chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Anxiety, Bone pain, Bronchitis
Clinical narrative: 3/14/18 20:29 Fever 100.8 TYLENOL given. 3/15/18 05:32 Fever 101.5. 3/15/18 08:19 Fever 103.1 TYLENOL given. 3/15/18 09:30 Seen by nurse practitioner in rounds. Pt. Pt offered complaints of withdrawal symptoms including abdominal cramps, anxiety, muscle and bone aches, shakes, fatigue, chills (hot/cold) and GI upset. Also complained of cold symptoms. Diagnosed with pharyngitis. Amoxicillin started. Fever continued to increase throughout the day. Pt. right upper arm noted to be swollen and tender. Fluids encouraged and tolerated well. 3/15/18 13:20 Fever 104.4 MD aware. MOTRIN given. Transported to Hospital via ambulance. Clinic notified of patient was admitted 3/16/18 03:27. Diagnosis of fever and pneumonia. Clinic was notified 3/16/18 10:38 that patient left Hospital and was returning to Clinic. VANTIN prescribed. Also on azithromycin and doxycycline for pneumonia/bronchitis. Sterile abscess at vaccination injection site. 03/17/18 05:15 temp 98.2. 03/17/18 patient discharged. Pneumonia/bronchitis improved. Injection site sterile abscess improving.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Feeling of body temperature change, Injection site pain, Injection site swelling
Clinical narrative: 3/14/18 20:29 Fever 100.8 TYLENOL given. 3/15/18 05:32 Fever 101.5. 3/15/18 08:19 Fever 103.1 TYLENOL given. 3/15/18 09:30 Seen by nurse practitioner in rounds. Pt. Pt offered complaints of withdrawal symptoms including abdominal cramps, anxiety, muscle and bone aches, shakes, fatigue, chills (hot/cold) and GI upset. Also complained of cold symptoms. Diagnosed with pharyngitis. Amoxicillin started. Fever continued to increase throughout the day. Pt. right upper arm noted to be swollen and tender. Fluids encouraged and tolerated well. 3/15/18 13:20 Fever 104.4 MD aware. MOTRIN given. Transported to Hospital via ambulance. Clinic notified of patient was admitted 3/16/18 03:27. Diagnosis of fever and pneumonia. Clinic was notified 3/16/18 10:38 that patient left Hospital and was returning to Clinic. VANTIN prescribed. Also on azithromycin and doxycycline for pneumonia/bronchitis. Sterile abscess at vaccination injection site. 03/17/18 05:15 temp 98.2. 03/17/18 patient discharged. Pneumonia/bronchitis improved. Injection site sterile abscess improving.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia, Nasopharyngitis, Pharyngitis, Pneumonia, Pyrexia
Clinical narrative: 3/14/18 20:29 Fever 100.8 TYLENOL given. 3/15/18 05:32 Fever 101.5. 3/15/18 08:19 Fever 103.1 TYLENOL given. 3/15/18 09:30 Seen by nurse practitioner in rounds. Pt. Pt offered complaints of withdrawal symptoms including abdominal cramps, anxiety, muscle and bone aches, shakes, fatigue, chills (hot/cold) and GI upset. Also complained of cold symptoms. Diagnosed with pharyngitis. Amoxicillin started. Fever continued to increase throughout the day. Pt. right upper arm noted to be swollen and tender. Fluids encouraged and tolerated well. 3/15/18 13:20 Fever 104.4 MD aware. MOTRIN given. Transported to Hospital via ambulance. Clinic notified of patient was admitted 3/16/18 03:27. Diagnosis of fever and pneumonia. Clinic was notified 3/16/18 10:38 that patient left Hospital and was returning to Clinic. VANTIN prescribed. Also on azithromycin and doxycycline for pneumonia/bronchitis. Sterile abscess at vaccination injection site. 03/17/18 05:15 temp 98.2. 03/17/18 patient discharged. Pneumonia/bronchitis improved. Injection site sterile abscess improving.
Age: 49.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Tremor, Vaccination site abscess sterile, Withdrawal syndrome
Clinical narrative: 3/14/18 20:29 Fever 100.8 TYLENOL given. 3/15/18 05:32 Fever 101.5. 3/15/18 08:19 Fever 103.1 TYLENOL given. 3/15/18 09:30 Seen by nurse practitioner in rounds. Pt. Pt offered complaints of withdrawal symptoms including abdominal cramps, anxiety, muscle and bone aches, shakes, fatigue, chills (hot/cold) and GI upset. Also complained of cold symptoms. Diagnosed with pharyngitis. Amoxicillin started. Fever continued to increase throughout the day. Pt. right upper arm noted to be swollen and tender. Fluids encouraged and tolerated well. 3/15/18 13:20 Fever 104.4 MD aware. MOTRIN given. Transported to Hospital via ambulance. Clinic notified of patient was admitted 3/16/18 03:27. Diagnosis of fever and pneumonia. Clinic was notified 3/16/18 10:38 that patient left Hospital and was returning to Clinic. VANTIN prescribed. Also on azithromycin and doxycycline for pneumonia/bronchitis. Sterile abscess at vaccination injection site. 03/17/18 05:15 temp 98.2. 03/17/18 patient discharged. Pneumonia/bronchitis improved. Injection site sterile abscess improving.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: Redness, swelling increased warmth and itching directly around vaccine site (total diameter-5cm) low grade fever noted (99.6 degrees F).
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: Redness, swelling increased warmth and itching directly around vaccine site (total diameter-5cm) low grade fever noted (99.6 degrees F).
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Dysgeusia, Paraesthesia, Urticaria
Clinical narrative: Patient received Tdap vaccine on 1/25/2018. The next day she reported to administering nurse that she felt clammy, had a metallic taste in her mouth, and her fingers felt tingly. There was no indication of trouble breathing or more serious allergic symptoms. When the nurse followed up with the patient the next day the patient reported some urticarial on her abdomen that had improved since she had taken some diphenhydramine earlier.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 03/19/2018 04:35 Pt. complained of pain in left arm where vaccine given. Was slightly red and painful to the touch. Swelling noted. TYLENOL and cold packs given. 03/19/18 11:30 Pt. seen in rounds by nurse practitioner. Left upper arm and elbow cellulitis. Erythema and swelling from middle of upper arm to elbow. Outlines in marker and KEFLEX ordered. Pt. being discharged routinely. Instructed to monitor and if redness or swelling extend beyond the outlined area to be seen immediately by PCP or in ED. Pt. has appt with PCP for 3/23/18.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Asthenia, Back pain, Blood test, Chest X-ray normal
Clinical narrative: Went home; felt a bit tired. By night arm was sore as expected. Next day, in the morning, felt very fatigued, arm was sore, and noticed bruising at the site of vaccination. Vaccine was administered high up in arm. Took TYLENOL for the pain. By night, arm was very sore to the point that it was hard to put on a jacket, tingling and numbness in right arm then it started moving to other parts of body. Felt really bad so called back vax administrator; was asked to come to the office since reported chest started feeling heavy. Went to pharmacy but there was a long waiting line so ended up going to walk-in medical center across the street. Per healthcare provider, symptoms could be related to the shot; patient told that if the breathing gets worse to come back. Next day, went to the ER. Testing included: EKG, chest X-ray and blood work. Patient was released. Recommended TYLENOL for pain, X-ray was good. Symptoms continued and getting worse; thought they were spreading. A couple of days later went to Dr. (who ran another set of tests (sonogram, EKG)). Went to specialist the same day, neurologist, Dr. who ran an MRI and nerve tests. Just provided recommendation for another doctor--not sure of test results. Went to another neurologist for a 2nd opinion; Dr. Per neurologist, symptoms indicate a mild GBS case; but patient told that she had to wait more time before testing--wait a month. By the time got to this doctor felt a little better--less of the tingling. Currently patient has pain in wrist, ankles, back pain and arms; feels weak. Before tingling was predominant now has pain. Patient is taking TYLENOL as often as needed. Pain is worse when lay down; 3 per day. When patient takes a shower she gets rashes on legs and feet--more sensitive to heat.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Electrocardiogram, Fatigue, Feeling abnormal, Guillain-Barre syndrome
Clinical narrative: Went home; felt a bit tired. By night arm was sore as expected. Next day, in the morning, felt very fatigued, arm was sore, and noticed bruising at the site of vaccination. Vaccine was administered high up in arm. Took TYLENOL for the pain. By night, arm was very sore to the point that it was hard to put on a jacket, tingling and numbness in right arm then it started moving to other parts of body. Felt really bad so called back vax administrator; was asked to come to the office since reported chest started feeling heavy. Went to pharmacy but there was a long waiting line so ended up going to walk-in medical center across the street. Per healthcare provider, symptoms could be related to the shot; patient told that if the breathing gets worse to come back. Next day, went to the ER. Testing included: EKG, chest X-ray and blood work. Patient was released. Recommended TYLENOL for pain, X-ray was good. Symptoms continued and getting worse; thought they were spreading. A couple of days later went to Dr. (who ran another set of tests (sonogram, EKG)). Went to specialist the same day, neurologist, Dr. who ran an MRI and nerve tests. Just provided recommendation for another doctor--not sure of test results. Went to another neurologist for a 2nd opinion; Dr. Per neurologist, symptoms indicate a mild GBS case; but patient told that she had to wait more time before testing--wait a month. By the time got to this doctor felt a little better--less of the tingling. Currently patient has pain in wrist, ankles, back pain and arms; feels weak. Before tingling was predominant now has pain. Patient is taking TYLENOL as often as needed. Pain is worse when lay down; 3 per day. When patient takes a shower she gets rashes on legs and feet--more sensitive to heat.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Went home; felt a bit tired. By night arm was sore as expected. Next day, in the morning, felt very fatigued, arm was sore, and noticed bruising at the site of vaccination. Vaccine was administered high up in arm. Took TYLENOL for the pain. By night, arm was very sore to the point that it was hard to put on a jacket, tingling and numbness in right arm then it started moving to other parts of body. Felt really bad so called back vax administrator; was asked to come to the office since reported chest started feeling heavy. Went to pharmacy but there was a long waiting line so ended up going to walk-in medical center across the street. Per healthcare provider, symptoms could be related to the shot; patient told that if the breathing gets worse to come back. Next day, went to the ER. Testing included: EKG, chest X-ray and blood work. Patient was released. Recommended TYLENOL for pain, X-ray was good. Symptoms continued and getting worse; thought they were spreading. A couple of days later went to Dr. (who ran another set of tests (sonogram, EKG)). Went to specialist the same day, neurologist, Dr. who ran an MRI and nerve tests. Just provided recommendation for another doctor--not sure of test results. Went to another neurologist for a 2nd opinion; Dr. Per neurologist, symptoms indicate a mild GBS case; but patient told that she had to wait more time before testing--wait a month. By the time got to this doctor felt a little better--less of the tingling. Currently patient has pain in wrist, ankles, back pain and arms; feels weak. Before tingling was predominant now has pain. Patient is taking TYLENOL as often as needed. Pain is worse when lay down; 3 per day. When patient takes a shower she gets rashes on legs and feet--more sensitive to heat.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site, Rash, Temperature intolerance, Ultrasound scan, Vaccination site bruising
Clinical narrative: Went home; felt a bit tired. By night arm was sore as expected. Next day, in the morning, felt very fatigued, arm was sore, and noticed bruising at the site of vaccination. Vaccine was administered high up in arm. Took TYLENOL for the pain. By night, arm was very sore to the point that it was hard to put on a jacket, tingling and numbness in right arm then it started moving to other parts of body. Felt really bad so called back vax administrator; was asked to come to the office since reported chest started feeling heavy. Went to pharmacy but there was a long waiting line so ended up going to walk-in medical center across the street. Per healthcare provider, symptoms could be related to the shot; patient told that if the breathing gets worse to come back. Next day, went to the ER. Testing included: EKG, chest X-ray and blood work. Patient was released. Recommended TYLENOL for pain, X-ray was good. Symptoms continued and getting worse; thought they were spreading. A couple of days later went to Dr. (who ran another set of tests (sonogram, EKG)). Went to specialist the same day, neurologist, Dr. who ran an MRI and nerve tests. Just provided recommendation for another doctor--not sure of test results. Went to another neurologist for a 2nd opinion; Dr. Per neurologist, symptoms indicate a mild GBS case; but patient told that she had to wait more time before testing--wait a month. By the time got to this doctor felt a little better--less of the tingling. Currently patient has pain in wrist, ankles, back pain and arms; feels weak. Before tingling was predominant now has pain. Patient is taking TYLENOL as often as needed. Pain is worse when lay down; 3 per day. When patient takes a shower she gets rashes on legs and feet--more sensitive to heat.
Age: 50.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Hypotension, Pyrexia
Clinical narrative: Very low blood pressure, fever, headache, fatigue, dizziness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Skin discolouration
Clinical narrative: Shortly after pt rec'd vacc both of his feet and half his legs turned purple/blue in color provider noticed and immediately evaluated pt. Oxygen level normal and we monitored pt for 30 min. Called CDC and employee advised me that pt had discolored leg syndrome, not critical and no treatment required mom notified and per provider ok for pt to go home.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Pain in extremity, Peripheral swelling
Clinical narrative: 24 hours within of receiving vaccine, developed left arm pain with swelling. Parent reported redness and swelling immediately after vaccine injection - sx continued past 24-48 hours. Enlarged tonsils on exam; rapid Strep test negative. Started KEFLEX for DX: Cellulitis. Returned to ER same day for continued swelling. Improved with BENADRYL.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test negative, Tonsillar hypertrophy
Clinical narrative: 24 hours within of receiving vaccine, developed left arm pain with swelling. Parent reported redness and swelling immediately after vaccine injection - sx continued past 24-48 hours. Enlarged tonsils on exam; rapid Strep test negative. Started KEFLEX for DX: Cellulitis. Returned to ER same day for continued swelling. Improved with BENADRYL.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Mass, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, redness, bruising, formation of lump, fever. Swelling and redness starting at deltoid, radiating toward elbow and behind arm - worst symptoms lasted approximately 48 hours, took about 7 days to resolved. Treated with TYLENOL.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Soon after injection, left deltoid (site of injection) has been very sore, and has been chronically sore in the months since.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Had horrible pain in the arm/muscle in which I was given the injection several hours after the shot and the next day. It had me in tears. It continues to be sore today, two days later. The day after the shot I started having flu like symptoms. It started with chills, and then head ache, body aches and tired. Spent the day in bead. This is the second day and I am feeling better then yesterday but still not myself.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Had horrible pain in the arm/muscle in which I was given the injection several hours after the shot and the next day. It had me in tears. It continues to be sore today, two days later. The day after the shot I started having flu like symptoms. It started with chills, and then head ache, body aches and tired. Spent the day in bead. This is the second day and I am feeling better then yesterday but still not myself.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Arm soreness, fever, chills, headache, every muscle and joint aches, tiredness and nausea, had to stay in bed for 2 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness, fever, chills, headache, every muscle and joint aches, tiredness and nausea, had to stay in bed for 2 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever, full body urticarial rash 24 hours after vaccination last 24 hours.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Myalgia
Clinical narrative: Mild pain in shoulder began in the evening of the shot. Next two days were characterized by fever (101), chills, muscle aches, and headaches. Third day, I was just tired, but no fever or chills. Did not take any medicine for the condition.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Mild pain in shoulder began in the evening of the shot. Next two days were characterized by fever (101), chills, muscle aches, and headaches. Third day, I was just tired, but no fever or chills. Did not take any medicine for the condition.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incorrect route of drug administration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received SHINGRIX vaccine subcutaneous instead of intermuscular. Felt feverish with chills. Severe injection site swelling, hot to touch, and pin-like pain. Called Dr. and she prescribed antibiotics and ibuprofen. Will see Dr. tomorrow if symptoms don't improve.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Received SHINGRIX vaccine subcutaneous instead of intermuscular. Felt feverish with chills. Severe injection site swelling, hot to touch, and pin-like pain. Called Dr. and she prescribed antibiotics and ibuprofen. Will see Dr. tomorrow if symptoms don't improve.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Face and mouth X-ray abnormal, Face injury, Fall, Jaw fracture
Clinical narrative: OV by dad with 4 children, 3 for imm. Patient given his vaccines, did well. About 5 minutes after imm given, I heard thump. Child on floor face down. Care given. Sent to ER. Liquid diet still restricted activity.
Age: 24.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Rash, Throat irritation
Clinical narrative: Patient received anthrax(#1), Japanese encephalitis(#1) and typhoid(booster) on 16 March 2018. Patient called staff on 22 March 2018 regarding non-itchy bumps on both arms (upper arm down to wrists) and a slight itch in his throat. Patient notice the symptoms day after vaccinations on 17 March 2018 but disregarded the symptoms thinking they would subside in a day or two. Patient did not report any other concerns. Staff contacted DHA services Nurse Practitioner whom is reaching out to Patient for further guidance.
Age: 33.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Chills, Erythema, Nausea, Night sweats, Pain in extremity
Clinical narrative: LEFT ARM PAIN W/ INCREASING REDNESS STARTING TODAY, 3 DAYS AFTER RECEIVING TYPHOID AND ANTHRAX VACCINE . ASSOCIATED SYMPTOMS INCLUDE MILD SWELLING, WARMTH TO TOUCH, NAUSEA, NIGHT SWEATS AND CHILLS. SHE DENIED ANY ADVERSE REACTIONS IN THE PAST.
Age: 33.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Skin warm, Swelling
Clinical narrative: LEFT ARM PAIN W/ INCREASING REDNESS STARTING TODAY, 3 DAYS AFTER RECEIVING TYPHOID AND ANTHRAX VACCINE . ASSOCIATED SYMPTOMS INCLUDE MILD SWELLING, WARMTH TO TOUCH, NAUSEA, NIGHT SWEATS AND CHILLS. SHE DENIED ANY ADVERSE REACTIONS IN THE PAST.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient experienced intense pain and swelling in the area 3 days after the injection. She also reported itching.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, musculoskeletal pain.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an adult patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 12-MAR-2018, the patient was vaccinated with a paediatric dose of VAQTA, strength: 25 U/0.5 ml, lot # N023953 with expiration date on 05-NOV-2018 via intramuscular route. No adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Emotional disorder
Clinical narrative: This spontaneous report as received from an unspecified field employee via company representative refers to her son of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with GARDASIL 9, (dosing details were not reported) (lot # and expiry date not reported) intramuscularly for prophylaxis. The reporter stated that on an unknown date her son had not been the same emotionally ever since (emotional disorder). The outcome of the event was unknown. Causality assessment was not reported. No product quality complaint involved.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, slightly swollen, warm area at injection site (4x5.5in).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Patient experienced swelling and redness on entire upper arm that was warm to the touch. Also experienced joint pain and aches and a bump at site of injection. Treated with BENADRYL and redness and started to recede.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abnormal behaviour, Crying, Insomnia, Irritability, Screaming
Clinical narrative: Child had shots 3/12/18 her reaction is has been super clingy since, will not fall asleep alone as before, seems fussy where as before my child only cried when hungry. She now randomly screams and cries at random moments even when feed, changed, and comfortable.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenopia, Conjunctival hyperaemia, Conjunctivitis, Conjunctivitis viral, Eye discharge
Clinical narrative: Unspecified acute conjunctivitis, bilateral: -Patient is a 25-year-old male primary vaccinee who received smallpox vaccine on 5 Mar 2018, which resulted in an appropriate take, and later developed conjunctival hyperemia burning, discharge, light sensitivity, and injection to his right eye and light sensitivity and hyperemia to his left eye. He has been seen by ophthalmology and was instructed it is most consistent with viral conjunctivitis, however due to his history they treated him for possible ocular vaccinia with ZIRGAN and VALTREX. His presentation is consistent with conjunctivitis. Possible etiologies are viral, bacterial or allergic. He has no history of atopy. Given his recent SPV ocular vaccinia needs to be considered and he would meet case the CDC case definition for a suspected ocular vaccinia based on presentation and temporal relationship. There are no specific lesions to collect samples for PCR. Patient has done well since initial visit. Eye symptoms have mostly resolved but still some symptoms of eyes 'feeling tired'. On exam, conjunctival injection and mucopurulent discharge has resolved. Continue current eye medications as prescribed by Ophtho. Continue to avoid contact lenses until vaccination site scab has fallen off. Follow-up with Ophtho on Thursday as scheduled. Follow-up with IHB as needed. He was instructed to contact us should he experience any worsening of symptoms, and number provided and reinforced. Patient voiced understanidng and agrees with plan, all questions answered. Adverse effect of other vaccines and biological substances, subsequent encounter: -plan as above. Patient meets CDC case definition of suspected ocular vaccinia.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Photophobia, Purulent discharge, Vaccinia virus infection
Clinical narrative: Unspecified acute conjunctivitis, bilateral: -Patient is a 25-year-old male primary vaccinee who received smallpox vaccine on 5 Mar 2018, which resulted in an appropriate take, and later developed conjunctival hyperemia burning, discharge, light sensitivity, and injection to his right eye and light sensitivity and hyperemia to his left eye. He has been seen by ophthalmology and was instructed it is most consistent with viral conjunctivitis, however due to his history they treated him for possible ocular vaccinia with ZIRGAN and VALTREX. His presentation is consistent with conjunctivitis. Possible etiologies are viral, bacterial or allergic. He has no history of atopy. Given his recent SPV ocular vaccinia needs to be considered and he would meet case the CDC case definition for a suspected ocular vaccinia based on presentation and temporal relationship. There are no specific lesions to collect samples for PCR. Patient has done well since initial visit. Eye symptoms have mostly resolved but still some symptoms of eyes 'feeling tired'. On exam, conjunctival injection and mucopurulent discharge has resolved. Continue current eye medications as prescribed by Ophtho. Continue to avoid contact lenses until vaccination site scab has fallen off. Follow-up with Ophtho on Thursday as scheduled. Follow-up with IHB as needed. He was instructed to contact us should he experience any worsening of symptoms, and number provided and reinforced. Patient voiced understanidng and agrees with plan, all questions answered. Adverse effect of other vaccines and biological substances, subsequent encounter: -plan as above. Patient meets CDC case definition of suspected ocular vaccinia.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: The patient had a red rash appear just below the injection site. The rash was slightly warm but not pain to the patient. Resolved without treatment.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Pt was accidentally given a PEDRIAX injection and a Hepatitis B injection instead of a PENTACEL and Hepatitis B injection.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Pyrexia, Urine analysis normal, Vomiting
Clinical narrative: Fever of 104.9, vomiting, lethargy.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomited food for 24hrs (Zero history of food vomiting).
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Pt. became faint and lightheaded. Applied cool cloth. Pt. became nauseated. Pt. given ZOFRAN 0.4 mg. Had pt. lay down with feet elevated. Gave pt. water. After approx. 20 min. pt. started feeling better.
Age: 15.0
Sex: F
Vaccine: FLU4, HEPA, HPV4, MNQ
Symptoms: No adverse event
Clinical narrative: Patient has not experienced any adverse reactions in relation to this early vaccine administration.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Abnormal behaviour, Fatigue, Hypersomnia, Regressive behaviour
Clinical narrative: The following day after vaccination Patient would not wake from naps to eat. I would have to wake her to eat. After eating she would promptly fall back asleep. The entire following week she regressed in motor skills. She was rolling over from belly to back, and she stopped. She was also cooing/talking and this stopped as well. She seemed very withdrawn and unusually tired and not herself. This is a major concern for me since she lost skills that she was doing without any problems prior to vaccination.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Confusional state, Feeling abnormal, Heart rate increased, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of arm soreness, slight fever (100 degrees), increase heart rate and confusion. Stated he felt like he could "see beating in his head" when he describe how he felt confused.
Age: 19.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event, Rubella antibody positive, Ultrasound antenatal screen
Clinical narrative: MMR vaccine given to a woman 15-16 weeks pregnant. Pregnancy Hx is G2P1. Her EDC: 08/13/2018. No current complications noted by OBGYN. US pending. Tdap vaccine was also given twice in 3 weeks. First dose given on 02/01/2018, and second dose 02/20/2018.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Livedo reticularis, Pain, Pyrexia, Rash
Clinical narrative: Patient's wife describes a mottled coloring along his back (rash), fever, chills, achiness all over body.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dysstasia, Eye irritation, Fatigue, Feeling cold
Clinical narrative: I had a severe reaction to the shingles shot I received on Monday, March 19. Extreme fatigue - began about 4 hours after the shot. I slept 9 straight hours until my alarm went off, and I hit the snooze button 3 times. I could barely stand up or open my eyes as I stumbled to the shower. After my shower I crawled into bed freezing, aching all over, eyes burning. Even odder it felt like each layer of my skin was burning - not like fire, but a chemical burn. I could not move for most of the day - it was almost like my body was paralyzed. I could not read, or watch anything for hours. I slept most of the day. I woke up for a couple hours, watched something, ate a bit, but then fell into a stupor at 7:30 pm and once again slept until the morning. I woke up with a horrible headache and back ache and still found it hard to stand up and walk. I finally felt a bit ok by the afternoon. The shot site was sore and warm, but no rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Hypersomnia, Injection site pain, Injection site warmth
Clinical narrative: I had a severe reaction to the shingles shot I received on Monday, March 19. Extreme fatigue - began about 4 hours after the shot. I slept 9 straight hours until my alarm went off, and I hit the snooze button 3 times. I could barely stand up or open my eyes as I stumbled to the shower. After my shower I crawled into bed freezing, aching all over, eyes burning. Even odder it felt like each layer of my skin was burning - not like fire, but a chemical burn. I could not move for most of the day - it was almost like my body was paralyzed. I could not read, or watch anything for hours. I slept most of the day. I woke up for a couple hours, watched something, ate a bit, but then fell into a stupor at 7:30 pm and once again slept until the morning. I woke up with a horrible headache and back ache and still found it hard to stand up and walk. I finally felt a bit ok by the afternoon. The shot site was sore and warm, but no rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Skin burning sensation, Stupor, Vaccination complication
Clinical narrative: I had a severe reaction to the shingles shot I received on Monday, March 19. Extreme fatigue - began about 4 hours after the shot. I slept 9 straight hours until my alarm went off, and I hit the snooze button 3 times. I could barely stand up or open my eyes as I stumbled to the shower. After my shower I crawled into bed freezing, aching all over, eyes burning. Even odder it felt like each layer of my skin was burning - not like fire, but a chemical burn. I could not move for most of the day - it was almost like my body was paralyzed. I could not read, or watch anything for hours. I slept most of the day. I woke up for a couple hours, watched something, ate a bit, but then fell into a stupor at 7:30 pm and once again slept until the morning. I woke up with a horrible headache and back ache and still found it hard to stand up and walk. I finally felt a bit ok by the afternoon. The shot site was sore and warm, but no rash.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site rash, Pain in extremity, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 59-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included Atorvastatin, Diltiazem and Ramipril. On 9th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced rash, pain in arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and pain in arm were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the rash and pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. Six hours later, rash and arm tenderness presented on the whole underside of (left) arm. Rash described as 12 inches in diameter. The reporter thinks SHINGRIX may have been administered subcutaneously but unable to fully confirm unknown route of administration, which led to incorrect route of administration. The patient required emergency room visit. The reported SHINGRIX batch number (374KL) did not exist in the sales database and was updated to 3Z4KL.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored (Oka-Merck)PROQUAD lot#N025717 with expiry date of 17-MAR-2019 for prophylaxis. (dosing details were not reported). The vaccine was reconstituted with properly stored sterile diluent. Temperature: -14 C to -10 C. Time frame: 15 hours 30 minutes. There was previous temperature excursion: -14 C to -10 C for 21 hours 30 minutes. The call was because of data logger. No adverse effects reported. No product quality complaint reported.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 82 year old male patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 04-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N022650; expiry date unknown) in the left arm for prophylaxis. Dosing details were not reported. On 05-DEC-2017, the patient was admitted to an unspecified hospital complaining of fever, generalized weakness, left shoulder pain and swelling. The patient was discharged from the hospital on 08-DEC-2018 and had fully recovered. Causality assessment was not provided by the reporter.
Age: 0.33
Sex: M
Vaccine: HPV9, PNC13, RV5, HPV9
Symptoms: No adverse event
Clinical narrative: There has been no adverse event as of this forms completion. However, the risk for significant adverse event warrants the occurrence documentation. My office contacted the manufacturer - Merck - employee there forwarded me to the Medical Team Rep -with their National Service Center. She in turn forwarded me to employee at Global Medical Dept for further guidance and care recommendations for the infant in general terms. The child's mother was then contacted around 1245pm.
Age: 0.33
Sex: M
Vaccine: HPV9, PNC13, RV5, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There has been no adverse event as of this forms completion. However, the risk for significant adverse event warrants the occurrence documentation. My office contacted the manufacturer - Merck - employee there forwarded me to the Medical Team Rep -with their National Service Center. She in turn forwarded me to employee at Global Medical Dept for further guidance and care recommendations for the infant in general terms. The child's mother was then contacted around 1245pm.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Constipation
Clinical narrative: Normal bowel movements 1-3 times daily prior to vaccination. Has not had a bowel movement since the evening after receiving the vaccine on 3/19/2018.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The evening after I administered PMEUMOVAX 23 by IM into the patient's left deltoid (three fingerbreadths down from the acromion process but above the armpit, she experienced arm pain which grew in severity over the night and prevented her from lifting her left arm for the next two days. There was no redness or induration at the site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Nausea
Clinical narrative: Pt reports being nausous once she arrived home on day vaccine was given. She reports the nausea subsided after 2 days. The morning following vaccination, 3/18/18, she reports waking up with her lips very swollen. They remained swollen throughout the day and subsided on 3/19/18.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Chills, Nausea, Tremor
Clinical narrative: Nausea, "wobbly, shaky" chills; onset 6 pm on day of vaccine - present.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Irritability, Myalgia, Pyrexia, Restlessness, Vomiting
Clinical narrative: Patient awoke this AM with fever, myalgias, fussiness, restlessness, vomiting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Adverse event - Injection site was hot, chills, nausea, faint, dizzy, headache, pain in left upper arm. Treatment - ibuprofen. Outcome - the event lasted about 7 hours at which time the adverse effects had subsided, however, I was fatigued for about 12 hours after. The injection site is still itchy as of 3/22/18.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Syncope
Clinical narrative: Adverse event - Injection site was hot, chills, nausea, faint, dizzy, headache, pain in left upper arm. Treatment - ibuprofen. Outcome - the event lasted about 7 hours at which time the adverse effects had subsided, however, I was fatigued for about 12 hours after. The injection site is still itchy as of 3/22/18.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA, VARZOS
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: On 3/15/18 patient received three vaccines. ENGERIX B (NDC 58160-0821-43) in her left arm. HAVRIX (NDC 58160-0826-43) and SHINGRIX (NDC 58160-0828-03) in her right arm (HAVRIX lower, SHINGRIX upper). Patient called today complaining of redness and swelling in her right arm. She said that it also feels warm to touch. She said where the redness located is more of her inward arm closer to her armpit, not in the exact spot where she got the shots at. But after the shots it was sore/hurting in the area that is now red, so she believes the redness is because of the shots. I told her that because of the warmth and swelling there, there is a chance it could be infected and she should visit her doctor in the case that it is infected so she could get an antibiotic. She said she is out of town so will be unable to go to her doctor. I recommended an urgent care.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Axillary pain, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Low grade fever (99.8) - resolved after 30 hours, nausea with 2 episodes of vomiting 3/21/18 at 2:00 and 4:00 am. Malaise, GI distress, Right Deltoid pain, hot to touch, mild edema; and Right axilla, shoulder and neck pain - resolving at present.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Low grade fever (99.8) - resolved after 30 hours, nausea with 2 episodes of vomiting 3/21/18 at 2:00 and 4:00 am. Malaise, GI distress, Right Deltoid pain, hot to touch, mild edema; and Right axilla, shoulder and neck pain - resolving at present.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Breath sounds abnormal, Dizziness, Loss of consciousness
Clinical narrative: 2-3 minute later we administer 2nd series of Anthrax IM on his Left arm. Patient states that he feel dizzy. Placed him to lay down and sit. 2-3 minute later we administer he passed out for 5 sec with both arms close to him with gurgling and came back. We gave him water to drink and seems like he was fine but after 2-3 minute later he passed out again with both arm close and gurgling sounds. We call Doctor and Emergency Care Center in the hospital and transfer him to emergency.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the next day 3/18 stating the injection site was red, swollen and warm. She was told to take TYLENOL for any pain and to ice the area. She came in on 3/21 and said it was getting better.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Hyperhidrosis, Induration, Mass
Clinical narrative: Hard egg shaped red lump developed by next morning. Then chills and sweating began. Now, 3 days later the hard lump is receding but the redness has grown to approximately 5 inches in diameter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Symptoms included fever hives. Patient was treated with BENADRYL. Symptoms subsided after BENADRYL.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, route of administration, anatomical location, lot number and expiration date were not reported) (Product storage error)for prophylaxis. The temperature excursion experienced by the administered vaccine, as well as, the time frame were unknown by the reporter and it was not reported if the event was recorded by a data logger. It was stated that the vaccine had not had any previous temperature excursions prior to January 2018. There was no adverse effect reported. No product quality complaint was involved. Upon receipt of follow-up information it was determined that this case is now valid because patient details were reported as "refused to answer". Follow-up information was received from medical assistant on 02-MAR-2018. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9(lot M043731, expiry date 22-JUN-2019). No adverse effects reported. Temperature was reported as 32°F up to 35°F. Time frame was reported as cumulative for 72 hours. There was no previous temperature excursion involved. The call was because of a data logger.
Age: 1.08
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother concerning a 14 month old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 15-MAR-2018, the patient was vaccinated with a dose of Oka-Merck PROQUAD and a dose of Oka/Merck VARIVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician reported to patient's mother that was an error, but it would not be harmful to the patient. Patient's mother was directed to report any rash. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was administered an improperly stored dose of Oka/Merck VARIVAX (lot # N012487, expiry date: 20-APR-2019) for prophylaxis (product storage error). Dosing details were not reported. It was reported that the MERCK STERILE DILUENT (lot # and expiry date unknown) used was properly stored. The temperature excursion occurred on unknown dates between -2.6 degrees Celsius (°C) for a time frame of 28 minutes. No previous temperature excursion occurred. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 20-MAR-2018, the patient was vaccinated with VAQTA lot # M022531 with expiration date of 23-FEB-2018, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Age: 78.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Rash, Skin burning sensation, Skin exfoliation, Skin irritation
Clinical narrative: Patient has rash and peeling on her hands. Her hands were red and very irritated. When she applies some "cream" on her hands, it burned. Patient also stated she had been working in the yard.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Cartilage injury, Injected limb mobility decreased, Injection site induration, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Pain in left arm with immediate onset, exacerbated my movement, never decreased in intensity even after 7 months. Induration palpated at the site on the left deltoid injection. Gradual decrease in the range of motion of left shoulder.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Tendon disorder, Ultrasound scan abnormal, X-ray limb normal
Clinical narrative: Pain in left arm with immediate onset, exacerbated my movement, never decreased in intensity even after 7 months. Induration palpated at the site on the left deltoid injection. Gradual decrease in the range of motion of left shoulder.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient states has pain lifting arm and wakes up at night due to soreness from sleeping on it. Pain is tolerated and not moderate or severe. Patient doesn't really recall actual date when he began having continual pain and difficulty lifting arm. I called him on Tuesday 03/13/18 for his second dose of SHIINGRIX is when I was informed. Pt never called us about his complaints. I advised him not to strain his arm more or try to under physical therapy without proper knowledge. Note: Pt state's If he is be contacted by agency, if he's is unable to answer his phone, please leave him a message and he will call back.