chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Feeling cold, Headache, Influenza virus test, Myalgia
Clinical narrative: Severe back, muscle, body pains, low grade fever, feeling cold, progressed to headache, green black phlegm coming from nose and lungs.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Sputum discoloured
Clinical narrative: Severe back, muscle, body pains, low grade fever, feeling cold, progressed to headache, green black phlegm coming from nose and lungs.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Hypoaesthesia, Pain
Clinical narrative: Discomfort, pain and slight numb after sleeping on left side.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal distension, Diarrhoea, Gastrointestinal sounds abnormal, Nausea, Rash
Clinical narrative: Stomach bloating, rumbling, slight nausea. Nighttime diarrhea Thurs night and next day.  Sat. Nov 28 - rash on both lower arms.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm getting worse after 3-4 weeks having difficulty lifting arm higher than shoulder.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt had shingles shot at pharmacy on 11/16/2015 and on 11/18/15 he had an outbreak of shingles.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm getting worse after 3-4 weeks not better hurts to lift arm like fixing hair, fastening bra etc.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Drug eruption, Hypersensitivity, Rash generalised, Rash pruritic
Clinical narrative: Rash started on my legs and neck.  By the next morning I was covered with the rash, no fever, but very itchy.  Not on my face or hands, but everywhere else and very, very itchy.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient informed me the day after she got her flu shot, that she broke out in hives a few hours after receiving the vaccination that got worse when she took a shower. She said she took some Benadryl that seemed to help and they eventually went away.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: RED, ITCH, BURN, SWOLLEN AROUND INJECTION SITE FOR SEVERAL DAYS AFTER INJECTION.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: DAY OF SHOT, INJECTION SITE SORE COMBINED WITH WEAKNESS AND STOMACH CRAMPS. THE NEXT FOLLOWING 3 DAYS INJECTION SITE INCREASED IN SWELLING TO BASEBALL SIZE WITH DARK RED DOT WHERE INJECTION OCCURRED. IT IS ALSO WARM TO TOUCH. NO OTHER SYSTEMIC SYMPTOMS PRESENT.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: DAY OF SHOT, INJECTION SITE SORE COMBINED WITH WEAKNESS AND STOMACH CRAMPS. THE NEXT FOLLOWING 3 DAYS INJECTION SITE INCREASED IN SWELLING TO BASEBALL SIZE WITH DARK RED DOT WHERE INJECTION OCCURRED. IT IS ALSO WARM TO TOUCH. NO OTHER SYSTEMIC SYMPTOMS PRESENT.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in the shoulder.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Severe headache lasting 1 day.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Contusion, Erythema, Pain in extremity
Clinical narrative: Arm has been hurting ever since her shot on 10/15/2015. Pt states arm was bruised and red and feels like her bone hurts.
Age: 25.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching on back of head and neck, hives formed. Took antihistamine.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Body temperature increased, Chills, Diarrhoea
Clinical narrative: 1) wheal and flare reaction 30 minutes after persisted for 5 days. 2) nausea, vomiting, diarrhea, chills, temp to 102, profound malaise for 5 days, body aches for 4 days, alternating hot and cold for 6 days.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Nausea, Pain, Urticaria, Vomiting
Clinical narrative: 1) wheal and flare reaction 30 minutes after persisted for 5 days. 2) nausea, vomiting, diarrhea, chills, temp to 102, profound malaise for 5 days, body aches for 4 days, alternating hot and cold for 6 days.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Chills, Diarrhoea, Disorientation, Dizziness
Clinical narrative: Chills, fever (possible), severe nausea, vomiting on first day--light headedness, weakness, disorientation on second day--diarrhea started on third day--general fatigue, slight cold symptoms and tingling in left arm after that and continuing (this is 1 week and three days later).
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Nasopharyngitis, Nausea, Paraesthesia, Vomiting
Clinical narrative: Chills, fever (possible), severe nausea, vomiting on first day--light headedness, weakness, disorientation on second day--diarrhea started on third day--general fatigue, slight cold symptoms and tingling in left arm after that and continuing (this is 1 week and three days later).
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthritis, Asthenia, Burning sensation, Depression
Clinical narrative: Severe muscle & nerve pain, dizziness, burning all over like fire, headache, weakness, stabbing pains, itching, horrible sweats esp. at night, arthritis, systemic nerve pain, depression, can't work or excercise.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Hyperhidrosis, Impaired work ability, Myalgia
Clinical narrative: Severe muscle & nerve pain, dizziness, burning all over like fire, headache, weakness, stabbing pains, itching, horrible sweats esp. at night, arthritis, systemic nerve pain, depression, can't work or excercise.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Neuralgia, Pain, Pruritus
Clinical narrative: Severe muscle & nerve pain, dizziness, burning all over like fire, headache, weakness, stabbing pains, itching, horrible sweats esp. at night, arthritis, systemic nerve pain, depression, can't work or excercise.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Bradycardia, Presyncope
Clinical narrative: VASOVAGAL RESPONSE. BRADYCARDIA.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt came in 11/20 w/local site reaction - (L) upper arm was red, swollen, warm to touch and painful (approximately 8 x 6 in) she reported the reaction developed the 2nd day after administration. Rph on duty sent her to urgent care nearby where she received injectable antibiotic and was sent home w/antibiotic prescription. Dx: cellulitis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Mobility decreased, Tremor
Clinical narrative: After receiving vaccine patient had shaking at night for 1 night. She was tired for 2-3 days after. Couldn't lift her arm for about 1 week.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, soreness, swelling
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: Husband called and said patient is having headache. It started after vaccination and she has been taking TYLENOL as she is pregnant.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Inflammation
Clinical narrative: Localized - inflamed red heated area. Pt saw her physician and was given cephalexin 500 mg.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Tdap administered on 11/16/2015. Pt reports pain and erythema at injection site within 24 hours of administration that gradually worsened over the course of the next few days. Pt evaluated and txed at clinic 11/21/2015 for this c/o.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Decreased appetite, Malaise
Clinical narrative: Generalized malaise, decreased appetite, rhabdomyolysis. IV fluid hydration for rhabdomyolysis.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Rhabdomyolysis
Clinical narrative: Generalized malaise, decreased appetite, rhabdomyolysis. IV fluid hydration for rhabdomyolysis.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Large rash at injection site- about the size of a softball or grapefruit. patient was unsure of exact day/time that rash started. Rash felt warm to the touch and itchy. She also reported pain and discomfort at injection site.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reports muscle pain at injection site on 11/22/15. Flu shot was given on 9/1/15.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Cyanosis, Erythema, Injection site pain
Clinical narrative: Patient received the shot on 11/18/15 (FLUZONE HD by Sanofi) - within 48 hours the patient became sore at the injection site - the lower portion of the arm became red, then turned blue in color with extensive bruising - 11/21/15 still sore and discolored.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: Patient developed a large round, hard, inflamed spot at both injection site 4 days later.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Drug administered at inappropriate site, Injection site pain, Pain
Clinical narrative: Based on additional information received on 27-Apr-2015, this case became medically confirmed. Initial unsolicited report received from non-healthcare professional on 13 September 2014. A 75-year-old male patient, whose medical history was unknown and concomitant medications were not reported, had received first dose of FLUZONE HD (batch number was unknown, intramuscular in left deltoid) on 29-Aug-2014. The patient's illness at the time of vaccination was unknown. It was reported that on an unspecified date, after receiving FLUZONE HD vaccine, the patient experienced pain in left arm while lifting items and pain in the left shoulder. The patient required ER/doctor visit. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none. Follow up information received by a healthcare professional (Nurse) on 27-Apr-2015. It was reported that the vaccine was not received at the office of the nurse. No further information was known about the vaccine. Follow-up misuse information received from consumer on 02-Jun-2015. Patient birth weight was reported as 3.26 kg (7 lbs 3 oz). The patient did not receive any vaccine within 4 weeks prior to vaccination. Illness at the time of vaccination and adverse event following prior vaccination was reported as none. The patient did not have any pre-existing physician diagnosed allergies, birth defects and medical conditions. Patient had received FLUZONE HD vaccine in local drug store. On 29-Aug-2014 in evening, same day after vaccination patient experienced sharp pain in left arm when lifting items, sharp pain in the left shoulder and also patient discomfort for three and half month. Patient stated that injection site of the vaccine was not correct. It was reported that, patient never had a reaction to the procedure in the past forty years. Patient went to orthopedic surgeon. Patient took three and half year to get better. Follow up information received from consumer on 03-August-2015. Illness at the site of vaccination was reported as none. It was reported that patient had no adverse event following prior vaccination. On 29-August 2014, same day in evening, the patient experienced events.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Burning sensation, Erythema
Clinical narrative: Initial report received from a consumer (the patient) on 17 September 2014. An 87-year-old female patient had received first dose of FLUZONE HD, (batch number unknown, route and site of vaccination was not reported) on 29 August 2014. The patient's illness at the time of vaccination was not reported and had no medical history other than glaucoma. On 31 August 2014, 2 days after vaccination, the patients experienced pain, burning, red rash, hives, on neck, front and sides of upper chest. The symptoms worsened and the patient took BENADRYL allergy ultratab after contacting the physician on 02 September 2014. The patient also experienced red, burning, itching hives in front of neck and upper chest; vertigo, red, itchy skin tags; and edema of left side of neck on 03 September 2014. On 06 September 2014, the patient had pain in upper back and shoulders for which she was treated and received relief. On 08 September 2014, the symptoms continued and the patient was treated with MEDROL 4 mg for 6 day supply. From 09 September 2014 to 15 September 2014, the edema went down, still had some itching, some pain, new development of painful varicose veins of right leg, pain in upper back, and felt weak with little energy. As of 17 September 2014, the patient had felt "better" in the mornings but by afternoon felt weak and unable to do her usual daily activities. The patient had always been active person but cannot do the walking she had always done. The patient was sent to emergency room and was evaluated by doctor. Laboratory details were not reported. At the time of this report the patient had not recovered. Documents held by sender: none. Follow up information received from a consumer on 30 December 2014. It was reported that the female patient was vaccinated at pharmacy. No concomitant medications were reported but patient had used drops for glaucoma on an unspecified date and no medical history reported. The patient did not required Emergency Room/Doctor Visit. It was also reported that the patient had an surgically root extracted on 16 December 2014. The patient's face and neck were greenish and dark reddish in color and had pain and discomfort from the surgery, but also from allergic reaction which had from 29 August 2014 because of flu shot. The patient was felt weakness, pain, burning, and rash on the front, side and back of her neck intensified. The adverse event onset date was 31 August 2014.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Hypersensitivity, Localised oedema, Pain, Post procedural discomfort
Clinical narrative: Initial report received from a consumer (the patient) on 17 September 2014. An 87-year-old female patient had received first dose of FLUZONE HD, (batch number unknown, route and site of vaccination was not reported) on 29 August 2014. The patient's illness at the time of vaccination was not reported and had no medical history other than glaucoma. On 31 August 2014, 2 days after vaccination, the patients experienced pain, burning, red rash, hives, on neck, front and sides of upper chest. The symptoms worsened and the patient took BENADRYL allergy ultratab after contacting the physician on 02 September 2014. The patient also experienced red, burning, itching hives in front of neck and upper chest; vertigo, red, itchy skin tags; and edema of left side of neck on 03 September 2014. On 06 September 2014, the patient had pain in upper back and shoulders for which she was treated and received relief. On 08 September 2014, the symptoms continued and the patient was treated with MEDROL 4 mg for 6 day supply. From 09 September 2014 to 15 September 2014, the edema went down, still had some itching, some pain, new development of painful varicose veins of right leg, pain in upper back, and felt weak with little energy. As of 17 September 2014, the patient had felt "better" in the mornings but by afternoon felt weak and unable to do her usual daily activities. The patient had always been active person but cannot do the walking she had always done. The patient was sent to emergency room and was evaluated by doctor. Laboratory details were not reported. At the time of this report the patient had not recovered. Documents held by sender: none. Follow up information received from a consumer on 30 December 2014. It was reported that the female patient was vaccinated at pharmacy. No concomitant medications were reported but patient had used drops for glaucoma on an unspecified date and no medical history reported. The patient did not required Emergency Room/Doctor Visit. It was also reported that the patient had an surgically root extracted on 16 December 2014. The patient's face and neck were greenish and dark reddish in color and had pain and discomfort from the surgery, but also from allergic reaction which had from 29 August 2014 because of flu shot. The patient was felt weakness, pain, burning, and rash on the front, side and back of her neck intensified. The adverse event onset date was 31 August 2014.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Procedural pain, Pruritus, Rash erythematous, Skin discolouration, Surgery
Clinical narrative: Initial report received from a consumer (the patient) on 17 September 2014. An 87-year-old female patient had received first dose of FLUZONE HD, (batch number unknown, route and site of vaccination was not reported) on 29 August 2014. The patient's illness at the time of vaccination was not reported and had no medical history other than glaucoma. On 31 August 2014, 2 days after vaccination, the patients experienced pain, burning, red rash, hives, on neck, front and sides of upper chest. The symptoms worsened and the patient took BENADRYL allergy ultratab after contacting the physician on 02 September 2014. The patient also experienced red, burning, itching hives in front of neck and upper chest; vertigo, red, itchy skin tags; and edema of left side of neck on 03 September 2014. On 06 September 2014, the patient had pain in upper back and shoulders for which she was treated and received relief. On 08 September 2014, the symptoms continued and the patient was treated with MEDROL 4 mg for 6 day supply. From 09 September 2014 to 15 September 2014, the edema went down, still had some itching, some pain, new development of painful varicose veins of right leg, pain in upper back, and felt weak with little energy. As of 17 September 2014, the patient had felt "better" in the mornings but by afternoon felt weak and unable to do her usual daily activities. The patient had always been active person but cannot do the walking she had always done. The patient was sent to emergency room and was evaluated by doctor. Laboratory details were not reported. At the time of this report the patient had not recovered. Documents held by sender: none. Follow up information received from a consumer on 30 December 2014. It was reported that the female patient was vaccinated at pharmacy. No concomitant medications were reported but patient had used drops for glaucoma on an unspecified date and no medical history reported. The patient did not required Emergency Room/Doctor Visit. It was also reported that the patient had an surgically root extracted on 16 December 2014. The patient's face and neck were greenish and dark reddish in color and had pain and discomfort from the surgery, but also from allergic reaction which had from 29 August 2014 because of flu shot. The patient was felt weakness, pain, burning, and rash on the front, side and back of her neck intensified. The adverse event onset date was 31 August 2014.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Varicose vein, Vascular pain, Vertigo
Clinical narrative: Initial report received from a consumer (the patient) on 17 September 2014. An 87-year-old female patient had received first dose of FLUZONE HD, (batch number unknown, route and site of vaccination was not reported) on 29 August 2014. The patient's illness at the time of vaccination was not reported and had no medical history other than glaucoma. On 31 August 2014, 2 days after vaccination, the patients experienced pain, burning, red rash, hives, on neck, front and sides of upper chest. The symptoms worsened and the patient took BENADRYL allergy ultratab after contacting the physician on 02 September 2014. The patient also experienced red, burning, itching hives in front of neck and upper chest; vertigo, red, itchy skin tags; and edema of left side of neck on 03 September 2014. On 06 September 2014, the patient had pain in upper back and shoulders for which she was treated and received relief. On 08 September 2014, the symptoms continued and the patient was treated with MEDROL 4 mg for 6 day supply. From 09 September 2014 to 15 September 2014, the edema went down, still had some itching, some pain, new development of painful varicose veins of right leg, pain in upper back, and felt weak with little energy. As of 17 September 2014, the patient had felt "better" in the mornings but by afternoon felt weak and unable to do her usual daily activities. The patient had always been active person but cannot do the walking she had always done. The patient was sent to emergency room and was evaluated by doctor. Laboratory details were not reported. At the time of this report the patient had not recovered. Documents held by sender: none. Follow up information received from a consumer on 30 December 2014. It was reported that the female patient was vaccinated at pharmacy. No concomitant medications were reported but patient had used drops for glaucoma on an unspecified date and no medical history reported. The patient did not required Emergency Room/Doctor Visit. It was also reported that the patient had an surgically root extracted on 16 December 2014. The patient's face and neck were greenish and dark reddish in color and had pain and discomfort from the surgery, but also from allergic reaction which had from 29 August 2014 because of flu shot. The patient was felt weakness, pain, burning, and rash on the front, side and back of her neck intensified. The adverse event onset date was 31 August 2014.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Throat tightness
Clinical narrative: Initial report received from a health care professional on 12 December 2014. This case is a part of cluster of 3 cases and is linked to case 2014SA156617, 2014SA173257 and 2014SA130000. A 57-year-old female patient, had received an intramuscular dose of FLUZONE vaccine (lot number: U158AA, dose number and site was not reported) on 16 September 2014 ("PM"). The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. On 16 September 2014 ("AM") i.e. same day after vaccination patient experienced throat tightness. Corrective treatment was not reported and no laboratory details. On an unspecified date patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: throat tightness. Follow-up information was received for this unsolicited case on 30 March 2015 from a healthcare provider. The patient was vaccinated intramuscularly into the right deltoid with "FLUZONE QIV", lot number UI158AA, previously reported as "FLUZONE" lot number U158AA. The patient did not experience facial swelling. The patient's name, address and reporter name were clarified. No further information was reported. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Oropharyngeal discomfort
Clinical narrative: Initial report received from healthcare professional on 22 September 2014. This case is a part of 2 cluster cases and is linked to case 2014SA130000 (same reporter, after FLUZONE QIV, batch number: UI158AA). A 25-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UI158AA, intramuscular in right deltoid) on 17 September 2014. The patient has nonspecific allergies and has no illness at the time of vaccination. It was reported that on 17 September 2014, on the same day after receiving FLUZONE QIV vaccine, the patient experienced throat discomfort and injection site swelling. The patient self-medicated with Ibuprofen and BENADRYL as corrective treatments and laboratory investigations were not reported. As of 22 September 2014, the patient was recovered from events. Documents held by sender: none. Follow-up information received from healthcare professional on 17 November 2014. The patient received 0.5 ml of FLUZONE QIV vaccine and did not receive any concomitant medications. It was reported that, no laboratory tests were performed. Follow-up information received from a non-health care professional on 2 March 2015. The patient had not received any other vaccinations within 4 weeks prior. It was reported that the patient had no further problems after 17-September 2014. Dose number (illegible). Documents held by sender: None. Follow-up information received from healthcare professional on 6 April 2015. It was reported that all the events ceased on 20 March 2015.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Nausea, Rash macular, Vomiting
Clinical narrative: Initial report received from a health care professional on 19 September 2014. A 64-year-old female patient, had received a dose of FLUZONE HD vaccine (lot number: U5017BA, expiry date- 07 Apr 2015, route and dose number not reported) in right deltoid on 15 September 2014 and had received a dose of PNEUMOVAX 23 (Manufacturer- Merck lot number: J-010396, route and dose number not reported) in left deltoid on 15 September 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On 16 September 2014 i.e. one day after vaccination patient had experienced nausea, vomiting and diarrhea and now has a red blotchy area with downward angle 4 inches long hot red. Corrective treatment was not reported and no laboratory details. At the time of this report, patient outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 23 December 2014: The patient was vaccinated with second dose of FLUZONE HD and PNEUMOVAX 23 intramuscularly. The patient had no illness at the time of vaccination. The patient visited the physician and received some prescriptions to assist with the symptoms she was experiencing. The medications to assist with symptoms were given from 19 September 2014 to 20 September 2014. The patient recovered after a couple of days of treatment.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 29 September 2014. A 68-year-old female patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD (batch number: U5024CA, expiry date: not reported) in deltoid on 22-Sep-2014. On 22-Sep-2014, patient experienced red, swollen, warm to touch area of arm and fever. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Peripheral swelling, Upper respiratory tract congestion
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. A 68-year-old male patient, whose medical history and concomitant medication were not reported, received a dose of FLUZONE HD (batch number U5015BA, expiration date and dose in series not reported), and a dose of PNEUMOCOCCAL (batch number K007773, expiration date and dose in series not reported) on 03 September 2014. The patient had experienced upper respiratory congestion, bilateral upper extremity swelling, and difficulty breathing on 05 September 2014. It was also reported that the patient was instructed to go to ED and declined by the patient and self medicated with OTC BENADRYL and stated to report he felt better and declined physician's evaluations. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were denied. The detail of laboratory investigations and no other corrective treatment were not reported. At the time of this report, the outcome of the events was reported as resolved. List of documents held by sender: none. Follow-up information received from a healthcare professional on 18 November 2014. It was reported that patient received FLUZONE HD in right deltoid and PNEUMOCOCCAL VACCINE in left deltoid. Stop date of event was reported as 05-Sep-2014. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood cholesterol increased, Ear pain, Herpes zoster, Pain, Pain of skin
Clinical narrative: This spontaneous report was received from a 70 year old female consumer regarding herself. The patient's pertinent medical history and concurrent condition included chronic obstructive pulmonary disease (COPD) and unspecified cholesterol disorder. The patient was allergic sulfa drugs. On an unspecified date in either "2007 or 2008", the patient was vaccinated with ZOSTAVAX one shot, once, as shingles vaccination. Concomitant medications included DIOVAN, unspecified COPD medication and unspecified cholesterol medication. On an unspecified date of 2014, the patient developed Shingles. She experienced lesions in her scalp, neck and chin (all on the right side). She experienced pain which felt "like an electric shock". She lost weight and couldn't sleep or eat. The pain was "unbearable" for about ten days after which it seems to resolve slightly and the pain became "tolerable". The lesions resolved "fairly quickly". The patient was administered an unspecified anti-viral medication, gabapentin and ibuprofen. The patient visited the emergency room of an unspecified hospital "around New Year's Day in 2015" related to the intense pain she experienced during her shingles experience. The patient was given pain medications and released. She was not admitted to the Hospital. The patient was still on therapy with gabapentin and ibuprofen. All medications except for the COPD medications were discontinued when the patient developed shingles. On an unknown date, an unspecified blood test was performed (results not reported). The outcome of pain was reported as recovering. The outcome of lesions was reported as recovered. The outcome of shingles, loss of weight and inability to sleep or eat was not reported. Causality assessment was not provided. No additional information was provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Feeding disorder, Herpes zoster, Insomnia, Pain
Clinical narrative: This spontaneous report was received from a 70 year old female consumer regarding herself. The patient's pertinent medical history and concurrent condition included chronic obstructive pulmonary disease (COPD) and unspecified cholesterol disorder. The patient was allergic sulfa drugs. On an unspecified date in either "2007 or 2008", the patient was vaccinated with ZOSTAVAX one shot, once, as shingles vaccination. Concomitant medications included DIOVAN, unspecified COPD medication and unspecified cholesterol medication. On an unspecified date of 2014, the patient developed Shingles. She experienced lesions in her scalp, neck and chin (all on the right side). She experienced pain which felt "like an electric shock". She lost weight and couldn't sleep or eat. The pain was "unbearable" for about ten days after which it seems to resolve slightly and the pain became "tolerable". The lesions resolved "fairly quickly". The patient was administered an unspecified anti-viral medication, gabapentin and ibuprofen. The patient visited the emergency room of an unspecified hospital "around New Year's Day in 2015" related to the intense pain she experienced during her shingles experience. The patient was given pain medications and released. She was not admitted to the Hospital. The patient was still on therapy with gabapentin and ibuprofen. All medications except for the COPD medications were discontinued when the patient developed shingles. On an unknown date, an unspecified blood test was performed (results not reported). The outcome of pain was reported as recovering. The outcome of lesions was reported as recovered. The outcome of shingles, loss of weight and inability to sleep or eat was not reported. Causality assessment was not provided. No additional information was provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Skin lesion, Weight decreased
Clinical narrative: This spontaneous report was received from a 70 year old female consumer regarding herself. The patient's pertinent medical history and concurrent condition included chronic obstructive pulmonary disease (COPD) and unspecified cholesterol disorder. The patient was allergic sulfa drugs. On an unspecified date in either "2007 or 2008", the patient was vaccinated with ZOSTAVAX one shot, once, as shingles vaccination. Concomitant medications included DIOVAN, unspecified COPD medication and unspecified cholesterol medication. On an unspecified date of 2014, the patient developed Shingles. She experienced lesions in her scalp, neck and chin (all on the right side). She experienced pain which felt "like an electric shock". She lost weight and couldn't sleep or eat. The pain was "unbearable" for about ten days after which it seems to resolve slightly and the pain became "tolerable". The lesions resolved "fairly quickly". The patient was administered an unspecified anti-viral medication, gabapentin and ibuprofen. The patient visited the emergency room of an unspecified hospital "around New Year's Day in 2015" related to the intense pain she experienced during her shingles experience. The patient was given pain medications and released. She was not admitted to the Hospital. The patient was still on therapy with gabapentin and ibuprofen. All medications except for the COPD medications were discontinued when the patient developed shingles. On an unknown date, an unspecified blood test was performed (results not reported). The outcome of pain was reported as recovering. The outcome of lesions was reported as recovered. The outcome of shingles, loss of weight and inability to sleep or eat was not reported. Causality assessment was not provided. No additional information was provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 11.0
Sex: F
Vaccine: MNQ, MEN
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Case number PHHY2015US143228 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 589570) website on 02 Nov 2015. This report refers to an 11 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with Meningococcal ACWY Vaccine (manufacturer and batch number: not reported) into the left arm on 10 Aug 2015. On 11 Aug 2015, the patient developed excessive sweating, hardness, itching, rash and pain at the injection site. Following the events she visited emergency room. The outcome of the events was reported as unknown. The event was reported as non-serious and causality of the event was not reported. Following an internal review on 06 November 2015 for the information received on 02 November 2015, following correction was done: The coding of the event vaccinated site swelling was changed to extensive swelling of vaccinated limb.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Bradycardia, Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with his first dose of GARDASIL (intramuscularly, dose was not provided). The patient experienced bradycardia and he felt light headed and fainted immediately following the vaccination. The patient recovered from the events while he was still at the physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscularly, dose was not provided). The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient recovered from all the events again while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Follow up information has been received from the physician on 18-NOV-2015 referring to the 13 years old patient. The patient did not have any symptoms or complaints at the time of vaccination. Nor did he have any allergies, birth defect and medical conditions. On 05-FEB-2015, the patient received the first dose of GARDASIL (lot # K008931). On an unknown date after the first vaccination, the patient had similar episode with the vaccine which lasted for few minutes only. During the second vaccination of GARDASIL (lot # K008931) on 16-APR-2015 8:53 a.m., the reporter made the patient lie down prior to vaccination and took all precautions to prevent syncope/vasovagal. After 2 minutes of the vaccine, the patient felt dizzy, weak and he was sweaty. Pulse dropped from 73/min to 57/min. Blood pressure (B.P) dropped from 111/66 to 96/60. The patient was getting drowsy so the reporter kept talking to him and did all measure for vasovagal/syncope. It took the patient about 7 minutes to recover. The patient was seated up and the reporter walked him to bed of 15 minutes before the patient returned to baseline. The causality was not reported. The reporter considered the events to be serious as medical/surgical interventions were required to prevent serious outcome. Additional information has been requested. Reporter, patient demographic, lab test, suspect drug, AES and narrative have been updated.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood pressure decreased, Bradycardia, Dizziness, Heart rate decreased
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with his first dose of GARDASIL (intramuscularly, dose was not provided). The patient experienced bradycardia and he felt light headed and fainted immediately following the vaccination. The patient recovered from the events while he was still at the physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscularly, dose was not provided). The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient recovered from all the events again while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Follow up information has been received from the physician on 18-NOV-2015 referring to the 13 years old patient. The patient did not have any symptoms or complaints at the time of vaccination. Nor did he have any allergies, birth defect and medical conditions. On 05-FEB-2015, the patient received the first dose of GARDASIL (lot # K008931). On an unknown date after the first vaccination, the patient had similar episode with the vaccine which lasted for few minutes only. During the second vaccination of GARDASIL (lot # K008931) on 16-APR-2015 8:53 a.m., the reporter made the patient lie down prior to vaccination and took all precautions to prevent syncope/vasovagal. After 2 minutes of the vaccine, the patient felt dizzy, weak and he was sweaty. Pulse dropped from 73/min to 57/min. Blood pressure (B.P) dropped from 111/66 to 96/60. The patient was getting drowsy so the reporter kept talking to him and did all measure for vasovagal/syncope. It took the patient about 7 minutes to recover. The patient was seated up and the reporter walked him to bed of 15 minutes before the patient returned to baseline. The causality was not reported. The reporter considered the events to be serious as medical/surgical interventions were required to prevent serious outcome. Additional information has been requested. Reporter, patient demographic, lab test, suspect drug, AES and narrative have been updated.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Similar reaction on previous exposure to drug, Somnolence, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with his first dose of GARDASIL (intramuscularly, dose was not provided). The patient experienced bradycardia and he felt light headed and fainted immediately following the vaccination. The patient recovered from the events while he was still at the physician's office. On an unknown date the patient was vaccinated with second dose of GARDASIL (intramuscularly, dose was not provided). The events reappeared after second vaccination. The physician implemented conservative measures when the second dose was administered which included having the patient lie down. The patient recovered from all the events again while he was still at physician's office. The causality assessment was not reported. No product quality issue was reported. Follow up information has been received from the physician on 18-NOV-2015 referring to the 13 years old patient. The patient did not have any symptoms or complaints at the time of vaccination. Nor did he have any allergies, birth defect and medical conditions. On 05-FEB-2015, the patient received the first dose of GARDASIL (lot # K008931). On an unknown date after the first vaccination, the patient had similar episode with the vaccine which lasted for few minutes only. During the second vaccination of GARDASIL (lot # K008931) on 16-APR-2015 8:53 a.m., the reporter made the patient lie down prior to vaccination and took all precautions to prevent syncope/vasovagal. After 2 minutes of the vaccine, the patient felt dizzy, weak and he was sweaty. Pulse dropped from 73/min to 57/min. Blood pressure (B.P) dropped from 111/66 to 96/60. The patient was getting drowsy so the reporter kept talking to him and did all measure for vasovagal/syncope. It took the patient about 7 minutes to recover. The patient was seated up and the reporter walked him to bed of 15 minutes before the patient returned to baseline. The causality was not reported. The reporter considered the events to be serious as medical/surgical interventions were required to prevent serious outcome. Additional information has been requested. Reporter, patient demographic, lab test, suspect drug, AES and narrative have been updated.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: A couple of hrs. after flu shot soreness to shoulder area. Increasing pain over the following days and limited mobility of rt. arm. Severe pain after 5 weeks. Pain meds and p.t. have been ineffective. MRI done 11/12/15.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: A couple of hrs. after flu shot soreness to shoulder area. Increasing pain over the following days and limited mobility of rt. arm. Severe pain after 5 weeks. Pain meds and p.t. have been ineffective. MRI done 11/12/15.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old male patient with high blood cholesterol and with no drug reaction or allergies. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX intramuscularly (dose, lot # and expiration date were not reported). Concomitant therapies included PRADAXA and atorvastatin calcium (reported as generic LIPITOR). In November 2015, reported as about 10 days ago, the patient experienced developed an itching rash on his chest, arms, and legs. The patient did not seek medical attention. No lab diagnostic tests have been performed. Unspecified cortisone ointment was used as a treatment. At the time of the report the patient did not recovered from the event. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old male patient with high blood cholesterol and with no drug reaction or allergies. On 02-NOV-2015, the patient was vaccinated with ZOSTAVAX intramuscularly (dose, lot # and expiration date were not reported). Concomitant therapies included PRADAXA and atorvastatin calcium (reported as generic LIPITOR). In November 2015, reported as about 10 days ago, the patient experienced developed an itching rash on his chest, arms, and legs. The patient did not seek medical attention. No lab diagnostic tests have been performed. Unspecified cortisone ointment was used as a treatment. At the time of the report the patient did not recovered from the event. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Vaccination complication
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 31-year-old female patient who received FLUARIX (batch number H99B5, expiry date 30th June 2016). On 20th October 2015, the patient received FLUARIX. In 2015, less than a month after receiving FLUARIX, the patient experienced pain in arm and bursitis. On an unknown date, the outcome of the pain in arm and bursitis were unknown. It was unknown if the reporter considered the pain in arm and bursitis to be related to FLUARIX. Additional details were provided as follows: This case was previously reported to a health department. The patient had extreme left arm pain since receiving the FLUARIX. The patient reported the pain to her primary care physician. The primary care physician told the patient that the pain was a result of the Flu shot and wound require physical therapy. The patient reported her physician's findings to health department. The reporting nurse from health department described it as bursitis in the upper left arm. The patient reported that the pain felt like a torn rotator cuff.