chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diarrhea; Injection site is sore; Felt hot; Pain from my arm radiated into my armpit; The most intense, crazy, scary nightmare that I've had in my entire life; Iodine flavor in his mouth; A spontaneous report was received from a consumer concerning for himself a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events most intense, crazy, scary nightmare that i've had in my entire life/nightmare, iodine flavor in his mouth/dysgeusia, diarrhea, pain from my arm radiated into my armpit/pain in extremities, felt hot, Injection site is sore/ Vaccination site pain.  The patient's Current Condition included TMJ. Concomitant medications reported were hydrocodone, Carisoprodol both used for TMJ.  On 13Mar2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13Mar2021, the patient experienced the event iodine flavor in his mouth. On 15Mar2021, the patient experienced the event most intense, crazy, scary nightmare that he had in his entire life and the same day he visited Emergency room. On an unknown date, the patient experienced the events diarrhea, pain from my arm radiated into my armpit, felt hot and injection site was sore. The event pain from his arm radiated to armpit was reported medically significant.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, most intense, crazy, scary nightmare that he had in his entire life, iodine flavor in his mouth, diarrhea, pain from arm radiated into his armpit, felt hot, injection site was sore was unknown, at the time of this report.; Reporter's Comments: This case concerns a 41 Y/O M with a serious unexpected event of pain in extremity and nonserious unexpected diarrhea, dysgeusia, feeling hot, nightmare, and expected vaccination site pain. Event onset the same day as first dose mRNA-1273. Treated with hydrocodone and Soma. Event outcomes 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysstasia, Fatigue, Nausea
Clinical narrative: Intense nausea and  vomiting; uncontrollable chills that lasted for hours; cold skin; weakness (unable to stand}; extreme exhaustion
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Vomiting
Clinical narrative: Intense nausea and  vomiting; uncontrollable chills that lasted for hours; cold skin; weakness (unable to stand}; extreme exhaustion
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Pt felt like her face was swelling, no swelling was appreciated by MD, PA-C or nurse, no other reactions
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Flushing, Immediate post-injection reaction, Respiration abnormal, Syncope
Clinical narrative: IMMEDIATELY FOLLOWING ADMINISTRATION, PATIENT BECAME FAINT AND LEANED OVER IN CHAIR. HER EYES ROLLED BACK. SHE CONTINUED BREATHING BUT BREATHS WERE SHORT AND HEAVY. SHE WAS FLUSHED. AFTER A MINUTE SHE CAME TO AND WAS RESPONSIVE. PATIENT REMAINED COHERENT AFTER COMING TO BUT WAS NOTICEABLY OUT OF IT.  SHE WAS GIVEN A BOTTLE OF WATER AND REMAINDED IN OBSERVATION FOR 30 MINUTES. AFTER OBSERVATION SHE CONFIRMED THAT SHE WAS OKAY TO LEAVE.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: New onset bells palsy, 2 days after first vaccine dose, no prior history of bells palsy. treating with pred/valtrex
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pregnancy test negative, Rash
Clinical narrative: Patient went to  ED on 3/21/2021, due to reaction from vaccine. C/o  chills, headache, generalized rash,  body aches and hives. At hospital when examined by physician patient observed with anterior chest and back with urticarial rash that is pleuritic, rash also evident in the left arm bilateral hands and soles of feet all of which are pruritic .
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin burning sensation, Urticaria
Clinical narrative: Patient went to  ED on 3/21/2021, due to reaction from vaccine. C/o  chills, headache, generalized rash,  body aches and hives. At hospital when examined by physician patient observed with anterior chest and back with urticarial rash that is pleuritic, rash also evident in the left arm bilateral hands and soles of feet all of which are pruritic .
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Fatigue, Headache, Herpes virus infection
Clinical narrative: Herpes outbreak:  neuralgia, burning sensation in legs, feet, burning/prickling beginning  2 days after vaccine, blisters at base of spine.  Started treating with Acyclovir, began to subside, stopped treatment at day 7;  however, started flaring up again on day 8 and am now currently continuing Acyclovir.  Headache and tiredness
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Herpes outbreak:  neuralgia, burning sensation in legs, feet, burning/prickling beginning  2 days after vaccine, blisters at base of spine.  Started treating with Acyclovir, began to subside, stopped treatment at day 7;  however, started flaring up again on day 8 and am now currently continuing Acyclovir.  Headache and tiredness
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Paraesthesia
Clinical narrative: Patient began feeling anxious, chest tightness,  and tingling  after receiving moderna vaccine.  Rn supervisor and paramedics intervened. No medical intervention necessary. Patient was guided through breathing techniques.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Weird chills; These symptoms include fainting / passed out on the floor, eyes rolled back; Chills were like shakes in my hand; Elevated heart rate (117); Weakness; Sweating profusely; Dizzines; Nausea; A spontaneous report was received from a 73-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed events, fainting / passed out/syncope, eyes rolled back/syncope, chills were weird/chills, chills were like shakes in my hand/tremor, heart rate was up/heart rate increased, nausea, weakness/asthenia, dizziness and sweating profusely/hyperhidrosis.  The patient's medical history included positive COVID-19 test on 11 Dec 2020. No relevant concomitant medications were reported.     On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Jan 2021, around 2'O clock in the morning, the patient experienced the symptoms including fainting, eyes rolling back, weird chills like shakes in her hand, sweating profusely, elevated heart rate (117), and other symptoms that occurred when she had COVID such as nausea, weakness, dizziness.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events fainting / passed out/syncope, eyes rolled back/syncope, chills were weird/chills, chills were like shakes in my hand/tremor, heart rate was up/heart rate increased, nausea, weakness/asthenia, dizziness and sweating profusely/hyperhidrosis was considered as resolved on 25 Jan 2021.; 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: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, SARS-CoV-2 test, Syncope, Tremor
Clinical narrative: Weird chills; These symptoms include fainting / passed out on the floor, eyes rolled back; Chills were like shakes in my hand; Elevated heart rate (117); Weakness; Sweating profusely; Dizzines; Nausea; A spontaneous report was received from a 73-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed events, fainting / passed out/syncope, eyes rolled back/syncope, chills were weird/chills, chills were like shakes in my hand/tremor, heart rate was up/heart rate increased, nausea, weakness/asthenia, dizziness and sweating profusely/hyperhidrosis.  The patient's medical history included positive COVID-19 test on 11 Dec 2020. No relevant concomitant medications were reported.     On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23 Jan 2021, around 2'O clock in the morning, the patient experienced the symptoms including fainting, eyes rolling back, weird chills like shakes in her hand, sweating profusely, elevated heart rate (117), and other symptoms that occurred when she had COVID such as nausea, weakness, dizziness.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events fainting / passed out/syncope, eyes rolled back/syncope, chills were weird/chills, chills were like shakes in my hand/tremor, heart rate was up/heart rate increased, nausea, weakness/asthenia, dizziness and sweating profusely/hyperhidrosis was considered as resolved on 25 Jan 2021.; 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.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: About 11:30 PM on 03/15/2021, started gasping for breath when laying down, sat up in lazy boy for a hour and half, beathing returned to normal.  About 3:30 PM on 3/16/2021, started gasping for breath again.  Called my daughter and she transported me to  Hospital.  They tested for covid - results negative.  They did a C-Scan of my chest and saw a blood clot in each lung.  While hooked to the monitors, they found I had Afib.  They also did an ultra-sound of my legs and found a small clot in each leg below the knees in a small vein.  I have never had any record of clots or Afib.  They transferred me to  Medical Center early on 3/17/2021.  They started a heparin drip to soften the clots.  In the afternoon of 3/17/2021, they performed a Suction Thrombectomy to remove the clots from my lungs.  On 3/19/2021, they put me on Eliquis Tab.  I was released from the hospital in the evening of 3/20/2021.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombectomy, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: About 11:30 PM on 03/15/2021, started gasping for breath when laying down, sat up in lazy boy for a hour and half, beathing returned to normal.  About 3:30 PM on 3/16/2021, started gasping for breath again.  Called my daughter and she transported me to  Hospital.  They tested for covid - results negative.  They did a C-Scan of my chest and saw a blood clot in each lung.  While hooked to the monitors, they found I had Afib.  They also did an ultra-sound of my legs and found a small clot in each leg below the knees in a small vein.  I have never had any record of clots or Afib.  They transferred me to  Medical Center early on 3/17/2021.  They started a heparin drip to soften the clots.  In the afternoon of 3/17/2021, they performed a Suction Thrombectomy to remove the clots from my lungs.  On 3/19/2021, they put me on Eliquis Tab.  I was released from the hospital in the evening of 3/20/2021.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: the patient fainted at the time of vaccine (rapid response called), patient was assets by MD kept  for observation for 30 mins. and discharged by MD.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak on right buttock
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Vital signs measurement
Clinical narrative: Patient began to feel dizzy 5 minutes after vaccination. !0 minutes later started coughing related to acid reflux. VSS. Patient improved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Red swollen and hard area around injection site, started two days after vaccine and is still ongoing fatigue headache lasting two days muscle spasms and twitching around injection site swollen lymph nodes in the neck on the same side as injection
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Muscle twitching
Clinical narrative: Red swollen and hard area around injection site, started two days after vaccine and is still ongoing fatigue headache lasting two days muscle spasms and twitching around injection site swollen lymph nodes in the neck on the same side as injection
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Laboratory test, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Chills, weakness, poor muscle control in legs, increased stinging and burning all over.  Decreased muscle strength
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin burning sensation
Clinical narrative: Chills, weakness, poor muscle control in legs, increased stinging and burning all over.  Decreased muscle strength
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Moderna only FDA approved for 18 years and older. Patient is 17 years and 3 months.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Lymph node pain, Musculoskeletal chest pain
Clinical narrative: Moderna COVID-19 Vaccine EUA  Redness and swelling at injection site which started 6 days after the vaccine (appears as  rash).   Also, some pain in the lymph node area in arm pit on the left side (vaccine side) with some tenderness left side of my chest as well. After two days, the redness & swelling has gone down, but can still see a faint discoloration in the area.  The tenderness and pain in the left armpit and left chest side is still there.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin discolouration
Clinical narrative: Moderna COVID-19 Vaccine EUA  Redness and swelling at injection site which started 6 days after the vaccine (appears as  rash).   Also, some pain in the lymph node area in arm pit on the left side (vaccine side) with some tenderness left side of my chest as well. After two days, the redness & swelling has gone down, but can still see a faint discoloration in the area.  The tenderness and pain in the left armpit and left chest side is still there.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy
Clinical narrative: My face is numb around my mouth. It started about 25 minutes after I got the vaccine. I also had swollen nymph lodes last time I got the vaccine in February. It has been an hour since I got the vaccine and I still feel the numbness.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Developed Cellulitis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysarthria, Dysgeusia, Electrocardiogram, Facial discomfort
Clinical narrative: believes blacked out for 5 to 8 minutes; left side of face felt weird; blurry vision in both eyes; slurred speech; metallic taste in mouth; unable to sit up; arm pain near injection site; A spontaneous report was received from a consumer concerning a 58 years old, male patient who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced a loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 19 Mar 2021,  the patient received their 0.5 ml of planned dose of mRNA-1273 (Lot number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19Mar2021, within 15 minutes of receiving the vaccine, the patient experienced face feeling weird, blurry vision in left eye, blurry vision in right eye, speech slurred, inability to sit up, metallic taste in the mouth,  loss of consciousness, and some arm pain near injection site. The patient went to the emergency room (ER) and underwent electrocardiogram (EKG), unspecified blood work, neurological tests, and computerized tomography (CT scan). Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was  unknown.  The outcome of the events loss of consciousness and slurred speech was resolved, and the outcome of the other events was not resolved.   The reported events are loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain, were considered related to mRNA-1273.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of consciousness, Neurological examination, Vaccination complication, Vaccination site pain
Clinical narrative: believes blacked out for 5 to 8 minutes; left side of face felt weird; blurry vision in both eyes; slurred speech; metallic taste in mouth; unable to sit up; arm pain near injection site; A spontaneous report was received from a consumer concerning a 58 years old, male patient who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced a loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 19 Mar 2021,  the patient received their 0.5 ml of planned dose of mRNA-1273 (Lot number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19Mar2021, within 15 minutes of receiving the vaccine, the patient experienced face feeling weird, blurry vision in left eye, blurry vision in right eye, speech slurred, inability to sit up, metallic taste in the mouth,  loss of consciousness, and some arm pain near injection site. The patient went to the emergency room (ER) and underwent electrocardiogram (EKG), unspecified blood work, neurological tests, and computerized tomography (CT scan). Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was  unknown.  The outcome of the events loss of consciousness and slurred speech was resolved, and the outcome of the other events was not resolved.   The reported events are loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain, were considered related to mRNA-1273.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: believes blacked out for 5 to 8 minutes; left side of face felt weird; blurry vision in both eyes; slurred speech; metallic taste in mouth; unable to sit up; arm pain near injection site; A spontaneous report was received from a consumer concerning a 58 years old, male patient who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced a loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 19 Mar 2021,  the patient received their 0.5 ml of planned dose of mRNA-1273 (Lot number: 046A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19Mar2021, within 15 minutes of receiving the vaccine, the patient experienced face feeling weird, blurry vision in left eye, blurry vision in right eye, speech slurred, inability to sit up, metallic taste in the mouth,  loss of consciousness, and some arm pain near injection site. The patient went to the emergency room (ER) and underwent electrocardiogram (EKG), unspecified blood work, neurological tests, and computerized tomography (CT scan). Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was  unknown.  The outcome of the events loss of consciousness and slurred speech was resolved, and the outcome of the other events was not resolved.   The reported events are loss of consciousness, facial discomfort, blurred vision, dysarthria, dysgeusia, vaccination complication, vaccination site pain, were considered related to mRNA-1273.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein normal, Ear pain, Full blood count normal, Metabolic function test
Clinical narrative: Received Moderna first dose on 3/11/21. Experienced sore arm and drowsiness same day. One week later (Thursday, 3/18/21), sore arm and slight muscle/joint pain came back and has subsided. Friday evening I experienced left jaw and ear pain and has subsided. Saturday morning, small bumps/rash appeared on left forearm (vaccine in left shoulder). Saturday evening, same thing on right forearm. Bumps/rash are similar to blisters and some have pustules. Itchy and painful. Took Benadryl. Sunday morning, more on hands, feet, and ankles. Continued Benadryl and monitoring. Sunday evening, increased density of sites on hands, feet, and ankles. Some showing on lower legs and knees. Monday morning (now), itchiness and pain increased. Increased Benadryl intake. This has helped reduce itchiness slightly. Sites are still painful. Hands feel slightly swollen/tight where sites are.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pain in jaw, Peripheral swelling, Rash
Clinical narrative: Received Moderna first dose on 3/11/21. Experienced sore arm and drowsiness same day. One week later (Thursday, 3/18/21), sore arm and slight muscle/joint pain came back and has subsided. Friday evening I experienced left jaw and ear pain and has subsided. Saturday morning, small bumps/rash appeared on left forearm (vaccine in left shoulder). Saturday evening, same thing on right forearm. Bumps/rash are similar to blisters and some have pustules. Itchy and painful. Took Benadryl. Sunday morning, more on hands, feet, and ankles. Continued Benadryl and monitoring. Sunday evening, increased density of sites on hands, feet, and ankles. Some showing on lower legs and knees. Monday morning (now), itchiness and pain increased. Increased Benadryl intake. This has helped reduce itchiness slightly. Sites are still painful. Hands feel slightly swollen/tight where sites are.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Rash vesicular, Red blood cell sedimentation rate normal, Somnolence
Clinical narrative: Received Moderna first dose on 3/11/21. Experienced sore arm and drowsiness same day. One week later (Thursday, 3/18/21), sore arm and slight muscle/joint pain came back and has subsided. Friday evening I experienced left jaw and ear pain and has subsided. Saturday morning, small bumps/rash appeared on left forearm (vaccine in left shoulder). Saturday evening, same thing on right forearm. Bumps/rash are similar to blisters and some have pustules. Itchy and painful. Took Benadryl. Sunday morning, more on hands, feet, and ankles. Continued Benadryl and monitoring. Sunday evening, increased density of sites on hands, feet, and ankles. Some showing on lower legs and knees. Monday morning (now), itchiness and pain increased. Increased Benadryl intake. This has helped reduce itchiness slightly. Sites are still painful. Hands feel slightly swollen/tight where sites are.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache
Clinical narrative: Woke with a stomach, my joints hurt, headache and extremely tired. Symptoms lasted 24 hours except for the joints hurting and that lasted for four days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Dizziness, Heart rate irregular, Loss of personal independence in daily activities
Clinical narrative: Within 10 minutes after vaccinated I experienced slow heart beat, unable to move all limbs, unable to talk except "what's happening" 2 hours after vaccinated. Weak, dizzy, blurred vision. This all lasted 2 hours and 15 minutes then I mustered all my energy to drive home then resumed my paralysis.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Within 10 minutes after vaccinated I experienced slow heart beat, unable to move all limbs, unable to talk except "what's happening" 2 hours after vaccinated. Weak, dizzy, blurred vision. This all lasted 2 hours and 15 minutes then I mustered all my energy to drive home then resumed my paralysis.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to individual under 18yrs of age.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash
Clinical narrative: FELT FLUSH, DEVELOPES RASH ON CHEST. GIVEN IV DIPHENHYDRAMINE AND NORMAL SALINE BOLUS. DECLINED EMS AFTER RECEIVING ADVICE FROM ER DR, NP AND EMS
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine by mistake even though their age did not meet the minimum age requirement for Moderna Covid19 vaccination of 18 years old. No adverse effects were reported upon notifying patient's mother
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Erythema, Fatigue, Nausea
Clinical narrative: Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Urticaria
Clinical narrative: Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood lactic acid, Blood magnesium, Blood phosphorus, C-reactive protein
Clinical narrative: Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Full blood count, Glomerular filtration rate, Incoherent, Metabolic function test
Clinical narrative: Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Procalcitonin, Pyrexia, Red blood cell sedimentation rate, Tremor, Urine analysis
Clinical narrative: Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Syncope
Clinical narrative: Fainted; Feeling dizzy; Weak; Exhausted; A spontaneous report was received from a consumer concerning a 66 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced fainted/syncope, feeling dizzy/dizziness, weakness/asthenia, and exhaustion/fatigue.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 11 Feb 2021. The patient received their second of two planned doses of mRNA-1273 (Batch number: 036A21A) on 11 Mar 2021 intramuscularly for prophylaxis of COVID-19 infection.    On 12 Mar 2021, the patient felt so weak and exhausted, she didn't have the strength to brush her teeth. She remembered feeling dizzy while standing in the bathroom. She fainted shortly after. She felt like couldn't stand up because she was so weak and was very scared. Treatment of the event was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events fainted, feeling dizzy, weakness, and fatigue were considered resolved on 13 Mar 2021.; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: About 4 pm, started feeling tired, rundown, by 6:30 had a fever and severe chills, got worse.  Went to bed at 8 pm, chills, fever, weak, achy, could hardly move.  Chills stopped about 10:30 pm, then slowly got hot, woke up sweating about 4:30 am.  Got up about 6:30 am feeling better but still weak, achy and tired.  Went back to bed about 9:30 am, got up at 11:30 am feeling better, just achy, tired and slight headache.  Reactions gone by 3 pm 3/26/21.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: About 4 pm, started feeling tired, rundown, by 6:30 had a fever and severe chills, got worse.  Went to bed at 8 pm, chills, fever, weak, achy, could hardly move.  Chills stopped about 10:30 pm, then slowly got hot, woke up sweating about 4:30 am.  Got up about 6:30 am feeling better but still weak, achy and tired.  Went back to bed about 9:30 am, got up at 11:30 am feeling better, just achy, tired and slight headache.  Reactions gone by 3 pm 3/26/21.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Feeling hot, Flushing
Clinical narrative: P:  Hypersensitivity reaction Patient received covid vaccine at 835  in covid clinic ( 3rd floor west auditorium).  Due to her h/o multiple allergies she was asked to stay for 30 min instead of 15.  About 10 min post vaccine she c/o feeling light headed and hot.      Did not have dyspnea, itching in throat or mouth, itching at inj site, no sensation of throat/face/mouth swelling.    O:  845:   bp 118/82, p 145, o2 sats 99%.    No respiratory distress, appeared anxious, HEENT:   flushed with redness to cheeks and forehead no facial swelling Mouth:  No swelling, pharynx without redness, no swelling to lips or tongue Neck: no redness, no increased warmth, no swelling Lungs:   lungs clear in all lung fields no wheezing or stridor both anterior and posterior CV: tachycardia with reg rhythm. No murmur  Given water, and ordered po benadryl 50mg  8:48:  C/o increased lightheadedness and feeling flushed,   Skin:  Urticaria to chest, neck and visible spreading of urticaria into face and scalp during observation.  Continues with stable respiratory status and airway, no stridor, no angioedema Due to rapid progression of hives, pt was given epi 0.3mg IM  EMS activated for transport to ER  8:52  Bp 122/82, p 150, o2 sats 99%.  Pt shaky and anxious, teary, calm after reassurance that this is normal reaction to epi and stress of situation for her.  9:00am EMS arrived and report given to EMS who then transported pt to ER.  A:  Hypersensitivity reaction to covid vaccine, possible more related to anxiety   1pm Patient called clinic to give a status update.  She was held in the ER and given additional benadryl, prednisone, zyrtec and then some ativan She did not have further hives after the initial epinephrine dose.  She was discharged with 5 days of prednisone and zyrtec as well as an epi pen.  Reports she feels tired and drained but no other symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Nervousness, Tachycardia, Urticaria
Clinical narrative: P:  Hypersensitivity reaction Patient received covid vaccine at 835  in covid clinic ( 3rd floor west auditorium).  Due to her h/o multiple allergies she was asked to stay for 30 min instead of 15.  About 10 min post vaccine she c/o feeling light headed and hot.      Did not have dyspnea, itching in throat or mouth, itching at inj site, no sensation of throat/face/mouth swelling.    O:  845:   bp 118/82, p 145, o2 sats 99%.    No respiratory distress, appeared anxious, HEENT:   flushed with redness to cheeks and forehead no facial swelling Mouth:  No swelling, pharynx without redness, no swelling to lips or tongue Neck: no redness, no increased warmth, no swelling Lungs:   lungs clear in all lung fields no wheezing or stridor both anterior and posterior CV: tachycardia with reg rhythm. No murmur  Given water, and ordered po benadryl 50mg  8:48:  C/o increased lightheadedness and feeling flushed,   Skin:  Urticaria to chest, neck and visible spreading of urticaria into face and scalp during observation.  Continues with stable respiratory status and airway, no stridor, no angioedema Due to rapid progression of hives, pt was given epi 0.3mg IM  EMS activated for transport to ER  8:52  Bp 122/82, p 150, o2 sats 99%.  Pt shaky and anxious, teary, calm after reassurance that this is normal reaction to epi and stress of situation for her.  9:00am EMS arrived and report given to EMS who then transported pt to ER.  A:  Hypersensitivity reaction to covid vaccine, possible more related to anxiety   1pm Patient called clinic to give a status update.  She was held in the ER and given additional benadryl, prednisone, zyrtec and then some ativan She did not have further hives after the initial epinephrine dose.  She was discharged with 5 days of prednisone and zyrtec as well as an epi pen.  Reports she feels tired and drained but no other symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Today, 8 days after vaccination, the injection site was itchy with a large red oval on the skin
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: PATIENT HAD RASH ON NECK AND UNDER BREAST AREA--IN THE FOLD AND CREASE AREA.   AROUND THE NECK -THE LEFT SIDE GOT IT MORE THEN THE RIGHT SIDE.  SAME UNDER THE BREAST. IT WAS MORE ON THE LEFT SIDE IT WAS MORE THAN THE RIGHT SIDE.-  PATIENT NOTICED THE LEFT SIDE WAS WORSE. PATIENT PUT DESITIN UNDER THE BREAST.  DR. TOLD HER TO PUT LOTION SO PATIENT GOT CALAMINE LOTION ON IT AND TO TAKE BENADRYL.    TODAY 3/26 IT HAS GOTTEN BETTER, STILL THERE BUT IT IS BETTER.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Patient daughter called to report a sudden onset of confusion.  She reports that she left to walk the dogs and the patient's behavior was normal she returned to find him confused for example using the wrong utensils to eat his food and saying things that did not make sense. His speech was clear but once again his responses were not appropriate to the conversation.  Patient's daughter reports he received his 1st COVID vaccine on 3.24.21 at a vaccine facility. Sent to ED for eval and treatment Reason for Disposition ? Very strange or paranoid behavior  Protocols used: CONFUSION - DELIRIUM-A-OH
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Severe, whole body rash. Very red skin.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: At approx. 1238, pt reported feeling lightheaded to vaccinator. Pt was assisted into anti-gravity chair. Pt appeared anxious and reported hx of lightheadedness and fuzzy vision after prior vaccinations. Pt stated "I'm not good with needles". Pt given water and emesis bag. Pt denied needing to vomit. Vital signs assessed at approx. 1240. BP 140/80 mmHg, PR 88 BPM, SpO2 99% RA. Patient advised to wait for 30 mins for further observation. At approx. 1310, vitals reassessed. BP 154/94 mmHg, PR 72 bpm, SpO2 98% RA. Pt advised to sign up with CDC V-safe. Pt left facility at approx. 1314 with steady gait and unlabored breathing..
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: After vaccine administration patient felt light headed, nausea, dizzy and shortness of breath. Called code green, paramedics arrived. Patient laid down, vital sign stable. Patient stable.   BP 114/76  100% o2sat  RR 16  HR 76
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram thorax, Constipation, Decreased appetite, Dizziness
Clinical narrative: INTENSE VERTIGO, NAUSEA, DIZZINESS, EYE PAIN, CONSTIPATION, LOSS OF APPETITE, LOSS OF BALANCE, MIGRAINE, SENSITIVITY TO LIGHT, LEFT ARM PAIN WHERE SHOT INJECTED. SOUGHT MEDICAL ATTENTION TWICE AT ER.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Full blood count, Injection site pain, Metabolic function test, Migraine
Clinical narrative: INTENSE VERTIGO, NAUSEA, DIZZINESS, EYE PAIN, CONSTIPATION, LOSS OF APPETITE, LOSS OF BALANCE, MIGRAINE, SENSITIVITY TO LIGHT, LEFT ARM PAIN WHERE SHOT INJECTED. SOUGHT MEDICAL ATTENTION TWICE AT ER.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photophobia, Vertigo
Clinical narrative: INTENSE VERTIGO, NAUSEA, DIZZINESS, EYE PAIN, CONSTIPATION, LOSS OF APPETITE, LOSS OF BALANCE, MIGRAINE, SENSITIVITY TO LIGHT, LEFT ARM PAIN WHERE SHOT INJECTED. SOUGHT MEDICAL ATTENTION TWICE AT ER.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 03/25/2021 Was tested for Covid before leaving the country and tested positive. Very confused as to why I am not immune!
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Rash
Clinical narrative: Patient started with terrible migraine the day after the vaccination (3/18/21), but 2 days later on 3/19/21 patient developed rash on neck.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Headache, Psoriasis, Rash
Clinical narrative: Patient started with terrible migraine the day after the vaccination (3/18/21), but 2 days later on 3/19/21 patient developed rash on neck.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Gradually spreading red rash below vaccine site.  Intense itching, light swelling, warm to touch.  Aches down the arm.  Started day 6 after vaccine and currently on day 8.  In addition, on day 4 significant flare of tendonitis in achilles of right leg.  No prior history of tendonitis in that area, no trigger or injury.   Woke up unable to walk on it, resolved itself 12 hours later.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tendonitis, Vaccination site rash
Clinical narrative: Gradually spreading red rash below vaccine site.  Intense itching, light swelling, warm to touch.  Aches down the arm.  Started day 6 after vaccine and currently on day 8.  In addition, on day 4 significant flare of tendonitis in achilles of right leg.  No prior history of tendonitis in that area, no trigger or injury.   Woke up unable to walk on it, resolved itself 12 hours later.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oropharyngeal discomfort, Tongue disorder
Clinical narrative: 30-45 minutes after  injection  I had the follow symptoms that were mild and lasted 15 minutes: 1. my tongue felt large, thick and I had trouble talking 2. lips felt numb 3.  bottom of throat felt closing - like a flap I was able to eat and drink and felt fine the rest of the day.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling of body temperature change, Headache, Influenza like illness, Lymph node pain
Clinical narrative: At the time of the injection, I only felt a little pressure. I didn't feel the prick of the needle. My are was stiff and sore. My symptoms changed about noon the day following the injection. (3/24/21. I had taken Tylenol at 8:45am to help the stiffness in my arm, and I realized about noon that I was starting to run a fever. My fever was 101.8 when I returned home from work at about 1pm. I was feeling very cold, but also hot & my muscles were all very sore. I also  had a sharp headache. I felt as though I had the flu. This lasted for about 24 hours. At about 1pm  on 3/25/21 the aches & pains were gone, my fever was breaking on it's own, but I still had a headache.  On Friday 3/26/2021, my fever was still climbing a little, but then breaking on it's own. My headache was still sharp, but it responded to Excedrin Tension.  My arm was still a little stiff and a lymph node in my left arm pit was sore. I took Tylenol at 4:00pm on Tuesday after my injection 3/23/21 1:00am 3/24/21 8:45am 3/24/21 6:00pm 3/24/21 5:45am 3/25/21 5:10am 3/26/21 (for my headache) My symptoms seem to fit what I was told to possibly expect & I did not need to be seen by a doctor. I just wanted to share my symptoms to help with the growth of information & the vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: At the time of the injection, I only felt a little pressure. I didn't feel the prick of the needle. My are was stiff and sore. My symptoms changed about noon the day following the injection. (3/24/21. I had taken Tylenol at 8:45am to help the stiffness in my arm, and I realized about noon that I was starting to run a fever. My fever was 101.8 when I returned home from work at about 1pm. I was feeling very cold, but also hot & my muscles were all very sore. I also  had a sharp headache. I felt as though I had the flu. This lasted for about 24 hours. At about 1pm  on 3/25/21 the aches & pains were gone, my fever was breaking on it's own, but I still had a headache.  On Friday 3/26/2021, my fever was still climbing a little, but then breaking on it's own. My headache was still sharp, but it responded to Excedrin Tension.  My arm was still a little stiff and a lymph node in my left arm pit was sore. I took Tylenol at 4:00pm on Tuesday after my injection 3/23/21 1:00am 3/24/21 8:45am 3/24/21 6:00pm 3/24/21 5:45am 3/25/21 5:10am 3/26/21 (for my headache) My symptoms seem to fit what I was told to possibly expect & I did not need to be seen by a doctor. I just wanted to share my symptoms to help with the growth of information & the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: mini chills
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Patient felt lethargic post vaccine. Looked pale. Awake, alert and oriented. No respiratory distress. Allowed to rest with feet up. vital signs normal. BP 100/75-110/86, O2 sat 97%, HR 76 BPM.  Water given. Went home with no incident after 20 minutes. Her partner drove her home and texted friend that she is ?ne when she arrived home.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: 102 fever, extreme chills for several hours. Achy and fatigued for over 24 hours after vaccine
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client was inadvertently given Moderna COVID vaccine dose #1 on 2/22/2021 at Teacher vaccination POD.  Per Department of Health guidance, it was stated that it was ok, with parental permission, for client to receive dose #2 of Moderna before her 18th birthday.  Although permissible per DH, a VAERS report needs to be submitted.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when touched or when I move it. headache & fatigue
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when touched or when I move it. headache & fatigue
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Magnetic resonance imaging head abnormal
Clinical narrative: pt with remote history of bells palsy who developed another episode of bells palsy 1/20/21 PRIOR to getting covid vaccine. however, that was resolving, when on 3/16/21 she developed ANOTHER episode of bells palsy, this one following her second dose of the pfizer covid vaccine which was on 2/25/21. MRI brain revealed marked CN VII inflammation c/w bells palsy. treated with pred/valtrex.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fluid replacement, Hypersomnia, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: i started to feel feverish and sick that evening.  I was unable to get out of bed for more than going to the bathroom for about 36 hours  I was unable to go to work.  Nauseated - still having issues with that, got bad enough I needed an IV at home due to lack of food or fluids.  low grade fever for 2 days 99 ish. Tylenol for it.  All over body aches for the 2 days after.  Slept close to 16 hours the next day.  Shoulder rash and pain for 2 days - had to use a ice pack even when sleeping to deal with the pain
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia, Rash
Clinical narrative: i started to feel feverish and sick that evening.  I was unable to get out of bed for more than going to the bathroom for about 36 hours  I was unable to go to work.  Nauseated - still having issues with that, got bad enough I needed an IV at home due to lack of food or fluids.  low grade fever for 2 days 99 ish. Tylenol for it.  All over body aches for the 2 days after.  Slept close to 16 hours the next day.  Shoulder rash and pain for 2 days - had to use a ice pack even when sleeping to deal with the pain
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Chest X-ray, Chest discomfort, Dizziness, Echocardiogram
Clinical narrative: Day #4 after covid vaccine #2 dose: mild sorethroat and mild neck enlarge lymph node - resolved in one day. Day #5: acid reflux symptoms, abdominal bloating - took Tums.. Day #6: chest discomfort with sharp pressure - worse with deep inspiration and temporarily relieved with belching/burping.   Day #7: continues to have chest discomfort - worsening fatigue and some light headedness when bends over or standing up.  EKG c/w acute pericarditis. Started on Colchicine.   Day #8: feels much better and discharged from hospital on Colchicine 0.6mg twice a day.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Eructation, Fatigue, Fibrin D dimer, Gastrooesophageal reflux disease
Clinical narrative: Day #4 after covid vaccine #2 dose: mild sorethroat and mild neck enlarge lymph node - resolved in one day. Day #5: acid reflux symptoms, abdominal bloating - took Tums.. Day #6: chest discomfort with sharp pressure - worse with deep inspiration and temporarily relieved with belching/burping.   Day #7: continues to have chest discomfort - worsening fatigue and some light headedness when bends over or standing up.  EKG c/w acute pericarditis. Started on Colchicine.   Day #8: feels much better and discharged from hospital on Colchicine 0.6mg twice a day.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Metabolic function test, Oropharyngeal pain, Red blood cell sedimentation rate normal, Resuscitation
Clinical narrative: Day #4 after covid vaccine #2 dose: mild sorethroat and mild neck enlarge lymph node - resolved in one day. Day #5: acid reflux symptoms, abdominal bloating - took Tums.. Day #6: chest discomfort with sharp pressure - worse with deep inspiration and temporarily relieved with belching/burping.   Day #7: continues to have chest discomfort - worsening fatigue and some light headedness when bends over or standing up.  EKG c/w acute pericarditis. Started on Colchicine.   Day #8: feels much better and discharged from hospital on Colchicine 0.6mg twice a day.