chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Nausea, Rash
Clinical narrative: My husband got first dose of Moderna on 2/16/21 without any side effects.  He got the second dose on 3/16/21 and after 10-12 hours had fatigue, myalgias and nausea which resolved within 10-12 hours.  HOWEVER, one week after second dose, on 3/23/21, my husband took a shower and noticed shortly thereafter around 8 AM a itchy rash on face and neck.  NO rash over Vaccine Site.  Over the day the rash got more intensely red and noticed blotches over his upper chest (symmetrical oval patches just beneath each nipple region).  He took 2 Benadryl Tabs at night and in morning of 3/24 the rash has improved considerably..  The rash was macular and erythematous and never raised with no blistering.   His first dose of Moderna was on 2/16/21 and lot number was 011M20M.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: My husband got first dose of Moderna on 2/16/21 without any side effects.  He got the second dose on 3/16/21 and after 10-12 hours had fatigue, myalgias and nausea which resolved within 10-12 hours.  HOWEVER, one week after second dose, on 3/23/21, my husband took a shower and noticed shortly thereafter around 8 AM a itchy rash on face and neck.  NO rash over Vaccine Site.  Over the day the rash got more intensely red and noticed blotches over his upper chest (symmetrical oval patches just beneath each nipple region).  He took 2 Benadryl Tabs at night and in morning of 3/24 the rash has improved considerably..  The rash was macular and erythematous and never raised with no blistering.   His first dose of Moderna was on 2/16/21 and lot number was 011M20M.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site irritation, Injection site rash
Clinical narrative: Patient noticed 2.5 inch circular rash around the injection site a week and a half after injection. The rash does not itch often but the skin is irritated. She has not tried anything for the rash yet.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Pain in extremity
Clinical narrative: Soreness in my arm for a few days, exhaustion 3 hours after injection, and itchiness around the injection site around day 2
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Antipsychotic drug level, Full blood count, International normalised ratio, Limb discomfort
Clinical narrative: Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down.  Patient went to ER for evaluation.  Started on prednisone.  Dx:  Vasculitis On Monday 3/22/21 evaluated by PCP.  Follow up blood work and office appointment in 8 to 10 days. Report to VEARS.  Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call.  Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen.  Purple skin discoloration remains on lower extremities but decreased pain.  VEARS form submitted.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down.  Patient went to ER for evaluation.  Started on prednisone.  Dx:  Vasculitis On Monday 3/22/21 evaluated by PCP.  Follow up blood work and office appointment in 8 to 10 days. Report to VEARS.  Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call.  Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen.  Purple skin discoloration remains on lower extremities but decreased pain.  VEARS form submitted.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Pain, Pain assessment, Vasculitis
Clinical narrative: Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down.  Patient went to ER for evaluation.  Started on prednisone.  Dx:  Vasculitis On Monday 3/22/21 evaluated by PCP.  Follow up blood work and office appointment in 8 to 10 days. Report to VEARS.  Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call.  Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen.  Purple skin discoloration remains on lower extremities but decreased pain.  VEARS form submitted.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dizziness, Headache, Myalgia
Clinical narrative: Starting a few hours after my vaccination, I?ve experienced The following: chills, fever, headache, muscle soreness all over my body, nausea, nearly uncontrollable shaking last night, extreme dizziness, and my body has felt heavy. It was worst as I was going to bed (midnight), and it woke me up at 5:30 am today. My fever may have broken, but I am still in pain and dizzy.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Starting a few hours after my vaccination, I?ve experienced The following: chills, fever, headache, muscle soreness all over my body, nausea, nearly uncontrollable shaking last night, extreme dizziness, and my body has felt heavy. It was worst as I was going to bed (midnight), and it woke me up at 5:30 am today. My fever may have broken, but I am still in pain and dizzy.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Large local inflammatory reaction on arm of vaccine started on Day 9 after 1st dose of Moderna vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Woken in early hours of 3/18 with fever, chills, body aches and pain at site of vaccine.  All symptoms improved within 48 hours of onset of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills, Fever, Muscles Pains, Fatigue, Loss of bladder control, loss of appetite
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Chills, Fever, Muscles Pains, Fatigue, Loss of bladder control, loss of appetite
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Gait disturbance, Vertigo, Vital signs measurement
Clinical narrative: Patient came for Covid19 vaccination, in observation area she started feeling dizzy. She had to lay down, room was spinning. Vitals were stable, there was no throat closure, no SOB or wheezing. She requested to get her albuterol inhaler refilled. Several attempts to get her to sit up and walk failed due to continue dizziness. She was transferred to room in blue side, there she used her inhaler, was given water, and laid down. She was observed for 3 hours. Eventually she contacted friend who came to pick her up. She was told not to drive until she felt better. Transported to friend's car with wheelchair. Friend was going to be with her for some time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Swollen red and hot where the injection was administered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Since getting the vaccine my sense of smell of very off. Everything has a rancid smell to it including non food items such as hand soap.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Extreme fatigue and headache set in 4-5 hours after vaccine was administered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Injection site and area around it, approximately 2x2 inches, is warm to touch and itchy. No redness or swelling. Itching developed almost immediately after vaccination and has continued since.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: One day after injection I got the typical expected site pain, but the real reason I am submitting this is because today (3/24/2021) at the reported time (approx. 11L00 am) I noticed a hard, red, swollen area around the injection site. It is painful and quite warm to the touch, and slightly itchy at times.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: One day after injection I got the typical expected site pain, but the real reason I am submitting this is because today (3/24/2021) at the reported time (approx. 11L00 am) I noticed a hard, red, swollen area around the injection site. It is painful and quite warm to the touch, and slightly itchy at times.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy, Rash erythematous
Clinical narrative: The day immediately following administration of my first dose, my arm was tender at the injection site and my body was fatigued. This went away the second day after administration.  There were no other symptoms or side effects after the second day post administration until the following event on March 14th. On March 11th, I flew out of state, direct flight. On March 13th, I flew from that state, to another, direct flight. On the morning of March 14th, I woke up with an approximately 5" diameter, raised red circle around the injection site and the lymph nodes on the left side of my body  were extremely large and swollen. The lymph nodes under my left arm pit were specifically extremely swollen. Anytime my left arm brushed against my lymphnodes in my armpit, it was extremely painful. This lasted until March 18th. My lymphnodes are still slightly swollen, but not as noticeable as before. The rash on my arm went away around the same time, forming a ring like appearance temporarily.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: At 1010, reports feeling like her throat is swollen. No SOB, able to swallow and drink water.  No signs of distress.  Pox 100, BP145/72. Continued to monitor, checking pox and BP every 5 minutes x 3 - stable.  No increase or decrease in symptoms reported.   50 mg benadryl liquid given PO at 1033.  Continued to monitor.  No change in symptoms, Vital signs stable. 1050- reports slight decrease in symptom.  VSS, no SOB, no distress.  Taking PO without difficulty.   1051- DC back to work at the hospital with  coworker present.  Instructed to report to the emergency department immediately with any increase in symptoms.  When she returns for her second dose, informed that she should plan to stay for monitoring for an extended period of time.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hypogeusia, Lethargy
Clinical narrative: Extreme fever and chills to the point my entire body was shaking; nausea; pounding headache and total body ache; completely robbed of strength and all this lasted until the next morning at about 9am I started feeling some better but not well.  Today I am getting back to normal but it has affected my appetite and sense of taste.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Extreme fever and chills to the point my entire body was shaking; nausea; pounding headache and total body ache; completely robbed of strength and all this lasted until the next morning at about 9am I started feeling some better but not well.  Today I am getting back to normal but it has affected my appetite and sense of taste.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash occurred at injection site after one week. Rash was round, about the size of a dime. Redness  (erythema) with itchy, mildly painful bumps. Bruising appeared at the same site approximately 2 days prior.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, fever from 3/23:  12:01 am -  3/24: 7:00 am
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Swollen tongue
Clinical narrative: She developed a swollen tongue within hours after the vaccine but woke her from sleep 16 hours post vaccine with significant swollen tongue. Did not go to ER but called our office the next morning.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Hot flush
Clinical narrative: Thursday, March 18, 2021 8pm: fatigue 9pm: chills 10:20 pm: severe chills, shaking, mild nausea, 99.3 degrees 11:05 pm: extreme shaking, severe chills, moderate headache, moderate nausea, extreme fatigue, took 2 ibuprofen, 99.9 degrees 12:24 pm: all of the above, 100.5 degrees  Friday, March 19, 2021 no fever, hot flashes, mild dehydration, moderate headache, fatigue, body aches  Saturday, March 20, 2021 fatigue, mild headache  Sunday, March 21, 2021 symptom free
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Tremor
Clinical narrative: Thursday, March 18, 2021 8pm: fatigue 9pm: chills 10:20 pm: severe chills, shaking, mild nausea, 99.3 degrees 11:05 pm: extreme shaking, severe chills, moderate headache, moderate nausea, extreme fatigue, took 2 ibuprofen, 99.9 degrees 12:24 pm: all of the above, 100.5 degrees  Friday, March 19, 2021 no fever, hot flashes, mild dehydration, moderate headache, fatigue, body aches  Saturday, March 20, 2021 fatigue, mild headache  Sunday, March 21, 2021 symptom free
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: Initial symptoms of the first shot included injection site pain, neck soreness, and severe headache that would come and go.    The next day I was so exhausted I couldn't work for 2 days.  I barely got out of bed until about 40 hours after the shot where I was able to get out and do some gardening.   The reason I am filling this out was at right around 72 hours after the vaccine, I was laying down watching a YouTube video feeling quite relaxed.  I then experienced a tachycardia event where my heart rate went up to 120 and stayed there for about an hour.  I remained calm and was not experiencing anxiety, but the heart rate persisted.  I have had this happen before in panic attacks, but it's quite rare and I am in acute, high level stress.    Almost 2 weeks later to the day, I had another tachycardia, stronger than any I've had my entire life that only lasted about 7 seconds, but I would estimate my heart rate jumped to over 250.   I thought I was going to go into cardiac arrest it was so jarring.  I'm not sure if that one was related to the vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Tachycardia
Clinical narrative: Initial symptoms of the first shot included injection site pain, neck soreness, and severe headache that would come and go.    The next day I was so exhausted I couldn't work for 2 days.  I barely got out of bed until about 40 hours after the shot where I was able to get out and do some gardening.   The reason I am filling this out was at right around 72 hours after the vaccine, I was laying down watching a YouTube video feeling quite relaxed.  I then experienced a tachycardia event where my heart rate went up to 120 and stayed there for about an hour.  I remained calm and was not experiencing anxiety, but the heart rate persisted.  I have had this happen before in panic attacks, but it's quite rare and I am in acute, high level stress.    Almost 2 weeks later to the day, I had another tachycardia, stronger than any I've had my entire life that only lasted about 7 seconds, but I would estimate my heart rate jumped to over 250.   I thought I was going to go into cardiac arrest it was so jarring.  I'm not sure if that one was related to the vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Shot given on 1/29  Flu symptoms started on 2/5 Ambulance ER visit with Flu diagnosis and later Covid diagnosis on 2/10 but sent home 2/11-2/13 progressively worsened with high fever starting, unable to walk from weakness and trouble breathing with coughing Taken by ambulance to Hospital on 2/13 and admitted to ICU 2/15 put on vent 3/22 switched from ET tube to tracheostomy  3/23 moved from ICU to LTAC still not fully awake and coherent and still on vent as of 3/24/21
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Haemoglobin decreased, Intensive care, Magnetic resonance imaging, Platelet count decreased
Clinical narrative: Shot given on 1/29  Flu symptoms started on 2/5 Ambulance ER visit with Flu diagnosis and later Covid diagnosis on 2/10 but sent home 2/11-2/13 progressively worsened with high fever starting, unable to walk from weakness and trouble breathing with coughing Taken by ambulance to Hospital on 2/13 and admitted to ICU 2/15 put on vent 3/22 switched from ET tube to tracheostomy  3/23 moved from ICU to LTAC still not fully awake and coherent and still on vent as of 3/24/21
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tracheostomy
Clinical narrative: Shot given on 1/29  Flu symptoms started on 2/5 Ambulance ER visit with Flu diagnosis and later Covid diagnosis on 2/10 but sent home 2/11-2/13 progressively worsened with high fever starting, unable to walk from weakness and trouble breathing with coughing Taken by ambulance to Hospital on 2/13 and admitted to ICU 2/15 put on vent 3/22 switched from ET tube to tracheostomy  3/23 moved from ICU to LTAC still not fully awake and coherent and still on vent as of 3/24/21
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Myalgia
Clinical narrative: fever 100.1-100.5 and chills for 12hrs overnight.  Next day headache, muscle and joint pain, little appetite.   Took Motrin for pain around 1:30pm Sunday.  Now Wednesday and woke up with headache and nausea. (may be unrelated unsure)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever 100.1-100.5 and chills for 12hrs overnight.  Next day headache, muscle and joint pain, little appetite.   Took Motrin for pain around 1:30pm Sunday.  Now Wednesday and woke up with headache and nausea. (may be unrelated unsure)
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives beginning with small sports like bug bites to almost covering my thighs, on my legs, arms and torso
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: States day of vaccine, March 13, developed fever, severs weakness, fatigue that developed 1 hour after receipt of the vaccine.  Also continues to have insomnia and lack of taste from previous COVID infections.  Reason for call was on 3/23/21 upon awaking had developed itching, swollen, red / hot area at injection site.    Instructed to try palliative remedies and if area continues to show symptoms or worsens over next few days to seek medical attention.   Spoke to client on 3/24/21 states arm "is about the same; my doctor is closed today but I am going to see him tomorrow; it looks like a cellulitis".
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: States day of vaccine, March 13, developed fever, severs weakness, fatigue that developed 1 hour after receipt of the vaccine.  Also continues to have insomnia and lack of taste from previous COVID infections.  Reason for call was on 3/23/21 upon awaking had developed itching, swollen, red / hot area at injection site.    Instructed to try palliative remedies and if area continues to show symptoms or worsens over next few days to seek medical attention.   Spoke to client on 3/24/21 states arm "is about the same; my doctor is closed today but I am going to see him tomorrow; it looks like a cellulitis".
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: Patient developed urticaria and tongue "tingling" after vaccine administration
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE information; Reports multiple temperature excursions/administered to patients; Information has been received from a nurse concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications. On 25-JAN-2021, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # S032355, exp. date 14-OCT-2021) for prophylaxis, that went through temperature excursion. The patient did not experienced any adverse event.        Temperature: minus 14.00°C for 0.25 hours Call made because of data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2103USA001252: US-009507513-2103USA001024:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Tinnitus, Vertigo
Clinical narrative: Tinnitus, exhaustion, diarrhea, and Vertigo.  Vertigo is still present 4 days after onset
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Discomfort, Dysstasia
Clinical narrative: I started to feel tired once I got the shot, I got the shot at around 1:15 pm. About 5 pm, I started to feel really cold and my whole body was shivering and vibrating. My whole body also started to ache and my bones felt heavy. At about 10 pm I started to get really high fever and felt so cold. I could not sleep even with a winter jacket on, I had a really bad headache in the center of my forehead, lower back pain and felt extremely sore and weak. I found it difficult to stand or walk. I woke up at 2:30 am from bed, to get a snack and took 2 ibuprofen to ease the symptoms. Woke up at about 10 am next day, felt slightly better. Fever has gone down slightly but not completely. Still feeling really cold and shivering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Gait disturbance, Headache, Pain
Clinical narrative: I started to feel tired once I got the shot, I got the shot at around 1:15 pm. About 5 pm, I started to feel really cold and my whole body was shivering and vibrating. My whole body also started to ache and my bones felt heavy. At about 10 pm I started to get really high fever and felt so cold. I could not sleep even with a winter jacket on, I had a really bad headache in the center of my forehead, lower back pain and felt extremely sore and weak. I found it difficult to stand or walk. I woke up at 2:30 am from bed, to get a snack and took 2 ibuprofen to ease the symptoms. Woke up at about 10 am next day, felt slightly better. Fever has gone down slightly but not completely. Still feeling really cold and shivering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: I started to feel tired once I got the shot, I got the shot at around 1:15 pm. About 5 pm, I started to feel really cold and my whole body was shivering and vibrating. My whole body also started to ache and my bones felt heavy. At about 10 pm I started to get really high fever and felt so cold. I could not sleep even with a winter jacket on, I had a really bad headache in the center of my forehead, lower back pain and felt extremely sore and weak. I found it difficult to stand or walk. I woke up at 2:30 am from bed, to get a snack and took 2 ibuprofen to ease the symptoms. Woke up at about 10 am next day, felt slightly better. Fever has gone down slightly but not completely. Still feeling really cold and shivering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pruritus, Injection site rash, SARS-CoV-2 test negative, Tremor
Clinical narrative: 1.  On March 10, I received dose 1 of Moderna Covid-19 vaccine (lot #03UA21A) with no observed side effects 2.  Day 7 - itching and rash at injection site.  No swelling or hardness just itching and pink 3.  Day 8:  7:30 pm - Temperature check - normal (temperature check for class)        9:30 pm - recommended dose of PEG- 17g PEG3350 in 250ml water        11:30 pm - intense chills and shakes that last for 15 - 20 minutes.           12:00am - Temperature check- normal                       6:00am - Temperature check - normal 4.  Day 10:  Rapid Covid test - negative
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Shot given to 16 yr old. No reported adverse events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: No reaction to first vaccine dose. Gum tingling starting 10 minutes after second vaccine shot. Progressed to intermittent numbness and tingling in tongue, gums and right side of face over five days. Still ongoing.  No prior history of Bell's Palsy.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: for the first 2 days extreme left arm muscle pain, inability to properly move arm, hot to the touch, with some swelling.  After symptoms went away.  Starting 3 days after injection, I developed extereme weakness, chills, low grade fever (100.2 or below), hypersensitivity to touch of the skin, with some bouts of nausea.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth, Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: for the first 2 days extreme left arm muscle pain, inability to properly move arm, hot to the touch, with some swelling.  After symptoms went away.  Starting 3 days after injection, I developed extereme weakness, chills, low grade fever (100.2 or below), hypersensitivity to touch of the skin, with some bouts of nausea.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a dose of PROQUAD which experienced a supported temperature excursion was administered; This spontaneous report as received from a physician refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number: T037955, expiration date: 09-MAY-2022; dose and route of administration were not provided) (product storage error temperature too high). The vaccine was stored in temperature 15.1 degrees Fahrenheit for 3 hours and 40 minutes. There was previous temperature excursion. Digital data lodger was involved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Left arm pain after shot given and then 2 weeks later still have left arm pain that did travel to the left side of her back.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient who received the COVID-19 vaccine on March 15, 2021 is presenting pain and redness at the site of the vaccine 1 day ago.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Day 12 from Moderna #1 I developed red patches at the injection site.  It only itched if I touched it, and stopped when I took my hand away.  No pain unless I pressed on it.  The next day the patches were slightly smaller and the itch response still active when touched.  No interference with any activities whatsoever.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Haemoptysis
Clinical narrative: coughing up blood
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Feeling abnormal, Feeling cold, Feeling of relaxation
Clinical narrative: Within 6 to 7 minutes from receiving the 1st dose I experienced the following symptoms: Cool sensation in my chest area and a little bit of pressure and 2 seconds later I experienced a fast heartbeat for 3-5 minutes. The nurses at the center took my blood pressure and it was high along with the fast heartbeat. They continued to take my blood pressure and they kept saying it was high. They also said I had a faint heart beat. The fast heart beat subsided after several minutes, but I felt a calm/relaxing feeling.  The paramedics were called and they took my blood pressure and vitals. They said my heart rate was normal but I did have pre-hypertention blood pressure.  I felt a little strange after the heartbeat subsided like a calm and tired feeling. About an hour and half later I felt sleepy and took a nap for about an hour. When I woke up I still felt calm and a slight pressure in my chest area and my arm was getting sore from the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Injection site pain, Prehypertension, Pulse abnormal
Clinical narrative: Within 6 to 7 minutes from receiving the 1st dose I experienced the following symptoms: Cool sensation in my chest area and a little bit of pressure and 2 seconds later I experienced a fast heartbeat for 3-5 minutes. The nurses at the center took my blood pressure and it was high along with the fast heartbeat. They continued to take my blood pressure and they kept saying it was high. They also said I had a faint heart beat. The fast heart beat subsided after several minutes, but I felt a calm/relaxing feeling.  The paramedics were called and they took my blood pressure and vitals. They said my heart rate was normal but I did have pre-hypertention blood pressure.  I felt a little strange after the heartbeat subsided like a calm and tired feeling. About an hour and half later I felt sleepy and took a nap for about an hour. When I woke up I still felt calm and a slight pressure in my chest area and my arm was getting sore from the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Within 6 to 7 minutes from receiving the 1st dose I experienced the following symptoms: Cool sensation in my chest area and a little bit of pressure and 2 seconds later I experienced a fast heartbeat for 3-5 minutes. The nurses at the center took my blood pressure and it was high along with the fast heartbeat. They continued to take my blood pressure and they kept saying it was high. They also said I had a faint heart beat. The fast heart beat subsided after several minutes, but I felt a calm/relaxing feeling.  The paramedics were called and they took my blood pressure and vitals. They said my heart rate was normal but I did have pre-hypertention blood pressure.  I felt a little strange after the heartbeat subsided like a calm and tired feeling. About an hour and half later I felt sleepy and took a nap for about an hour. When I woke up I still felt calm and a slight pressure in my chest area and my arm was getting sore from the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Chest discomfort, Fatigue
Clinical narrative: Within 6 to 7 minutes from receiving the 1st dose I experienced the following symptoms: Cool sensation in my chest area and a little bit of pressure and 2 seconds later I experienced a fast heartbeat for 3-5 minutes. The nurses at the center took my blood pressure and it was high along with the fast heartbeat. They continued to take my blood pressure and they kept saying it was high. They also said I had a faint heart beat. The fast heart beat subsided after several minutes, but I felt a calm/relaxing feeling.  The paramedics were called and they took my blood pressure and vitals. They said my heart rate was normal but I did have pre-hypertention blood pressure.  I felt a little strange after the heartbeat subsided like a calm and tired feeling. About an hour and half later I felt sleepy and took a nap for about an hour. When I woke up I still felt calm and a slight pressure in my chest area and my arm was getting sore from the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate decreased, Heart rate increased, Pain in extremity, Pyrexia
Clinical narrative: Within 6 to 7 minutes from receiving the 1st dose I experienced the following symptoms: Cool sensation in my chest area and a little bit of pressure and 2 seconds later I experienced a fast heartbeat for 3-5 minutes. The nurses at the center took my blood pressure and it was high along with the fast heartbeat. They continued to take my blood pressure and they kept saying it was high. They also said I had a faint heart beat. The fast heart beat subsided after several minutes, but I felt a calm/relaxing feeling.  The paramedics were called and they took my blood pressure and vitals. They said my heart rate was normal but I did have pre-hypertention blood pressure.  I felt a little strange after the heartbeat subsided like a calm and tired feeling. About an hour and half later I felt sleepy and took a nap for about an hour. When I woke up I still felt calm and a slight pressure in my chest area and my arm was getting sore from the injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: arm sore; she could hardly use it (her arm)/not being able to rise her arm up to put food in her mouth or to take her coat off; This spontaneous report was received from a 72 year old female patient with high blood pressure. The patient's medical history was not reported. She had no drug allergies or reactions. Concomitant therapies included "blood pressure medicine".  On 03-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the right arm for prophylaxis (dose, frequency and route, as lot # and expiration date were not reported). On the same date, her arm was "messed up", right after receiving the vaccine she was driving and her arm got sore and she could hardly use it (her right arm). She reported not being able to rise her arm up to "put food in her mouth" or to "take her coat off". The consumer mentioned sought medical attention and being prescribed 2 different creams, but could not remember the names of them. The creams did not work. On an unknown date, a routine blood work was performed but the results were not provided. The outcome of the events was not recovered at the report time. No additional adverse event, no product quality complaint and no more information were provided.  The causal assessment between all the events and the suspect therapy was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over my body. Still there .  Took Benadryl at advice of Doctor.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: pain at the injection site, headache, muscle soreness, fatigue, fever and chills. Chills began the following day in the afternoon and fever came down within ~6 hours. By midnight I had recovered from all adverse events.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain at the injection site, headache, muscle soreness, fatigue, fever and chills. Chills began the following day in the afternoon and fever came down within ~6 hours. By midnight I had recovered from all adverse events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: >50% of vaccine leaked down arm - dose repeated
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: The patient stated had got headache, nausea, and vomiting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Insomnia, Mobility decreased
Clinical narrative: high fever; aches; sweats; chills; no sleep; my arm hurts!!!; will not be able to do anything for a couple of days,; feeling crappy; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, for tolernace refer case US2021AMR063110).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 36 hrs after receiving Shingles vaccine, the patient experienced fever, pain, sweating, chills, sleeplessness, pain in arm, feeling bad and mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, pain, sweating, chills, sleeplessness and pain in arm were unknown and the outcome of the feeling bad and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the fever, pain, sweating, chills, sleeplessness, pain in arm, feeling bad and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that bad side effects were experienced after receiving both the doses but it was worth it. The patient experienced high fever, aches, sweats, chills, no sleep and pain in arm after 36 hours of vaccination. The patient stated of feeling creepy for 24 to 48 hours after the shot and not able to do anything for a couple of days. The patient also mentioned that drink water frequently throughout and only take medicine like Tylenol, Advil, Aleve after the dose. If these medicines taken prior to the shot, the proper immunity would not build up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063110:Same patient , 1st DOse
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: high fever; aches; sweats; chills; no sleep; my arm hurts!!!; will not be able to do anything for a couple of days,; feeling crappy; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, for tolernace refer case US2021AMR063110).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 36 hrs after receiving Shingles vaccine, the patient experienced fever, pain, sweating, chills, sleeplessness, pain in arm, feeling bad and mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, pain, sweating, chills, sleeplessness and pain in arm were unknown and the outcome of the feeling bad and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the fever, pain, sweating, chills, sleeplessness, pain in arm, feeling bad and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that bad side effects were experienced after receiving both the doses but it was worth it. The patient experienced high fever, aches, sweats, chills, no sleep and pain in arm after 36 hours of vaccination. The patient stated of feeling creepy for 24 to 48 hours after the shot and not able to do anything for a couple of days. The patient also mentioned that drink water frequently throughout and only take medicine like Tylenol, Advil, Aleve after the dose. If these medicines taken prior to the shot, the proper immunity would not build up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063110:Same patient , 1st DOse
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Melaena
Clinical narrative: Had solid black feces - indicator for blood in the feces; Very shiny feces; A spontaneous report was received from a consumer who was also a male patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and had solid black feces "an indicator for blood in the feces" (melena) and very shiny feces (abnormal feces).  No medical history was reported. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced melena and abnormal feces. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event of melena and abnormal feces was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Haemorrhage, Joint swelling, Mobility decreased
Clinical narrative: Right arm full of blood; Fell while walking, over the right arm; Has to crawl, drag herself to the phone; Joints still swollen; Muscles, legs, hip, and knees were steel; Arm sore; Elbow sore; A spontaneous report  was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm full of blood/ hemorrhage, fell while walking/ fall, has to crawl/ mobility decreased, joints swollen, muscles, legs, hip, and knees were steel/ musculoskeletal stiffness, arm sore/ pain in extremity, and elbow sore/ arthralgia.  The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinners, blood pressure medications, and vitamins.  On 4 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not provided) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient could not get up from bed. She stated her muscles, legs, hip and knees were steel. The patient stated she fell while walking, over her right arm- which resulted in the right arm sore and full of blood. The patient stated she had to crawl, drag herself and her joints still swollen, and elbow sore. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Right arm full of blood; Fell while walking, over the right arm; Has to crawl, drag herself to the phone; Joints still swollen; Muscles, legs, hip, and knees were steel; Arm sore; Elbow sore; A spontaneous report  was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm full of blood/ hemorrhage, fell while walking/ fall, has to crawl/ mobility decreased, joints swollen, muscles, legs, hip, and knees were steel/ musculoskeletal stiffness, arm sore/ pain in extremity, and elbow sore/ arthralgia.  The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinners, blood pressure medications, and vitamins.  On 4 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not provided) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient could not get up from bed. She stated her muscles, legs, hip and knees were steel. The patient stated she fell while walking, over her right arm- which resulted in the right arm sore and full of blood. The patient stated she had to crawl, drag herself and her joints still swollen, and elbow sore. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Heart Stroke; A spontaneous report was received from a consumer concerning a male patient of 76 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced heart stroke.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 18 Feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number: 006M20A) vaccine intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021,patient experienced stroke. The event was also considered to be medically significant.  Treatment for the event included Blood Thinners.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event of heart stroke was considered resolved on 02 Mar 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Mental impairment, Pain
Clinical narrative: difficulty thinking "Spacey"; sweats; severe diarrhea; severe body ache; chills; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe body ache, severe diarrhea, sweats, chills and difficulty thinking.  current condition of patient include lung cancer. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, severe body ache. severe diarrhea, sweats, chills, difficulty thinking spacey.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  Seriousness of events not reported. Event difficulty thinking(mental impairment) upgraded to medically significant based on IME list.  Events Pain, hyperhidrosis, chills,  diarrhea was considered to be recovered/ resolved on 7 Mar 2021.The patient recovered from the event difficulty thinking (mental impairment) on 8 Mar 2021.; Reporter's Comments: This case concerns a 78-year-old male on chemotherapy for lung cancer, who had a serious unexpected event of mental impairment along with events of unexpected pain, diarrhea, hyperhidrosis and expected chills. Event onset occurred the same day after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on 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.