chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Joint swelling, Lymphadenopathy
Clinical narrative: 22 minutes after the shot  1:04PM tongue started to feel tingly and numb, followed by the lips. Felt flushed.  1:07 PM I started to feel a tingling in my throat.  Took a benadryl given to me by EMS.  1;18PM Started to feel lightheaded. Had trouble speaking (slurring words) 2:30PM Felt like I had been drinking (I don't drink). Noticeable by my peers and my husband. Acting loopy.  Altered taste of food.  Everything tasted like blood.  Issues with my tongue/lips subsided after about 4 hours. Taste Issues resolved by the next morning.  Light soreness on the left arm on the day of the shot, better the next day.  One week later, 3/24/21,  Vaccine area felt warm, hard, swollen to the touch. Arm felt like someone had hit me with a bat. Pain went from Vaccine area to fingers. Finger joints felt swollen. Lasted for about a week  Armpit felt swollen, bumpy (grape sized bumps), and painful. Lasted for more than 1 week.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Pharyngeal paraesthesia, Taste disorder
Clinical narrative: 22 minutes after the shot  1:04PM tongue started to feel tingly and numb, followed by the lips. Felt flushed.  1:07 PM I started to feel a tingling in my throat.  Took a benadryl given to me by EMS.  1;18PM Started to feel lightheaded. Had trouble speaking (slurring words) 2:30PM Felt like I had been drinking (I don't drink). Noticeable by my peers and my husband. Acting loopy.  Altered taste of food.  Everything tasted like blood.  Issues with my tongue/lips subsided after about 4 hours. Taste Issues resolved by the next morning.  Light soreness on the left arm on the day of the shot, better the next day.  One week later, 3/24/21,  Vaccine area felt warm, hard, swollen to the touch. Arm felt like someone had hit me with a bat. Pain went from Vaccine area to fingers. Finger joints felt swollen. Lasted for about a week  Armpit felt swollen, bumpy (grape sized bumps), and painful. Lasted for more than 1 week.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cough, Dry throat, Flushing, Throat irritation
Clinical narrative: Felt hot, face was flushed, began coughing, throat itched,  blood pressure was elevated 184 / 118. Heart rate was " fast" but was not told rate, but even.  No treatment given ...just monitored for approximately 45 min and sent home when coughing stopped and blood pressure was down to 164 / 106.  They did check bp repeatedly,  checked o2 levels, blood sugar, heart rate repeatedly. Told cannot return for 2nd vaccine.  Primary doctor today verifies cannot have 2nd vaccine due to reaction to first vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cough, Feeling hot, Flushing, Heart rate increased
Clinical narrative: Felt hot, face was flushed, began coughing, throat itched,  blood pressure was elevated 184 / 118. Heart rate was " fast" but was not told rate, but even.  No treatment given ...just monitored for approximately 45 min and sent home when coughing stopped and blood pressure was down to 164 / 106.  They did check bp repeatedly,  checked o2 levels, blood sugar, heart rate repeatedly. Told cannot return for 2nd vaccine.  Primary doctor today verifies cannot have 2nd vaccine due to reaction to first vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incomplete course of vaccination, Throat irritation
Clinical narrative: Felt hot, face was flushed, began coughing, throat itched,  blood pressure was elevated 184 / 118. Heart rate was " fast" but was not told rate, but even.  No treatment given ...just monitored for approximately 45 min and sent home when coughing stopped and blood pressure was down to 164 / 106.  They did check bp repeatedly,  checked o2 levels, blood sugar, heart rate repeatedly. Told cannot return for 2nd vaccine.  Primary doctor today verifies cannot have 2nd vaccine due to reaction to first vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Feeling abnormal, Headache, Inflammation, Influenza virus test negative
Clinical narrative: Fever persisting for several weeks and precipitation of uveitis, which is a known manifestation of the patient's underlying auto-immune disease.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Malaise, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Fever persisting for several weeks and precipitation of uveitis, which is a known manifestation of the patient's underlying auto-immune disease.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Urinary tract infection, X-ray
Clinical narrative: Fever persisting for several weeks and precipitation of uveitis, which is a known manifestation of the patient's underlying auto-immune disease.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Pyrexia, Uveitis
Clinical narrative: Fever persisting for several weeks and precipitation of uveitis, which is a known manifestation of the patient's underlying auto-immune disease.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Lot# 013M20A (1st Dose) Arm, hand, wrist, elbow, neck, face, armpit swelling.  Extreme pain in arm, hand, elbow, shoulder blade, wrist. Loss of feeling and numbness. Headache, earache, multi site itching, rash on chest.  Pain so bad it hurts when cloth touches the skin on any part of my hand or arm. Sweating, fever and chills
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Induration, Musculoskeletal stiffness, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: Lot# 013M20A (1st Dose) Arm, hand, wrist, elbow, neck, face, armpit swelling.  Extreme pain in arm, hand, elbow, shoulder blade, wrist. Loss of feeling and numbness. Headache, earache, multi site itching, rash on chest.  Pain so bad it hurts when cloth touches the skin on any part of my hand or arm. Sweating, fever and chills
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face, Throat irritation
Clinical narrative: Lot# 013M20A (1st Dose) Arm, hand, wrist, elbow, neck, face, armpit swelling.  Extreme pain in arm, hand, elbow, shoulder blade, wrist. Loss of feeling and numbness. Headache, earache, multi site itching, rash on chest.  Pain so bad it hurts when cloth touches the skin on any part of my hand or arm. Sweating, fever and chills
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Ear pain, Headache, Hyperhidrosis
Clinical narrative: Lot# 013M20A (1st Dose) Arm, hand, wrist, elbow, neck, face, armpit swelling.  Extreme pain in arm, hand, elbow, shoulder blade, wrist. Loss of feeling and numbness. Headache, earache, multi site itching, rash on chest.  Pain so bad it hurts when cloth touches the skin on any part of my hand or arm. Sweating, fever and chills
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Lot# 013M20A (1st Dose) Arm, hand, wrist, elbow, neck, face, armpit swelling.  Extreme pain in arm, hand, elbow, shoulder blade, wrist. Loss of feeling and numbness. Headache, earache, multi site itching, rash on chest.  Pain so bad it hurts when cloth touches the skin on any part of my hand or arm. Sweating, fever and chills
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: Lot# 013M20A (1st Dose) Arm, hand, wrist, elbow, neck, face, armpit swelling.  Extreme pain in arm, hand, elbow, shoulder blade, wrist. Loss of feeling and numbness. Headache, earache, multi site itching, rash on chest.  Pain so bad it hurts when cloth touches the skin on any part of my hand or arm. Sweating, fever and chills
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Paraesthesia oral
Clinical narrative: OK for about 20 minutes, then VERY lightheaded and back of tongue felt strange, thick.  Did not have trouble breathing but tongue remained thick and lightheadedness increased markedly, worse when I was laid flat.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Swollen tongue
Clinical narrative: OK for about 20 minutes, then VERY lightheaded and back of tongue felt strange, thick.  Did not have trouble breathing but tongue remained thick and lightheadedness increased markedly, worse when I was laid flat.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Felt hot, diaphoretic, lightheaded, dizzy and nausea.  Observed for 35 minutes. BP 105/66, HR 72.  Bulse ox 98% on room air, rr 20.  Reports feeling better but waves of nausea and lightheadedness.  Legs propped up and felt better.  Needed 2 person assist to the restroom.  Started to feel dizzy and lowered to the floor.  BP 131/90, HR 74.  Transported to the ED via wheelchair - discharged from ED after examination and observation.  No reaction with first dose.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Felt hot, diaphoretic, lightheaded, dizzy and nausea.  Observed for 35 minutes. BP 105/66, HR 72.  Bulse ox 98% on room air, rr 20.  Reports feeling better but waves of nausea and lightheadedness.  Legs propped up and felt better.  Needed 2 person assist to the restroom.  Started to feel dizzy and lowered to the floor.  BP 131/90, HR 74.  Transported to the ED via wheelchair - discharged from ED after examination and observation.  No reaction with first dose.
Age: 30.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Back pain, Dyspnoea
Clinical narrative: caller claims to have had a back pain that worsened to severe stomach pain after getting the vaccine. The symptoms resolved 1 day after getting the vaccine.She called her pcp's office Rn adv her that the Dr recommends her not taking the 2nd shot.
Age: 30.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Sleep disorder
Clinical narrative: caller claims to have had a back pain that worsened to severe stomach pain after getting the vaccine. The symptoms resolved 1 day after getting the vaccine.She called her pcp's office Rn adv her that the Dr recommends her not taking the 2nd shot.
Age: 30.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain
Clinical narrative: caller claims to have had a back pain that worsened to severe stomach pain after getting the vaccine. The symptoms resolved 1 day after getting the vaccine.She called her pcp's office Rn adv her that the Dr recommends her not taking the 2nd shot.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hypertension
Clinical narrative: THIS PATIENT IS A 42 YO MALE WHO STARTED TO COMPLAIN OF LIGHTHEADEDNESS/DIZZINESS/FEELING FLUSHED ABOUT 30 MINUTES AFTER RECIEVING VACCINE. PATIENT WAS INITIALLYVISUALLY MONITORED FOR 15 MINUTES WITH NO SIDE EFFECTS. PATIENT LEAFT THE CLINIC SITE, AND RETURNED ABOUT 15 MINUTES LATER REPORTING SYMPTOMS ABOVE. PATIENT A&OX4, GCS 15, NOMAL SKINS. PATIENT DENIES HEADACHE, CHEST PAIN, SHORTNESS OF BREATH. EKG COMPLETED, NO STEMI OBSERVED. PATIENT LED INTO QUIET/DARK ROOM TO REST AND FOR CONTINUED MONITORING OF BLOOD PRESSURE. DUE TO NO CHANGE IN ELEVASTED BP, RECOMMENDATION WAS MADE TO TRANSPORT PATIENT TO CLOSEST ED. PATIENT VERBALLY AGREED. PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO AMR UNIT AND PATIENT CARE WAS HANDED OVER TO UNIT PARAMEDIC. PATIENT TRANSFERRED WITHOUT INCIDENT. LAST  NOTED BP ON SITE WAS 176/132 IN A SUPINE POSITION.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Flushing
Clinical narrative: THIS PATIENT IS A 42 YO MALE WHO STARTED TO COMPLAIN OF LIGHTHEADEDNESS/DIZZINESS/FEELING FLUSHED ABOUT 30 MINUTES AFTER RECIEVING VACCINE. PATIENT WAS INITIALLYVISUALLY MONITORED FOR 15 MINUTES WITH NO SIDE EFFECTS. PATIENT LEAFT THE CLINIC SITE, AND RETURNED ABOUT 15 MINUTES LATER REPORTING SYMPTOMS ABOVE. PATIENT A&OX4, GCS 15, NOMAL SKINS. PATIENT DENIES HEADACHE, CHEST PAIN, SHORTNESS OF BREATH. EKG COMPLETED, NO STEMI OBSERVED. PATIENT LED INTO QUIET/DARK ROOM TO REST AND FOR CONTINUED MONITORING OF BLOOD PRESSURE. DUE TO NO CHANGE IN ELEVASTED BP, RECOMMENDATION WAS MADE TO TRANSPORT PATIENT TO CLOSEST ED. PATIENT VERBALLY AGREED. PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO AMR UNIT AND PATIENT CARE WAS HANDED OVER TO UNIT PARAMEDIC. PATIENT TRANSFERRED WITHOUT INCIDENT. LAST  NOTED BP ON SITE WAS 176/132 IN A SUPINE POSITION.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bladder catheterisation, CNS ventriculitis, Computerised tomogram abdomen normal, Computerised tomogram pelvis abnormal, Computerised tomogram thorax normal
Clinical narrative: Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies.  Lumbar puncture performed showing  elevated cell count, elevated protein and low glucose.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Dysuria, Fall, Magnetic resonance imaging abnormal, Magnetic resonance imaging head abnormal
Clinical narrative: Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies.  Lumbar puncture performed showing  elevated cell count, elevated protein and low glucose.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging spinal abnormal, Mobility decreased, Motor dysfunction, Muscular weakness
Clinical narrative: Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies.  Lumbar puncture performed showing  elevated cell count, elevated protein and low glucose.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Sensory loss, Spinal cord oedema
Clinical narrative: Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies.  Lumbar puncture performed showing  elevated cell count, elevated protein and low glucose.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF cell count increased, CSF glucose decreased, CSF protein increased, CSF test, Fungal test negative
Clinical narrative: Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies.  Lumbar puncture performed showing  elevated cell count, elevated protein and low glucose.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Myelitis transverse, Parasitic blood test negative, Treponema test negative, Viral test negative
Clinical narrative: Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies.  Lumbar puncture performed showing  elevated cell count, elevated protein and low glucose.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Pulmonary embolism
Clinical narrative: Two days after the patient's 2nd dose of Moderna vaccine, the patient died of a pulmonary embolism. After vaccine had body aches and fatigue and stayed in bed then became unresponsive early morning on 2/27/21. The coroner reported this death as well on temporary VAERS report number 341199.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Deep vein thrombosis, Dizziness, Eye pain, Influenza like illness
Clinical narrative: Two days after the patient's 2nd dose of Moderna vaccine, the patient died of a pulmonary embolism. After vaccine had body aches and fatigue and stayed in bed then became unresponsive early morning on 2/27/21. The coroner reported this death as well on temporary VAERS report number 341199.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Pain, Pulmonary embolism, Unresponsive to stimuli
Clinical narrative: Two days after the patient's 2nd dose of Moderna vaccine, the patient died of a pulmonary embolism. After vaccine had body aches and fatigue and stayed in bed then became unresponsive early morning on 2/27/21. The coroner reported this death as well on temporary VAERS report number 341199.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Fatigue, Mobility decreased, Pain, Pulmonary embolism
Clinical narrative: Two days after the patient's 2nd dose of Moderna vaccine, the patient died of a pulmonary embolism. After vaccine had body aches and fatigue and stayed in bed then became unresponsive early morning on 2/27/21. The coroner reported this death as well on temporary VAERS report number 341199.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Two days after the patient's 2nd dose of Moderna vaccine, the patient died of a pulmonary embolism. After vaccine had body aches and fatigue and stayed in bed then became unresponsive early morning on 2/27/21. The coroner reported this death as well on temporary VAERS report number 341199.
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Condition aggravated, Death
Clinical narrative: Facility reported death on 3/4/21
Age: 94.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Facility reported death on 3/4/21
Age: 99.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Decreased appetite, Fluid intake reduced, Lethargy
Clinical narrative: Facility reported death of patient on 3-4-21
Age: 99.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Facility reported death of patient on 3-4-21
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Heart rate increased, Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: Five minutes after injection heart rate began increasing and felt like it was racing. Left arm started feeling numb and tingling, then overall felt weak and dizzy. Got flushed/red in the face. Remained seated and propped up feet, applied ice packs. Heart rate was elevated again at 30 minutes after injection. Developed chills/shaking. Remained at pharmacy under observation another 30 minutes. Symptoms mainly resolved and felt generally better over the course of 2-3 hours.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Erythema, Flushing
Clinical narrative: Five minutes after injection heart rate began increasing and felt like it was racing. Left arm started feeling numb and tingling, then overall felt weak and dizzy. Got flushed/red in the face. Remained seated and propped up feet, applied ice packs. Heart rate was elevated again at 30 minutes after injection. Developed chills/shaking. Remained at pharmacy under observation another 30 minutes. Symptoms mainly resolved and felt generally better over the course of 2-3 hours.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Palpitations, Paraesthesia, Tremor
Clinical narrative: Five minutes after injection heart rate began increasing and felt like it was racing. Left arm started feeling numb and tingling, then overall felt weak and dizzy. Got flushed/red in the face. Remained seated and propped up feet, applied ice packs. Heart rate was elevated again at 30 minutes after injection. Developed chills/shaking. Remained at pharmacy under observation another 30 minutes. Symptoms mainly resolved and felt generally better over the course of 2-3 hours.
Age: 88.0
Sex: M
Vaccine: COVID19, PPV, COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: weak, old man voice. Sounds like there is a frog in his voice all ofthe time. Voice isn't as clear as it used to be.; liver enzymes shot up over 400 points. / increased liver enzymes.; very low hemoglobin.; back in 2015-had reaction to pneumonia vaccine. Had a fever for 2-3 days.; This spontaneous report was received from a consumer via other's company letter, and refers to an 88-year-old male patient. The patient's pertinent medical history, concomitant therapies, previous drug reactions, and allergies were not reported.      On an unknown date in 2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) as prophylaxis (formulation, dose, dose number, route of administration, anatomical site of vaccination, lot number, and expiration date were not provided). Additionally, the patient stated he experienced a bad reaction to it, he had fever (Pyrexia) for 2-3 days.  On an unspecified day in September 2020, the patient had a blood transfusion. Also, he stated his hemoglobin had not quite gotten to where it needed to be. It was 4 pints, but may be measured differently at the hospital. Every other time, the patient underwent to a drawing of his blood to check on his hemoglobin (also reported "Reason for drawing blood was to check on his very low hemoglobin") (haemoglobin decreased). He clarified it "was a matter of routine". Additionally, the reporter stated a doctor wanted to be preventative from getting the disease. He had a weak, old man voice and sounded like if there was a frog in his voice all of the time. Voice was not as clear as it used to be (dysphonia).  On 20-JAN-2021, the patient had a blood drawn (unknown results).     On 21-JAN-2021, the patient was vaccinated with the first shot of sars-cov-2 spike protein mrna vaccine (PFIZER) (lot number EL3247 and expiration date 01-MAR-2021), administered in the left shoulder as prophylaxis of COVID-19.  On 03-FEB-2021, the patient had another blood drawn where his liver enzymes shot up over 400 points (hepatic enzyme increased).         At the time of reporting, the outcome of haemoglobin decreased and dysphonia was reported as not recovered/not resolved. The outcome of hepatic enzyme increased was unknown. The outcome of pyrexia was reported as recovered/resolved. The causal relationship between the occurred events and the suspect vaccines was not provided.  Upon internal review, the event of haemoglobin decreased was determined to be medically significant.
Age: 88.0
Sex: M
Vaccine: COVID19, PPV, COVID19
Symptoms: Blood test, Haemoglobin, Hepatic enzyme increased
Clinical narrative: weak, old man voice. Sounds like there is a frog in his voice all ofthe time. Voice isn't as clear as it used to be.; liver enzymes shot up over 400 points. / increased liver enzymes.; very low hemoglobin.; back in 2015-had reaction to pneumonia vaccine. Had a fever for 2-3 days.; This spontaneous report was received from a consumer via other's company letter, and refers to an 88-year-old male patient. The patient's pertinent medical history, concomitant therapies, previous drug reactions, and allergies were not reported.      On an unknown date in 2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) as prophylaxis (formulation, dose, dose number, route of administration, anatomical site of vaccination, lot number, and expiration date were not provided). Additionally, the patient stated he experienced a bad reaction to it, he had fever (Pyrexia) for 2-3 days.  On an unspecified day in September 2020, the patient had a blood transfusion. Also, he stated his hemoglobin had not quite gotten to where it needed to be. It was 4 pints, but may be measured differently at the hospital. Every other time, the patient underwent to a drawing of his blood to check on his hemoglobin (also reported "Reason for drawing blood was to check on his very low hemoglobin") (haemoglobin decreased). He clarified it "was a matter of routine". Additionally, the reporter stated a doctor wanted to be preventative from getting the disease. He had a weak, old man voice and sounded like if there was a frog in his voice all of the time. Voice was not as clear as it used to be (dysphonia).  On 20-JAN-2021, the patient had a blood drawn (unknown results).     On 21-JAN-2021, the patient was vaccinated with the first shot of sars-cov-2 spike protein mrna vaccine (PFIZER) (lot number EL3247 and expiration date 01-MAR-2021), administered in the left shoulder as prophylaxis of COVID-19.  On 03-FEB-2021, the patient had another blood drawn where his liver enzymes shot up over 400 points (hepatic enzyme increased).         At the time of reporting, the outcome of haemoglobin decreased and dysphonia was reported as not recovered/not resolved. The outcome of hepatic enzyme increased was unknown. The outcome of pyrexia was reported as recovered/resolved. The causal relationship between the occurred events and the suspect vaccines was not provided.  Upon internal review, the event of haemoglobin decreased was determined to be medically significant.
Age: 17.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported.; 17 year old consumer received PROQUADand VARlVAX concomitantly.; 17 year old consumer received PROQUAD and VARlVAX concomitantly.; This spontaneous report, received from a 17 year old patient, referring to himself. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 19-FEB-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis and concomitantly received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route of administration, frequency, lot/batch # and expiration date were not reported) (inappropriate schedule of product administration and overdose). No additional AE reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; VAX FOR SHIUNGLES I GOT IT ANYWAY/Suspected vaccination failure; UNRELENTING PAIN / LIKE YOU ARE BEING BORED WOTH A RED HOT POKER; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated for shingles but the patient got it anyway. The patient also said thankfully it did not enter patient's eye. The patient stated it also was unrelenting pain and felt like you were bored worth a red hot poker. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Influenza like illness, Insomnia, Mydriasis
Clinical narrative: an internal vibrating tremor inside of her body; flu like symptoms; high blood pressure; insomnia; increase pulse; Dilated pupils; A spontaneous report was received from a healthcare professional concerning a 39-year-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, a feeling of an internal vibrating tremor inside of her body/tremor, high blood pressure/increased blood pressure, insomnia, dilated pupil/mydriasis and increase pulse/heart rate increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24-Jan-2021, prior to the onset of the events, the patient received the second dose of two planned doses of mRNA-1273 (lot/batch: unknown)on left arm for prophylaxis of COVID-19 infection.  On 25-Jan-2021, The patient experienced flu like symptoms, but in the afternoon of the same day she also started to experience an internal "vibrating" tremor inside of her body.  She had this symptom for 4 weeks now along with high blood pressure, insomnia, dilated pupils and increase pulse. A neurologist told her that it could be an adrenergic hyper response to the vaccine.  No Laboratory details provided.  Treatment information provided was beta blockers prescribed in the ER visit.   Action taken with mRNA-1273 in response to the events is not applicable.   At the time of this report, the outcome of the events experienced flu like symptoms, a feeling of an internal vibrating tremor inside of her body, high blood pressure, insomnia, dilated pupil and increase pulse is Unknown.; Reporter's Comments: This case concerns a 39 Y/O F with a serious unexpected event of tremor and NS unexpected influenza like illness, blood pressure increased, heart rate increased, mydriasis, insomnia, and possibly a "adrenergic hyper response to the vaccine". Treated with beta blockers. Event onset 2 days after first dose mRNA-1273. Outcome unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: an internal vibrating tremor inside of her body; flu like symptoms; high blood pressure; insomnia; increase pulse; Dilated pupils; A spontaneous report was received from a healthcare professional concerning a 39-year-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, a feeling of an internal vibrating tremor inside of her body/tremor, high blood pressure/increased blood pressure, insomnia, dilated pupil/mydriasis and increase pulse/heart rate increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24-Jan-2021, prior to the onset of the events, the patient received the second dose of two planned doses of mRNA-1273 (lot/batch: unknown)on left arm for prophylaxis of COVID-19 infection.  On 25-Jan-2021, The patient experienced flu like symptoms, but in the afternoon of the same day she also started to experience an internal "vibrating" tremor inside of her body.  She had this symptom for 4 weeks now along with high blood pressure, insomnia, dilated pupils and increase pulse. A neurologist told her that it could be an adrenergic hyper response to the vaccine.  No Laboratory details provided.  Treatment information provided was beta blockers prescribed in the ER visit.   Action taken with mRNA-1273 in response to the events is not applicable.   At the time of this report, the outcome of the events experienced flu like symptoms, a feeling of an internal vibrating tremor inside of her body, high blood pressure, insomnia, dilated pupil and increase pulse is Unknown.; Reporter's Comments: This case concerns a 39 Y/O F with a serious unexpected event of tremor and NS unexpected influenza like illness, blood pressure increased, heart rate increased, mydriasis, insomnia, and possibly a "adrenergic hyper response to the vaccine". Treated with beta blockers. Event onset 2 days after first dose mRNA-1273. Outcome unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Back pain, Dizziness, Electrocardiogram, Heart rate
Clinical narrative: AFib; Lightheaded; Pain in the right rear back and couldn't bend over to tie shoes; A spontaneous report was received from a male consumer 75-year-old who experienced, a sore Arm/Pain in Extremity, Afib and lightheadedness.  The patient's medical history was not provided. Products known to be used by the patient within two weeks prior to the event was simvastatin, tadalafil, androgel, prevision, magnesium, vitamin D3, vitamin B12, calcium and fish oil.  On 04-Feb-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 Intramuscularly for prophylaxis of COVID-19.  On unknown date, the patient experienced sore arm, lightheadness, lasted for 3-4 days and went away.   On unknown date, the patients vitals were checked and the heart rate was elevated to 148 and was admitted to the hospital. EKG and pulse rate was irregular. The patient was diagnosed with A fib. Treatment included apixaban, metoprolol and fluids.  The patient received both doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome for the events, sore arm, lightheadness and A-fib was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; A spontaneous report was received from a consumer concerning her husband, a 59- years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bell's palsy (Facial Paralysis).   The patient's medical history included diabetes. Concomitant product use was not provided by the reporter.     On 10 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A)Intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed the event bell's palsy and was considered to be medically significant. No treatment information was not provided.    Action taken with mRNA-1273 in response to the event bell's palsy was not reported  The outcome of the event bell's palsy was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia
Clinical narrative: Heart rate dropped into the 30's; A spontaneous report was received from a consumer concerning her mother, a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced decreased in heart rate to 30's.    The patient's medical history was not provided. No concomitant medications were provided.  The patient received their first of two planned doses of mRNA-1273 (Lot/batch number: unknown) on an unspecified date. On an unspecified date, prior to onset of the events decreased in heart rate to 30's and reaction, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient's heart rate decreased to 30's (medically significant). The patient having to get a pacemaker.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events was not applicable.  The event, decreased in heart rate to 30's was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Critical details such as treatment date, the onset date of event, patient's medical history and concomitant medication, hospitalization details including diagnostic results are lacking. Further information has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pulmonary embolism
Clinical narrative: Pulmonary embolism; tested positive for covid; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary embolism, and tested for positive for Covid-19/COVID-19.  The patient's medical history included arthritis, and high blood pressure.  Concomitant medication history was not provided.  On 26-Jan-2021,  the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 12-Feb-21, she started experiencing shortness of breath and went to her local urgent care. They sent her to the emergency room where she was admitted and diagnosed with a Pulmonary Embolism. The patient was prescribed a blood thinner.   While in the hospital, she tested positive for Covid-19 on 14-Feb-21. She was in the hospital from 12-Feb-21 to 22-Feb-21.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, pulmonary embolism were recovered.  The outcome of the event, COVID-19 was recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed to be unlikely related.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Impaired work ability, Sitting disability, Walking disability
Clinical narrative: general weakness My whole body is "soft"; He cannot walk; I cannot sit; I can't do anything; A spontaneous report was received from a Consumer concerning an 85 Year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Asthenia, Walking disability, Sitting disability, and Impaired work ability.  The patient's medical history was not provided. No Concomitant medications used by the patient was reported.  On 25 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient was unable to do anything. His whole body was soft and disabled .Also he was not able to sit,walk and do nothing. All the events were considered as medically significant.   No Laboratory details were provided.  No Treatment details was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Really bad seizure; A spontaneous report was received from a physician  concerning a 31 year old female patient  who received   Moderna's  Covid 19 vaccine(mRNA1273) who developed unusual seizure.  The patient's medical history as provided by the reporter included 215Q- 2 copies of a piece of chromosome 15 and the patient was on medications for seizure, sleep disorder and urinary incontinence. Products known to have been used by the patient, within two weeks prior to the event, included daprica, Trazodone, Oxybutynin and Carnitine.   On 18-FEB-2021 approximately eight days prior to the onset of symptoms the patient received first of two planned dose of mRNA-1273 (Batch Number 024M20A) for prophylaxis of Covid 19 infection.  On25 -FEB-2021 patient had a really bad seizures without the usual triggers. The pulse rate of patient was 89 and came back up.The event was considered as medically significant. The treatment for the event include Valium 5mg.  Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the event  really bad seizure was considered as 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: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report, was received from consumer concerning a patient  of unknown age, gender, race and ethnicity, who was administered Moderna's COVID-19 vaccine, and experienced Bell's Palsy.  Patient identifier details was reported as someone from the church.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reporter stated that the patient was physically and mentally healthy before vaccination.  On an unknown date, the patient got the second dose of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  Ona unknown date, after receiving the second dose, the patient experienced Bell's Palsy.  Action taken with mRNA-1273 in response to the Bell's Palsy was not applicable.   The outcome of the event Bell's Palsy was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-028166:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Gait disturbance, Gingival pruritus, Loss of consciousness
Clinical narrative: Loss of consciousness; Could not think straight; Difficulty walking; Having difficulty speaking; Fast heart beat; Dizziness; Gums began tingling; Gums itching; A spontaneous report was received from a consumer concerning a 70-year-old, female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced events Loss of consciousness, difficulty in walking (difficulty walking), Mental Impairment(couldn't think straight), Dysarthria(difficulty speaking), Tachycardia(fast heart beat), Dizziness, Paraesthesia oral (gum  tingling) and Gingival pruritic(gum itching).  The patient's medical history was reported as seizure disorder, diabetic, and allergies. Concomitant medications known to have been used by the patient, within two weeks prior to the event included amlodipine, Aspirin, Benadryl, azosemide, fara sulfate, levothyroxine, losartan, magnesium oxide, metformin, meloxicam, Minoxidil, montelukast , omeprazole, potassium chloride er, primidone, propranolol, rosuvastatin, stool softener, Tylenol extra strength, vitamin D3, voltaren topical gel and tramadol  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the difficulty walking, couldn't think straight, difficulty speaking, fast heartbeat, dizziness, loss of consciousness, gum tingling and gum itching. Laboratory details were not provided. Treatment details was given as Tylenol and Ativan.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event Loss of consciousness was reported as resolved. The outcome of the event, Gait inability, Mental Impairment, Dysarthria, Tachycardia, Dizziness, Paraesthesia and Gingival pruritis 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 these events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Paraesthesia oral, Tachycardia
Clinical narrative: Loss of consciousness; Could not think straight; Difficulty walking; Having difficulty speaking; Fast heart beat; Dizziness; Gums began tingling; Gums itching; A spontaneous report was received from a consumer concerning a 70-year-old, female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced events Loss of consciousness, difficulty in walking (difficulty walking), Mental Impairment(couldn't think straight), Dysarthria(difficulty speaking), Tachycardia(fast heart beat), Dizziness, Paraesthesia oral (gum  tingling) and Gingival pruritic(gum itching).  The patient's medical history was reported as seizure disorder, diabetic, and allergies. Concomitant medications known to have been used by the patient, within two weeks prior to the event included amlodipine, Aspirin, Benadryl, azosemide, fara sulfate, levothyroxine, losartan, magnesium oxide, metformin, meloxicam, Minoxidil, montelukast , omeprazole, potassium chloride er, primidone, propranolol, rosuvastatin, stool softener, Tylenol extra strength, vitamin D3, voltaren topical gel and tramadol  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the difficulty walking, couldn't think straight, difficulty speaking, fast heartbeat, dizziness, loss of consciousness, gum tingling and gum itching. Laboratory details were not provided. Treatment details was given as Tylenol and Ativan.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event Loss of consciousness was reported as resolved. The outcome of the event, Gait inability, Mental Impairment, Dysarthria, Tachycardia, Dizziness, Paraesthesia and Gingival pruritis 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 these events, a causal relationship cannot be excluded.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disability, Fall, Tremor
Clinical narrative: weakness; Unable to move; So weak he fell over on the carpet; Trembling,tremor; teeth chattering, chills; A spontaneous report was received from a consumer concerning a 94-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthenia, disability, muscular weekness, trembling, tremor and chills.    The patient's medical history was not provided.    No relevant concomitant medications were reported.    On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023L20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, at 21:00, patient experienced chills, trembling, weakness, tremor, teeth chattering ,so weak he fell over the carpet and unable to move.At 03:00 am the patient was hospitalized.   The reporter also added that the patient usually is a very active for a 94 year old man person .The reporter was worried when the patient was unable to move.  On 17 Feb 2021 the patient was discharged from hospital. The events weakness  and unable to move were considered as serious.   No laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory for the event of asthenia.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Death
Clinical narrative: Dead on the bed with his legs dangling off one side of the bed; Complained about an upset stomach; A spontaneous report was received from a nurse concerning a 70-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history included hypertension and diabetes. No concomitant medications were provided.  On 20 Feb 2021, Saturday, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 21 Feb 2021, Sunday 9:36 AM the patient's experienced an upset stomach and attributed it to dinner last night and later on 22 Feb 2021, Monday he was found dead on the bed with his legs dangling off one side of the bed. The cause of death was unknown.  Treatment information for event upset stomach included half a spoon of an Indian thing.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event upset stomach was fatal and patient died on 21 Feb 2021.; Reporter's Comments: This is a 70-year-old, male patient, who received Moderna's COVID-19 vaccine and history of risk factors for CAD such as hypertension and diabetes, was found dead 2 days after vaccination. Very limited information regarding this events has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: Unknown cause of death