chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Chest X-ray, Diarrhoea, Dysphonia, Headache, Non-cardiac chest pain
Clinical narrative: Patient came in to health department on 10/10/12 complaining of a reaction to her immunizations she received on 10/1/12. Patient states that she received Tdap and Flu vaccine on 10/1/12. On 10/2/12 she started with diarrhea that lasted for one day. She also complained of pain in her right lung that started on 10/2/12 and lasted for a total of 5 days and a dry cough and hoarseness that started on 10/2/12 and appears to be ongoing but is improving. On 10/8/12 she admits to starting with headaches that are in the back of her head on the right side only. The headaches have improved but do seem to come back with the coughing spells. She has taken ROBITUSSIN DM cough medicine four times a day for the cough, ADVIL 2 tabs every 6 hours as needed for the headache and cough drops for the cough and hoarseness. She denies any reaction at the injection site. She also denies any rash, chills fever or nausea. She did admit to her temperature remaining 97.2 throughout all of this. She is scheduled to go to urgent care this afternoon, 10/10/12, to be evaluated for her symptoms.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Productive cough
Clinical narrative: Patient came in to health department on 10/10/12 complaining of a reaction to her immunizations she received on 10/1/12. Patient states that she received Tdap and Flu vaccine on 10/1/12. On 10/2/12 she started with diarrhea that lasted for one day. She also complained of pain in her right lung that started on 10/2/12 and lasted for a total of 5 days and a dry cough and hoarseness that started on 10/2/12 and appears to be ongoing but is improving. On 10/8/12 she admits to starting with headaches that are in the back of her head on the right side only. The headaches have improved but do seem to come back with the coughing spells. She has taken ROBITUSSIN DM cough medicine four times a day for the cough, ADVIL 2 tabs every 6 hours as needed for the headache and cough drops for the cough and hoarseness. She denies any reaction at the injection site. She also denies any rash, chills fever or nausea. She did admit to her temperature remaining 97.2 throughout all of this. She is scheduled to go to urgent care this afternoon, 10/10/12, to be evaluated for her symptoms.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Fall, Paraesthesia
Clinical narrative: A few minutes after receiving FLUVIRIN and PNEUMOVAX 23, pt had needle-like pain in back and hips so severe she had to fall to the floor. She felt better after another few minutes, but her BP was elevated (191/86), so I referred her to her primary physician who saw her that day.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Malaise, Panic reaction
Clinical narrative: First influenza vaccination; within minutes c/o "not feeling well" ; clutching chest; c/o difficulty breathing; became panicky. EPIPEN given; sx began to subside in < 1 minute. Transported to ER via ambulance.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity, Skin irritation
Clinical narrative: Pt suffered painful, swollen arm which developed a day or two after receiving the PNEUMOVAX and FLUVIRIN shots. She called to explain her symptoms and we told her to see her MD. (She said the area irritated was the back of her arm and not the area where the shots were given) MD determined it was cellulitis and prescribed cefadroxil for her. Pt has high risk of C. difficile and was concerned about having to take antibiotic. Pt very upset about reaction she had.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Mobility decreased, Swelling, Ultrasound scan
Clinical narrative: Pt. describes soreness within 2 hrs. and pain at site. Next day c/o swelling and difficulty moving arm. 9-10-12 ER visit with diagnosis of cellulitis - IV antibiotics and sent home with steroid pack and BENADRYL. Began PT to prevent frozen shoulder 10-10-12.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Headache, Paraesthesia, Urticaria
Clinical narrative: Patient's mother called a couple of hours after the vaccination was administered to tell me that he had a headache, tingling in legs, temperature and hives. I advised to call paramedics. He was treated and released.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Infection, Pain in extremity
Clinical narrative: Patient received vaccine, and reported no reaction at that time. Then later that day patient called complaining of arm pain. Next day the patient's son called the pharmacy to report that his father/patient was in the hospital with an infection.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Pain, Pyrexia, Sinus congestion
Clinical narrative: 2 hours after receiving shot started with a dry cough, full sinuses within an hour or so of cough, had chills, fever 101 +, and unbelievable aches.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2/3 of (L) upper arm red and swollen.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Quarter size red area on (L) arm where injection was given.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with red swollen spot where injection was given 3 days ago. Injection was given to subcutaneous at left upper arm, and swelling went almost down to he elbow.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Erythema, tenderness/pain, itching at injection site beginning immediately after injection continuing through > 48 hrs.
Age: 28.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Chest pain, Cough, Feeling hot, Flushing
Clinical narrative: Within approx 5 min of receiving FLUMIST, patient felt heart racing and was "hot". Face flushed. 2 hrs. later had "really sore lungs" and had pain under sternum. Was healthy the day she received the mist. By 11 pm had deep cough, fever and sore chest and achy. Had to miss work. T. in am - 100.3 by report. Emesis from FLUMIST x 1.
Age: 28.0
Sex: F
Vaccine: FLUN3
Symptoms: Non-cardiac chest pain, Pain, Palpitations, Pyrexia, Vomiting
Clinical narrative: Within approx 5 min of receiving FLUMIST, patient felt heart racing and was "hot". Face flushed. 2 hrs. later had "really sore lungs" and had pain under sternum. Was healthy the day she received the mist. By 11 pm had deep cough, fever and sore chest and achy. Had to miss work. T. in am - 100.3 by report. Emesis from FLUMIST x 1.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oropharyngeal pain, Pruritus, Swollen tongue, Throat tightness
Clinical narrative: Pt received IM flu vaccine (R) arm approximately 5-10 min pt c/o itchiness (R) arm, then began w/ itch back/head, legs mild redness (R) arm 50 mg BENADRYL 1910 - pt felt less itchiness c/o tongue swollen and throat sore/tight pt observed 20 min swelling decreased - cont w/ itchiness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Arm is warm to touch, red around injection side.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Skin warm, Swelling, Wrong drug administered
Clinical narrative: Red, swelling, warm area bout 5x5 began about 12 hours after vaccine and slowly increased in size. Accidentally given a 3rd Hep A.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Electrocardiogram, Fatigue, Full blood count, Gaze palsy
Clinical narrative: Headache, stomach ache, fatigue, eyes rolled back in head. Took to ER.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Urine analysis
Clinical narrative: Headache, stomach ache, fatigue, eyes rolled back in head. Took to ER.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Received flu vaccine IM (RA) on 10-9-12 at school. That night client stated he began itching / sl. redness on arm. Then Thursday morning was worse warmth / redness / swelling noted. To see Dr if worsens.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Developed chicken pox about 2 weeks after vaccination. I had contacted chicken pox previously when I was 32 years of age. Treated with Avoclyr by personal physician.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: (R) deltoid localized vaccine reaction noticed by mother on 10/4/12 with redness, warm, minor tender to touch, no pain measured at 4 x 3 inches on 10/5/12 at 16:00.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Employee got intradermal flu vaccine. Within several hours, right arm swollen, red, pain and after 3 days redness covered entire bicep. Employee complaining of pain into neck and a headache. Symptoms now decreasing.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: Red rash around injection site. Body aches.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Bone pain, Erythema, Oedema peripheral
Clinical narrative: Patient called pharmacy on 10-5-12 complaining of her left arm being red and swollen. Her bones and knees were hurting as well. The pharmacist suggests she take BENADRYL and call her doctor, patient states she is fine today, 10-9-12. Her doctor told her to wait until Sunday 10-7-12 for further directions. No directions necessary she also used cold compresses.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Pt states that left deltoid muscle painful after administered Pneumococcal vaccine on Thursday Oct 4, 2012. Pt states that the pain was noticed about 4 hours after administration. Pt was given a cold pack to put on deltoid muscle and to take OTC Ibuprofen every four hours as needed.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red, tender area at spot of injection - advised to use BENADRYL.
Age: 1.28
Sex: M
Vaccine: PNC13
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Patient became very lethargic, feverish at 6 PM 10/15/12 - and left leg painful to touch, wouldn't stand on it. Slept for 14 hrs. - presents with fever, lethargy and leg pain.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Oedema peripheral, Pain in extremity
Clinical narrative: Pt's daughter called on 10/5/12. Pt c/o itching and redness at site of vaccination. Redness went up to neck. Arm was swollen and painful. Pt contacted MD - took ibuprofen, refused BENADRYL. Followed up with pt 10/6/12. Pt doing better, would not see MD.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site urticaria
Clinical narrative: Hives from administered site to shoulder.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was administered GARDASIL (lot number not provided) on an unspecified date that had been improperly stored. The GARDASIL had been stored at room temperature of 72-74 F for 2 weeks prior to administration. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Pt described that the day after receiving her shot that area, area developed. Some itching noticed. No pain. By Saturday AM she had come to the clinic for evaluation. The area of induration was 6" x 6". Warm to touch. A ARNP reviewed the situation and prescribed KEFLEX as precaution for cellulitis.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Nausea, Pyrexia, Vomiting
Clinical narrative: 3 hours after vaccine admin developed cough, later that eve developed fever, chills, nausea and vomiting.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema/edema (R) thigh.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain, Rash erythematous
Clinical narrative: Pt. had reaction to PNEUMOVAX vaccine. Got red spots on arm and experienced pain. Went ER room. Doctor said it was cellulitis. Pt. is to follow-up with Dr. in 4 days. Wife got same shot, same vial no issues.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Patient received both flu and pneumonia vaccines on the same day/same arm. She called two days later complaining of swelling, redness, tenderness to her elbow. She took diphenhydramine with no relief then physician prescribed KEFLEX in case of infection.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Arm where vaccine was injected swelled more than normal and steroids were given by patient's primary care physician. No other signs or symptoms occurred.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Several hours after a flu and pneumonia shot the patient required an ER visit for arm pain and impaired movement.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Swelling face
Clinical narrative: Swelling under (L) eye, and pt. f/u with ER and given PEDIAPRED 1 tsp x 5 days.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Nasal discomfort, Oedema peripheral, Paraesthesia
Clinical narrative: Redness, itching, swelling of arms, legs, back, hands. Tingling and itching throat and nose, shortness of breath. Rec'd BENADRYL / SOLU-MEDROL IM and BENADRYL - MEDROL Dose Pak.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation
Clinical narrative: Redness, itching, swelling of arms, legs, back, hands. Tingling and itching throat and nose, shortness of breath. Rec'd BENADRYL / SOLU-MEDROL IM and BENADRYL - MEDROL Dose Pak.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever up to 104.0 within 12 hours of TWINRIX & ADACEL vaccines given.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Redness, itch, rash, horizontal welts. Treatment at ER Prednisone 60mg, Famotidine 20mg, BENADRYL 50mg.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Influenza was mistakenly administered subdermal instead of PPD. Forearm became red, swollen, itchy, warm at site of injection. Treated with triamcinolone 1% cream. Symptoms subsided after 2 days. Small residual red "nickel" size spot remains today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Pt. received flu vaccine 10/11/12, said arm started hurting 10/13/12, came in 10/16/12 to see if sore arm, radiating into back was normal.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: Tingling of lips and tongue, scratchy throat - gave EPIPEN x 1 dose called 911 - pt brought to hospital.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Influenza was mistakenly administered subdermal instead of PPD. Forearm became red, swollen, warm at site of injection. Treated with ice pack. Symptoms subsided after 2 days. Small residual red "nickel" size spot remains today.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pruritus generalised, Pyrexia, Rash
Clinical narrative: Itching all over. Rash on arms. Fever for 3 days. Fatigue.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Throat irritation
Clinical narrative: Developed itching in face, head and throat. Used albuterol inhaler about 30 mins after vaccination. BENADRYL 30 mg po x 1 at 425 pm - complete symptom resolution.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient had rash a few inches below injection site. She thought it was from flu shot.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Cytomegalovirus test, Epstein-Barr virus test, Full blood count, Headache, Joint swelling
Clinical narrative: Fever shortly after vaccine given that is still present 4 days later, body aches, headache, left knee swelling.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Fever shortly after vaccine given that is still present 4 days later, body aches, headache, left knee swelling.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain, Pyrexia, Vomiting
Clinical narrative: Apparently a few hours after FLUMIST was admin. pt developed fever, vomiting and abdominal pain. As of 11 AM on 10-16-12 symptoms continue.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Employee (physician) states following flu shot she developed a stiff neck, left upper extremity muscular pain and headache.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Chest X-ray normal, Papule, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Patient presented to ER on 10/12/12 with complaint of fever 103 degrees. He was discharged. Seen at PCP office on 10/16/12 for a rash which started on 10/13/12. Flesh colored papules on trunk, bilateral legs and arms. MD diagnosis was probable post-varicella rash. Calamine and BENADRYL as needed for itching.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection
Clinical narrative: The patient came in to see me at the pharmacy late Monday afternoon to see if I thought she was having an allergic reaction to the ZOSTAVAX she got on Saturday. The site was red & hard, about 2 inches diameter. We got her in to see her PCP Tuesday afternoon. He said the injection site was infected and he gave her antibiotics and she is much better now.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Directly after receiving flu vaccine employee came to me with c/o itching, red patchy macular rash to forearms, face and flushed and feels like a "heating pad on my neck. Sent to ER and on arrival rash spread to trunk and began vomiting. Treated with IM BENADRYL and IM SOLUMEDROL and symptoms subsided.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Vomiting
Clinical narrative: Directly after receiving flu vaccine employee came to me with c/o itching, red patchy macular rash to forearms, face and flushed and feels like a "heating pad on my neck. Sent to ER and on arrival rash spread to trunk and began vomiting. Treated with IM BENADRYL and IM SOLUMEDROL and symptoms subsided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed hives approx. 4 hrs after received flu vaccine. Took BENADRYL and resolved.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Meningitis viral
Clinical narrative: Patient states she was diagnosed with viral meningitis after receiving FLUZONE.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt. describes numbness down entire left arm and tingling and numbness in left hand and fingers. Unknown if due to fibromyalgia.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Occurred 3 days after receiving vaccine was seen by MD. Area of erythema to (R) arm. Treated with KEFLEX 500mg 1 cap TID x 20 days.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Nausea, Pyrexia, Vomiting
Clinical narrative: 10/11/12 - Mild reaction as reported by patient: Low-fever 100.5, vomiting, nausea, can't left left arm, can't get out of bed.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Immediate post-injection reaction, Injection site pain, Rash
Clinical narrative: Patient experienced pain at the time injection was administered on 10/11/12. Pain was worst on 10/12/12 in the morning around 8:30am and continued. Rash was noticed next to right armpit. On 10/12/12 pain was 90% better (subsided) by 10/15/12. Patients rash cleared up in 10/14/12 after taking BENADRYL on 10/13/12.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Severe rigors, myalgia, fevers, and body aches. No rash or allergic reaction.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Injection site urticaria
Clinical narrative: Hives on left arm at injection site. Later that evening felt short of breath, member took a shower (hot shower) and symptoms increased. Member took a BENADRYL and felt slightly better. Members SOB is intermittent and she takes BENADRYL for it tightness in chest. No further treatment required.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse concerning a female patient who received GARDASIL doses on 18-MAR-2012 and 02-FEB-2012. The patient had not yet received the third dose. No adverse effect was reported. No further information was available. 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 mother refers to her daughter of unknown age. The patient was vaccinated with dose 1, 0.5 ml GARDASIL in October 2007, by intramuscular injection. No other co-suspects were reported. No concomitant medications were reported. The patient got her second 0.5ml dose intramuscularly in December 2007 and third 0.5 ml dose intramuscularly in December 2009. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via a medical representative concerning a patient of unknown age and gender. On an unknown date, approximately in September 2008 (about 4 years ago), the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number unspecified as the patient had no record of first dose). No concomitant medications were reported. On 13-SEP-2012, the patient was given the second dose of GARDASIL (dose, route and lot number unspecified). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Fatigue
Clinical narrative: Information was received by a physician regarding a teenage female who was vaccinated with GARDASIL intramuscularly (dose was given as "0, 2, and 6 months"); however it is unknown how many doses the patient received. Subsequently, the patient complained of hair loss and fatigue. It was unsure if dosing schedule had been completed. It was reported that the events did not improve/ that the patient had not recovered. No further information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age. The patients were vaccinated with 0.5 ml GARDASIL (lot number 661953/1130X; expired date 13-MAR2011) between the dates of July 2012 to October 2012 exact dates unknown. No other co-suspects were reported. No concomitant medication were reported. The two patients administered GARDASIL between the dates of July 2012 to October 2012, they were expired. No adverse effects reported. The outcome was unknown at the time of report. It was unspecified if the patients had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a her daughter, a female patient of unknown age. On an unknown date the patient was vaccinated GARDASIL, dose and route were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown the reporter thinks her daughter is having a reaction to GARDASIL. No treatment information was reported. The outcome of thinks her daughter is having a reaction is unknown. The relatedness for thinks her daughter is having a reaction was not reported for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 years old male patient. The patient was vaccinated with the first dose GARDASIL (lot number and expired date were not reported) (0.5 ml/3 shot series intramuscular injection) on 25-JUL-2011. No other co-suspects were reported. No concomitant medications were reported. The second shot of GARDASIL was given on 30-SEP-2011 and the third shot was given on 01-DEC-2011. The patient received his third dose of GARDASIL too early. No adverse reaction was reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a physician concerning a 20 year old female patient, who was vaccinated with her first dose of GARDASIL in 2009. In JUL-2012, the patient was vaccinated with her second dose of GARDASIL, 0.5 ml intramuscularly. No further information was provided. No additional adverse event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a consumer regarding her daughter (age not provided). The state sent the consumer a letter saying her daughter missed her third dose of GARDASIL. The consumer thinks her daughter had all three doses but the physician's office thinks she only had two. No AE symptoms were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RVX
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a health care worker (C.M.A) concerning a patient of unknown age who on 01OCT2012 was vaccinated with rotavirus vaccine, live, oral, pentavalent. The health care worker reported that the patient was administered an expired dose of rotavirus vaccine, live, oral, pentavalent. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # (661953/1130X), expired on 13-MAR-2011) on 20-SEP-2012. No adverse effect reported. This is one of several reports received from the same source. (MARRS 1210USA006583). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # (661953/1130X), expired on 13-MAR-2011) on 21-SEP-2012. No adverse effect reported. This is one of several reports received from the same source. (MARRS 1210USA006583). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pain, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient without drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot # reported as H011426, expiration date 12-SEP-2013) on 29-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-OCT-2012 the patient experienced local injection site reaction after receiving ZOSTAVAX. The patient started having symptoms of pain, redness, swelling and warm to touch on 01-OCT-2012. No treatment for the adverse event. The outcome of event was reported as not recovered/not resolved. The patient had sought unspecified medical attention via calling pharmacist. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot number 670818/0662AA; expire date: 04-AUG-2012) (vaccination site unspecified) on 01-OCT-2012. No adverse events experienced. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 years old female patient with no drug reactions/allergies. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number not reported) 0.65 ml on 01-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 02-OCT-2012, the next morning after vaccination with ZOSTAVAX, the patient experienced a half-egg shaped swelling with redness and heat at the injection site and in the afternoon the patient went to her doctor because she had vesicles on both sides of her body from her armpit to her waist. The patient took BENADRYL on her own. On 02-OCT-2012, the patient's husband also experienced half-egg shaped swelling with redness and heat at the injection site and vesicles (location unspecified) (MARRS # 1210USA006414). At the time of the report, the patient's outcome was unknown. The relatedness for half-egg shaped swelling with redness and heat at the injection site and vesicles on both sides of her body from her armpit to her waist was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 63 years old female patient. The patient was vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (reported lot # 0468AA, is an invalid lot number for ZOSTAVAX; exp date 04-APR-2012) on 17-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient had a local injection site reaction to ZOSTAVAX. The patient developed itchy redness in the upper left arm. The registered nurse stated that the patient called in to report this the day after the vaccination on 18-SEP-2012. The events persisted for 7 days (until approximately 24-SEP-2012). No treatment was given for the events and no lab diagnostic tests were performed. The outcome of local injection site reaction and itchy redness in the upper left arm was reported as recovered. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to an adolescent male patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of RECOMBIVAX HB (Lot # not reported, expiration date 09-OCT-2012) SQ on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to patient of an unknown age who on 05-OCT-2012, was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (lot # 669776/0614AA) that was expired. The vaccine expired on 27-SEP-2012. No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 49 years old male patient who on an unknown date, was vaccinated intramuscularly in his left arm with a 0.5 ml dose of PNEUMOVAX 23 (lot # 669776/0614AA) that was expired. The vaccine expired on 27-SEP-2012. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician refers to a female patient in her 60's. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles and post herpetic neuralgia after receiving the vaccine. It was unspecified if the patient sought medical attention. No treatment information was reported. The outcome of shingles and post herpetic neuralgia was unknown. The relatedness for shingles and post herpetic neuralgia was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles, 2 days after receiving the vaccine. It was unknown if the patient sought medical attention. No treatment information was reported. The outcome of shingles was unknown. The relatedness for shingles was not provided for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Oedema peripheral, Tenderness
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a female patient of unknown age. On 13-SEP-2012, the patient was vaccinated with ZOSTAVAX (lot # reported as 0071AE, expiry 03-APR-2013). No concomitant medications were reported. On an unknown date, the patient's arm became swollen and redness around the injection site was about the size of an orange. Patient also experienced tenderness. Patient sought medical attention by visiting the physician's office. Patient received treatment with prednisone. The outcome of the events were unknown. The relatedness for the events was unknown for ZOSTAVAX. Nurse requested for lot # check and requested result of the lot # check sent to the office. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 13 years old female patient with no pertinent medical history or drug allergy. The patient was vaccinated with the first dose of VARIVAX (Merck) on 22-DEC-1999. No other co-suspects were reported. No concomitant medications were reported. On an unknown date after the vaccination of VARIVAX (Merck) the patient developed chickenpox. The patient's mother called office where the medical assistant worked for medical attention. The reporter stated that the patient was never administered the second dose of VARIVAX (Merck). The outcome of chickenpox was reported as recovered/resolved on an unknown date. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 months old male patient. The reporter reported that a patient received PNEUMOVAX 23 (lot # was unknown) as a first dose at 3 months of age in October 2011 and as a second dose at 4 months of age, in November 2011 for vaccination. The error was just recently discovered (date of discovery unspecified) and the patient was now 15 months of age. No product confusion discovered, No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified patient. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # 663197/1418X, expiration date 04-APR-2010) on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was inadvertently administered with VARIVAX (Merck) (subcutaneously, lot # unspecified) instead of ZOSTAVAX on 28-SEP-2012. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Artificial rupture of membranes, Delivery, Human chorionic gonadotropin positive, Live birth, Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), typhoid vaccine (non-gsk) and anthrax vaccine (non-gsk). Concurrent medical conditions included seasonal allergy. Concurrent medications included ZYRTEC and SINGULAIR. On 20 July 2011 the subject received a dose of BOOSTRIX (details unknown), 1st dose of typhoid vaccine (Non-GSK) (details unknown), 2nd dose of anthrax (Non-GSK) (details unknown), and experienced vaccine exposure during pregnancy. The subject was approximately 30 days pregnant at the time of vaccination. Date of last menstrual period was not provided. Estimated delivery date was 02 March 2012. No other adverse events were reported. Follow-up information was received on 10 January 2012 via healthcare professional. Concurrent medical conditions included allergy to pet dander, asthma, hyperemesis gravidarum, pollen allergy and seasonal allergy. Additional co-suspect medications included ZOFRAN, albuterol and FLOVENT. On 20 July 2011 the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown), 1st dose of typhoid vaccine (Non-GSK) (.5 ml, intramuscular, unknown), 2nd dose of anthrax vaccine (.5 ml, intramuscular, unknown). The subject's last menstrual period was on 27 June 2011 and estimated date of delivery is 05 April 2012 (previously reported as 02 March 2012). The pregnancy was by normal conception and consisted of one fetus. Relevant test results included: On 01 August 2011, Qualitative human chorionic gonadotropin (hCG) serum positive and hCG quantitative, serum 1072. On 16 August 2011, hCG quantitative, serum 44747. On 20 September 2011, OB ultrasound showed 1) Live single intrauterine gestation demonstrating NL interval growth and grossly normal anatomy. 2) Overall decreased echotexture and size of the previously noted subchronic hemorrhage compatible with interval maturation. No new hemorrhage identified. Hyperemesis gravidarum. On 12 December 2011, OB ultrasound showed fetal measurement consistent with dating. No evidence of major fetal abnormalities. At the time of the report the outcome of the pregnancy was ongoing. Follow-up information was received on 10 April 2012. It was reported that the subject delivered a live, full term, baby boy on 05 April 2012 via spontaneous vaginal birth. The neonate weighed 3.7 kg and had APGAR scores of 9.0 and 9.0 at 1 and 5 minutes following delivery. The delivery was complicated by moderate meconium. There was artificial rupture of membranes and spontaneous crying of the baby at the perianum at the time of delivery. No other events were noted or reported.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Meconium stain
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), typhoid vaccine (non-gsk) and anthrax vaccine (non-gsk). Concurrent medical conditions included seasonal allergy. Concurrent medications included ZYRTEC and SINGULAIR. On 20 July 2011 the subject received a dose of BOOSTRIX (details unknown), 1st dose of typhoid vaccine (Non-GSK) (details unknown), 2nd dose of anthrax (Non-GSK) (details unknown), and experienced vaccine exposure during pregnancy. The subject was approximately 30 days pregnant at the time of vaccination. Date of last menstrual period was not provided. Estimated delivery date was 02 March 2012. No other adverse events were reported. Follow-up information was received on 10 January 2012 via healthcare professional. Concurrent medical conditions included allergy to pet dander, asthma, hyperemesis gravidarum, pollen allergy and seasonal allergy. Additional co-suspect medications included ZOFRAN, albuterol and FLOVENT. On 20 July 2011 the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown), 1st dose of typhoid vaccine (Non-GSK) (.5 ml, intramuscular, unknown), 2nd dose of anthrax vaccine (.5 ml, intramuscular, unknown). The subject's last menstrual period was on 27 June 2011 and estimated date of delivery is 05 April 2012 (previously reported as 02 March 2012). The pregnancy was by normal conception and consisted of one fetus. Relevant test results included: On 01 August 2011, Qualitative human chorionic gonadotropin (hCG) serum positive and hCG quantitative, serum 1072. On 16 August 2011, hCG quantitative, serum 44747. On 20 September 2011, OB ultrasound showed 1) Live single intrauterine gestation demonstrating NL interval growth and grossly normal anatomy. 2) Overall decreased echotexture and size of the previously noted subchronic hemorrhage compatible with interval maturation. No new hemorrhage identified. Hyperemesis gravidarum. On 12 December 2011, OB ultrasound showed fetal measurement consistent with dating. No evidence of major fetal abnormalities. At the time of the report the outcome of the pregnancy was ongoing. Follow-up information was received on 10 April 2012. It was reported that the subject delivered a live, full term, baby boy on 05 April 2012 via spontaneous vaginal birth. The neonate weighed 3.7 kg and had APGAR scores of 9.0 and 9.0 at 1 and 5 minutes following delivery. The delivery was complicated by moderate meconium. There was artificial rupture of membranes and spontaneous crying of the baby at the perianum at the time of delivery. No other events were noted or reported.
Age: 33.0
Sex: F
Vaccine: ANTH, TDAP, TYP, ANTH, TDAP, TYP
Symptoms: Artificial rupture of membranes, Delivery, Human chorionic gonadotropin positive, Hyperemesis gravidarum, Live birth
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), typhoid vaccine (non-gsk) and anthrax vaccine (non-gsk). Concurrent medical conditions included seasonal allergy. Concurrent medications included ZYRTEC and SINGULAIR. On 20 July 2011 the subject received a dose of BOOSTRIX (details unknown), 1st dose of typhoid vaccine (Non-GSK) (details unknown), 2nd dose of anthrax (Non-GSK) (details unknown), and experienced vaccine exposure during pregnancy. The subject was approximately 30 days pregnant at the time of vaccination. Date of last menstrual period was not provided. Estimated delivery date was 02 March 2012. No other adverse events were reported. Follow-up information was received on 10 January 2012 via healthcare professional. Concurrent medical conditions included allergy to pet dander, asthma, hyperemesis gravidarum, pollen allergy and seasonal allergy. Additional co-suspect medications included ZOFRAN, albuterol and FLOVENT. On 20 July 2011 the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown), 1st dose of typhoid vaccine (Non-GSK) (.5 ml, intramuscular, unknown), 2nd dose of anthrax vaccine (.5 ml, intramuscular, unknown). The subject's last menstrual period was on 27 June 2011 and estimated date of delivery is 05 April 2012 (previously reported as 02 March 2012). The pregnancy was by normal conception and consisted of one fetus. Relevant test results included: On 01 August 2011, Qualitative human chorionic gonadotropin (hCG) serum positive and hCG quantitative, serum 1072. On 16 August 2011, hCG quantitative, serum 44747. On 20 September 2011, OB ultrasound showed 1) Live single intrauterine gestation demonstrating NL interval growth and grossly normal anatomy. 2) Overall decreased echotexture and size of the previously noted subchronic hemorrhage compatible with interval maturation. No new hemorrhage identified. Hyperemesis gravidarum. On 12 December 2011, OB ultrasound showed fetal measurement consistent with dating. No evidence of major fetal abnormalities. At the time of the report the outcome of the pregnancy was ongoing. Follow-up information was received on 10 April 2012. It was reported that the subject delivered a live, full term, baby boy on 05 April 2012 via spontaneous vaginal birth. The neonate weighed 3.7 kg and had APGAR scores of 9.0 and 9.0 at 1 and 5 minutes following delivery. The delivery was complicated by moderate meconium. There was artificial rupture of membranes and spontaneous crying of the baby at the perianum at the time of delivery. No other events were noted or reported.