chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pharyngeal swelling
Clinical narrative: At the time of vaccination, Lot # 040A21A at 10 minutes after the vaccine was given to me, my the glands in my throat started to swell. I went back to the pharmacy and they gave me an epi pen injection and then called 911 to get me to the emergency room. I had to take Benadryl, steroids and Pepcid AC through an IV.  They also prescribed those three medications and an epi pen to my pharmacy for an additional 4 days.  It is day two and there is a slight improvement, but the swelling is still there.  I had no issue with the first shot, Lot #013M20A.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Rash pruritic
Clinical narrative: Large itchy rash and swelling on left arm near the site of injection, developed on the seventh day from the day of vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Chills        Low grade fever         Nausea          Stomach pains         Light headed
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive
Clinical narrative: Chills        Low grade fever         Nausea          Stomach pains         Light headed
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dizziness, Electrocardiogram, Hypoaesthesia
Clinical narrative: Numbness on left side of body (face, arm, leg)  onset at 12:25pm approximately 3 hours after leaving vaccination facility. Dizziness. Heart palpations. Numbness subsides 24 hours later, and had tingling sensations in left hand/ fingers 6 days later.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Numbness on left side of body (face, arm, leg)  onset at 12:25pm approximately 3 hours after leaving vaccination facility. Dizziness. Heart palpations. Numbness subsides 24 hours later, and had tingling sensations in left hand/ fingers 6 days later.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: PATIENT HAD DIZZINESS AND BLURRED VISION 1 HOUR AFTER ADMINISTRATION.  SHE SAID SHE DID NOT EAT BREAKFAST AND IT HAD HAPPENED TO HER BEFORE WHEN SHE WAS HUNGRY.  SHE WAS GIVEN FOOD TO EAT WHILE SITTING DOWN. HER INITIAL BP WAS AROUND 150/90 BUT WENT DOWN TO 127/80 AFTER A FEW MINUTES.  HER BLURRED VISION WENT AWAY AFTER SHE ATE ALTHOUGH SHE STILL HAD SOME DIZZINESS. SHE WAS WELL ENOUGH TO WALK AND DRIVE.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: MY WIFE DIED UNEXPECTEDLY 4 DAYS AFTER HER SECOND DOSAGE SHOT, ON FEBRUARY 17, 2021.  SHE HAD BEEN HEALTHY AND HAD A RECENT CHECKUP AT WHICH THE DOCTOR GAVE  HER A CLEAN BILL OF HEALTH.  SHE WAS ALERT AND IN GOOD SPIRITS JUST THE NIGHT BEFORE WHEN WE WATCHED A MOVIE TOGETHER.  I SAW NO INDICATION THAT SHE WAS FEELING POORLY OR OTHERWISE.  I FOUND HER IN BED, DECEASED, UPON COMING HOME FROM WORK THE NEXT DAY.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Diarrhoea, Fatigue
Clinical narrative: Vomiting and diarrhea from 4-7 am Tues morning. Followed by fatigue all day and Tues night.  Temp on Tues afternoon was 101.4. aches and chills periodically on Tues afternoon. Weakness on Tues morning into late afternoon. Temp 99.6 on wed morning and afternoon. Temp normal at 8pm wed.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Vomiting and diarrhea from 4-7 am Tues morning. Followed by fatigue all day and Tues night.  Temp on Tues afternoon was 101.4. aches and chills periodically on Tues afternoon. Weakness on Tues morning into late afternoon. Temp 99.6 on wed morning and afternoon. Temp normal at 8pm wed.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness & fatigue, 48 hours
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient experienced a rash approximately 3-4 hours after receiving vaccine. Rash located in the same arm as vaccination was placed. Rash extended to the elbow. Patient took benadryl 25 mg and rash subsided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Myalgia, Pain
Clinical narrative: Pain, muscle aches, hot flashes, chills.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Severe headache, dizziness, mild nausea, chills that lasted 5 hours, with milder headache and fatigue for another day
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: Firm/hard red bump that it is itchy around the injection site. It is growing. It was about the size of a pen tip and grew to nickel within a few hours and the size of a quarter within 30 min of  itching onset. It is still expanding in size, approximately 11 hrs after shot.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Felt mild numbness on left side of face the same night as I received the vaccine. It got worse the next day. I contacted a doctor via telemedicine and she did an evaluation. She said it was a mild Bell?s Palsy but likely not serious because she couldn?t observe it when asking me to raise my eyebrows or smile ? it was just  something I could feel. It went away on its own within another day or so.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling cold, Feeling hot, Headache, Muscle spasms
Clinical narrative: extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper torso moderate headache , cold all over   .relieved with ibuprofin and tylenol every 6 hours .all ending about 24 hours later with a warm mild fever like sensation and 2 hours of sleep.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper torso moderate headache , cold all over   .relieved with ibuprofin and tylenol every 6 hours .all ending about 24 hours later with a warm mild fever like sensation and 2 hours of sleep.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: Within 20 minutes of jab: Lightheadedness, pressure in the head  Within 60 minutes: Slight fatigue Within 90 minutes: Headache, foggy brain, slight  focus/concentration issue Within 2 hours: Extreme fatigue  After 6 hours: All issues better but still present. Fatigue especially better but still an issue.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Within 20 minutes of jab: Lightheadedness, pressure in the head  Within 60 minutes: Slight fatigue Within 90 minutes: Headache, foggy brain, slight  focus/concentration issue Within 2 hours: Extreme fatigue  After 6 hours: All issues better but still present. Fatigue especially better but still an issue.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: Severe pain in arm of injection site, body aches, fatigue, nausea
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Second day, March 5th muscle pain all over body, mostly on lower level, legs very painful feeling. Pain level 9 constant. Could not move or do much. Body aches.  Third day March 6- continue body pain and aches. Headaches long lasting - pain level continue at 9. Took Tylenol. Every 8 hours. Help for a little bit. Could not sleep headache came back, developed low fever and chills and body pain, legs muscles painful. Day 4- March 7- same as day prior.  Day 5- to now March 8-10. Chests pains, back of chests pains. Lung pain, sharp. Very hard to catch a breath, very painful in my longs, lost appetite, blurry vision,  my longs hurt while breathing. Difficult to breath. Will make appt with doctor. Pain level 9.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain, Pain in extremity, Pulmonary pain
Clinical narrative: Second day, March 5th muscle pain all over body, mostly on lower level, legs very painful feeling. Pain level 9 constant. Could not move or do much. Body aches.  Third day March 6- continue body pain and aches. Headaches long lasting - pain level continue at 9. Took Tylenol. Every 8 hours. Help for a little bit. Could not sleep headache came back, developed low fever and chills and body pain, legs muscles painful. Day 4- March 7- same as day prior.  Day 5- to now March 8-10. Chests pains, back of chests pains. Lung pain, sharp. Very hard to catch a breath, very painful in my longs, lost appetite, blurry vision,  my longs hurt while breathing. Difficult to breath. Will make appt with doctor. Pain level 9.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Vision blurred
Clinical narrative: Second day, March 5th muscle pain all over body, mostly on lower level, legs very painful feeling. Pain level 9 constant. Could not move or do much. Body aches.  Third day March 6- continue body pain and aches. Headaches long lasting - pain level continue at 9. Took Tylenol. Every 8 hours. Help for a little bit. Could not sleep headache came back, developed low fever and chills and body pain, legs muscles painful. Day 4- March 7- same as day prior.  Day 5- to now March 8-10. Chests pains, back of chests pains. Lung pain, sharp. Very hard to catch a breath, very painful in my longs, lost appetite, blurry vision,  my longs hurt while breathing. Difficult to breath. Will make appt with doctor. Pain level 9.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Loss of consciousness, Scan brain
Clinical narrative: Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty breathing. Went into adverse reaction. Did not wake up - moved to ER
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty breathing. Went into adverse reaction. Did not wake up - moved to ER
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Decreased appetite, Discomfort
Clinical narrative: On February 18th - My dad started with fever/chills within the next day after getting his second shot, stopped eating/lost appetite, couldn't eat anything - couldn't eat any solid food - only had liquids and Ensure for 10 days.  He has also experienced pain in his chest pain (unclear if muscle pain).  He is still experiencing discomfort.    Has lost weight. Then got a little better for 2 days, then lost appetite and unable to get out of bed.  Then arm and legs swollen on 3/9/2021 but swelling has gone down today. He is conscious but is having a hard time getting out of bed and has no energy.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia, Weight decreased
Clinical narrative: On February 18th - My dad started with fever/chills within the next day after getting his second shot, stopped eating/lost appetite, couldn't eat anything - couldn't eat any solid food - only had liquids and Ensure for 10 days.  He has also experienced pain in his chest pain (unclear if muscle pain).  He is still experiencing discomfort.    Has lost weight. Then got a little better for 2 days, then lost appetite and unable to get out of bed.  Then arm and legs swollen on 3/9/2021 but swelling has gone down today. He is conscious but is having a hard time getting out of bed and has no energy.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Blindness, Condition aggravated, Facial neuralgia, Oral discomfort
Clinical narrative: moderna covid-19 vaccineEUA  Lost sight twice 1 second ea . all facial nerve pain & burning mouth  has been much more severe
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral, Pain in extremity
Clinical narrative: I experienced pain and swelling in my right arm-pit, as well as pain in my right arm when I move it around beginning on 3/10
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash appeared 1 week after vaccination at injection site
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Fever and chills started about 22 hours after and lasted one day. Shot site has been sore and is still sore.  Round red circle about two inches below injection site showed up 2 days after the shot. About 2.5 inch diameter. It hurts and occasionally itches.  No medical treatment sought so far. I have taken ibuprofen and Tylenol.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Condition aggravated, Gingival bleeding, Immune thrombocytopenia, Increased tendency to bruise
Clinical narrative: ITP relapse - platelet drop >10,000 which lead to petechia, bleeding gums, bruising easily.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: ITP relapse - platelet drop >10,000 which lead to petechia, bleeding gums, bruising easily.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: extreme pain in arm the day of the vaccine until 3 days after vaccine, followed by a fever, chills, body aches and headaches only the day after the vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site induration, Injection site swelling
Clinical narrative: large hard swelling bump 7 days after injection at the injection site, slight pain in armpit as well.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Swelling of eyelid
Clinical narrative: 12 days after his second Moderna COVID vaccine, my father developed Shingles. His left eyelid is incredibly swollen and his right eyelid began to swell today. That is his only symptom. He?s on an antiviral and gabapentin. He had received both doses of his shingles vaccines about 3 years prior. We have no idea if related to COVID vaccine but wanted to make you all aware.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: I got a 100-101 fever for 24h and then that went away. Also had a headache but that was expected.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Pt was mistakenly given flu vaccine instead of TB skin test serum.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Movement disorder
Clinical narrative: Severe lower back ache appeared two days after each dose, sufficient to restrict ordinary movements. Pain abated slowly over following weeks. At time of reporting, two weeks after second dose, significant improvement noted but not full recovery.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain at time of injection, then severe arm pain and inability to lift arm.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Narcolepsy, Somnolence
Clinical narrative: Irresistible sleepiness generally culminating in a first ever episode of narcolepsy as I was in my car
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fall, Headache
Clinical narrative: 02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it.  In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell.  He felt like he was going to vomit too.  He was so weak that he could not get up off the floor by himself.  My son lifted him up.  He also noticed Friday night that there was a bubble where the vaccine was given in his arm.  02/27/2021, the bubble had burst and liquid was coming out.  It was an open wound which was sore and really red.  He also had a headache and continued weakness.  02/28/2021, he still had a headache and the arm was sore.  03/01/2021, felt pretty good.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discharge, Injection site erythema, Injection site infection, Injection site pustule, Injection site ulcer
Clinical narrative: 02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it.  In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell.  He felt like he was going to vomit too.  He was so weak that he could not get up off the floor by himself.  My son lifted him up.  He also noticed Friday night that there was a bubble where the vaccine was given in his arm.  02/27/2021, the bubble had burst and liquid was coming out.  It was an open wound which was sore and really red.  He also had a headache and continued weakness.  02/28/2021, he still had a headache and the arm was sore.  03/01/2021, felt pretty good.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: 02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it.  In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell.  He felt like he was going to vomit too.  He was so weak that he could not get up off the floor by himself.  My son lifted him up.  He also noticed Friday night that there was a bubble where the vaccine was given in his arm.  02/27/2021, the bubble had burst and liquid was coming out.  It was an open wound which was sore and really red.  He also had a headache and continued weakness.  02/28/2021, he still had a headache and the arm was sore.  03/01/2021, felt pretty good.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large swollen  hot tender spot . I have heard it called Covid arm or Moderna arm. Did not happen after first dose. Noticed it 4 days after second dose. Not as hot on 5th day. On the 6th day  only symptoms itchy.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  102 fever, body aches, chills, headache, nausea, tiredness
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  102 fever, body aches, chills, headache, nausea, tiredness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Fatigue, Hallucination, Hyperhidrosis, Sleep disorder
Clinical narrative: I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Chills (lasting 5 hrs), fever (lasting about 16 hrs), headache, dizziness, muscle ache, fatigue, sore vaccinated arm and other arm, too
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills (lasting 5 hrs), fever (lasting about 16 hrs), headache, dizziness, muscle ache, fatigue, sore vaccinated arm and other arm, too
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Itching and redness at the vaccine site on arm.  Over 2 days (currently), has developed into a large red patch, aprox 2 inches x 3 inches, with less itching.  General soreness in the same area.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Mental impairment, Pain, Pyrexia
Clinical narrative: Evening of the 2nd dose started having severe headaches.  Continued having severe headaches, fever, sharp internal pains moving from one organ to another throughout the night.  Next day severe headaches, fever,  internal pains, lethargy.  Difficulty thinking.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Sleep disorder, Tachypnoea, Tremor
Clinical narrative: Pain at sight immediately that continued for 30min At 7:30pm fever chills constant shaking that subsided at 9:00pm woke up at 10:45pm and can?t stop shaking legs and rapid breathing....still going in at 12;30am as I wrote this
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms evening after receipt of vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Facial paresis, Full blood count, Human chorionic gonadotropin, Metabolic function test
Clinical narrative: Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left facial droop.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left facial droop.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Insomnia
Clinical narrative: Arm soreness radiating to joints and neck Feverish Chills Insomnia Generalized weakness GI upset
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness radiating to joints and neck Feverish Chills Insomnia Generalized weakness GI upset
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle tightness, Pain, Pain in jaw, Swelling
Clinical narrative: Diarrhea since 03/06/2021.   Pain-sensitivity-TMJ/lockjaw type symptoms in the right side of face from temple & ear-cheek-jaw, down to right side of neck. Area that's worse is upper right jaw, aligned with ear & running down & underneath jaw bone. Entire right side face feels swollen and jaw is tightening up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Diarrhea since 03/06/2021.   Pain-sensitivity-TMJ/lockjaw type symptoms in the right side of face from temple & ear-cheek-jaw, down to right side of neck. Area that's worse is upper right jaw, aligned with ear & running down & underneath jaw bone. Entire right side face feels swollen and jaw is tightening up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After receipt of dose 1 noticed a couple of episodes of intense tinnitus. After a few days the symptoms disappeared. Did not report. Upon second dose, several episodes of intense tinnitus reoccurred. The first event was within an hour of receiving second  dose. Tinnitus continues to varying degrees, but not entirely absent. No treatment to date. Audiology referral pending.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Nodule
Clinical narrative: Red nonitchy spot around the injection site, the size about 6 inches. The knot that developed in my arm the day following my injection was the size of a golf ball for three days. The injection spot was closer to my shoulder than middle of my arm. The red spot it slightly larger currently.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: My menstrual period had terminated on the previous Saturday. On the day of the vaccine (Tuesday) 3/4 hours after the vaccine I started spotting. This then transformed into moderate vaginal bleeding which lasted for about 4 days. I had no other symptoms and this was very unusual and scary. I had a vaginal ultrasound 2 days after the bleeding started and no abnornalities were found. My pap smear is also clear.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red, sore and itchy injection site beginning 7 days after vaccination.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Chills, Death, Nausea
Clinical narrative: Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultimately succumbed to cardiac arrest.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy, Urticaria, Vaccination site erythema
Clinical narrative: ?Covid arm? - redness, hive (3+ inches), swelling, pruritis Axillary lymph node tenderness in same side as vaccination Joint aches and stiffness
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: ?Covid arm? - redness, hive (3+ inches), swelling, pruritis Axillary lymph node tenderness in same side as vaccination Joint aches and stiffness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest X-ray normal, Electrocardiogram abnormal, Full blood count, Hypotension
Clinical narrative: patient awakened 12 hours after vaccine given with svt- seen at er with hypotension and svt. adenosine given and arrhythmia terminated. labs normal
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Supraventricular tachycardia, Troponin normal
Clinical narrative: patient awakened 12 hours after vaccine given with svt- seen at er with hypotension and svt. adenosine given and arrhythmia terminated. labs normal
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I did not have any arm soreness on the day of the vaccine was given. The next day I felt exhausted like I hadn't slept and texted my son "boy, do I feel wiped out." I slept on and off all day and most of the night Tuesday til Wednesday evening around 11pm. This was approximately from 2pm Tuesday through 11pm Wednesday- 33 hours. I am writing this report at 2:24 AM on Thursday morning reasonably awake.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Stomatitis
Clinical narrative: 103 fever,body aches,headaches two days,fever sores on mouth 5 days. one week after shot still have headaches
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: 103 fever for two days body aches and joint pain.headaches for 5 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Injection site reaction
Clinical narrative: Pain and weakness at injection site continuing to get worse 12 hours later.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain
Clinical narrative: At 1:30am I woke up with the chills and body aches, I had to bundle up with my jacket, over my pajamas and add a second blanket. I also felt wide awake and I'm not a morning person. My entire body aches every for my head. My joints and muscles hurt from my toes up to my shoulders
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt. in observation lane felt dizzy.  Paramedic assessed her after vitals were clear once the symptoms subsided, Paramedics cleared her to leave.  Tent 14
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Lethargy
Clinical narrative: Starting around 8pm on the day of the injection, I had the chills and was excessively tired.  By the time I went to bed, I developed a fast heartbeat (similar to anxiety spells), front temple head ache, body aches, lethargic feeling.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Starting around 8pm on the day of the injection, I had the chills and was excessively tired.  By the time I went to bed, I developed a fast heartbeat (similar to anxiety spells), front temple head ache, body aches, lethargic feeling.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral
Clinical narrative: Pt. felt mouth numb and had a headache in observation line.  Paramedic assessed her until pt. symptoms subsided.  Paramedics released her to leave.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nervousness
Clinical narrative: After client received her vaccine client stated she feels flushed and shaky.  Vital signs obtained.  BP 126/83, HR 93, O2 Sat 99%.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Injection site soreness/pain set in 5 hours after vaccination, much faster than with first dose. Woke up at 2:00am with headache and severe fever chills. Took 2 standard size tablets of acetaminophen at 3:30am and went to sleep.  Woke up again at 5:00am with  no headache or fever chills but feeling very hot and sweaty.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Injection site soreness/pain set in 5 hours after vaccination, much faster than with first dose. Woke up at 2:00am with headache and severe fever chills. Took 2 standard size tablets of acetaminophen at 3:30am and went to sleep.  Woke up again at 5:00am with  no headache or fever chills but feeling very hot and sweaty.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Endotracheal intubation, Neck pain
Clinical narrative: Patient came to emergency department after receiving second dose of COVID-19 vaccine, unknown which manufacturer as occurred prior to emergency department visit, with worsening neck pain. Wound up being treated for possible anaphylaxis and intubated. He was intubated around 12 hours after the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Client c/o feeling lightheaded immediately after receiving the vaccine.  Client seen and assessed by EMT.  Vital signs are:  BP 122/79, HR 92, O2 98, BS 85.  After 15 minutes of observation, client verbalized that symptoms had diminished and was cleared to go home by EMT.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body ache fever chills sore throat headache
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: headache, feeling tired, muscle aches, fever, nausea
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash pruritic
Clinical narrative: Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tiredness
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Mild Headache -15 mins. after injection Nausea- evening 3/9/21 Tummy ache- 3/10/21 @11 am Low grade fever-3/10/21 @ 5 pm Chills-3/10/21
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness in the morning that wore off, followed by late night nausea, vomiting lasting 2 hours.  Nausea still present but improving.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Erythema, Glossodynia, Headache
Clinical narrative: DAY 1-red face, itching face and neck,headache, sore armsore throat, swollen lymph node in neck, cough that night/took benadryl and put caladryl lotion on face and neck DAY 2-arm sore, neck and chest itching/took ibprofen and benadrylDAY3itching is worse/took 3 benadryl during day and used hydrocortisone creamDAY4 same itching, headache/took tylenol and benadrylDAY5face red, eyes sensitive to lightDAY6 cough,congestion, headache/took zyrtec,tylenolDAY7 cough, congestion,side of tongue sore/took musinexDAY8cough and diahreah/took zyrtecDAY9cough,sorethroat/zyrtec Day10 rash on arm, swollen, hot to touch/ibprofen and BCDay11rash on arm bigger,arm itching, headache,eyes sensitive to light/took zyrtec and ibprofenDAY12 still rash on arm
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Photophobia
Clinical narrative: DAY 1-red face, itching face and neck,headache, sore armsore throat, swollen lymph node in neck, cough that night/took benadryl and put caladryl lotion on face and neck DAY 2-arm sore, neck and chest itching/took ibprofen and benadrylDAY3itching is worse/took 3 benadryl during day and used hydrocortisone creamDAY4 same itching, headache/took tylenol and benadrylDAY5face red, eyes sensitive to lightDAY6 cough,congestion, headache/took zyrtec,tylenolDAY7 cough, congestion,side of tongue sore/took musinexDAY8cough and diahreah/took zyrtecDAY9cough,sorethroat/zyrtec Day10 rash on arm, swollen, hot to touch/ibprofen and BCDay11rash on arm bigger,arm itching, headache,eyes sensitive to light/took zyrtec and ibprofenDAY12 still rash on arm
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Respiratory tract congestion, Skin warm
Clinical narrative: DAY 1-red face, itching face and neck,headache, sore armsore throat, swollen lymph node in neck, cough that night/took benadryl and put caladryl lotion on face and neck DAY 2-arm sore, neck and chest itching/took ibprofen and benadrylDAY3itching is worse/took 3 benadryl during day and used hydrocortisone creamDAY4 same itching, headache/took tylenol and benadrylDAY5face red, eyes sensitive to lightDAY6 cough,congestion, headache/took zyrtec,tylenolDAY7 cough, congestion,side of tongue sore/took musinexDAY8cough and diahreah/took zyrtecDAY9cough,sorethroat/zyrtec Day10 rash on arm, swollen, hot to touch/ibprofen and BCDay11rash on arm bigger,arm itching, headache,eyes sensitive to light/took zyrtec and ibprofenDAY12 still rash on arm
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pain in extremity
Clinical narrative: HA and muscle pain at injection site within  1 hour, joint  pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all  treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30  minutes at 14 hours post dose - no treatment, self-resolved
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HA and muscle pain at injection site within  1 hour, joint  pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all  treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30  minutes at 14 hours post dose - no treatment, self-resolved
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Upper-airway cough syndrome
Clinical narrative: Mild headache, sustained nasal dripping, fatigue.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Fever, aches, chills, shaking.   I had a severe case of covid one year ago.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash around injection site 8 days after Shot..  Burning and Itchy.  Seems to be getting better 3 days later.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: 3 hrs after injection got real tired and took a nap for 20mints. 12 hours after injection got fever of 101, chills, body aches, pain from left arm up to my neck down to my hips and into my artificial knee-rt side. Fever came down to 99 after taking 600mg motrin. Injection site still painful.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102  for 4 days  Arm sore and red hot to the touch  Headaches for 4 days  Tired
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Fever of 102  for 4 days  Arm sore and red hot to the touch  Headaches for 4 days  Tired
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: THE PATIENT RECEIVED THE VACCINE AND WAS SEATED IN THE WAITING AREA . AFTER A FEW MINUTES, THE PATIENT BEGAN TO FAINT. THE PHARMACIST AND TECHNICIAN HELPED HIM TO THE FLOOR. HE STATED THAT THIS HAS HAPPENED TO HIM BEFORE WHEN HE HAD BLOOD DRAWN. HE ALSO CALLED HIS MOTHER AND SHE CONFIRMED THAT HE HAS A HISTORY OF SYNCOPE WHEN RECEIVING SHOTS. THE PATIENT DID NOT GO TO THE HOSPITAL, BUT HAD A FRIEND COME TO GET HIM. HE WAS CALLED LATER THAT NIGHT AND STATED THAT EVERYTHING WAS BACK TO NORMAL.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of PROQUAD was given; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient concomitant medication, pertinent medical history and drug reactions and allergies were not provided.      On 18-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type (rHA)) (strength and route were not provided; lot# was S023651 and expiration date was 26-JAN-2021), 0.5 ml for prophylaxis (expired product administered). No additional adverse event (AE) was reported. This vaccine did not experience a temperature excursion.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Sleep disorder, Swelling
Clinical narrative: Go to sleep with no issue unlike the first dose; post-vaccine swelling; post-vaccine pain; post-vaccine redness; This case was reported by a other health professional via call center representative and described the occurrence of sleep disorder in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sleep disorder, swelling, pain and erythema. On an unknown date, the outcome of the sleep disorder, swelling, pain and erythema were unknown.   It was unknown if the reporter considered the sleep disorder, swelling, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced post-vaccine swelling, pain, redness and she could not go to sleep without problems.  Upon follow up with the patient, the patient stated she did not experience any adverse reaction to the 2nd Shingrix vaccine. The patient called to request information for vaccine stability after a warm compress was used to manage pain at site of injection. This was the 2nd dose and the use of heat helped a lot in the management of the pain as per reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010498:same patient
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: developed "all internal shingles"; sharp pain on one side; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DH34, expiry date unknown) for prophylaxis.   On 28th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In December 2020, between 2 and 4 months after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient received Shingrix in the right deltoid and developed all internal shingles in December 2020. It presented as sharp pain on one side. The reporter did not consent to follow up. Additional information was not known and the HCP declined follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Bradykinesia, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: anaphylactic reaction; Sweating; Slow hands movement; nausea; Body aches; A spontaneous report was received from a consumer who was a 37-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, sweating, body aches and anaphylactic reaction.   The patient's medical history included a previous anaphylactic reaction to her first Moderna Covid-19 vaccine.  .Concomitant medications were not reported.  On 30-DEC-2020,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) and on 27-JAN-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly  for prophylaxis of COVID-19 infection.   On 27-JAN-2021, after receiving the second dose of mRNA-1273, the patient reported that she experienced nausea, sweating, body aches, and an anaphylactic reaction that was characterized by slow hand movements and facial swelling.  The patient reported that she would see her doctor on 18-Feb-2021.   Treatment for the events were not reported.  The patient received both doses of mRNA-1273, therefore, action taken with the drug was not applicable.    The outcomes of the events, nausea, sweating, body aches and anaphylactic reaction, were 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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site discharge
Clinical narrative: A few drops of the vaccine leaked out; A few drops of the vaccine leaked out; A spontaneous report  was received from a nurse concerning a patient of unknown age and gender, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and a few drops of the vaccine leaked out   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection and a few drops of the vaccine leaked out (accidental underdose).  No AEs were reported, and no treatment medications were reported.  Action taken with mRNA-1273 was not reported.  The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of accidental underdose and vaccination site discharge for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: Broken Hip; Fall; A report was received from a consumer who was also a 73-year old, male patient who had a fall and broke his hip.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 20 FEB 2021 the patient had a fall and broke his hip. The patient received surgery to repair the injury and was prescribed pain medications.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of fall, a causal relationship cannot be excluded and the event of hip fracture is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 3rd dose 28 days after the 2nd one; A spontaneous report was received from a healthcare professional  concerning an male patient of an unknown age (approximately 60+ years old), received  third dose of Moderna's COVID-19 vaccine (mRNA-1273) vaccine by mistake (extra dose administered). (Case crosslinked to MOD21-037355, MOD21-037502, MOD21-037503, MOD21-037495). No Adverse events were reported.  The patient's medical history was not provided and concomitant medications were also not provided.  On 22 Feb 2021, the patient received their third dose of mRNA-1273 (Lot/batch: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  The third dose was given 28 days after the second one, which had also been given 28 days after the first dose (extra dose administered).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event third dose was given 28 days after the second one was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of Extra dose administered for mRNA-1273, lot #unknown, with no associated AEs.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Gait inability, Malaise, Memory impairment
Clinical narrative: Activated a BAKERS SYSTS; she could not get up, she could not go to bathroom; Left leg was very sore; Left leg very swollen; Chills; Had fever; Inconsistencies to remember; Not feel well; Delirious; A spontaneous report was received from a consumer concerning 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, began to not feel well, had fever, was delirious, inconsistencies with speech, problems with the left leg, left leg was very sore, very swollen, could not get up, had chills, couldn't sit in the bathroom, overreaction and activated a Baker's cyst  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, approximately three hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced to not feel well, had fever, was delirious(considered medically significant event), inconsistencies to remember, problems with the left leg. On Wednesday 17 Feb 2021, the patient experienced left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills. On Thursday 18 Feb 2021, the patient experienced could not sit in the bathroom. On Friday 19 Feb 2021, the patient was still very swollen. On an unknown date, the patient experienced activated a BAKERS SYSTS  Laboratory details included, on Saturday 20 Feb 2021, the patient went to the hospital and got an ECO DOPPLER.  Treatment for the event included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, bad reaction, began to not feel well, she had a fever, she was delirious, said inconsistencies, problems with the left leg, left leg was very sore, very swollen, could not get up, could not go to the bathroom,  had a fever and chills, couldn't sit in the bathroom, overreaction and activated a BAKERS SYSTS was considered recovering(getting better every day).; Reporter's Comments: Based on the current available information and  a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship cannot be excluded.