chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral test
Clinical narrative: Information was received on 12-JUL-2017 from a nurse practitioner via a company representative concerning a 47 year old female patient. Current medications included valacyclovir  hydrochloride(VALTREX)(indication unknown). No medical history was reported. On 10-JUL-2017, the patient was administered a dose of VARIVAX (lot N001528, unknown expiration date)(route, dose and site not reported) for prophylaxis. After receiving the vaccine, the patient developed a herpes type rash by the mouth 20 minutes after receiving the vaccine. "Rash is non painful and non itchy and is the size of a golf ball."  A cream was prescribed but the  patient could not afford it so the patient was not treated. Titer was checked prior to receiving the vaccine and the titer was low. The patient was taking valacyclovir (VALTREX) and was instructed by the nurse practitioner to stop the medication on the day she received the vaccination and to remain off of the medication for 2 weeks, based on the research of the 2 medications. A viral culture was performed on 10-JUL-2017 (no results reported). The nurse practitioner believes "the rash is from stopping the valacyclovir (VALTREX) and not from the vaccine."  No other information was provided. As of the time of reporting, the patient had not yet recovered. Additional information is not expected. No consent to contact reporter.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner communicated to a sales representative. A 92 year old female patient received a dose of PREVNAR 13 on 17Jul2017 at 0.5ml single dose for immunization. Initially the patient was fine. The patient returned to the office on 25Jul2017 and presented with a 4-6cm swollen area that was pink at the injection site. The reporter also said that along the edge of the swollen area there was a rash. The reaction occurred 8 days after receiving the injection. The outcome of the event was unknown.
Sex: U
Vaccine: HPVX, MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant reported through a Pfizer sales representative. This medical assistant reported similar events for two patients. This is the first of two reports. A patient of unspecified age, race/ethnicity and gender received TRUMENBA (Lot number 526962), intramuscular at single dose in the right arm on 13Jul2017 for immunisation. The patient medical history was not reported. Concomitant medication included HPV vaccine intramuscular in the left arm on 13Jul2017 for immunisation. On 14Jul2017, the patient experienced a more swollen than normal injection site reaction. In additional, there were three horizontal lines under the injection site. The caller believed that the lines were red lines. The outcome of the events was unknown.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Migraine
Clinical narrative: Severe migraine morning after vaccine lasting over 4 days. Patient went to Emergency room for relief.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Malaise, Nausea, Vomiting
Clinical narrative: On 7/3/2017 patient had pneumo vaccine around 1230, around 8 PM the same evening began to feel sick. Awakened 7/4 with generalized weakness. Tried to go to work that evening but found temp to be 107. Taking to ED on 7/4. Temp 101.8 WBC 23. Discharged with possible viral illness. Developed an episode of nausea and vomiting and was taken back to the hospital on 7/5. Temp was 99.2, WBC 33.3 EST 41.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: On 7/3/2017 patient had pneumo vaccine around 1230, around 8 PM the same evening began to feel sick. Awakened 7/4 with generalized weakness. Tried to go to work that evening but found temp to be 107. Taking to ED on 7/4. Temp 101.8 WBC 23. Discharged with possible viral illness. Developed an episode of nausea and vomiting and was taken back to the hospital on 7/5. Temp was 99.2, WBC 33.3 EST 41.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received MENVEO (batch number M16124, expiry date unknown). On an unknown date, the patient received MENVEO .5 ML. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to MENVEO. Additional details were provided as follows: It was reported that, the clinic recently changed their meningococcal vaccine from MENACTRA to MENVEO. All the injection site reactions were resolved without further sequelae. The nurse raised concern that there was an increased rate of reactions when compared to what they were used to seeing when they used MENACTRA. In obtaining the lot number for the report, the nurse noted that all doses from that box have been administered. No additional reports from remainer of the doses administered from that box were noted. The case was linked to US2017GSK117470 and US2017GSK119107, reported by same reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Rash papular, Rash pruritic, Vaccination site erythema, Vaccination site swelling
Clinical narrative: re/mom [lobby]: [7/24] TRUMENBA given---[7/25] redness/swelling left deltoid, applied ice pack---[7/28] erythematous pruritic papular lesions upper chest and upper back---[7/30] rash face....denies applying any new cosmetic/lotion, denies eating new foods. Start BENADRYL tablet, 50 mg, 1 tab q 6-8 hours x 3d then prn rash, PO, 30 days, 30, Refills 0. Start hydrocortisone topical ointment, 1%, 1 app, applied topically, 3 times a day, 7 days, 30 Gram, Refills 0. Notes: will report to VARS [with photos]. advised not to have TRUMENBA #2.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin irritation, Skin warm
Clinical narrative: The next day patient woke up with the area being red, raised but smooth, hot, and itching. 3 inches length and 2 inches wide. The patient was instructed to on 7/24/2017 when the pharmacy was informed to apply Vaseline and cover the area. She was also told to take BENADRYL 25mg. The patient contacted the pharmacy again on 7/27/17 because another area of the arm had developed 3 raised itchy areas. The patient was instructed to visit her medical doctor the next day for further evaluation.   On 8/1/2017 the pharmacy contacted the patient regarding her progress. The physician did not recommend any further treatment and advise patient to continue current recommendation. The patient reported that the skin irritations is almost heal and no longer bothersome.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blepharospasm, Blood glucose normal, Head titubation, Loss of consciousness, Pallor
Clinical narrative: Syncopal episode 2-5 minutes after administration of vaccine. Patient was sitting in chair, had brief episode of head dropping, eye twitching, head shaking and momentary loss of consciousness. Came to awareness within seconds then second similar episode occurred few minutes later. No incontinence. Appeared pale and drowsy immediately after event but became fully alert within minutes.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Posture abnormal, Somnolence, Syncope
Clinical narrative: Syncopal episode 2-5 minutes after administration of vaccine. Patient was sitting in chair, had brief episode of head dropping, eye twitching, head shaking and momentary loss of consciousness. Came to awareness within seconds then second similar episode occurred few minutes later. No incontinence. Appeared pale and drowsy immediately after event but became fully alert within minutes.
Age: 1.5
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Enterovirus infection, Enterovirus test positive, Febrile convulsion, Pyrexia, Seizure
Clinical narrative: Approximate 1 pm, patient had a seizure lasting from 30 seconds to 1 minute. Mother took to ER for evaluation- pt had another seizure of same length, also had fever of over 102 per Mom. Dx with enterovirus and febrile seizures.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness, warmth and swelling at injection site. On 7/26 swelling was 5.5x2.5 on 7/28 swelling was 12x5.5. Physician ordered KEFLEX and MEDROL dose pack on 07/26 then patient seen in ER on 7/28.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MNQ, TD, VARCEL
Symptoms: Papule, Rash erythematous, Rash pruritic, Scab, Varicella post vaccine
Clinical narrative: PT ACCOMPANIED BY MOTHER SHOWING GENERALIZED PAPULES WITH OCCASIONAL OPEN SCABS MAINLY ON TRUNK OF HER BODY WITH A FEW ON LIMBS AND BACK. SHE DIDN'T COMPLAIN OF ANY ITCHING OR DISCOMFORT. SEEN BY DR. WHEN MOTHER REPORTED THAT 8 DAYS AFTER RECEIVING VACCINATION ON 5/24/2017, PT HAD ITCHY RED RASH OVER HER BODY AND MOM TOOK PT TO A PHYSICIAN WHO TOLD HER THAT PT HAD CHICKEN POX.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth, Rash
Clinical narrative: On 7/30/2017, patient's mother brought patient into the clinic at approximately 1pm to have the vaccine site looked at. The left posterior upper arm had erythema, warmth, and tenderness to palpation extending 9cm down the arm from the injection site; the affected area measured 8cm in width. The child had a temperature of 100.2 orally and mom states that he had a low grade temperature since the evening of the day of the vaccine. Mom stated she had been giving the child TYLENOL but he had not had any so far that day. There was concern for cellulitis due to the warmth and tenderness and treated with cephalexin (250mg/5ml oral suspension) 7ml twice per day for 1 week. Instructed mom to use children's loratadine (otc) daily, according to package directions, until rash cleared. Instructed mom to continue children's TYLENOL according to package directions as needed for pain/fever. Instructed mom to f/u for any worsening or failure to improve.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: 7/24/17- 102-104 fever. 7/25/17- to Dr., ATB given in case of UTI, ATB started. 7/26/17- continued fever, rash noted on back. 7/27/17- rash head to toe, no itching, small red pinpoint rash, to Dr. stop ATB. 7/28/17- fever broke in middle of night, continued rash. 7/30/17- rash lessened. 8/1/17- rash only in few spots.
Age: 63.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Presyncope, Syncope
Clinical narrative: Patient was given Hep B shot with no issues. I then prepared the Hep A vaccine, administered it, then the patient fainted. I had the cashier call 911 and  the tech called for a store management. Right after coming to (about 20 seconds), EMS arrived and tend to the patient. She complained of being overheated, so I put an ice pack on the back of her neck and chest and gave her water to drink. After talking with EMS, we discovered the patient has 'vasovagal syndrome' and she mentioned, after receiving a Hep A shot in 2005, she fainted at that time as well. EMS transported the patient to the hospital after taking her vitals and other info.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received 13-JUL-2017 via a phone call from a pharmacist who reported that an unspecified adult patient received expired doses of 2 pediatric RECOMBIVAX HB 2.5/0.5 on 11-JUL-2017.  Lot numbers and expiration dates were unknown and no additional information was provided. "Unknown adverse effects reported." Follow up information was received 17-JUL-2017 via phone call from the same pharmacist who confirmed expired doses of RECOMBIVAX HB Lot # L002717, expiration date 01-JUN-2017 and administration date of 13-JUL-2017 (previously reported administration date was 11-JUL-2017). Additional information was requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: My daughter fainted and had seizure like movement. She has never done this following a vaccination. It really scared me and was very unusual for this to happen to her. She is not afraid of shots.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eyelid oedema, Fatigue, Lip swelling, Somnolence
Clinical narrative: Mother states that after immunization injection, he felt light headed and dizzy lasting only a short time. After they arrived home he was tired and went to sleep till 4 PM. Woke up w/Lips and eyelid swelling but no airway compromise. Gave him a dose of BENADRYL, had dinner a while later and given another dose around 9-10 PM. Checked on him several times during the night, no other reactions noted. Woke in the morning and still had facial swelling, given another dose of BENADRYL. Symptoms slowly improved, still noticed some swelling until the evening of the 24th of July.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: Mother states that after immunization injection, he felt light headed and dizzy lasting only a short time. After they arrived home he was tired and went to sleep till 4 PM. Woke up w/Lips and eyelid swelling but no airway compromise. Gave him a dose of BENADRYL, had dinner a while later and given another dose around 9-10 PM. Checked on him several times during the night, no other reactions noted. Woke in the morning and still had facial swelling, given another dose of BENADRYL. Symptoms slowly improved, still noticed some swelling until the evening of the 24th of July.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Contusion, Induration, Pain, Tenderness
Clinical narrative: Bruising with hard, tenderness and soreness.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Syncope, Tinnitus
Clinical narrative: 10 hours after administration, arm became swollen and patient developed syncope. Patient also experienced tinnitus, although not 100% sure this was connected to the vaccination.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia totalis, Condition aggravated, Fatigue
Clinical narrative: Alopecia totalis 24 hours after final shot; Extreme fatigue.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: Patient's arm was slightly swollen and red. Had some pain and heat radiating from site. Explained to patient that these reactions where a normal reactions to the vaccine. Advise patient to apply an ice pack to the site every 15 mins, take tylenol for the pain and fever, and benadryl for swelling and allergic reaction. After I comfort her and advised her on what to do, she was at ease. I assure her that she was not having any analphylactic reactions. However, I told her if her condition gets worst, she needs to be seen immediately, such as chest tightness or shortness of breath.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Peripheral swelling
Clinical narrative: Swelling, redness and muscular pain in left arm. Pt used ice but still having pain and swelling more than 24 hrs later.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient had a large red swollen patch on her upper arm the size of a softball. She complained that it hurt to touch and felt warm.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Vasovagal syncope approximately 5 minute post vaccination; normal breathing and color minutes after syncope (fall); patient was assessed by paramedics and send home.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: PATIENT EXPERIENCED VOMITING & DIARRHEA STARTING ON 7/22/17 LASTING 3 DAYS AFTER IMMUNIZATIONS & THEN HAD A FIRST TIME SEIZURE LASTING 3-4MINUTES ON 7/24/17.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS OVER UPPER ARM AND SHOULDER AROUND INJECTION SITE.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Neck pain, Pain, Paraesthesia
Clinical narrative: S/S paresthesias in arms and legs. Shooting pain in neck. Dizziness. Patient is an otherwise healthy 20-year-old female without significant medical history who presents for evaluation of what she described as pain all over. She admits that she had a Tdap shot in her left shoulder and has paresthesias in her arms and legs as well as intermittent shooting pain in her neck. She denies any focal headache. She denies any hearing or vision changes. She denies any pain with neck flexion. She denies any chest pain or pressure. She denies any SOB. She denies any recent illness. She denies any vomiting or diarrhea. She denies any urinary symptoms. Admits her last menstrual period is now. Denies any skin complaints or rashes. Otherwise appears in no distress. Her mother on further questioning indicates the patient has actually been fatigued for the past several months and was supposed to follow up with her primary care physician at her appointment today but did not mention any of these things to them. She subsequently wanted her to be evaluated in the ED. Patient denies any complaints at the moment with the exception of the paresthesias in her arms and legs.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Abnormal behaviour, Autism spectrum disorder, Diarrhoea, Drug hypersensitivity, Ear infection
Clinical narrative: My son had a couple more doses left of the amoxicillin left when these vaccines were given at his well check visit the following week after we brought him in for the ear infection. I had specifically questioned about the vaccines as I was worried about him still taking the final doses of the medication prescribed. All involved assured me it would be safe. Once home the next week he developed a high fever, rash (like Measles) diarrhea and within the week a massive yeast infection so bad it was foaming out of his mouth and but. For the next almost three months he was in and out of the doctor's office. He developed a double ear infection and was sick/ lethargic for a long time. His doctor never reported to VAERS but insisted he must have has a reaction to the antibiotic. I was never informed of VAERS until recently like the last two years. After he was getting better we noticed he would ignore us like he could not hear us. He lost the few words he had developed and started shying away from his sister, cousins and his father a lot. He was a babbler and a ham early on but after this illness he was not the same outgoing little boy. He was not talking or engaging with us as much and every time I asked his doctor about it she would say boys are different and it's been a long time since you had a baby. He will catch up (we have a 12 year gap between him and his older sister). When we finally decided to get him into preschool the teachers suspected Autism right away.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Foaming at mouth, Fungal infection, Lethargy, Malaise, Pyrexia
Clinical narrative: My son had a couple more doses left of the amoxicillin left when these vaccines were given at his well check visit the following week after we brought him in for the ear infection. I had specifically questioned about the vaccines as I was worried about him still taking the final doses of the medication prescribed. All involved assured me it would be safe. Once home the next week he developed a high fever, rash (like Measles) diarrhea and within the week a massive yeast infection so bad it was foaming out of his mouth and but. For the next almost three months he was in and out of the doctor's office. He developed a double ear infection and was sick/ lethargic for a long time. His doctor never reported to VAERS but insisted he must have has a reaction to the antibiotic. I was never informed of VAERS until recently like the last two years. After he was getting better we noticed he would ignore us like he could not hear us. He lost the few words he had developed and started shying away from his sister, cousins and his father a lot. He was a babbler and a ham early on but after this illness he was not the same outgoing little boy. He was not talking or engaging with us as much and every time I asked his doctor about it she would say boys are different and it's been a long time since you had a baby. He will catch up (we have a 12 year gap between him and his older sister). When we finally decided to get him into preschool the teachers suspected Autism right away.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Rash morbilliform, Speech disorder, Unresponsive to stimuli
Clinical narrative: My son had a couple more doses left of the amoxicillin left when these vaccines were given at his well check visit the following week after we brought him in for the ear infection. I had specifically questioned about the vaccines as I was worried about him still taking the final doses of the medication prescribed. All involved assured me it would be safe. Once home the next week he developed a high fever, rash (like Measles) diarrhea and within the week a massive yeast infection so bad it was foaming out of his mouth and but. For the next almost three months he was in and out of the doctor's office. He developed a double ear infection and was sick/ lethargic for a long time. His doctor never reported to VAERS but insisted he must have has a reaction to the antibiotic. I was never informed of VAERS until recently like the last two years. After he was getting better we noticed he would ignore us like he could not hear us. He lost the few words he had developed and started shying away from his sister, cousins and his father a lot. He was a babbler and a ham early on but after this illness he was not the same outgoing little boy. He was not talking or engaging with us as much and every time I asked his doctor about it she would say boys are different and it's been a long time since you had a baby. He will catch up (we have a 12 year gap between him and his older sister). When we finally decided to get him into preschool the teachers suspected Autism right away.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swollen painful unable to touch L-Deltoid.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Fatigue, Pain, Pyrexia
Clinical narrative: The day after vaccine, Pt reports low grade fever, body aches, fatigue and chest pain. Did not seek medical help at the time. Call placed to office on 7/28/17 at 09:30.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Groin pain, Injection site erythema, Injection site pain
Clinical narrative: Patient had redness, pain all over upper thigh that spread into groin area.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash generalised, Urticaria
Clinical narrative: 2 minutes after vaccines administered hive like rash note all over body and scalp. Appeared in no distress O2 Sat 100 Pulse 145 observed x 30 min hives cleared child comfortable. Will F/U with patient.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site bruising, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Numbness and tingle to right leg pain to feet which began after injection and became worse throughout the day. Injection received at 8:30 AM on 7-31-17. S/s then moved up to right arm with numbness and tingle. No treatment given. Pain at injection site with bruising today.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Skin warm, Swelling
Clinical narrative: Patient reports feeling pain at injection site starting on 7/31/17 around dinner time. Then patient experienced redness as big as their fist, swelling, and warmness that has persisted up until 8/1/17 when they reported the reaction. Patient self medicated with TYLENOL on 7/31/17 at dinner and again at bedtime.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Blood pressure decreased, Cold sweat, Fatigue, Feeling cold
Clinical narrative: About 5 minutes after receiving the vaccine, I was checking out at the front desk of the doctor's office and I turned around and saw my daughter sitting in a chair convulsing - it looked like she was having a seizure. My daughter was non responsive and I yelled for help. The nurse came out and we helped my daughter back to a chair and my daughter started saying that she couldn't see.  The nurse took her blood pressure and it was 60 over 30 in contrast to 120 over 80 when we arrived at the office. My daughter was cold and clammy - kept saying she was freezing and couldn't see. They layer her down and after about 15 minutes her blood pressure started coming back up.  She is still feeling tired and has a headache. This was a very scary incident - she has not had issues previously with any other vaccine and has no heath issues at all.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Seizure, Unresponsive to stimuli
Clinical narrative: About 5 minutes after receiving the vaccine, I was checking out at the front desk of the doctor's office and I turned around and saw my daughter sitting in a chair convulsing - it looked like she was having a seizure. My daughter was non responsive and I yelled for help. The nurse came out and we helped my daughter back to a chair and my daughter started saying that she couldn't see.  The nurse took her blood pressure and it was 60 over 30 in contrast to 120 over 80 when we arrived at the office. My daughter was cold and clammy - kept saying she was freezing and couldn't see. They layer her down and after about 15 minutes her blood pressure started coming back up.  She is still feeling tired and has a headache. This was a very scary incident - she has not had issues previously with any other vaccine and has no heath issues at all.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Mom reported 30 minutes after getting MENACTRA and GARDASIL 9 vaccine, patient became feverish, chills, lethargic, headache and nauseated for 3-4 hrs. Patient slept must of the day and evening on the couch. He called in sick to work the next day and did not move until mid-morning. Right upper arm GARDASIL 9 injection site did get a "little" raised, red and tender for 2-3 days.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Nausea, Pyrexia
Clinical narrative: Mom reported 30 minutes after getting MENACTRA and GARDASIL 9 vaccine, patient became feverish, chills, lethargic, headache and nauseated for 3-4 hrs. Patient slept must of the day and evening on the couch. He called in sick to work the next day and did not move until mid-morning. Right upper arm GARDASIL 9 injection site did get a "little" raised, red and tender for 2-3 days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Blood test, Chest X-ray, Chest pain, Dyspnoea
Clinical narrative: Since a few hours after vaccine was administered on 7/18/17. She had - injection site (L) arm - pain, puffiness (subsided). Pain continues shoulder, back, leg, chest pain - all on the left side. Shortness of breath.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Since a few hours after vaccine was administered on 7/18/17. She had - injection site (L) arm - pain, puffiness (subsided). Pain continues shoulder, back, leg, chest pain - all on the left side. Shortness of breath.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO. In July 2017, the patient received BEXSERO. In July 2017, less than a week after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to BEXSERO. Additional details were reported as follows: This case was reported by a Licensed Nurse Practitioner (LPN). The age at vaccination was not reported. About 2 hours before the time of reporting, the nurse reported that within the past 2 weeks the patient received a dose of BEXSERO. The next day of vaccination, the patient returned to the office for redness, heat, and pain at the injection site. No further related details were provided by the reporter. The reporter gave permission to contact her at the clinic, if necessary. This case had been linked with case US2017113731, reported by the same reporter.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swelling in the arm. Redness, ball like knot. Hot to touch. PO BENADRYL. Painful. 4-5 days approx.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swelling in the arm. Redness - ball like knot. Hot to touch. Painful - 4-5 days approx. PO BENADRYL wasn't enough went to urgent care.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test normal, Dizziness, Electrocardiogram normal, Loss of personal independence in daily activities, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tremor in a 10-year-old male patient who received HAVRIX 720 Junior (batch number MG4R9, expiry date 30th September 2018). On 20th July 2017, the patient received the 1st dose of HAVRIX 720 Junior. On 21st July 2017, 1 days after receiving HAVRIX 720 Junior, the patient experienced tremor and dizziness. On an unknown date, the outcome of the tremor was unknown and the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the tremor and dizziness to be related to HAVRIX 720 Junior. Additional details were reported as follows: No other concomitant vaccine was given. The patient's parent brought the patient to the emergency room and had full workup of EKG (electrocardiogram), BP (blood pressure) which showed normal results. The patient then followed up with PCP on 24th July 2017. The blood work was examined normal and reported that the only time the patient felt dizzy was when he bent down to tie his shoes when he was getting weighed. The patient still complained of dizziness at the time of reporting and had to leave camp after 1 hour.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Pt. reported to office w/blisters on both legs, arms and few on the back. Provider diagnosed with varicella without complication.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Burning sensation, Skin irritation
Clinical narrative: Patient is a 65 year old male who received the PCV13 vaccine on 3/29/17. At allergy clinic visit on 5/12/17 patient reported that after the vaccine he had burning and irritation on his hands which progressed to arm and both feet. He was advised by the call center to take antihistamine and patient took loratadine which helped but dried out his nasal mucosa. There are environmental factors at patients home that may contribute to patients condition. Consults were placed to social work and immunology in attempt to improve patients living situation and attempt to avoid other mitigation factors so that patient can stop loratadine.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fall, Loss of consciousness, Rash
Clinical narrative: Pt had appointment 4/27 with PCP who ordered PPSV23 and testosterone injection for same day administration in clinic. Pt received injection and reported back to PCP 4/28 with complaints of rash possibly d/t PPSV23 immunization. PCP advise him to place ice packs on the area, prn ADVIL, and go to the ER if he experienced any further symptoms. Upon telephone f/u with pharmacist on 5/1 pt reported on the afternoon of 4/28 he was dizzy while washing dishes, woke up laying on floor (not sure how long laid there), when woke up so weak couldn't get up, laid for 10 min then was able to get up. After that event he took an ADVIL and was alright the rest of the night. Pt reported using NEOSPORIN and taking ALIEVE on 4/29 and 4/30 with improvement of rash symptoms. On 5/1 pt reported rash had been alleviated. Skin Rash and Rash. Naproxen 500 mg every day, Neomycin/polymyx/pramoxine.
Age: 73.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in muscle in left arm. Cannot lift arm (left). Has been in pain for 1 month. Felt pain at injection, had gotten worse by 07/01 and could not lift arm.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever, maculopapular rash 10 days after MMR.
Sex: U
Vaccine: MMR
Symptoms: Pallor, Pyrexia, Rash
Clinical narrative: Fever to 103 7-30-17. Rash 7-31-17 - uniform blanchable not raised.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Face injury, Fall, Syncope
Clinical narrative: After shots and patient walked out of immunization room, he then collapsed and fell face first hitting a hard object. Did not loose consciousness but appear weak. Was transported to hospital by ambulance staff.
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, Injection site infection, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site infection in a 60-year-old female patient who received MENVEO (batch number M16127, expiry date 31st July 2018). On 19th July 2017, the patient received MENVEO. On 19th July 2017, unknown after receiving MENVEO, the patient experienced inappropriate age at vaccine administration. On 20th July 2017, the patient experienced injection site infection, fever, injection site pain and injection site swelling. The patient was treated with antibiotics nos (Brand Names Not Known). On an unknown date, the outcome of the injection site infection, fever, injection site pain, injection site swelling and inappropriate age at vaccine administration were unknown. The reporter considered the injection site infection, fever, injection site pain and injection site swelling to be almost certainly related to MENVEO. Additional details were provided as follows: The 60 years old patient received MENVEO in the pharmacy, which led to inappropriate age at vaccine administration. On 20th July 2017, 1 day after vaccination, the patient experienced injection site infection, fever, sore arm and arm swelling. Later, the patient went to emergency room, subsequently she was prescribed an unknown antibiotic and was released. The patient reported that, the antibiotic did not work and she was presented to the emergency room again. The patient was examined, and released. The patient visited the emergency room again, and an unknown procedure was done on the arm.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received MENVEO (batch number M16124, expiry date unknown). On an unknown date, the patient received MENVEO .5 ml. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to MENVEO. Additional details were provided as follows: It was reported that, the clinic recently changed their meningococcal vaccine from MENACTRA to MENVEO. All the injection site reactions were resolved without further sequelae. The nurse raised concern that there was an increased rate of reactions when compared to what they were used to seeing when they used MENACTRA. In obtaining the lot number for the report, the nurse noted that all doses from that box have been administered. No additional reports from remainder of the doses administered from that box were noted. The case was linked to US2017GSK117470 and US2017GSK119108, reported by same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received MENVEO (batch number M16124, expiry date unknown). On an unknown date, the patient received MENVEO .5 ml. On an unknown date, less than a week after receiving MENVEO, the patient  experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to MENVEO. Additional details were provided as follows: It was reported that, the clinic recently changed their meningococcal vaccine from MENACTRA to MENVEO. The patient received the dose 2 days earlier and had redness that was 1 and 1/2 to 2 inches. All the injection site reactions were resolved without further sequelae. The nurse raised concern that there was an increased rate of reactions when compared to what they were used to seeing when they used MENACTRA. In obtaining the lot number for the report, the nurse noted that all doses from that box have been administered. No additional reports from remainder of the doses administered from that box were noted. The case was linked to 2 other cases (US2017GSK119107 and US2017GSK119108), reported by same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm pain and swelling, no fever started TYLENOL/MOTRIN, BENADRYL for next 72 hours, start AUGMENTIN. Call office or return if needed.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient states that by the time she got home form office inj. site was sore, red and swollen. Pain was a '10' till 7-26-17. Redness and welts spread down to (L) elbow. Welts were 3" x 2" and 3" x 1". Inj. site redness and welt was 3.5" x 2". (L) arm was itchy also. Upper (L) arm was warmer to touch than forearm. Patient states has 'Bad' headache also. No fever. (lasted 8 days)
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pruritus, Urticaria
Clinical narrative: Patient states that by the time she got home form office inj. site was sore, red and swollen. Pain was a '10' till 7-26-17. Redness and welts spread down to (L) elbow. Welts were 3" x 2" and 3" x 1". Inj. site redness and welt was 3.5" x 2". (L) arm was itchy also. Upper (L) arm was warmer to touch than forearm. Patient states has 'Bad' headache also. No fever. (lasted 8 days)
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash erythematous, Vaccination site induration, Vaccination site reaction
Clinical narrative: Red rash at site of vaccination. Area is hardened and bumpy. Patient reported a fever. Symptoms ongoing for 1 week now.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Cough, Fatigue, Nasal congestion
Clinical narrative: Friday 7-28-17 evening patient got chills, achy joints, deep cough, fatigued, stuffy nose, fever. Shot vaccine location was warm and achy. Fever is gone today (7-31-17).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Friday 7-28-17 evening patient got chills, achy joints, deep cough, fatigued, stuffy nose, fever. Shot vaccine location was warm and achy. Fever is gone today (7-31-17).
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PPV
Symptoms: Feeling abnormal, Gait disturbance, Pain, Pain in extremity, Walking aid user
Clinical narrative: Severe pain for three months. Back to doctor and emergency room three times. Medication. I have permanent numbness in front part of right foot. I walk with a limp as a result of the pneumonia shot.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PPV
Symptoms: Gait disturbance, Hypoaesthesia, Pain
Clinical narrative: Severe pain for three months. Back to doctor and emergency room three times. Medication. I have permanent numbness in front part of right foot. I walk with a limp as a result of the pneumonia shot.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anal pruritus, Back pain, Cheilitis, Constipation, Erythema
Clinical narrative: Temp to 101, headache, full extreme body aches; from low back down to feet, lasting 5-6 days. Red scaly patch on left eye lid and on edge of left ear canal; raw feeling on edge of tongue and inner lips. Extreme.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye inflammation, Fatigue, Glossitis, Haemorrhoids, Headache
Clinical narrative: Temp to 101, headache, full extreme body aches; from low back down to feet, lasting 5-6 days. Red scaly patch on left eye lid and on edge of left ear canal; raw feeling on edge of tongue and inner lips. Extreme.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Pain in extremity, Proctalgia, Pyrexia, Skin exfoliation
Clinical narrative: Temp to 101, headache, full extreme body aches; from low back down to feet, lasting 5-6 days. Red scaly patch on left eye lid and on edge of left ear canal; raw feeling on edge of tongue and inner lips. Extreme.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vulvovaginal pain, Vulvovaginal pruritus
Clinical narrative: Temp to 101, headache, full extreme body aches; from low back down to feet, lasting 5-6 days. Red scaly patch on left eye lid and on edge of left ear canal; raw feeling on edge of tongue and inner lips. Extreme.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Body temperature increased, Cheilitis, Erythema, Eyelid exfoliation
Clinical narrative: Temp to 101, headache, full extreme body aches; from low back down to feet, lasting 5-6 days. Red scaly patch on left eye lid and on edge of left ear canal; raw feeling on edge of tongue and inner lips. Extreme.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Glossitis, Headache, Pain, Pain in extremity
Clinical narrative: Temp to 101, headache, full extreme body aches; from low back down to feet, lasting 5-6 days. Red scaly patch on left eye lid and on edge of left ear canal; raw feeling on edge of tongue and inner lips. Extreme.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Started developing a rash on her leg the evening of 7/31/17, then by 8/1/17 had widespread urticaria - was seen by myself to confirm diagnosis.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache
Clinical narrative: (Mother) stated that patient had a severe headache suddenly about a half hour after getting vaccinations. She describes the headache as severe and said that patient told her his head is pounding and was holding his head. Mother took him to the ER where they treated him for a migraine. On morning of 08/02/2017 mother states patient is feeling better.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse who reported that an unknown number of patients, names and other demographics unknown, received an unknown number of doses of PROQUAD (lot # M039448, expiration 20-MAR-2018) and VARIVAX (see MARRS # 1707USA002713) following a temperature excursion of -4.5C for two hours and two minutes. No adverse effects were reported in any patients. No other information is available. There was no previous temperature excursion. Call was because of a data logger. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients, names and other demographics unknown, who on multiple unspecified dates were vaccinated with improperly stored GARDASIL 9 (lot # and expiration date were unknown), or VAQTA (lot # and expiration date were unknown), or RECOMBIVAX HB (lot # and expiration date were unknown), or M-M-R II (lot # and expiration date were unknown) that were reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date unknown). The vaccines involved: GARDASIL 9, VAQTA, RECOMBIVAX HB and M-M-R II  were stored at temperatures in the range of 0 degrees Celsius to 1 degrees Celsius for 98 hours, 9 degrees Celsius to 25 degrees Celsius for 19 hours for a time frame of 0 degrees Celsius to 1 degrees Celsius for 98 hours, 9 degrees Celsius to 25 degrees Celsius for 19 hours as identified by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No further information was provided.  Additional information has been requested.
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: This initial spontaneous report was received from a physician via a company representative and refers to a 2 month old male patient. The patient was born a "preemie" at 33 weeks. Concomitant medications included ranitidine hydrochloride (ZANTAC). In January7 2017 (reported as six months ago), at age 2 months, the patient was vaccinated with his first dose of ROTATEQ 2 ml orally for the prevention of rotavirus along with PENTACEL and PREVNAR. In January 2017 (reported as six months ago), the patient experienced severe watery diarrhea which subsided. In March 2017 (reported as at 4 months old), he received his second dose of ROTATEQ and had another case of watery diarrhea but not as severe as the first case. This case of diarrhea also subsided. The physician also reported that the mother who breast fed the baby was on some type of "elimination diet". The patient did not received his third dose of ROTATEQ (also reported that it was withdrawn). The patient recovered from the diarrhea. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received on 12-JUL-2017 from a pharmacist (Pharm D) refers to a female patient of unknown age. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The pharmacist (Pharm D) reported that the first dose of VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) was administered to the female patient on an unspecified date "two years ago"  for prophylaxis. No symptoms reported. The pharmacist (Pharm D) was reporting on 12-JUL-2017 that an adult female patient was at the pharmacy right now (on 12-JUL-2017) to receive a second dose of VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) which will be late. The indication for the vaccine is prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT)(Lot number and expiration date were not reported).     The outcome of the adverse experience of inappropriate schedule of drug administration was reported as unknown. The pharmacist was busy at the time of this report and could not answer further questions. No further information was reported. Additional information has been requested.