenderness. Pt reports sx gradually became worse til the Redness ~ 5 -7 cm. Pt then went to an urgent tx center, was dx with cellulitis and started on Keflex 500mg QID.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient woke up in the morning with Hives. She has not been around anything new other than the flu vaccination yesterday. This is the first time she had an allergic reaction after a flu vaccine.
Age: 0.43
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Appendicectomy, Barium enema, Enema administration, Intussusception, Laparoscopic surgery
Clinical narrative: Pt started with vomiting on 9/5/13.  Had decrease wet diapers and lethargy on 9/6/13.  Pt then was taken to ER for evaluation.  Pt was transferred to hospital for intussusception.  Pt had barium enema x 2 without success.  Pt then underwent laparoscopic eval with spontaneous reduction and appendecomty.  Pt released from hospital on 9/8/13.
Age: 0.43
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lethargy, Urine output decreased, Vomiting
Clinical narrative: Pt started with vomiting on 9/5/13.  Had decrease wet diapers and lethargy on 9/6/13.  Pt then was taken to ER for evaluation.  Pt was transferred to hospital for intussusception.  Pt had barium enema x 2 without success.  Pt then underwent laparoscopic eval with spontaneous reduction and appendecomty.  Pt released from hospital on 9/8/13.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Myalgia
Clinical narrative: Muscle aches, right arm red hot and hard at injection site.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pruritus, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Mild allergic reaction consisting of itchy eyes, skin, and scalp. Minor hive-like bumps appeared on legs. Self-administered Benadryl antihistamine tablet to control the allergic reaction.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Started as soreness at the injection site immediately after injection followed by itchiness and redness surrounding the injection site within 24 hours from the time of vaccination.  The redness increased in size after 24 hours from time of injection hence sought consultation at the Student Health Center.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Feeling cold, Oropharyngeal pain, Pyrexia
Clinical narrative: Throat sore and swollen. By 5:00 PM high fever and chills.
Age: 1.26
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event noted.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue
Clinical narrative: Fatigue and weariness coming on in waves.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Pruritus, Rash pustular
Clinical narrative: Itching then burning with pustules of the lower legs.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Vomiting
Clinical narrative: Chills, rigor, vomiting, lasting two hours.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: 1 1/2 inch slightly raised area, red and sore to touch at ZOSTAVAX site. Red area one inch below FLUZONE site, slightly warm to touch about 2 inches long.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Chills, Cough, Feeling hot, Influenza
Clinical narrative: This spontaneous report as received from a 67 year old female consumer with a history of shingles from 15-DEC-2012 till March 2013 (it was also reported that patient had none pertinent medical history) reporting on herself. On 21-AUG-2013 the patient was vaccinated with ZOSTAVAX (strength, dose not provided). Concomitant medication include cholestyramine but the patient did not take the day of vaccination. On 22-AUG-2013 the patient was sick, nauseous, had a fever, flu symptoms, body aches, chills, runny nose, huge spot the size of a lemon and skin underneath this area was very thick at the back of the arm at the injection site, could not use left arm and had problems putting on and taking off clothes. The consumer stated that on 22-AUG-2013 at 12 PM, she experienced a sharp pain on the left side of rib underneath the breast and a warming sensation on the back of the arm in which she discovered a huge mark. The patient went to the pharmacist who administered with ZOSTAVAX and saw a nurse practitioner at her physician's office. The patient mentioned she took an unspecified ace inhibitor (manufacturer unknown) that made her cough. Also was reported that an ibuprofen, dose: 800 mg a day, was given as a treatment for adverse event. The outcome of events was reported as not recovered/not resolved. This report is one of 2 reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Malaise, Musculoskeletal chest pain, Musculoskeletal disorder, Nausea
Clinical narrative: This spontaneous report as received from a 67 year old female consumer with a history of shingles from 15-DEC-2012 till March 2013 (it was also reported that patient had none pertinent medical history) reporting on herself. On 21-AUG-2013 the patient was vaccinated with ZOSTAVAX (strength, dose not provided). Concomitant medication include cholestyramine but the patient did not take the day of vaccination. On 22-AUG-2013 the patient was sick, nauseous, had a fever, flu symptoms, body aches, chills, runny nose, huge spot the size of a lemon and skin underneath this area was very thick at the back of the arm at the injection site, could not use left arm and had problems putting on and taking off clothes. The consumer stated that on 22-AUG-2013 at 12 PM, she experienced a sharp pain on the left side of rib underneath the breast and a warming sensation on the back of the arm in which she discovered a huge mark. The patient went to the pharmacist who administered with ZOSTAVAX and saw a nurse practitioner at her physician's office. The patient mentioned she took an unspecified ace inhibitor (manufacturer unknown) that made her cough. Also was reported that an ibuprofen, dose: 800 mg a day, was given as a treatment for adverse event. The outcome of events was reported as not recovered/not resolved. This report is one of 2 reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rhinorrhoea, Skin hypertrophy
Clinical narrative: This spontaneous report as received from a 67 year old female consumer with a history of shingles from 15-DEC-2012 till March 2013 (it was also reported that patient had none pertinent medical history) reporting on herself. On 21-AUG-2013 the patient was vaccinated with ZOSTAVAX (strength, dose not provided). Concomitant medication include cholestyramine but the patient did not take the day of vaccination. On 22-AUG-2013 the patient was sick, nauseous, had a fever, flu symptoms, body aches, chills, runny nose, huge spot the size of a lemon and skin underneath this area was very thick at the back of the arm at the injection site, could not use left arm and had problems putting on and taking off clothes. The consumer stated that on 22-AUG-2013 at 12 PM, she experienced a sharp pain on the left side of rib underneath the breast and a warming sensation on the back of the arm in which she discovered a huge mark. The patient went to the pharmacist who administered with ZOSTAVAX and saw a nurse practitioner at her physician's office. The patient mentioned she took an unspecified ace inhibitor (manufacturer unknown) that made her cough. Also was reported that an ibuprofen, dose: 800 mg a day, was given as a treatment for adverse event. The outcome of events was reported as not recovered/not resolved. This report is one of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL, injection (strength, route, lot number and exp.date not provided). The nurse stated that she had a couple of patients who experienced syncope after GARDASIL dose in the past on unspecified dates but could not provide any further adverse event information. This is one of two reports concerning the same reporter link (#1309USA003869; 1309USA003200). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. Information on medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route, frequency, indication not reported). It was reported that the patient received GARDASIL, reported as HPV, early in pregnancy. The patient became pregnant on unknown date. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The outcome of pregnancy was unknown. The outcome of received HPV early in pregnancy was unknown. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse who refers to a female patient of unknown age. The nurse reported that the patient of an unknown date reported as 9 months approximately was vaccinated with a first dose of GARDASIL (dose, route and lot# not reported). The second dose of GARDASIL (dose, route and lot# not reported) patient received on 05-SEP-2013. No adverse symptoms reported. The outcome and action taken were not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Soreness, swelling, discoloration at injection site.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 4 year old patient of unknown gender. On 04-SEP-2013, the patient was vaccinated with a dose of an improperly stored M-M-R II (lot number and expiry date were reported as H018950 and 18-OCT-2014 respectively, dose and route unspecified) which was exposed to 66 degrees Fahrenheit (F) for 41.5 hours. No concomitant therapy was reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None noted. Mom will monitor pt for adverse effects at home.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 4 year old patient of unknown gender. On 05-SEP-2013, the patient was vaccinated with a dose of an improperly stored M-M-R II (lot number and expiry date were reported as H018950 and 18-OCT-2014 respectively, dose and route unspecified) which was exposed to 66 degrees Fahrenheit (F) for 41.5 hours. No concomitant therapy was reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Occult blood positive, Vomiting
Clinical narrative: Patient started with vomiting on 9-10-13 at 1430 and was seen in provider office at 1540 and had diarrhea also. Followed up 9-11-13 at 0915 with improved vomiting but heme (+) diarrhea in office.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Human chorionic gonadotropin normal, Syncope
Clinical narrative: Syncope two minutes after vaccine administration; mentation resolved spontaneously without treatment or intervention; vital signs and CBG within normal limits.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture positive, Culture stool negative, Culture urine negative, Diarrhoea, Full blood count abnormal
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of fever in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). 1 day after vaccination with ROTARIX, the subject experienced fever and diarrhea. The subject's parents contacted the physician who referred the subject to the emergency room for evaluation. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with ROTARIX. Follow up was received from physician on 29 March 2013. The physician reported concurrent vaccination included DTaP+HepB+IPV (GlaxoSmithKline; intramuscular; unknown given on 5 March 2013; Hib (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 5 march 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; intramuscular; unknown give 5 March 2013. Per the physician, on 5 March 2013 the subject received 1st dose of ROTARIX (1 ml, oral). On 5 March 2013, less than one day after vaccination with ROTARIX, the subject experienced fever and diarrhea. The physician reported that the subject "developed a fever of 102 degrees Fahrenheit on the night of 5 March 2013 after receiving vaccine. Also developed diarrhea." The physician also reported that there was no medical history or concurrent illness that could have been associated with the events. The physician also stated that the subject was "well and asymptomatic prior to vaccine administration." Relevant test results included on 5 March 2013: Complete Blood Count with white blood cell count of 13.3, Blood Culture with result "positive for staph (contaminant)". On 7 March 2013, the subject received a urinalysis with normal result and urine culture with negative result. The physician also documented that on 8 March 2013, 4 days after events onset, the events were resolved. The physician also documented that the adverse events resolved on 7 March 2013, 3 days after events onset. The physician identified ROTARIX as the suspect product. The physician did not consider this case serious. The physician indicated that the subject did not have a congenital defect. The physician also documented that due to the adverse events, the subject was not hospitalized or jeopardized or required intervention. The physician considered the events were possibly related to vaccination with ROTARIX.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Staphylococcal infection, Urine analysis normal, White blood cell count increased
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of fever in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (1 ml, oral). 1 day after vaccination with ROTARIX, the subject experienced fever and diarrhea. The subject's parents contacted the physician who referred the subject to the emergency room for evaluation. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with ROTARIX. Follow up was received from physician on 29 March 2013. The physician reported concurrent vaccination included DTaP+HepB+IPV (GlaxoSmithKline; intramuscular; unknown given on 5 March 2013; Hib (non-gsk); non-GSK manufacturer; intramuscular; unknown given on 5 march 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; intramuscular; unknown give 5 March 2013. Per the physician, on 5 March 2013 the subject received 1st dose of ROTARIX (1 ml, oral). On 5 March 2013, less than one day after vaccination with ROTARIX, the subject experienced fever and diarrhea. The physician reported that the subject "developed a fever of 102 degrees Fahrenheit on the night of 5 March 2013 after receiving vaccine. Also developed diarrhea." The physician also reported that there was no medical history or concurrent illness that could have been associated with the events. The physician also stated that the subject was "well and asymptomatic prior to vaccine administration." Relevant test results included on 5 March 2013: Complete Blood Count with white blood cell count of 13.3, Blood Culture with result "positive for staph (contaminant)". On 7 March 2013, the subject received a urinalysis with normal result and urine culture with negative result. The physician also documented that on 8 March 2013, 4 days after events onset, the events were resolved. The physician also documented that the adverse events resolved on 7 March 2013, 3 days after events onset. The physician identified ROTARIX as the suspect product. The physician did not consider this case serious. The physician indicated that the subject did not have a congenital defect. The physician also documented that due to the adverse events, the subject was not hospitalized or jeopardized or required intervention. The physician considered the events were possibly related to vaccination with ROTARIX.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder developmental
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 3 year old male patient. On an unknown date, the patient may have been vaccinated with a dose of M-M-R II, (lot#, expiry not reported). On an unknown date, the patient experienced speech delay. The patient sought medical attention-contacted the office. The outcome of speech delay was reported as not recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient developed rash after receiving ZOSTAVAX. The outcome of rash was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Patient felt lightheaded after injection and was prompted to lay flat for a few minutes. No change in vital signs. Left facility with Mother. Per Mother after getting home still complained of leg weakness and lightheadedness.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Pain at injection site - swelling of lymph nodes. Saw private M.D. who treated with KEFLEX and without improvement. Pt went to ER and was admitted.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder, Throat tightness
Clinical narrative: Throat was closing and respiratory problems. Was given steroid shot and BENADRYL.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Fatigue, Feeling cold, Injection site erythema, Injection site pain
Clinical narrative: Patient present to school RN, redness, pain, and swelling of 2/3 of upper (R) arm. Patient also c/o cold chills, nausea, and tiredness. Temp 97.6. RN instructed patient to take Ibuprofen as needed and will reevaluate site tomorrow. Also notified patient to go to E.R. if any life threatening s/s occur. Will reevaluate tomorrow.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling, Nausea
Clinical narrative: Patient present to school RN, redness, pain, and swelling of 2/3 of upper (R) arm. Patient also c/o cold chills, nausea, and tiredness. Temp 97.6. RN instructed patient to take Ibuprofen as needed and will reevaluate site tomorrow. Also notified patient to go to E.R. if any life threatening s/s occur. Will reevaluate tomorrow.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Musculoskeletal stiffness, Vomiting
Clinical narrative: Severe headache, stiff neck, vomiting, chills but no fever.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cyanosis, Dysphagia, Gait disturbance, Headache
Clinical narrative: Body aches, headache, numbness to extremities, chills, fever, difficulty swallowing, difficulty moving/walking, cyanotic bilateral hands.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Pyrexia
Clinical narrative: Body aches, headache, numbness to extremities, chills, fever, difficulty swallowing, difficulty moving/walking, cyanotic bilateral hands.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Immediately upon giving the vaccination the patient's arm began to swell in the area of injection and around it, it turned purple/red in color.  The reaction measured at 2"x2" area.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Nausea, Pruritus, Urticaria, Vomiting
Clinical narrative: Approximately 15 minutes after flu vaccination, she began experiencing nausea and then vomited.  She took Benadryl 50mg po.  She then over the next 20-30 minutes started itching and had hives to her chest and abdomen.  She then experienced chest tightness, persistent nausea and vomiting.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation
Clinical narrative: Localized inflammation/questionable infection 4 x 6 cm developed 24 hrs s/p intradermal vaccination, worsening after 24 hrs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Heart rate irregular
Clinical narrative: Burning chest sensation across chest with irregular heartbeat.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus, Injection site reaction, Rash macular, Vomiting
Clinical narrative: Employee started to feel itchy at the site and there was blotchy redness. Bandaid removed at the site immediately. Given PO Benadryl 50 mg at 11:10 am, started vomiting about 2mins later. Moved to room with assistance from writer to lie down. Rolled to side and continued vomiting periodically. Nurse Practitioner gave Epi pen to L thigh at 11:25. Immediately after Epi pen, 911 called to transfer to Emergency. Oxygen 2 l by Nasal canula applied.  Patient continued to vomit.  Red Blotchy area spread to chest area. Patient Awake, Alert and Oriented during the entire event.  Ambulance arrived and patient transferred by stretcher.  Report given to EMT's handling care for the patient.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Patient reports that 24 hous after shots she experienced cellulitis of left arm, itching, redness, swelling, fever of 101. Required MD visit on 8/2/2013. Received prescription for Bactrim. Saw Dr. at Medical Clinic
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Blood glucose decreased, Breath sounds abnormal, Chest discomfort, Chills, Depressed level of consciousness
Clinical narrative: 30-45 seconds after MMR vaccine administered SQ in left deltoid SQ fatty tissue, patient slumped in chair, eyes halfclosed, upper and lower extremities started to jerk spasmodically, sonorous respirations heard, patient unresponsive to verbal command, decreased level of consciousness, biting tip of tongue. Reaction lasted approximately 30 seconds, then patient's limbs relaxed, eyes opened, and he became responsive. Amnesic to event, skin pale, and started have rigors/chills without feeling cold. 911 activated while vital signs obtained: BP 100/60, hr 46-53, pulse ox 96% on room air, respiratory rate 12-16, respirations easy and unlabored. Denies any difficulty breathing, denies any sensation of anxiety prior to or during vaccination. Denies dizziness or lightheadedness, nausea, or abdominal discomfort. Stated he felt like his heart rate sped up just prior to reaction, now no palpitations. After 5-7 minutes states his chest is feeling "tight", denies chest pain. Nurse practitioner prepares to administer EpiPen, patient reports that sensation of tightness has passed, paramedics arrive and assume care.  Epinepherine not adminstered.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Dyskinesia, Heart rate increased, Pallor, Posture abnormal, Tongue biting
Clinical narrative: 30-45 seconds after MMR vaccine administered SQ in left deltoid SQ fatty tissue, patient slumped in chair, eyes halfclosed, upper and lower extremities started to jerk spasmodically, sonorous respirations heard, patient unresponsive to verbal command, decreased level of consciousness, biting tip of tongue. Reaction lasted approximately 30 seconds, then patient's limbs relaxed, eyes opened, and he became responsive. Amnesic to event, skin pale, and started have rigors/chills without feeling cold. 911 activated while vital signs obtained: BP 100/60, hr 46-53, pulse ox 96% on room air, respiratory rate 12-16, respirations easy and unlabored. Denies any difficulty breathing, denies any sensation of anxiety prior to or during vaccination. Denies dizziness or lightheadedness, nausea, or abdominal discomfort. Stated he felt like his heart rate sped up just prior to reaction, now no palpitations. After 5-7 minutes states his chest is feeling "tight", denies chest pain. Nurse practitioner prepares to administer EpiPen, patient reports that sensation of tightness has passed, paramedics arrive and assume care.  Epinepherine not adminstered.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Unresponsive to stimuli
Clinical narrative: 30-45 seconds after MMR vaccine administered SQ in left deltoid SQ fatty tissue, patient slumped in chair, eyes halfclosed, upper and lower extremities started to jerk spasmodically, sonorous respirations heard, patient unresponsive to verbal command, decreased level of consciousness, biting tip of tongue. Reaction lasted approximately 30 seconds, then patient's limbs relaxed, eyes opened, and he became responsive. Amnesic to event, skin pale, and started have rigors/chills without feeling cold. 911 activated while vital signs obtained: BP 100/60, hr 46-53, pulse ox 96% on room air, respiratory rate 12-16, respirations easy and unlabored. Denies any difficulty breathing, denies any sensation of anxiety prior to or during vaccination. Denies dizziness or lightheadedness, nausea, or abdominal discomfort. Stated he felt like his heart rate sped up just prior to reaction, now no palpitations. After 5-7 minutes states his chest is feeling "tight", denies chest pain. Nurse practitioner prepares to administer EpiPen, patient reports that sensation of tightness has passed, paramedics arrive and assume care.  Epinepherine not adminstered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth at site of injection, no treatment, approx 4 cm X 1 cm.
Age: 11.0
Sex: M
Vaccine: MMRV, TDAP
Symptoms: Headache
Clinical narrative: Severe headache requiring another office visit.
Age: 16.0
Sex: F
Vaccine: DTAP, HPVX
Symptoms: Coeliac disease, Dizziness, Lymphadenopathy, Malaise, Nausea
Clinical narrative: At second Gardasil shot, very sick feeling, nausea, dizzy, pain, fever. More extreme than normal.
Age: 16.0
Sex: F
Vaccine: DTAP, HPVX
Symptoms: Pain, Polycystic ovaries, Pyrexia
Clinical narrative: At second Gardasil shot, very sick feeling, nausea, dizzy, pain, fever. More extreme than normal.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Generalised erythema, Pruritus, Somnolence
Clinical narrative: Patient recieved a Fluzone quad vaccine. Injection was administered at approx 9:30am. Employee presented 2.5 hours later with redness on arms, legs, ear and nose. Also reported itchy hands. No respiratory distress.  BP was 128/90, P 76. IM Benadryl was administered at 12:05pm. 12:15pm BP was 122/90 p 72. 12:35pm BP was 140/90 p 74. 12:55pm BP 136/90. At 12:45pm, patient was oriented x2, sleepiness from Benadryl, rash continued to subside.
Age: 0.3
Sex: M
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: My 3 month old son was given the flu vaccine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Hurts to raise arm, hurts to use arm, limited range of motion, hurts to rotate arm, there is stiffness when using the arm.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: Hives developed in the arm in which the vaccine was administered. Pt took 25 mg of diphenhydramine. Pt also started to feel tingling sensations on her tongue.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Discoloration of arm severe pain.
Age: 75.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Laboratory test, Throat tightness
Clinical narrative: Shortness of breath, throat closing up, sick to stomach, dizzy. Called Primary doctor, was advised to call 911. Paramedics took me to hospital emergency room.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site swelling, Joint range of motion decreased
Clinical narrative: Swelling at injection site. Injection site not the deltoid muscle.  Injection site looks like on top of shoulder; injection site small round swollen area surrounded by red swollen tissue around the injection site lump; pain on scale of 0-10 "8-9".  Took 3 OTC ibuprofen (200mg each) and ice on the left arm.  Left arm stiff and unable to move the left arm.  No pain relief with vicodin.  Called local ER and advised by them to call PCP.  PCP said take two Benadryl, 2 pain pills and ice the area.  Symptoms did improve by morning on Sept 11th.  Pain now a 5-6 on scale of 0-10 and able to move the arm but limited in rom and function.  Took another toradol and went to work.  Still sore in evening of Sept 11th but better than yesterday per member.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Swelling at injection site. Injection site not the deltoid muscle.  Injection site looks like on top of shoulder; injection site small round swollen area surrounded by red swollen tissue around the injection site lump; pain on scale of 0-10 "8-9".  Took 3 OTC ibuprofen (200mg each) and ice on the left arm.  Left arm stiff and unable to move the left arm.  No pain relief with vicodin.  Called local ER and advised by them to call PCP.  PCP said take two Benadryl, 2 pain pills and ice the area.  Symptoms did improve by morning on Sept 11th.  Pain now a 5-6 on scale of 0-10 and able to move the arm but limited in rom and function.  Took another toradol and went to work.  Still sore in evening of Sept 11th but better than yesterday per member.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Swelling at injection site. Injection site not the deltoid muscle.  Injection site looks like on top of shoulder; injection site small round swollen area surrounded by red swollen tissue around the injection site lump; pain on scale of 0-10 "8-9".  Took 3 OTC ibuprofen (200mg each) and ice on the left arm.  Left arm stiff and unable to move the left arm.  No pain relief with vicodin.  Called local ER and advised by them to call PCP.  PCP said take two Benadryl, 2 pain pills and ice the area.  Symptoms did improve by morning on Sept 11th.  Pain now a 5-6 on scale of 0-10 and able to move the arm but limited in rom and function.  Took another toradol and went to work.  Still sore in evening of Sept 11th but better than yesterday per member.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, sore, swollen area around the injection sight - oval shaped area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Flu like symptoms, arm red and swollen at site of injection, continued to swell, went to doctor red area was 5 cm by 8 cm and was still feeling bad, no energy and weak.(Shingles vaccine)
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: 6:00pm lower jaw began to be numb, 6:05pm right arm was numb, gave 50mg of Benadryl orally. 6:20pm symptoms resolved and feeling better pt will follow up with provider.
Age: 19.0
Sex: F
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Anaphylactic reaction, Angioedema, Pruritus, Tachycardia, Urticaria
Clinical narrative: Acute anaphylaxis with urticaria pruritis and angioedema and tachycardia. Started minutes after IM injection. Given therapeutics in clinic and transferred to ER.
Age: 68.0
Sex: M
Vaccine: PPV, TD
Symptoms: Asthenia, Influenza like illness, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Swelling of the upper arm, extremely sore in upper arm. Felt weak like a mild case of the flu. Had to leave the arm immobile for three days. Soreness diminished by fourth day but the swelling persisted for five days. When swelling diminished in the upper arm, the lower arm was swollen, especially around the elbow.
Age: 1.42
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pyrexia, Rash
Clinical narrative: Shingles on the right side of face: Forehead, eye, nose. Date Shingles appeared: 03/26/2011. Was misdiagnosed by pediatrician as a simple rash. Visited Urgent Care after symptoms got worse, affecting eye: 03/29/2011. Properly diagnosed and sent to hospital. Hospitalized same day: 03/29/2011. Advised shingles were the result of the varicella vaccine. Discharged: 03/31/2011. High Fever (104): 04/01/2011 - 04/04/2011. Finished antibiotic: 04/06/2011. 04/13/2011: Shingles still visible, but showing improvement.
Age: 45.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Computerised tomogram normal, Diarrhoea, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Diarrhea and intense abdominal pain-ongoing.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme within 72 hours of vaccines. The morphology of this rash is most consistent with that of erythema multiforme which could be vaccine related given the temporal correlation or could be due to infection acquired from the community. I discussed the natural history of erythema multiforme with the parents, explaining that most of the rash will erupt within 72 hours and then will gradually resolve with 2 weeks' time. I did advise them to monitor for any mucosal and ocular involvement and explained that some of the centers could turn into crusted blisters. The child currently does not seem to be bothered at all but I did recommend doxepin 0.5 mL p.o. q.h.s. for itch and to help with sleep. Reassurance was provided. This rash will likely resolve. However, if it is worsening, I advised the parents to call our office and let us know. Rarely postinflammatory hyperpigmentation can develop. I also recommended that this should be reported as a vaccine adverse event by her PCP.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Anaphylactic reaction, Exposure during pregnancy
Clinical narrative: Case number PHHY2012US013541 is an initial literature report received on 14 Feb 2012 and a follow up report received on 09 Sep 2013. Authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a female patient (age not specified). She was vaccinated with influenza (manufacturer and batch number: unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of vaccination. She had an anaphylactic reaction after vaccination on an unspecified date. Authors concluded that the pregnant women who were vaccinated with H1N1 vaccination with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes. The most common pregnancy specific adverse event was spontaneous abortion (SAB) and stillbirth, and more than a third of women who experienced SAB had at least one risk factor (advance maternal age). Seventy two percent of women who had stillbirth had at least one risk factor or had a pathological finding in the fetus or placenta, suggesting factor other than vaccination that may be contributed to the fetal demise. This suggested that women with higher risk were over represented in VAERS database. Follow up report received on 09 Sep 2013: The case was lost to follow up, as no response upon several follow up attempts.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, who reported that on 02-AUG-2013, two patients of unknown age and gender received a dose of GARDASIL (lot # reported as J004197, expiration date 27-NOV-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to 1308USA010552, 1309USA004737, 1309USA004746, and 1309USA004747 via same reported link. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Swelling, redness, pain in immunized arm. MD advised to apply ice and take BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Erythema, Hyperhidrosis, Lethargy, Local swelling
Clinical narrative: Patient received both flu vaccine (2013/2014) and PNEUMOVAX in (L) arm at about 9am on 09/07/13 and by noon was sweaty, in pain, nauseous, vomiting and lethargic. Arm red and swollen. Patient coughed profusely and slept. Still feeling unwell at 72 hours. 9/11/13 pt feeling much better resumed to normal self.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Nausea, Pain, Vomiting
Clinical narrative: Patient received both flu vaccine (2013/2014) and PNEUMOVAX in (L) arm at about 9am on 09/07/13 and by noon was sweaty, in pain, nauseous, vomiting and lethargic. Arm red and swollen. Patient coughed profusely and slept. Still feeling unwell at 72 hours. 9/11/13 pt feeling much better resumed to normal self.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hyperhidrosis, Oropharyngeal pain, Vomiting
Clinical narrative: Patient states she received a flu shot yesterday during an office visit, and had a sore throat within an hour after receiving the shot, then 2 hours later started vomiting and continued for 90 minutes, no pain/swelling at injection site. Patient states both sore throat and vomiting have resolved and at the time of this phone call (11:04 am) she feels weak, chills, sweats, patient states no fever and she is recovering.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Local swelling, Skin warm, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 55 year old patient of unknown gender, who on 20-AUG-2013, was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # J003796, expiration date 28-JUN-2014). The pharmacist reported that the patient who received ZOSTAVAX, on 20-AUG-2013, presented to the pharmacy the following day with a raised, warm hive- or wheal-like area approximately 3 inches by one inch. She stated that the area was definitely not a rash; it looked more like an allergic reaction to the ZOSTAVAX. The pharmacist did not specify if this patient notified her physician, or if the affected area has resolved. She did state that she did not have a lot of the patient's medical history on hand. The pharmacist was requesting a lot check for ZOSTAVAX (lot # J003796, expiration 28-JUN-2014), since two other patients have also reported adverse effects since receiving ZOSTAVAX of this lot. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTP, HEP, HIBV, PPV, RV1
Symptoms: Cardiac murmur
Clinical narrative: This case was reported by a physician and described the occurrence of heart murmur in a 5-month-old female subject who was vaccinated with ROTARIX. Concurrent vaccination included Haemophilius influenzae type B vaccine; manufacturer unspecified; unknown; unknown given in 2012; combined diphtheria, tetanus, pertussis (A or W not known) vaccine; manufacturer unspecified; unknown; unknown given in 2012; hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given in 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given in 2012. In 2012 the subject received 1st dose of ROTARIX (oral). On 14 August 2012, less than one year after vaccination with ROTARIX, the subject experienced heart murmur. The physician reported that she diagnosed the subject, who had been vaccinated elsewhere with one dose of ROTARIX with a heart murmur. The physician had limited information regarding previous history because the subject has recently moved from a different treating physician. At the time of reporting the outcome of the event was unspecified.
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: This case is linked to case number 2012-06128 and 2012-06129. A 10-year-old male patient, who has medical history of seasonal allergies, whose and concomitant medications were not reported, received first dose of IMOGAN (batch number, route and site of administration not reported) and IMOVAX (batch number, route of administration not reported) in the buttock on 10 August 2011. The patient received subsequent dose of IMOVAX on 13 August 2012, 17 August 2012, 24 August 2012 and 7 September 2012 in the alternate arms. The mother of the patient informed that after each dose of IMOVAX, the patient complained of flu like symptoms with nausea, fever, headache, fatigue and malaise starting after few hours of vaccination and lasting approximately for 2 day. Corrective medications were not reported. The patient had recovered on an unspecified date. List of documents held by sender: none
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: This case is linked to case number 2012-06128 and 2012-06129. A 10-year-old male patient, who has medical history of seasonal allergies, whose and concomitant medications were not reported, received first dose of IMOGAN (batch number, route and site of administration not reported) and IMOVAX (batch number, route of administration not reported) in the buttock on 10 August 2011. The patient received subsequent dose of IMOVAX on 13 August 2012, 17 August 2012, 24 August 2012 and 7 September 2012 in the alternate arms. The mother of the patient informed that after each dose of IMOVAX, the patient complained of flu like symptoms with nausea, fever, headache, fatigue and malaise starting after few hours of vaccination and lasting approximately for 2 day. Corrective medications were not reported. The patient had recovered on an unspecified date. List of documents held by sender: none