chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Diplopia, Magnetic resonance imaging abnormal, Meningitis aseptic, Migraine
Clinical narrative: Bilateral neck stiffness with limited mobility, nausea and vomiting.  Started next day and persisted. ER visit on 1/12 migraine cocktail and bilateral nerve blockers no assistance. Used anti-inflammatory meds, acetaminophen and Zofran for daily treatment. Progression of symptoms got worse occurring with double vision. Had ER visit after several test listed below diagnosed with aseptic meningitis. Placed on pain killer and steroids treatment to subside symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Nausea, Vomiting, X-ray
Clinical narrative: Bilateral neck stiffness with limited mobility, nausea and vomiting.  Started next day and persisted. ER visit on 1/12 migraine cocktail and bilateral nerve blockers no assistance. Used anti-inflammatory meds, acetaminophen and Zofran for daily treatment. Progression of symptoms got worse occurring with double vision. Had ER visit after several test listed below diagnosed with aseptic meningitis. Placed on pain killer and steroids treatment to subside symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Fibrin D dimer increased, Impaired work ability
Clinical narrative: Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest.  Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving.  Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day.  Did not have to seek emergency treatment but did miss 1 day of scheduled work.  Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Lip swelling, Oral discomfort, Pruritus, Rash
Clinical narrative: Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest.  Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving.  Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day.  Did not have to seek emergency treatment but did miss 1 day of scheduled work.  Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Systemic lupus erythematosus, Urticaria
Clinical narrative: Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest.  Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving.  Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day.  Did not have to seek emergency treatment but did miss 1 day of scheduled work.  Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Illness
Clinical narrative: (Starting at about 12 hours post vaccine) Developed severe headache (turned into Migraine) that lasted about 4 days, Fever (100.8) x 24 hours (medicated with Tylenol Q 4 hours),  joint pain and fatigue. Developed moderate amount of swelling at the injection site day 2 and a large red area (about the size of an orange) that lasted over a week. The red area burned and itched.   January 1, became very ill with Upper Respiratory symtoms. Shortness of breath, wheezing, fatigue, fever. Saw PCP who tested for Covid 19 (negative) and flu (negative).  Returned to PCP on January 3 with worsening symptoms of shortness of breath. Another Covid 19 test run (negative) and presc. for Steriods given. Took 1 week to recover.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (Starting at about 12 hours post vaccine) Developed severe headache (turned into Migraine) that lasted about 4 days, Fever (100.8) x 24 hours (medicated with Tylenol Q 4 hours),  joint pain and fatigue. Developed moderate amount of swelling at the injection site day 2 and a large red area (about the size of an orange) that lasted over a week. The red area burned and itched.   January 1, became very ill with Upper Respiratory symtoms. Shortness of breath, wheezing, fatigue, fever. Saw PCP who tested for Covid 19 (negative) and flu (negative).  Returned to PCP on January 3 with worsening symptoms of shortness of breath. Another Covid 19 test run (negative) and presc. for Steriods given. Took 1 week to recover.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Respiratory symptom, SARS-CoV-2 test negative, Wheezing
Clinical narrative: (Starting at about 12 hours post vaccine) Developed severe headache (turned into Migraine) that lasted about 4 days, Fever (100.8) x 24 hours (medicated with Tylenol Q 4 hours),  joint pain and fatigue. Developed moderate amount of swelling at the injection site day 2 and a large red area (about the size of an orange) that lasted over a week. The red area burned and itched.   January 1, became very ill with Upper Respiratory symtoms. Shortness of breath, wheezing, fatigue, fever. Saw PCP who tested for Covid 19 (negative) and flu (negative).  Returned to PCP on January 3 with worsening symptoms of shortness of breath. Another Covid 19 test run (negative) and presc. for Steriods given. Took 1 week to recover.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Severe shingles on left side. Areas affected: left cheek, left ear, jawline, left side of neck, upper back, top of shoulder, upper chest along collarbone.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Skin warm
Clinical narrative: 10 days after vaccination developed an erythematous, raised rash that was warm to the touch.  Lasted approximately 4 days.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bladder pain, Chills, Diarrhoea, Dizziness
Clinical narrative: Within a few hours became feverish, nauseated, diarrhea.  Indescribable headache and severe eye pain.  Severe fatigue, dizziness, severe joint and muscle pain.  severe pain in bladder area.  Injection site became extremely swollen from just above elbow to shoulder.  Became bright red, painful, and itchy.  Vacillated between chills and excessive sweating from onset of symptoms.  Lasted from approx. 1pm Saturday, Jan 30th 2021 until Monday, Feb 1st 2020 at 6pm.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Fatigue, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Within a few hours became feverish, nauseated, diarrhea.  Indescribable headache and severe eye pain.  Severe fatigue, dizziness, severe joint and muscle pain.  severe pain in bladder area.  Injection site became extremely swollen from just above elbow to shoulder.  Became bright red, painful, and itchy.  Vacillated between chills and excessive sweating from onset of symptoms.  Lasted from approx. 1pm Saturday, Jan 30th 2021 until Monday, Feb 1st 2020 at 6pm.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Myalgia, Nausea
Clinical narrative: Within a few hours became feverish, nauseated, diarrhea.  Indescribable headache and severe eye pain.  Severe fatigue, dizziness, severe joint and muscle pain.  severe pain in bladder area.  Injection site became extremely swollen from just above elbow to shoulder.  Became bright red, painful, and itchy.  Vacillated between chills and excessive sweating from onset of symptoms.  Lasted from approx. 1pm Saturday, Jan 30th 2021 until Monday, Feb 1st 2020 at 6pm.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Within a few hours became feverish, nauseated, diarrhea.  Indescribable headache and severe eye pain.  Severe fatigue, dizziness, severe joint and muscle pain.  severe pain in bladder area.  Injection site became extremely swollen from just above elbow to shoulder.  Became bright red, painful, and itchy.  Vacillated between chills and excessive sweating from onset of symptoms.  Lasted from approx. 1pm Saturday, Jan 30th 2021 until Monday, Feb 1st 2020 at 6pm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Loss of personal independence in daily activities, Migraine
Clinical narrative: (Starting at about 12 hours post vaccine) at Midnight woke up with fever 100.7, severe chills, joint and muscle aches and an intense migraine. By 3 am was up again vomiting. That lasted a few hours. Temp hovered around 101-102 all day (alternating Tylenol 1000mg and Motrin 600 mg q 3 -4 hours). Could not get out of bed all day.  It was pretty intense. By evening the N/V subsided but the other symptoms remained. Temp broke by 10 pm.  The next morning temp was normal, chills were gone, still had the migraine (which migraines are not unusual).  Felt fatigue and body aches, but was functional. By the evening joints hurt so bad could barely walk again. Cont. next page....
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: (Starting at about 12 hours post vaccine) at Midnight woke up with fever 100.7, severe chills, joint and muscle aches and an intense migraine. By 3 am was up again vomiting. That lasted a few hours. Temp hovered around 101-102 all day (alternating Tylenol 1000mg and Motrin 600 mg q 3 -4 hours). Could not get out of bed all day.  It was pretty intense. By evening the N/V subsided but the other symptoms remained. Temp broke by 10 pm.  The next morning temp was normal, chills were gone, still had the migraine (which migraines are not unusual).  Felt fatigue and body aches, but was functional. By the evening joints hurt so bad could barely walk again. Cont. next page....
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea
Clinical narrative: Developed shortness of breath, nausea and headache 24 hours after injection.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Tongue disorder
Clinical narrative: PT STATED " MY CHEST FEELS LIKE ITS GETTING TIGHT AND MY TONGUE FEELS LIKE ITS GETTING THICK"
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Sleep disorder
Clinical narrative: Pain with performance of anything involving left arm.  Interruption of sleep due to pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Migraine, Pyrexia
Clinical narrative: Fever (100.8 F)  days, Malaise  days, joint pain  2 days, tiredness, migraine intense  persistent.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The next morning after the vaccination I woke up very fatigued,  had diarrhea, nauseaed, headache and had a fever.  I didnt go to a dr. but I self treated myself with tylenol, motrin and ibuprophen for about 16hrs after.  The following day I was still a little fatigued but felt a lot better.  My arm was sore also.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache, Tiredness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Hypertension, Nausea
Clinical narrative: Arm soreness - 48 hours Fatigue/body aches - 36 hours Fever - 24 hours Nausea - 12 hours Headache - 40hours Backache - 40 hours
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Arm soreness - 48 hours Fatigue/body aches - 36 hours Fever - 24 hours Nausea - 12 hours Headache - 40hours Backache - 40 hours
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: tiredness muscle pain chills nausea feeling unwell lasted one day after the shot
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Fatigue, Heart rate increased
Clinical narrative: dizzy after vaccine, increased heart rate, itchy skin , temperature , swelling in lymph nodes under left arm and left breast, stiff neck , rib cage pain on left side, weakness, fatigue, nausea ,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy, Musculoskeletal chest pain, Musculoskeletal stiffness, Nausea
Clinical narrative: dizzy after vaccine, increased heart rate, itchy skin , temperature , swelling in lymph nodes under left arm and left breast, stiff neck , rib cage pain on left side, weakness, fatigue, nausea ,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urine analysis
Clinical narrative: dizzy after vaccine, increased heart rate, itchy skin , temperature , swelling in lymph nodes under left arm and left breast, stiff neck , rib cage pain on left side, weakness, fatigue, nausea ,
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: Employee has severe pain and unable to lift left arm.  Treatment: Advil, ice hot, lidocaine patches.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a rash on his back and chest.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: 101.5 fever, body aches, joint pain, headaches, chills.  From 2 am February 1-February 2nd 3pm
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Large red mark on left arm, well below the site of injection, noticed it Monday evening 2/1/21; have been icing it.  It is not worse today, but it's not better either.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Sensitive skin
Clinical narrative: Sensitve and painful rash on right side of face on forehead and near right eye
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Throat tightness
Clinical narrative: About 10 minutes after receiving  COVID vaccine, patient reported that her throat got tight and she became dizzy.  Vital signs stable.  Patient was administered 12.5mg PO Benadryl and symptoms subsided.  Patient was able to be discharged home and asked to contact allergist for further recommendations
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Injection site pain, Sluggishness
Clinical narrative: Began with sluggish feeling/ tired, low grade fever 99.9 , lots of arm pain yesterday 1/27/21 -localized where shot given - hard to lay on arm -hurts to lift arm or put seatbelt on. Patient reports pain level 9/10 Denies dyspnea, no painful respirations, no loss of taste or smell Patient has tried tyelnol
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Syncope
Clinical narrative: sore arm, fatique, fainting
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neuralgia
Clinical narrative: Got jab at 12:15pm.  By 7pm a burning sensation began.  By 9pm nearly my entire body had significant burning neuropathic pain that continues to worsen and has not resolved in 4 weeks.  I had no significant neuropathic pain prior to vaccine and had not taken any medication for neuropathic pain since 2019.    Pain started within hours of the vaccine.  The vaccine was the only new variable in my routine.   Now I'm taking gabapentin 3x daily to help mitigate pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Covid Arm...Delayed Cutaneous Hypersensitivity...Swelling, itching, Heat at site, redness which has spread over my upper arm, pain
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Covid Arm...Delayed Cutaneous Hypersensitivity...Swelling, itching, Heat at site, redness which has spread over my upper arm, pain
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Persistent pain, erythema and swelling on the arm > 14 days
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness, Throat irritation
Clinical narrative: Throat itchy, lips felt tight immediately after vaccination.  Only last few minutes and then everything returned to normal.  Patient followed up with provider and denied having any further adverse reactions.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pain in extremity
Clinical narrative: 101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm.  Symptoms started early morning of  01/29/2021 and lasted until midday on 01/30/2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101.2 fever, chills, body aches, nausea, diarrhea, very sore left arm.  Symptoms started early morning of  01/29/2021 and lasted until midday on 01/30/2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Fatigue, Feeling hot
Clinical narrative: Fatigue; Chest pain; Short of breath; Hot; Tingly; Flush; Heart racing; Oxygen level low; Tachycardia; Anxiety issues; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, anxiety issues, difficulty breathing, fatigue, chest pain,  tachycardia, and low oxygen saturation.  The patient's medical history includes contact dermatitis.  Concomitant product use were not provided/unknown by the reporter.  On 28 Dec 2020, approximately five minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On 28 Dec 2020 the patient felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation.    On 29 Dec 2020 the patient experienced fatigue, chest pain, and shortness of breath.  She was triaged to the emergency room where her EKG and vital signs were normal.  The events were treated with oxygen and cetirizine.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, warm and tingly, flushing, experienced rapid heart rate, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation was considered resolved on Dec 28 2020. The outcome of the events, fatigue, chest pain, and shortness of breath, was considered unknown.; Reporter's Comments: This case concerns a 47-year-old female patient, with medical history of contact dermatitis with polyethylene glycol containing makeup and shampoo products, who experienced a serious unexpected event of dyspnea and non-serious unexpected events of feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, anxiety, and chest pain, and non-serious expected event of fatigue.The event of dyspnea, feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, and anxiety occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of    occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included nasal oxygen and Zyrtec. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Oxygen saturation decreased, Palpitations, Panic disorder
Clinical narrative: Fatigue; Chest pain; Short of breath; Hot; Tingly; Flush; Heart racing; Oxygen level low; Tachycardia; Anxiety issues; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, anxiety issues, difficulty breathing, fatigue, chest pain,  tachycardia, and low oxygen saturation.  The patient's medical history includes contact dermatitis.  Concomitant product use were not provided/unknown by the reporter.  On 28 Dec 2020, approximately five minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On 28 Dec 2020 the patient felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation.    On 29 Dec 2020 the patient experienced fatigue, chest pain, and shortness of breath.  She was triaged to the emergency room where her EKG and vital signs were normal.  The events were treated with oxygen and cetirizine.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, warm and tingly, flushing, experienced rapid heart rate, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation was considered resolved on Dec 28 2020. The outcome of the events, fatigue, chest pain, and shortness of breath, was considered unknown.; Reporter's Comments: This case concerns a 47-year-old female patient, with medical history of contact dermatitis with polyethylene glycol containing makeup and shampoo products, who experienced a serious unexpected event of dyspnea and non-serious unexpected events of feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, anxiety, and chest pain, and non-serious expected event of fatigue.The event of dyspnea, feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, and anxiety occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of    occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included nasal oxygen and Zyrtec. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tachycardia
Clinical narrative: Fatigue; Chest pain; Short of breath; Hot; Tingly; Flush; Heart racing; Oxygen level low; Tachycardia; Anxiety issues; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, anxiety issues, difficulty breathing, fatigue, chest pain,  tachycardia, and low oxygen saturation.  The patient's medical history includes contact dermatitis.  Concomitant product use were not provided/unknown by the reporter.  On 28 Dec 2020, approximately five minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right shoulder for prophylaxis of COVID-19 infection.  On 28 Dec 2020 the patient felt warm and tingly, flushing, experienced rapid heart rate, shortness of breath, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation.    On 29 Dec 2020 the patient experienced fatigue, chest pain, and shortness of breath.  She was triaged to the emergency room where her EKG and vital signs were normal.  The events were treated with oxygen and cetirizine.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, warm and tingly, flushing, experienced rapid heart rate, panic, difficulty breathing, shortness of breath, tachycardia, and low oxygen saturation was considered resolved on Dec 28 2020. The outcome of the events, fatigue, chest pain, and shortness of breath, was considered unknown.; Reporter's Comments: This case concerns a 47-year-old female patient, with medical history of contact dermatitis with polyethylene glycol containing makeup and shampoo products, who experienced a serious unexpected event of dyspnea and non-serious unexpected events of feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, anxiety, and chest pain, and non-serious expected event of fatigue.The event of dyspnea, feeling hot, paraesthesia, flushing, palpitations, oxygen saturation decreased, tachycardia, and anxiety occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of    occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included nasal oxygen and Zyrtec. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Face injury, Injury, Insomnia, Loss of consciousness
Clinical narrative: passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Extreme pain in my right thumb/ very sharp pain in the middle and base of my thumb; This is a spontaneous report from a contactable pharmacist reported for himself. A 38-year-old male patient received second dose of bnt162b2 (Lot number: EJ1686), via an unspecified route of administration in left arm on 07Jan2021 09:00 at single dose for covid-19 immunization. Medical history included HTN (hypertension) from an unknown date and unknown if ongoing. Concomitant medication included amlodipine, hctz, amfetamine sulfate (AMPHETAMINE-SALTS). The patient previous received first dose of bnt162b2 (Lot number: EJ1685), via an unspecified route of administration in left arm on 17Dec2020 11:00 AM for covid-19 immunization. The patient experienced extreme pain in his right thumb/ very sharp pain in the middle and base of my thumb on 09Jan2021 05:00. The event was reported as serious per disability. No treatment received for the adverse event. The adverse event result in disability or permanent damage. 36-48 hours after the second dose, the patient started experiencing extreme pain in my right thumb whenever he attempted to use his right hand for something including the simplest of tasks like tying his shoe. When he holds, lift, pull using his right hand he experienced a very sharp pain in the middle and base of his thumb.  At first, he thought maybe he hit it on something, but he did not.  A week later his wife was at work (she was a hair stylist) and was talking with one of her clients.  Her client who is a nurse said recently she had also taken the vaccine (2nd shot) and said the weirdest thing had happened. She told her that she can't hold anything in her right hand, and she has been experiencing unbearable pain in her right thumb when she used it for anything.  The pain has lasted almost two weeks now and was not going away. He still speak with the lady who has pain too and she said the same thing and he know it came after the second shot of the vaccine. The outcome of event was not resolved. Facility where the most recent COVID-19 vaccine was administered: Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "pain in thumb" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021058634 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: some minor TIAs; had excessive bleeding from administration site; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown) via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had excessive bleeding from administration site and using four baby wipes until saturated and bled for approximately one hour.  She received her vaccine last Thursday and is due for the next dose 05Feb2021. She is currently on clopidogrel and metoprolol for some minor TIAs. Is this a common issue with the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Loss of vision; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration from an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced loss of vision in her right eye on an unspecified date. The outcome was unknown  Information on the Lot/Batch number has been requested
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chest discomfort, Chest pain, Chills, Dyspnoea
Clinical narrative: Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient).  A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lymphadenopathy, SARS-CoV-2 test negative
Clinical narrative: Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient).  A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: my blood sugar has been up; I was 197 before breakfast; my blood sugar has been up; I was 197 before breakfast; This is a spontaneous report from a contactable consumer reporting for self. A 65-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing insulin dependent diabetic, hypertension, and kidney disorder.  Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (LANTUS), acetylsalicylic acid (ASPIRIN), lisinopril to make his kidneys strong. The patient stated he had the first shot and he believe one of the side effects was it can cause your blood sugar to go up. So, he had to monitor his blood sugar more closely. He got the vaccine on Thursday (14Jan2021), since then his blood sugar had been up. He stated that he was taking his insulin aspart and insulin glargine. Like today (18Jan2021) he took 4 units of because he was 197 before breakfast. The outcome of event was unknown.    Information on Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Visual impairment
Clinical narrative: I do not see well at all; Lost my sense of taste and smell; Those were the symptoms of the virus; Lost my sense of taste and smell; Those were the symptoms of the virus; Worried; This is a spontaneous report from a contactable consumer. A patient of unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced lost sense of taste and smell. Patient worried that those were the symptoms of the virus; do not see well at all. Patient also stated that not see well at all in Jan2021. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Atrial fibrillation, Atrial flutter, Blood lactic acid, Cardiac failure chronic
Clinical narrative: CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Condition aggravated, Echocardiogram, Lactic acidosis, Pneumonia aspiration
Clinical narrative: CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Day 8 I woke up the injection spot felt tender and sore again. I noticed the spot was red, warm, a little itchy and swollen around the injection site.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: DAYS 1-4 NOTHING BUT NORMAL REDNESS AND WARM TO THE TOUCH. DAY 5 CLEARED UP NOTHING THERE. DAY 6-7  WATER BLISTERS, VERY SWOLLEN AND HARD. DAY 8 MUCH BETTER AND NOT AS HARD
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: On January 26, 2021,  identified a potential temperature excursion impacting a total of four hundred sixty (460) doses of Moderna vaccine. It is suspected that the vaccine was thawed from a  frozen state at the hub location (the "Hospital") and was transported to the vaccination clinic  (the "Clinic") approximately twenty (20) minutes away in a partially frozen state and subsequently refrozen at the Clinic.  Storage at Hospital When the vaccine was received at the Hospital from the distributor, it was stored in a freezer at a temperature of -25 degrees Celsius to -15 degrees Celsius. On January 20, 2021 and again on January 22,
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Patient reported itching, hives on neck and arms and headache within 20-25 minutes of receiving her vaccine. Patient was evaluated in the EC and treated with Benadryl, Pepcid, Prednisone and Tylenol. Patient was discharged from EC at 4:45pm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Skin warm
Clinical narrative: Noticed on day 7 after vaccine that skin over L deltoid was warm, with 2x3inch erythema without signs of infection; resolved approximately day 9 Muscle pain in Left Deltoid began on day 1, lasted approximately 72 hours
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Death, Nausea, Vomiting
Clinical narrative: patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Lethargy, Nausea, Vomiting
Clinical narrative: patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urea increased, Death, Lethargy, Malaise, Myalgia
Clinical narrative: patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Systemic inflammatory response syndrome, Tryptase increased
Clinical narrative: patient passed away 2 days after vaccine. patient had temperature, nausea, and vomiting after vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Death, Nausea, Vomiting
Clinical narrative: On 1/31/2021 at approximately 3:00PM resident presented with symptoms of nausea/vomiting. New order received for Phenergan 25 mg IM and clear liquid diet if needed. Resident rested throughout the night without any further vomiting episodes. At approximately 10:00AM on 2/1/2021, resident noted with a temperature of 102.6. Tylenol suppository given and fluids encouraged and accepted. At approximately 11:47AM on 2/1/2021, resident temperature dropped to 99.5. Resident was noted to be somewhat lethargic and NP saw resident at approximately 3:44PM. Resident had no complaints of pain at this time and fluids were accepted. Resident was pronounced deceased at 5:40PM by Registered Nurse.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Lethargy, Nausea, Vomiting
Clinical narrative: On 1/31/2021 at approximately 3:00PM resident presented with symptoms of nausea/vomiting. New order received for Phenergan 25 mg IM and clear liquid diet if needed. Resident rested throughout the night without any further vomiting episodes. At approximately 10:00AM on 2/1/2021, resident noted with a temperature of 102.6. Tylenol suppository given and fluids encouraged and accepted. At approximately 11:47AM on 2/1/2021, resident temperature dropped to 99.5. Resident was noted to be somewhat lethargic and NP saw resident at approximately 3:44PM. Resident had no complaints of pain at this time and fluids were accepted. Resident was pronounced deceased at 5:40PM by Registered Nurse.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urea increased, Death, Lethargy, Malaise, Myalgia
Clinical narrative: On 1/31/2021 at approximately 3:00PM resident presented with symptoms of nausea/vomiting. New order received for Phenergan 25 mg IM and clear liquid diet if needed. Resident rested throughout the night without any further vomiting episodes. At approximately 10:00AM on 2/1/2021, resident noted with a temperature of 102.6. Tylenol suppository given and fluids encouraged and accepted. At approximately 11:47AM on 2/1/2021, resident temperature dropped to 99.5. Resident was noted to be somewhat lethargic and NP saw resident at approximately 3:44PM. Resident had no complaints of pain at this time and fluids were accepted. Resident was pronounced deceased at 5:40PM by Registered Nurse.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Systemic inflammatory response syndrome, Tryptase increased
Clinical narrative: On 1/31/2021 at approximately 3:00PM resident presented with symptoms of nausea/vomiting. New order received for Phenergan 25 mg IM and clear liquid diet if needed. Resident rested throughout the night without any further vomiting episodes. At approximately 10:00AM on 2/1/2021, resident noted with a temperature of 102.6. Tylenol suppository given and fluids encouraged and accepted. At approximately 11:47AM on 2/1/2021, resident temperature dropped to 99.5. Resident was noted to be somewhat lethargic and NP saw resident at approximately 3:44PM. Resident had no complaints of pain at this time and fluids were accepted. Resident was pronounced deceased at 5:40PM by Registered Nurse.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: recieved shot on 1/28/21 at 10:10 am , reaction started 1/29/21 in the morning area was red and warm it has progressivly gotten  better over the last couple days she has taken motrin and benadryl. The area was slightly itchy. She has alternated with ice and heat.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: SOB, chest tightness, no relief when using rescue inhaler, occasional sharp pains in chest and continued tight chest.  EMS presented and transported patient to ER, solumedrol, Pepcid, Benadryl and prescribed an autoinjector epi-pen.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness, Tiredness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Associate received first COVID-19 vaccine on January 5, 2021 at another facility within our Health System. Came to our facility 28 days later for second dose of  vaccine. After vaccine given, realized the first dose had been Moderna. Lot # 037K20A No adverse effects - associate did not receive the correct vaccine; talked to associate - no immediate effects, no need to receive further vaccination
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Vaccinee noted mild soreness at injection site on day of vaccine. Next day vaccinee noted fever to 101.5 and tender axillary adenopathy, fatigue and malaise. Two days after injection noted headaches with come and go
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Vaccinee noted mild soreness at injection site on day of vaccine. Next day vaccinee noted fever to 101.5 and tender axillary adenopathy, fatigue and malaise. Two days after injection noted headaches with come and go
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphadenopathy
Clinical narrative: Patient developed swelling from the left breast to the anterior aspect of the neck with anterior lymphadenopathy.  Patient received 8 mg of Decadron IM on 2/2/21.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Full blood count normal, Injection site erythema, Injection site pruritus
Clinical narrative: on 1/22 developed dizziness as well as itching and redness at the injection site.  On 1/24 developed redness and itching on abdomen and trunk.