chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: approximately 10 minutes after injection developed numbness and mainly tingling sensation above Left deltoid, left scapula area , up left side of neck, left side of face and bottom lip. The symptoms are continuing . tingling sensation also left hand and arm.down to finger tips.Also pain in the back of head left side only. The symptoms have continue after 24 hours. MD contacted. Following up with allergy soon.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Pain in extremity
Clinical narrative: Slightly sore arm upon vaccination. Went to bed and woke up with other arm feeling sore, cold sweat, and headache. Tylenol relieved headache but pain still slightly present.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Sore arm at the time of injection. 24 hours later developed chills, fatigue, headache and itchy, red, hot rash at injection site.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Sore arm at the time of injection. 24 hours later developed chills, fatigue, headache and itchy, red, hot rash at injection site.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, fatigue
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Raised, warm, red rash in a 4" x 4" square on the left arm around the vaccination site.  Mild pain and swelling.  Symptoms started 7 days after injection.  Starting to fade 3 days later but still swollen, warm and mildly painful.  Treating with ibuprofen.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Raised, warm, red rash in a 4" x 4" square on the left arm around the vaccination site.  Mild pain and swelling.  Symptoms started 7 days after injection.  Starting to fade 3 days later but still swollen, warm and mildly painful.  Treating with ibuprofen.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Burning sensation, Chest X-ray
Clinical narrative: About 6 hours after vaccine injection I began to have weakness, numbness, tingling, and burning from my hips down. From the top of my legs all the way to my feet. Also numbness in my hands. Went to the ER approximately 15 hours after receiving my vaccination. Was discharged, awaiting on leptospirosis bloodwork and if conditions do not improve I will return to the ER to get a lumbar puncture to check for Guillain Barre Syndrome.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Leptospirosis, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: About 6 hours after vaccine injection I began to have weakness, numbness, tingling, and burning from my hips down. From the top of my legs all the way to my feet. Also numbness in my hands. Went to the ER approximately 15 hours after receiving my vaccination. Was discharged, awaiting on leptospirosis bloodwork and if conditions do not improve I will return to the ER to get a lumbar puncture to check for Guillain Barre Syndrome.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: About 6 hours after vaccine injection I began to have weakness, numbness, tingling, and burning from my hips down. From the top of my legs all the way to my feet. Also numbness in my hands. Went to the ER approximately 15 hours after receiving my vaccination. Was discharged, awaiting on leptospirosis bloodwork and if conditions do not improve I will return to the ER to get a lumbar puncture to check for Guillain Barre Syndrome.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Disturbance in attention, Fatigue, Headache
Clinical narrative: Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred vision, loss of focus, general malaise and body pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Pain, Pyrexia, Rash
Clinical narrative: Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred vision, loss of focus, general malaise and body pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred vision, loss of focus, general malaise and body pain.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Contusion, Decreased appetite, Dyspepsia, Dyspnoea
Clinical narrative: Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Migraine, Pain
Clinical narrative: Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Contusion, Cough, Decreased appetite, Feeling hot
Clinical narrative: Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Nausea, Skin discolouration, Vomiting
Clinical narrative: Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Burning sensation, Decreased appetite, Gait disturbance, Illness
Clinical narrative: Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Extreme Fatigue, Severe Chills, Severe Migraine, Severe Heartburn, Severe Body aches, loss of appetite, shortness of breath, bruise on my right foot a fee hours after the vaccine was given.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, C-reactive protein, Diagnostic aspiration, Fibrin D dimer, Inflammation of wound
Clinical narrative: Itching right thigh at site of 11-year-old hip replacement at 1st vaccine. At 2nd vaccine, within 2 days, large open wound about 3 inches in diameter in middle of otherwise linear scar . Wound was/is open, it is red/purple, oozing and draining constantly a sticky yellow liquid. Pain and inflammation
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wound, Wound complication, Wound drainage, Wound secretion, X-ray of pelvis and hip
Clinical narrative: Itching right thigh at site of 11-year-old hip replacement at 1st vaccine. At 2nd vaccine, within 2 days, large open wound about 3 inches in diameter in middle of otherwise linear scar . Wound was/is open, it is red/purple, oozing and draining constantly a sticky yellow liquid. Pain and inflammation
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Nausea w/in 30 minutes of injection. Vomiting. Headache. Fatigue.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I started menstruating after receiving shot and have not had a period over year. Lasted 5 days. Was not heavy but a light period. I had just seen OB/ Gyn  4 days before vaccine for my annual visit and everything was normal.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Lip swelling, Pruritus, Swollen tongue
Clinical narrative: Shortness of breath, lightheadedness, itching and swelling of tongue and lips
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Erythema, Feeling abnormal, Heart rate increased
Clinical narrative: Felt a little hit after shot and was asked to stay 30 minutes cause was a little red and heart rate was a little elevated. The following 2 days had a 103 fever shivers muscle pain and fog in head 4 days later still don't feel 100 percent
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Felt a little hit after shot and was asked to stay 30 minutes cause was a little red and heart rate was a little elevated. The following 2 days had a 103 fever shivers muscle pain and fog in head 4 days later still don't feel 100 percent
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Tinnitus dizziness
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Mobility decreased, Muscle tightness
Clinical narrative: Fever,chills, muscles locked up from left shoulder across top of back to right arm. I couldn't move barely or life myself up. 2nd day after still sore when use arms, runny nose cough is worse. Fatigue,body aches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever,chills, muscles locked up from left shoulder across top of back to right arm. I couldn't move barely or life myself up. 2nd day after still sore when use arms, runny nose cough is worse. Fatigue,body aches
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Janssen COVID-19 Vaccine EUA Left arm soreness (including extreme finger and elbow joint pain) all first 36+ hours Low grade fever after 24 hours (lasting about 3 hours) Full body aches on and off for first 36 hours, worst at 24 hour mark Nausea at 36 hour mark  Treatment: rest, hydration, some Tylenol at 24 hour mark, pepto for nausea at 36 hour mark
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dissociation, Fatigue, Irritability, Thirst
Clinical narrative: Chills; extraordinary, unslakable thirst; exhaustion; detachment from reality; crankiness--duration about 8 hours
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: High pulse rate of 139 bpm, cold sweats, severe fatigue/muscle aches, severe headache, dizzy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: High pulse rate of 139 bpm, cold sweats, severe fatigue/muscle aches, severe headache, dizzy.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache
Clinical narrative: patient reports headache and chills after 2nd dose of covid vaccine
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chills, Deafness, Diarrhoea, Dyspnoea
Clinical narrative: Felt pain in left arm immediately followed by difficulty breathing, sweating, nausea,  loss of hearing and vision. No treatment given. Suddenly felt ok after a few moments. Went home, got full body aches, chills, tiredness, inability to sleep, and diarrhea
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Insomnia, Nausea, Pain
Clinical narrative: Felt pain in left arm immediately followed by difficulty breathing, sweating, nausea,  loss of hearing and vision. No treatment given. Suddenly felt ok after a few moments. Went home, got full body aches, chills, tiredness, inability to sleep, and diarrhea
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt pain in left arm immediately followed by difficulty breathing, sweating, nausea,  loss of hearing and vision. No treatment given. Suddenly felt ok after a few moments. Went home, got full body aches, chills, tiredness, inability to sleep, and diarrhea
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Tender, painful & hot at injection site.  I just waited.  I'm sorry of I'm reporting too minor of a reaction.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears ringing-high pitched, stronger in left ear
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Throat tightness
Clinical narrative: In a time span of 40 minutes after been provided with the Jansen vaccine, my tongue began to felt asleep and my throat became to feel very tight. An hour after having been administer the vaccine I took 50mg of Benadryl and went to my nearest emergency room where they provided a decahedron syringe 2 hours after vaccine administration.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: I had my vaccine Monday. On Tuesday morning I was nauseous and had diarrhea. I had a brief time where I felt very hot, sweaty, nauseous,  my arms felt like pins and needles, and my hearing started sounding muffled or far away.   I drank water, cooled down my arms and face as soon as I could,  and laid down. I felt nauseous the rest of the day and today. I feel ok now. I've never fainted before I'm not sure if that was happening but it was completely unexpected and not listed on vaccine side effects.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope, Tinnitus
Clinical narrative: within in minutes of the vaccine and while driving to the rest area almost fainted, started to black out, dizziness an hollow hearing/tinitus. Lasted for 10 mins and gradually subsided over 20 minutes
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased
Clinical narrative: Fever of 102.8.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Cardiolipin antibody, Factor II mutation, Factor V Leiden mutation, Full blood count
Clinical narrative: Fever of 102.8.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Janus kinase 2 mutation, Lipase, Liver function test, Metabolic function test, Myeloproliferative neoplasm
Clinical narrative: Fever of 102.8.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paroxysmal nocturnal haemoglobinuria, Portal vein thrombosis, Prothrombin time
Clinical narrative: Fever of 102.8.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Induration, Lymphadenopathy
Clinical narrative: Pain, Tenderness, Swelling, Hardness, Redness, Fatigue, Muscle Pain, Joint Pain, Nausea, The biggest problem is I have severe swelling of the lymph nodes in the same arm of the injection for several days. I want to know when this pain will go away.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Swelling, Tenderness
Clinical narrative: Pain, Tenderness, Swelling, Hardness, Redness, Fatigue, Muscle Pain, Joint Pain, Nausea, The biggest problem is I have severe swelling of the lymph nodes in the same arm of the injection for several days. I want to know when this pain will go away.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Started with the lower right leg and foot being itchy and red 7 days post vaccine. It then progressed to the right lower leg. After a few hours, the upper legs became red and itchy. It then affected my right arm, a little on my abdomen, and then the right elbow area. Benadryl, a cold shower, and icing the areas made the symptoms go away for several hours, but they returned over night at 3am.  Day 8, the symptoms were gone most of the day, but returned in the evening around 8pm. Benadryl taken and iced down the arms and legs.  Symptoms subsided.  They returned again at 3am and woke me from sleeping. It affected both feet, both legs, both arms, a little on my back and sides.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Dyspnoea
Clinical narrative: Fever of 37.5 to 38.5 for 6-7 days every evening and night after the vaccine (starting on 03/28 and stopping by 04/02-04/03) + chills, body aches, headache, nausea. Starting 04/03 chest pain and tightness, back pain between shoulder blades, difficulty breathing when going up the stairs, throat and jaw pain, blood pressure higher than usual. Starting 04/06 warm rash on the injection site and itchy bumps on fingers and toes (chilblains).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Injection site rash, Nausea, Oropharyngeal pain
Clinical narrative: Fever of 37.5 to 38.5 for 6-7 days every evening and night after the vaccine (starting on 03/28 and stopping by 04/02-04/03) + chills, body aches, headache, nausea. Starting 04/03 chest pain and tightness, back pain between shoulder blades, difficulty breathing when going up the stairs, throat and jaw pain, blood pressure higher than usual. Starting 04/06 warm rash on the injection site and itchy bumps on fingers and toes (chilblains).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw, Pyrexia, Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: Fever of 37.5 to 38.5 for 6-7 days every evening and night after the vaccine (starting on 03/28 and stopping by 04/02-04/03) + chills, body aches, headache, nausea. Starting 04/03 chest pain and tightness, back pain between shoulder blades, difficulty breathing when going up the stairs, throat and jaw pain, blood pressure higher than usual. Starting 04/06 warm rash on the injection site and itchy bumps on fingers and toes (chilblains).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: New onset atrial fibrillation diagnosed in emergency room
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: I have been experiencing a very sore/painful arm. I was not able to move it without experiencing high pain level.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash appeared on my shoulder around the injection site on the 5th. I had been in the sun, thought it could just be that I didn?t apply enough sunscreen.  Didn?t really notice any pain or swelling the 6th, almost forgot about it. Today, the 7th, noticed it itching and tender during work. By the evening a noticeably red, slightly elevated rash had appeared. At this point, now 9:30 pm, it is a puffy, tender, red rash about three inches long and two inches wide. What I imagine is the injection site is about a quarter-inch wide dot near the center.  I applied Neosporin and then read that the internet consensus is that "covid arm" is uncommon but not alarming. Hopefully the medical prognosis as well.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Haematuria, Sexually transmitted disease test, Urine analysis, Urine analysis abnormal
Clinical narrative: Hematuria (bright red blood), pain while urinating, passage of mucus in urine and possible kidney stone over the course of two days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Pain with needle insertion. Sore arm. Red, raised, hot injection site. Approximately 8-9 hours later (after working) I noticed my entire left arm was inflamed, and slightly itchy. I had been itchy from metformin the days before my vaccination and stopped taking it the day of. Took a benadryl and went to sleep. Woke up SUPER itchy with small red dots (hives?) on my arms, chest, back, etc. Took tylenol for my arm pain. Took 2 benadryl for my itchiness. Had "chills" and slept 5 hours (12pm-5pm). Woke up still itchy but tolerable. Entire upper arm is sore up into my neck on left side. Arm is red from shoulder to wrist. Plan on going to walk in clinic tomorrow.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Pain with needle insertion. Sore arm. Red, raised, hot injection site. Approximately 8-9 hours later (after working) I noticed my entire left arm was inflamed, and slightly itchy. I had been itchy from metformin the days before my vaccination and stopped taking it the day of. Took a benadryl and went to sleep. Woke up SUPER itchy with small red dots (hives?) on my arms, chest, back, etc. Took tylenol for my arm pain. Took 2 benadryl for my itchiness. Had "chills" and slept 5 hours (12pm-5pm). Woke up still itchy but tolerable. Entire upper arm is sore up into my neck on left side. Arm is red from shoulder to wrist. Plan on going to walk in clinic tomorrow.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Pain with needle insertion. Sore arm. Red, raised, hot injection site. Approximately 8-9 hours later (after working) I noticed my entire left arm was inflamed, and slightly itchy. I had been itchy from metformin the days before my vaccination and stopped taking it the day of. Took a benadryl and went to sleep. Woke up SUPER itchy with small red dots (hives?) on my arms, chest, back, etc. Took tylenol for my arm pain. Took 2 benadryl for my itchiness. Had "chills" and slept 5 hours (12pm-5pm). Woke up still itchy but tolerable. Entire upper arm is sore up into my neck on left side. Arm is red from shoulder to wrist. Plan on going to walk in clinic tomorrow.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a large red rash all the way around the front and back of my shoulders. When I was young I got the chickenpox or smallpox shot and no reaction (most people have a scar at injection site) I was tested and they found I was naturally immune to the virus.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Injection site skin rash
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives over entire body
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Pt developed hives. No other constitutional symptoms
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Headache, Movement disorder, Pain
Clinical narrative: Running 101.9 temperature,  aching all over, left arm in pain and can not lift, joints and teeth hurt, headache and runny nose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, Toothache
Clinical narrative: Running 101.9 temperature,  aching all over, left arm in pain and can not lift, joints and teeth hurt, headache and runny nose.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Decreased appetite, Headache
Clinical narrative: Fluctuating fever ranging between 99.9-102.4 over the course of 26 hours so far Severe headache Severe arm pain Chills Back and neck pain Joint pain Loss of appetite
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Fluctuating fever ranging between 99.9-102.4 over the course of 26 hours so far Severe headache Severe arm pain Chills Back and neck pain Joint pain Loss of appetite
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Chest pain, Headache, Pain, Pyrexia
Clinical narrative: Head ache, high temperature, sore down side of injection and pains and tightening of chest .
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea, Pain
Clinical narrative: Fever of 102, body chills, nausea, headache, body aches, pain in lower back/kidneys, frequent nighttime urination. Headache and body/ kidney aches persisted until 1pm the following day, chills, fever frequent urination, nausea persisted until 7am the following day.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Fever of 102, body chills, nausea, headache, body aches, pain in lower back/kidneys, frequent nighttime urination. Headache and body/ kidney aches persisted until 1pm the following day, chills, fever frequent urination, nausea persisted until 7am the following day.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Fever, headache, dizziness. Started about 8 hour after shot.  Symptoms not resolved yet
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation which referred to a currently 80-year-old patient (gender was not specified). Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as long-term prevention of shingles and zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) by a pharmacist (the patient was approximately 76-years-old when the vaccine was administered). Afterwards, on an unknown date (reported as subsequently), the patient was treated by a physician for the following injury resulting from zoster vaccine live (ZOSTAVAX) used: shingles (herpes zoster). As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer personal injuries, loss of services and loss of consortium damages. The outcome of the event herpes zoster was not reported. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: Product storage error
Clinical narrative: Caller stated that some of the vaccines have been administered since the temperature excursion; No additional AE reported; This spontaneous report was received from a medical assisstant concerning an unknown number of patients of unknown age and gender.   The patients' concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, there was a temperature excursion for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and hepatitis a vaccine, inactivated (VAQTA) vaccines (11 Celcius degrees for 1 hour and 27 minutes). On unknown dates, some of those vaccines were administered to an unknown number of patients (dose, route of administration, lot #, and expiration date were not reported for any of the reported vaccines) for prophylaxis (product storage error). The reporter was unsure of which vaccines were administered. It was reporter that there was no previous excursion. No aditional adverse events were reported.  This case was considered non-valid due to lack of patients' identifiers.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort
Clinical narrative: HEAD PRESSURE; FATIGUE; This spontaneous report received from a patient concerned a of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced head pressure. On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head pressure, and fatigue on 20-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART PALPITATIONS; TINGLING INSIDE FEET AND LEGS; THROBBING MOVEMENT INSIDE FEET AND LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced heart palpitations, tingling inside feet and legs, and throbbing movement inside feet and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart palpitations, tingling inside feet and legs and throbbing movement inside feet and legs was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy
Clinical narrative: LETHARGY; SHIVERING; HEADACHE; This spontaneous report received from a patient concerned a 57 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 01-APR-2021, the subject experienced lethargy. On 01-APR-2021 at around 11:30 , the subject experienced shivering. On 01-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering on APR-2021, and had not recovered from headache, and lethargy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES IN UPPER LEGS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced muscle aches in upper legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle aches in upper legs. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Myalgia
Clinical narrative: DIZZINESS; CHILLS; FEVER; MUSCLES ACHES; HEADACHE; This spontaneous report received from a patient concerned a 49 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with codeine, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on right arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 31-MAR-2021 18:00, the subject experienced dizziness. On 31-MAR-2021 18:00, the subject experienced chills. On 31-MAR-2021 18:00, the subject experienced fever. On 31-MAR-2021 18:00, the subject experienced muscles aches. On 31-MAR-2021 18:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, and had not recovered from muscles aches, headache, and dizziness. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZINESS; CHILLS; FEVER; MUSCLES ACHES; HEADACHE; This spontaneous report received from a patient concerned a 49 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with codeine, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on right arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 31-MAR-2021 18:00, the subject experienced dizziness. On 31-MAR-2021 18:00, the subject experienced chills. On 31-MAR-2021 18:00, the subject experienced fever. On 31-MAR-2021 18:00, the subject experienced muscles aches. On 31-MAR-2021 18:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, and had not recovered from muscles aches, headache, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: LIMITED MOVEMENT TO ARM; PAIN IN ARM; This spontaneous report received from a patient concerned a 73 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, administered on 10-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced pain in arm. On 19-MAR-2021, the subject experienced limited movement to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm, and had not recovered from limited movement to arm. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Fluid replacement
Clinical narrative: JOINT PAIN; LEFT WEAK; CHILLS; TIREDNESS; NAUSEA; HEADACHE; FEVER; HYDRATING; ACHES,PAIN; This spontaneous report received from a patient via a company representative concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported and has been requested, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 10:55 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hydrating. On 31-MAR-2021, the subject experienced aches, pain. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced left weak. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, and fever on 01-APR-2021, was recovering from headache, had not recovered from aches, pain, tiredness, and joint pain, and the outcome of hydrating and left weak was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: JOINT PAIN; LEFT WEAK; CHILLS; TIREDNESS; NAUSEA; HEADACHE; FEVER; HYDRATING; ACHES,PAIN; This spontaneous report received from a patient via a company representative concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported and has been requested, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 10:55 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hydrating. On 31-MAR-2021, the subject experienced aches, pain. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced left weak. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, and fever on 01-APR-2021, was recovering from headache, had not recovered from aches, pain, tiredness, and joint pain, and the outcome of hydrating and left weak was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Product dose omission issue, Vertigo
Clinical narrative: Missed dose; Loss of consciousness 3 times each one lasting 3-4 minutes; Vertigo; sweating; A spontaneous report was received from a consumer, concerning a 72-year-old male patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and Loss of consciousness 3 times each one lasting 3-4 minutes/loss of consciousness, vertigo, sweating/hyperhidrosis and missed dose/product dose omission issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient suffered from loss of consciousness every 3-4 days. The patient had  three episodes where he experienced loss of consciousness with each experience lasting 3-4 minutes. The patient also experienced vertigo and was sweating when he woke up from losing consciousness. Treatment for the event was unknown.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, loss of consciousness 3 times each one lasting 3-4 minutes, was not resolved. The outcome of the events, vertigo, sweating, and missed dose, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity, Paralysis
Clinical narrative: Upper extremity dysfunction; felt like it was paralyzed; Left arm hurt; pain in shoulder down to armpit; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (felt like it was paralyzed) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinus disorder. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL (ALBUTEROL HFA) for Asthma, IBUPROFEN for Migraine.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Jan-2021, the patient experienced PARALYSIS (felt like it was paralyzed) (seriousness criterion medically significant), PAIN IN EXTREMITY (Left arm hurt) and PAIN (pain in shoulder down to armpit). On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Upper extremity dysfunction). At the time of the report, PARALYSIS (felt like it was paralyzed) and PAIN IN EXTREMITY (Left arm hurt) had resolved and PAIN (pain in shoulder down to armpit) and MUSCULOSKELETAL DISORDER (Upper extremity dysfunction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Body temperature decreased, Chills, Cluster headache
Clinical narrative: very weak; very tired; heart was pounding; vomit; headaches; passed out 3 times; seizure; lost control of her bowels; very low blood pressure; migraine; very low temperature; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out 3 times), SEIZURE (seizure), ANAL INCONTINENCE (lost control of her bowels) and HYPOTENSION (very low blood pressure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included DILTIAZEM for Arrhythmia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 26-Mar-2021, the patient experienced SYNCOPE (passed out 3 times) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), ANAL INCONTINENCE (lost control of her bowels) (seriousness criterion medically significant), HYPOTENSION (very low blood pressure) (seriousness criterion medically significant), MIGRAINE (migraine), BODY TEMPERATURE DECREASED (very low temperature), VOMITING (vomit) and CLUSTER HEADACHE (headaches). On 28-Mar-2021, the patient experienced PALPITATIONS (heart was pounding). On 29-Mar-2021, the patient experienced ASTHENIA (very weak) and FATIGUE (very tired). On 26-Mar-2021, SYNCOPE (passed out 3 times), SEIZURE (seizure), ANAL INCONTINENCE (lost control of her bowels), HYPOTENSION (very low blood pressure), BODY TEMPERATURE DECREASED (very low temperature), PYREXIA (fever), VOMITING (vomit), CLUSTER HEADACHE (headaches) and CHILLS (chills) had resolved. On 28-Mar-2021, PALPITATIONS (heart was pounding) had resolved. At the time of the report, MIGRAINE (migraine) had resolved and ASTHENIA (very weak) and FATIGUE (very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-064116 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypotension, Migraine, Palpitations, Pyrexia
Clinical narrative: very weak; very tired; heart was pounding; vomit; headaches; passed out 3 times; seizure; lost control of her bowels; very low blood pressure; migraine; very low temperature; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out 3 times), SEIZURE (seizure), ANAL INCONTINENCE (lost control of her bowels) and HYPOTENSION (very low blood pressure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included DILTIAZEM for Arrhythmia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 26-Mar-2021, the patient experienced SYNCOPE (passed out 3 times) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), ANAL INCONTINENCE (lost control of her bowels) (seriousness criterion medically significant), HYPOTENSION (very low blood pressure) (seriousness criterion medically significant), MIGRAINE (migraine), BODY TEMPERATURE DECREASED (very low temperature), VOMITING (vomit) and CLUSTER HEADACHE (headaches). On 28-Mar-2021, the patient experienced PALPITATIONS (heart was pounding). On 29-Mar-2021, the patient experienced ASTHENIA (very weak) and FATIGUE (very tired). On 26-Mar-2021, SYNCOPE (passed out 3 times), SEIZURE (seizure), ANAL INCONTINENCE (lost control of her bowels), HYPOTENSION (very low blood pressure), BODY TEMPERATURE DECREASED (very low temperature), PYREXIA (fever), VOMITING (vomit), CLUSTER HEADACHE (headaches) and CHILLS (chills) had resolved. On 28-Mar-2021, PALPITATIONS (heart was pounding) had resolved. At the time of the report, MIGRAINE (migraine) had resolved and ASTHENIA (very weak) and FATIGUE (very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-064116 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope, Vomiting
Clinical narrative: very weak; very tired; heart was pounding; vomit; headaches; passed out 3 times; seizure; lost control of her bowels; very low blood pressure; migraine; very low temperature; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out 3 times), SEIZURE (seizure), ANAL INCONTINENCE (lost control of her bowels) and HYPOTENSION (very low blood pressure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included DILTIAZEM for Arrhythmia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 26-Mar-2021, the patient experienced SYNCOPE (passed out 3 times) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), ANAL INCONTINENCE (lost control of her bowels) (seriousness criterion medically significant), HYPOTENSION (very low blood pressure) (seriousness criterion medically significant), MIGRAINE (migraine), BODY TEMPERATURE DECREASED (very low temperature), VOMITING (vomit) and CLUSTER HEADACHE (headaches). On 28-Mar-2021, the patient experienced PALPITATIONS (heart was pounding). On 29-Mar-2021, the patient experienced ASTHENIA (very weak) and FATIGUE (very tired). On 26-Mar-2021, SYNCOPE (passed out 3 times), SEIZURE (seizure), ANAL INCONTINENCE (lost control of her bowels), HYPOTENSION (very low blood pressure), BODY TEMPERATURE DECREASED (very low temperature), PYREXIA (fever), VOMITING (vomit), CLUSTER HEADACHE (headaches) and CHILLS (chills) had resolved. On 28-Mar-2021, PALPITATIONS (heart was pounding) had resolved. At the time of the report, MIGRAINE (migraine) had resolved and ASTHENIA (very weak) and FATIGUE (very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-064116 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.