chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible headache, advised to take Tylenol or ibuprofren if not allergic to same- unknown outcome at this time.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Dyspnoea, Fatigue
Clinical narrative: I was working and around 10 o'clock my back started aching a little bit, and then mild body aches spread all over my body. I started feeling weaker. When I got home I was weak, and I had chills and fever and I was tired. I woke up a few times in the night with night sweats and chills. I was short of breath.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: I was working and around 10 o'clock my back started aching a little bit, and then mild body aches spread all over my body. I started feeling weaker. When I got home I was weak, and I had chills and fever and I was tired. I woke up a few times in the night with night sweats and chills. I was short of breath.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: headaches, nausea/dizziness, and chills
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Peripheral swelling
Clinical narrative: The next day after I was so weak and fatigued I couldnt get out of bed.  I was literally stayed in bed for 36hr because I was so weak and tired. My arm swole up just as bad as from the previous arm did from the 1st vaccination but this time when healing it was like red and pink streaks were up and down my arm.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: 1st vaccine received 12/31 at 0730.  2nd vaccine received 2/4 at 1100.  Full body rash from neck to ankles. caller adv it is not itchy or painful
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: I had no effects the day of the vaccine. When I woke up the next morning (2/11/2021) I had a rash on my face. It looked like small white heads. I popped a couple of them and then noticed they were all over and my face was red under the bumps. It itches, but there is no pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Feeding disorder, Joint stiffness, Myalgia
Clinical narrative: Severe muscle aches all over body. Joints are painful and tight. Stomach pain and cramps. Nausea to the point of not being able to eat.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Severe muscle aches all over body. Joints are painful and tight. Stomach pain and cramps. Nausea to the point of not being able to eat.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Low grade fever of 99.4 headache, general fatigue & malaise. Started late evening on 2/9/2021 until 2/10/2031 early evening. Approximately 24 hours.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus, Vaccination complication
Clinical narrative: First day very nauseous. Three days very tired Then very itchy left arm seven days later. Looks like 20 small spider bites all in one area
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm which got worse later in the day and at night. On date of vaccination. Arm hurt from shoulder down to wrist. On the next day only site of vaccination hurt and today 2 days later the vaccination area hurt less but still noticeable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever, chills, fatigue. Soreness, swelling and heat at injection site.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, fatigue. Soreness, swelling and heat at injection site.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Oral herpes
Clinical narrative: within 24 hours:  blistering lesion with surrounding erythema on R buttocks and herpes simplex (cold sore) on lip
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: "Received second Injection 1-26-21 Next day experienced mild headache, moderate muscle and neck pain, skin extremely sensitive to the touch, and fatigue. This resolved about 36 hours after the injection.  Was feeling fine until today 2/3/21 (one week after injection) . New symptoms developed as I am now feeling like I have tightness in my lungs when I breathe with mild difficulty. (kind of like when I have a chest cold). Also my throat feels funny like my trachea hurts.I have been reporting daily with the CDC app as suggested and have reported these symptoms as well."
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Sensitive skin, Throat irritation, Tracheal pain
Clinical narrative: "Received second Injection 1-26-21 Next day experienced mild headache, moderate muscle and neck pain, skin extremely sensitive to the touch, and fatigue. This resolved about 36 hours after the injection.  Was feeling fine until today 2/3/21 (one week after injection) . New symptoms developed as I am now feeling like I have tightness in my lungs when I breathe with mild difficulty. (kind of like when I have a chest cold). Also my throat feels funny like my trachea hurts.I have been reporting daily with the CDC app as suggested and have reported these symptoms as well."
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received Moderna vaccine. Per CDC guidelines patient is to receive dose 2 of Moderna, patient scheduled to receive Moderna dose 2 on 3/6/21.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient received COVID-19 Vaccine at 8:23 am, complained of itching, a rapid response was called, the employee was taken to the ED and signed in at 8:57am.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: red mark that each day spreads now from shoulder down to my elbow . its itchy,  its on the inside of my arm. its very large
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: red mark that each day spreads now from shoulder down to my elbow . its itchy,  its on the inside of my arm. its very large
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tongue disorder
Clinical narrative: woke up in the night with a "thick tongue" on 2/10/21. this resolved by morning, patient has body aches now but will take tylenol. advised to take benadryl and call 911 if tongue swelling returns or any other signs/symptoms of allergic reaction
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lymphadenopathy, Nausea, SARS-CoV-2 test negative
Clinical narrative: had telehealth with a provider he told me to get tested for Covid which I did and the result is negative Headache, nausea, lightheadedness, and swollen neck lymph nodes
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram abnormal, Headache, Lumbar puncture, Magnetic resonance imaging head abnormal
Clinical narrative: Patient reports that 4 days after her first dose of the COVID-19 vaccine she started experiencing a continuous holocephalic headache and intermittent word-finding difficulty. She reports that she can usually find the word after a couple of minutes. She has never had any of these symptoms before. She went to her PCP and underwent CT of the head which showed wedge-shaped hypodensities in various vascular distributions and was sent for STAT brain MRI which demonstrated several T1 hypointense, T2 hyperintense lesions with small amounts of peripheral enhancement concerning for active demyelination. She was then sent to Medical Center for further  workup and treatment. While here, she underwent lumbar She underwent lumbar puncture which showed a pleiocytosis of 21, otherwise unremarkable. She was started on 1000 mg IV methyprednisone 5 day course. Other labs pending.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash macular
Clinical narrative: Large red blotch covering upper arm. Sore, then itchy. Went away, now back again.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Blood pressure increased, Dizziness, Dysphonia
Clinical narrative: Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Extensive swelling of vaccinated limb, Fatigue, Headache, Heart rate increased
Clinical narrative: Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Lymphadenopathy, Nausea, Pain, Pain in extremity
Clinical narrative: Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling face, Systemic lupus erythematosus, Toothache
Clinical narrative: Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Injection site reaction, Lethargy
Clinical narrative: Tender macular rash about injection site that lasted 4 days; lethargy, myalgia and arthralgia the day after vaccine; and Headache lasting at least 6 days not been relieved with ibuprophen or tylenol (last symptom is the reason for the submission)
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash macular
Clinical narrative: Tender macular rash about injection site that lasted 4 days; lethargy, myalgia and arthralgia the day after vaccine; and Headache lasting at least 6 days not been relieved with ibuprophen or tylenol (last symptom is the reason for the submission)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling hot, Heart rate increased
Clinical narrative: ABOUT 3 MINS AFTER THE VACCINE  I GOT A WARM FEELING THEN MY HEART STARED BEATING FAST AND MY BLOOD PRESSURE WAS ELEVATED LASTED FOR ABOUT AN HOURS, NURSES ON SITE WAS ABOUT TO CALL 911 BUT THEN I STRATED TO FEEL BETTER    MY QUESTION  IS SHOULD I TAKE THE SECOND SHOT.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: Hives  -   Rash all over my back , arms , legs .  also itchy welps and bumps everywhere  . swollen left hand with red bumps in the palm of my hand.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later.   H/O Bell's Palsy; team member advised to f/u with her PCP; unk. if she did seek medical treatment.  She also reported HA, fatigue, fever, chills.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later.   H/O Bell's Palsy; team member advised to f/u with her PCP; unk. if she did seek medical treatment.  She also reported HA, fatigue, fever, chills.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I received 1st Vaccination on 12-30-2020. After Receiving Vaccine Left Side of face has become numb. Not having face drop but definite continued numbness on left side of face. I did report to Employee Health as well as Moderna hotline. Everything is fine but was told to report the adverse reaction via Safer by Employee Health. Seems to be getting slightly better and hopefully nothing to be concerned about.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Chest pain, Death, Dyspnoea, Pericarditis
Clinical narrative: The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a "severe reaction" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Chest pain, Condition aggravated, Dyspnoea
Clinical narrative: The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a "severe reaction" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a "severe reaction" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash about 1" wide by 2" long at injection site. No more pain other than sore arm 1 day post vaccination. Resolved within one week.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: hives and redness in area of injection
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lethargy, Nausea, Paranasal sinus discomfort
Clinical narrative: Had severe headache first 2 days after 2nd dose with mild nausea, lethargy and dizziness. Symptoms subsided on the 3rd day except for mild headache. Started to experience moderate headache today with sinus pressure, mild nausea and dizziness.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache  Slight fever
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Nervousness
Clinical narrative: A 54yr old male patient had an appt at 4pm.  4:00 pm  The patient decided not to get vaccine after he arrived.          His wife received hers and told him it was fine to get the shot. The patient agreed.  4:50 the patient received the vaccine. the patient kept stating he was nervous and appeared very anxious.  4:55 patient was sitting in booth with wife and daughter and employee heard the family yell "Daddy"         Employee saw the patient slumped over in booth.          Employee alerted some one who was in the observation area who then called the Emergency Dept. STAT to the Observation area.  4:56 RN and  RN responded to the area.  See RN statement below.         I was called to the cafeteria by RN for a possible reaction to a vaccine. When I arrived in the cafeteria patient was sitting in the seat with his head leaned on the back with his eyes closed. I asked him how he was feeling and he responded "I feel ok". He stated he hadn't eaten or drank anything that morning so he was given a Diet Coke and picked out a snack from the basket. He ate some crackers and drank some Diet Coke and stated he felt fine. His wife then stated that every time he is around needles he passes out. He said he felt better and was fine now. I told them when he got up if he felt weak or dizzy to call me back and I returned to the emergency room.  Emergency Nurses stayed with patient until they were sure he was fine and able to leave under his own power with his wife and daughter.  2/9/2021-  09:30 Follow up call made to patient by Emergency Dept. Manager. Patient stated he was fine and hadn't experienced any other symptoms. ED manager instructed patient the come to the ED or seek medical care if he experienced any other symptoms. Patient stated he understood and will comply. 02/10/21 08:30 call and spoke with patient . Patient states he feels fine , no other symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Decreased appetite, Fatigue
Clinical narrative: Tiredness, chills, sinus congestion, chest congestion, no sense of taste or smell, body aches, no appetite.  Stayed home and the symptoms got better after 4 days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion, Sinus congestion
Clinical narrative: Tiredness, chills, sinus congestion, chest congestion, no sense of taste or smell, body aches, no appetite.  Stayed home and the symptoms got better after 4 days.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Nasal congestion, Palpitations
Clinical narrative: 1st shot 1/13/21, 2nd shot 2/3/21 0830 am 1st dose pfizer # EK 9231, 2nd dose pfizer# EL8982  shivers, heart pounding, bp 153/86 elevated for her, congestion
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Patient had sl. reddened area at vaccination site after his first dose ,which lasted only a day. Now a week after his second dose, he has developed a red rash at the injection site, approximately 4 inches in diameter. There is also a hhardened area approximatedly 2 inches in diameter within the reddened area. He complained of itchiness at the site, but no pain. I gave him benedryl 25 mg last night. and the itchiness went away. This morning, he still has the rash, but denies any pain or itchiness. and he feels fine.i did call the doctor's office, but the nurse felt no other treatment was needed.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: 9 days after vaccine administered, I developed Covid Arm at the site.  Itchy rash.  It is still there 4 days after onset.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site swelling
Clinical narrative: Redness, slight swelling, slight numbness extending ~3 inches around injection site. Noticed on 2/9, 8 days after vaccination. Took 25mg Benadryl on 2/9, symptoms began to lessen 2/10 and are almost gone at time of reporting (2/11).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: on 1/20/21 began itching in the evening.  on 1/21/21 developed redness which got worse until 1/24/21 when called the dr.  Had a Doctor appt. on 1/26/21 and started on Prednisone pack.  This helped decrease the redness, itching.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Fever, body aches. lethargy
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Migraine, Pain
Clinical narrative: Almost 12 hours after the second shot was received (no side effects from the 1st shot), at about 8:30 PM I started to feel some mild achiness in my body accompanied by fatigue. As a result I felt the need to go to bed early at about 9:30 PM. At about midnight I woke up with severe chills and intense body aches. I didnt get much sleep but the chills went away before 6:00 AM. The achiness remained but not as intense. I then had a migraine with a lost of appetite and more fatigue most of the day on February 10. Around 4:00 PM on the 10th all the symptoms suddenly started to leave and I began to feel normal.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Almost 12 hours after the second shot was received (no side effects from the 1st shot), at about 8:30 PM I started to feel some mild achiness in my body accompanied by fatigue. As a result I felt the need to go to bed early at about 9:30 PM. At about midnight I woke up with severe chills and intense body aches. I didnt get much sleep but the chills went away before 6:00 AM. The achiness remained but not as intense. I then had a migraine with a lost of appetite and more fatigue most of the day on February 10. Around 4:00 PM on the 10th all the symptoms suddenly started to leave and I began to feel normal.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Injection was very high on left deltoid, felt like almost joint instead of muscle.    By evening shoulder was very sore, got worse through the night - it felt similar to a torn ligament I had years ago.    By Friday morning, I could not lift arm, started taking Advil.   This continued Saturday.  Pain started to diminish Saturday night.  Pain and mobility improved Sunday.  By Monday morning, almost 4 days after injection, shoulder was normal.   I contacted Dr. on Monday, thinking the location of the injection had caused the problem.  He was going to talk to the person who gave the injection to make sure she gives future shots in the center of the deltoid.  He also encouraged me to do this report to the CDC.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Dizziness, Heart rate increased
Clinical narrative: I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and weak. then my back started to hurt. I got a very fast heartbeat. I slept for a long while. I also had chest pain.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and weak. then my back started to hurt. I got a very fast heartbeat. I slept for a long while. I also had chest pain.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Feeling of body temperature change, Foaming at mouth
Clinical narrative: 2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 am bad seizure with foaming at nose and mouth, convulsions, dizzy, unable to move, terrible head pain, nausea, rapid heart beat, extreme hot and cold spells; freezing from bones out. The seizure got bettter after about an hour, but the tremors did not stop until around 6:00 am.The morning of the shot, I ate a banana for breakfast.  Only thing I ate after the shot was late lunch was rice with tomatos in it, green beans, fried squash (all out of my garden).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Seizure, Tremor
Clinical narrative: 2:00 am seizure, dizzy, weak, diarrhea, nausea, head pain, rapid heart beat. This got better. 3:30 am bad seizure with foaming at nose and mouth, convulsions, dizzy, unable to move, terrible head pain, nausea, rapid heart beat, extreme hot and cold spells; freezing from bones out. The seizure got bettter after about an hour, but the tremors did not stop until around 6:00 am.The morning of the shot, I ate a banana for breakfast.  Only thing I ate after the shot was late lunch was rice with tomatos in it, green beans, fried squash (all out of my garden).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inner ear disorder, Pain, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Shortly after I begin to feel a little sniffly, body aches and soreness.  I got tested for COVID which was neg and was prescribed a Z-Pack and after a few days I felt better.  I had a little fluid built up in the inner ear also.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Moderna Vaccine - hypertensive to 220
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; a temperature excursion involving GARDASIL 9; This spontaneous report as received from a "HBP" refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 16-DEC-2020, the patient was vaccinated with an improperly stored sdose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602284, expiation date 26-SEP-2021 (also reported as 06-SEP-2021, but upon internal validation established as 26-SEP-2021), 0.5 ml for prophylaxis (route of administration was not reported).  Administered dose of vaccine underwent the temperature excursion of 31.2 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous excursions reported. No adverse events were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA010328: US-009507513-2101USA010448:
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Injury, Loss of personal independence in daily activities, Pain
Clinical narrative: varicella type rashes and lesions on her right upper arm and left leg. Also suffered shingles on her arms; varicella type rashes; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  In or around 28-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).       On an unknown date (shortly after receiving vaccine live (ZOSTAVAX), the patient experienced varicella type rashes and lesions on her right upper arm and left leg. Also suffered shingles on her arms (herpes zoster). As a result of the manufacture, marketing, advertising, promotion, distribution of vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. She suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Physical disability, Rash, Rash vesicular, Skin lesion
Clinical narrative: varicella type rashes and lesions on her right upper arm and left leg. Also suffered shingles on her arms; varicella type rashes; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  In or around 28-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).       On an unknown date (shortly after receiving vaccine live (ZOSTAVAX), the patient experienced varicella type rashes and lesions on her right upper arm and left leg. Also suffered shingles on her arms (herpes zoster). As a result of the manufacture, marketing, advertising, promotion, distribution of vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. She suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Neurological symptom, Pain, Visual impairment
Clinical narrative: hearing loss; vision issues; neurological issues; pain; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 76-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-FEB-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequently, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) use: hearing loss, vision issues, neurological issues and pain. The outcome of deafness, visual impairment, nervous system disorder and pain was reported. The reporter considered deafness, visual impairment, nervous system disorder and pain to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness  was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Nausea
Clinical narrative: Feeling not well; Shivering; Headache; Nausea; This case was reported by a consumer and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (1st dose received on an unknown date, did not have these side effects with the initial dose).   On 9th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced feeling unwell, shivering, headache and nausea. On an unknown date, the outcome of the feeling unwell, shivering, headache and nausea were unknown.   It was unknown if the reporter considered the feeling unwell, shivering, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received Shingrix vaccine and that night started feeling not well. By the next morning, in the less than a week after vaccination, the patient experienced shivering, headache and nausea. The patient did not have these side effects with the initial dose of Shingrix. The patient asked question regarding continuation.
Sex: F
Vaccine: HPVX
Symptoms: Coma
Clinical narrative: HPV shot put my neighbors daughter in a coma; This case was reported by a consumer via interactive digital media and described the occurrence of coma in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   Concurrent medical conditions included autism.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced coma (serious criteria GSK medically significant). On an unknown date, the outcome of the coma was unknown.   It was unknown if the reporter considered the coma to be related to HPV vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient received a dose of HPV vaccine and was in coma after the vaccination. The reporter mentioned that, the babies with autism were given HPV shot when they had no way to stop the eugenics programs. Poison pushing establishments have profitted while people have actually suffered. The reporter also mentioned that, there was no accountability on how the doctors were administrating the shots even after reading the pamphlets but again the FDA had ruled that those shots were safe. The case is linked with the case number- US2021AMR028881, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028881:Same reporter
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: nausea; fever; extreme shivering; arm pain; woke up from his sleep around midnight; This case was reported by a consumer and described the occurrence of nausea in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2020, refer case US2020AMR256481).   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, less than a day after receiving Shingrix, the patient experienced nausea, fever, shivering, pain in arm and sleep disturbance. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, shivering, pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the nausea, fever, shivering, pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in the left arm. The reporter stated that, after vacination had upper arm pain started in the night and woke up from his sleep around midnight with extreme shivering and fever varying between 99 to 100 degrees celcius. The patient usually sleeps on his stomach but because of the nausea he could not but today morning the nausea has resolved. Th patientr took Advil. The reporter consented to follow up. For the tolerence of 1st dose refer case US2020AMR256481.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256481:
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: nausea; fever; extreme shivering; arm pain; woke up from his sleep around midnight; This case was reported by a consumer and described the occurrence of nausea in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2020, refer case US2020AMR256481).   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, less than a day after receiving Shingrix, the patient experienced nausea, fever, shivering, pain in arm and sleep disturbance. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, shivering, pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the nausea, fever, shivering, pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in the left arm. The reporter stated that, after vacination had upper arm pain started in the night and woke up from his sleep around midnight with extreme shivering and fever varying between 99 to 100 degrees celcius. The patient usually sleeps on his stomach but because of the nausea he could not but today morning the nausea has resolved. Th patientr took Advil. The reporter consented to follow up. For the tolerence of 1st dose refer case US2020AMR256481.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256481:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Two droplets rolled down the arm of the patient/not receiving the complete dose; A spontaneous report was received on 03 FEB 2021 from a pharmacist concerning a 54-year-old, female patient, who received  Moderna's COVID-19 vaccine (mRNA-1273) and when the needle pulled out, two droplets rolled down the arm of patient and not received the complete dose.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273 (LOT number: 010M20A) with expiration date 19 JUL 2021, intramuscularly for the prophylaxis of COVID-19 infection. The Pharmacist reported that when the vaccine administrator gave the shot, and pulled the needle out of the patient's arm, two droplets rolled down the arm of the patient and a band aid placed over the injection site.   On 31 JAN 2021, The consumer called the pharmacist back and expressed concern about not receiving the complete dose. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The event, two droplets rolled down the arm of patient and not received complete dose was considered resolved on 28 JAN 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 010M20A. There were no reported AEs associated with this case of Incorrect dose administered.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: 5 year old male patient was inadvertently administered an expired dose of IPOL, no AE; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 5 years old male patient who was inadvertently administered an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included second dose of VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 01-Feb-2021, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) (lot P1F541M and expiry date: 07-Dec-2020) via an subcutaneous route in the left leg for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency on same day).  Reporter relationship: health care professional (HCP), Product used: used, First time product used: no Still using product: no  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia oral
Clinical narrative: 5 minutes after administration the patient reported tingling and warming sensation of the tongue and lips. She was given 25 mg of oral diphenhydramine. After 10 minutes she reported that the symptoms were getting worse, upon visual inspection, it did not appear that her tongue, lips, mouth or throat were swelling. The patient refused an epi-pen and to call 911 as she felt there was no problem with breathing. She was given 50 mg of diphenhydramine intramuscular injection after refusing an epi-pen. After 10 minutes she said the tingling and warming sensation began to subside. She sat under observation for a total of an hour and 40 minutes after receiving the vaccine before leaving the site. Patient was highly encouraged to not be alone the rest of the day and to report to the ER if any further signs or symptoms developed.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Significant dizziness/ vertigo started on Saturday, worsened on Tuesday and continues to persist.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: injection site is swollen and itchy.  Feels like a hard bump under skin.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: about a week after the 1st injection, pain, swelling, tenderness and itchy patch(?) appeared 2-3 inches down from injection site for about 3 days
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Grip strength decreased, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness within one hour.  That subsided after another 30 minutes but then I lost  control of thumb and pointer finger.  That loss of control/strength has continued until today(2/11/2021).  I tend to drop things from my left hand.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Clumsiness, Injection site hypoaesthesia, Injection site paraesthesia, Loss of personal independence in daily activities, Neuropathy peripheral
Clinical narrative: Tingling and numbness within one hour.  That subsided after another 30 minutes but then I lost  control of thumb and pointer finger.  That loss of control/strength has continued until today(2/11/2021).  I tend to drop things from my left hand.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Blood test, Computerised tomogram, Electrocardiogram, Hypoaesthesia
Clinical narrative: Received vaccine at 0830 at 1400 developed numbness on left side of face
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: Received vaccine at 0830 at 1400 developed numbness on left side of face
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Lymphadenopathy, Urticaria
Clinical narrative: Red around the injection site and itchy. Red itchy Also red hive on leg, swollen lymph node in arm pit.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Body aches Stiffness Fatigue Nausea Foggy Extreme right arm soreness Joint pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Body aches Stiffness Fatigue Nausea Foggy Extreme right arm soreness Joint pain
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms; Muscles aches, feverish, headache, fatigue, Staring 11 hours after 2nd Covid 19 Vaccination   Lasted approx. 18 hours.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightness
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Chills. Fever. Nausea. Ached
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: *Pregnancy: Estimated Due Date- 9/21/2021 (8wks pregnant, 1st trimester) No adverse impact to pregnancy at this time.   Adverse Impact from 1st dose: Sore Arm at injection site, including surrounding muscles into the neck and pectoral muscle (left arm and left pectoral muscle)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "On 2/9/2021 I noticed multiple red lesions on both of legs. They are not itchy or blisters or weeping. Most are round of variable diameter and I also have three purple linear lesions on my right knee."
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Tremor
Clinical narrative: chills and shakes,,,, intense total body pain that last from several hours after receiving vaccine #2, until 36 hours later. i did not get any reaction after first vaccine 4 weeks earlier.