chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: April 8th at 11pm I started to have slight body aches. I woke up at 3am with intense body aches/ chills/sweats, felt like I had a cabin fever for the entire day of April 9th. I felt dizzy,  had a headache, my eyes aches and very very fatigued and couldn?t eat. Night of April 9th I started to not feel so dizzy but I was very very hot and could not cool down. Ever since April 10th I?ve have runny/stuffy nose/ body aches, sore throat, I developed a cough week of April 12th, eyes ached and very very fatigued. Today, April 21st, I am still a little fatigued, little soar throat, but runny/stuff nose still, and body soreness/aches.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: Around 12 hours after the shot, I took Tylenol for body aches and fever. I woke around 3:30 am to shaking and stomach pains then fell back asleep. I woke up again around 5:15 am to intense involuntary shaking. My family members wrapped me in blankets and applied pressure to my body until the shaking stopped. Within the next 40 minutes I vomited and had diarrhea. At the time also had body aches, chills, fever, and mild swelling of various areas if the body. I slept most of the morning and ate lunch around 1:30 pm. I took Tylenol again at 2:00 pm with the symptoms lessening over the next 5-6 hours. After that fever, chills, and body aches returned.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Swelling, Tremor, Vomiting
Clinical narrative: Around 12 hours after the shot, I took Tylenol for body aches and fever. I woke around 3:30 am to shaking and stomach pains then fell back asleep. I woke up again around 5:15 am to intense involuntary shaking. My family members wrapped me in blankets and applied pressure to my body until the shaking stopped. Within the next 40 minutes I vomited and had diarrhea. At the time also had body aches, chills, fever, and mild swelling of various areas if the body. I slept most of the morning and ate lunch around 1:30 pm. I took Tylenol again at 2:00 pm with the symptoms lessening over the next 5-6 hours. After that fever, chills, and body aches returned.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Meningitis
Clinical narrative: Menningitis not sure if viral or bacterial; Massive headache on a scale of 1-10 it is a 10; Chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MENINGITIS (Menningitis not sure if viral or bacterial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced MENINGITIS (Menningitis not sure if viral or bacterial) (seriousness criterion medically significant), HEADACHE (Massive headache on a scale of 1-10 it is a 10) and CHILLS (Chills). At the time of the report, MENINGITIS (Menningitis not sure if viral or bacterial), HEADACHE (Massive headache on a scale of 1-10 it is a 10) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No medical history provided. Lab test for viral versus bacterial meningitis being done. No results provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Serious headache last 5days
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Discomfort, Fatigue, Feeling of body temperature change
Clinical narrative: At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning  and pretty normal  by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning  and pretty normal  by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning  and pretty normal  by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Body aches, nausea, headache, lack of appetite, loss of smell  for 4 hours, treated with 200 mg ibuprofen
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Eye irritation, Eye pruritus, Feeling abnormal
Clinical narrative: Sore throat, headache, chills, sweats, itchy/burning eyes, feeling "off", nausea, diarrhea, lethargy, body aches  No treatment outside of home as of yet.  Hydration, rest, OTC cold/flu medications to help decrease symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lethargy, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat, headache, chills, sweats, itchy/burning eyes, feeling "off", nausea, diarrhea, lethargy, body aches  No treatment outside of home as of yet.  Hydration, rest, OTC cold/flu medications to help decrease symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore throat, headache, chills, sweats, itchy/burning eyes, feeling "off", nausea, diarrhea, lethargy, body aches  No treatment outside of home as of yet.  Hydration, rest, OTC cold/flu medications to help decrease symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood follicle stimulating hormone, Blood luteinising hormone, Blood thyroid stimulating hormone, Differential white blood cell count
Clinical narrative: I received the Janssen vaccine on 3/5/2021.  My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period.  I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom.  There were clots in the blood in addition to extraordinarily heavy blood flow.  The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor.  I asked her to "run" all tests that were available and approved by insurance, which she did.  All came back normal.  Due to the significant difference in my period this month, the ARNP  requested an inner-uterine ultrasound which found the below:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Endometriosis, Full blood count, Heavy menstrual bleeding, Metabolic function test, Thrombosis
Clinical narrative: I received the Janssen vaccine on 3/5/2021.  My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period.  I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom.  There were clots in the blood in addition to extraordinarily heavy blood flow.  The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor.  I asked her to "run" all tests that were available and approved by insurance, which she did.  All came back normal.  Due to the significant difference in my period this month, the ARNP  requested an inner-uterine ultrasound which found the below:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen, Uterine leiomyoma, Vitamin B12, Vitamin D
Clinical narrative: I received the Janssen vaccine on 3/5/2021.  My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period.  I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom.  There were clots in the blood in addition to extraordinarily heavy blood flow.  The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor.  I asked her to "run" all tests that were available and approved by insurance, which she did.  All came back normal.  Due to the significant difference in my period this month, the ARNP  requested an inner-uterine ultrasound which found the below:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: little fatigue and left arm pain for next 24 hours.
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Illness, Life support, Loss of consciousness, Mydriasis
Clinical narrative: Was not responding/wouldn't open her eyes; Very sick; Her pupils were dilated; Hypoxia; Life support; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes), ILLNESS (Very sick), MYDRIASIS (Her pupils were dilated), HYPOXIA (Hypoxia) and LIFE SUPPORT (Life support) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes) (seriousness criteria hospitalization and medically significant), ILLNESS (Very sick) (seriousness criterion hospitalization), MYDRIASIS (Her pupils were dilated) (seriousness criterion hospitalization), HYPOXIA (Hypoxia) (seriousness criterion hospitalization) and LIFE SUPPORT (Life support) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 09-Apr-2021 to 11-Apr-2021 due to LIFE SUPPORT, then on 09-Apr-2021 due to HYPOXIA, ILLNESS, LOSS OF CONSCIOUSNESS and MYDRIASIS. On 11-Apr-2021, LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes), ILLNESS (Very sick), MYDRIASIS (Her pupils were dilated), HYPOXIA (Hypoxia) and LIFE SUPPORT (Life support) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Oxygen saturation: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on life support.  Very little regarding these events has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.; Sender's Comments: Very little regarding these events has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: Was not responding/wouldn't open her eyes; Very sick; Her pupils were dilated; Hypoxia; Life support; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes), ILLNESS (Very sick), MYDRIASIS (Her pupils were dilated), HYPOXIA (Hypoxia) and LIFE SUPPORT (Life support) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes) (seriousness criteria hospitalization and medically significant), ILLNESS (Very sick) (seriousness criterion hospitalization), MYDRIASIS (Her pupils were dilated) (seriousness criterion hospitalization), HYPOXIA (Hypoxia) (seriousness criterion hospitalization) and LIFE SUPPORT (Life support) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 09-Apr-2021 to 11-Apr-2021 due to LIFE SUPPORT, then on 09-Apr-2021 due to HYPOXIA, ILLNESS, LOSS OF CONSCIOUSNESS and MYDRIASIS. On 11-Apr-2021, LOSS OF CONSCIOUSNESS (Was not responding/wouldn't open her eyes), ILLNESS (Very sick), MYDRIASIS (Her pupils were dilated), HYPOXIA (Hypoxia) and LIFE SUPPORT (Life support) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Oxygen saturation: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on life support.  Very little regarding these events has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.; Sender's Comments: Very little regarding these events has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pain, Paraesthesia
Clinical narrative: Shingles.     January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of Remicade 500 mg February 13th - skin started to get pins and needles and very painful February 15th - Received second Pfizer vaccine at hospital February 17th - Patches started appearing, extremely painful, went to dermatologist and was diagnosed with Shingles.  February 18th - blisters started appearing on right side of face . Cheekbones, nose, under eye, cheek, upper lip
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Hypoaesthesia, Injection site pain
Clinical narrative: 1. injection site pain, swelling for ~7days                                                                                                       6. joints pain 2. unable to lift up arm pass 15-degree angle for days                                                                            7. fatigue 3. left arm got numb/tingling, cool to touch- required long sleeve shirt & gloves (resolve next day) 4. itchiness of throat for ~3-4 days 5. generalized body aches for @ least ~ 5 days
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Movement disorder, Pain, Paraesthesia, Throat irritation
Clinical narrative: 1. injection site pain, swelling for ~7days                                                                                                       6. joints pain 2. unable to lift up arm pass 15-degree angle for days                                                                            7. fatigue 3. left arm got numb/tingling, cool to touch- required long sleeve shirt & gloves (resolve next day) 4. itchiness of throat for ~3-4 days 5. generalized body aches for @ least ~ 5 days
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Fever 102.3 F, nausea, chills, sweats, headache, fatigue, joint pain and body weakness
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever 102.3 F, nausea, chills, sweats, headache, fatigue, joint pain and body weakness
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles on April 6.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Woke up at 2:15am with a deep heart pain reminiscent of my pericarditis symptoms back in my early 20s.  Pain lasted a few minutes, I drank some water, and went back to bed 20 minutes later.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure fluctuation, Tachycardia
Clinical narrative: Arrhythmia; BP  altered; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (BP  altered) and TACHYCARDIA (Tachycardia). At the time of the report, ARRHYTHMIA (Arrhythmia), BLOOD PRESSURE FLUCTUATION (BP  altered) and TACHYCARDIA (Tachycardia) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment taken in response to the events was not provided. No more information was provided. The patient was Spanish speaking.  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.; Sender'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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Physical examination, Vision blurred, Visual impairment
Clinical narrative: Started getting a blurry circle in my vision around 11am. It kept bothering me. I kept closing my eye and thinking it was just something bright I looked at that made the circle appear, but then I couldn?t really see and there was a white line that snaked around and started strobing a few different colors and my eye felt lazy and heavy. This lasted around 25-30 minutes. I have never experienced this before in my life and really freaked me out thinking I had a stroke, but could walk and talk fine and
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Bump under the injection sight that has swelled, same size as a golf ball around. Aches a bit, and is red.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: 1. injection site pain                        6. cough 2. throat itchiness                            7. dizziness 3. generalized aches                        8. hard to breath 4. joint pain 5. tiredness
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Throat tightness
Clinical narrative: 1. injection site pain                        6. cough 2. throat itchiness                            7. dizziness 3. generalized aches                        8. hard to breath 4. joint pain 5. tiredness
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Lymph node pain, Lymphadenopathy, Muscle fatigue
Clinical narrative: Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph node with extreme pain. On 4/16/21 the pain from my left armpit lymph node almost made me vomit. Swelling has persisted through today 4/20/21. Chills started on 4/15/21 and ended 4/18/21. Fever from 4/15/21 to 4/17/21.  Treated with bedrest and ice pack / warm compress.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Swelling, Tremor
Clinical narrative: Fever, chills with uncontrollable shaking, whole body muscle fatigue and soreness, swollen lymph node with extreme pain. On 4/16/21 the pain from my left armpit lymph node almost made me vomit. Swelling has persisted through today 4/20/21. Chills started on 4/15/21 and ended 4/18/21. Fever from 4/15/21 to 4/17/21.  Treated with bedrest and ice pack / warm compress.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bad tinnitus
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: metallic taste in the mouth, arm soreness, redness around the injection site, swelling
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Heart rate irregular, Palpitations
Clinical narrative: I have had heart palpitations and what feels like an irregular heartbeat. It began , I believe a  day or so after receiving the  1st Pfizer vaccine although I can?t recall with absolute  certainty if it started just before or shortly after being vaccinated.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fall, Paralysis, Unresponsive to stimuli
Clinical narrative: Stroke 6 days after receiving the second dose of the vaccine; Paralysed left side; Fell on the floor unresponsive; Fell on the floor Unresponsive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine), PARALYSIS (Paralysed left side) and UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine) (seriousness criteria hospitalization and medically significant), PARALYSIS (Paralysed left side) (seriousness criteria hospitalization and disability), UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) (seriousness criteria hospitalization and medically significant) and FALL (Fell on the floor Unresponsive). The patient was hospitalized on 10-Mar-2021 due to CEREBROVASCULAR ACCIDENT, PARALYSIS and UNRESPONSIVE TO STIMULI. The patient was treated with Surgery for Cerebrovascular accident and Surgery for Paralysis. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine), PARALYSIS (Paralysed left side), UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) and FALL (Fell on the floor Unresponsive) outcome was unknown. Not Provided          Medical history was not reported. The patient was taking unspecified Antihypertensive medication. The patient was placed on a feeding tube and was transferred to a Nursing home and would require medical service for the rest of her life.  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. Further information has been requested.; Sender'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. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Several days after second shot, first site location began to swell. It was a slow but steady progression that didn?t stop until I contacted my doctor to get a steroid shot to help stop the reaction. I took photographs of the growth of the redness and swelling around the site.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Temporary numbness in lower half of face. Appeared about 30-45 minutes after injection and lasted for about an hour
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Endoscopy, Gastrooesophageal reflux disease, Nausea, Throat irritation, Vomiting
Clinical narrative: Before the vaccine, I was able to and hold down food. After words, my throat was irritated and I kept throwing up due to that feeling. It's been going on for close to over a month and I'm currently taking Acid Reflux medication, Vomiting and Nausea medication after going to the a gastroenterologist to which they didn't find anything doing an endoscopy that occurred on April 12th, 2021. Still waiting on the biopsy. With medication, current only symptom is painful stool (due to medication most likely) and after eating, burning in the throat (most likely due to acid reflux type symptoms). Only able to eat a certain amount before throwing up again.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Influenza like illness, Tinnitus, Vertigo
Clinical narrative: I developed loud tinnitus in both ears the day after receiving the vaccine. It is very uncomfortable.     I never had this before. I also feel dizzy like vertigo or the flu.   I had severe flu symptoms for six days afterwards.  I still get waves of  flu symptoms.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart rate jumped to 170 then to 200; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart rate jumped to 170 then to 200) in a 32-year-old male patient who received mRNA-1273  (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate jumped to 170 then to 200) (seriousness criteria hospitalization). The patient was hospitalized from 10-Apr-2021 to 11-Apr-2021 due to HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED (Heart rate jumped to 170 then to 200) outcome was unknown. Not Provided.    The action taken with mRNA-1273  (Intramuscular) was unknown.       Treatment information included Beta blockers.  The ER doctor said it could be atrial fibrillation, sinus tachycardia or supraventricular tachycardia.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bandaemia, Feeling hot, Hypotension, Lymphocyte count increased, Pain
Clinical narrative: Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk.  Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sepsis, Systemic inflammatory response syndrome, Tachycardia, White blood cell count increased
Clinical narrative: Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk.  Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Echocardiogram, Ejection fraction decreased, Hypotension, Inflammation
Clinical narrative: Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk.  Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left ventricular failure, Liver function test abnormal, Mitral valve incompetence, Myocarditis, Pulmonary arterial pressure increased
Clinical narrative: Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk.  Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Tricuspid valve incompetence, Troponin increased
Clinical narrative: Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk.  Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain, Injection site reaction, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: Left Shoulder Pain,left shoulder stiffness,weakness. Treatments include anti inflammatory medications,physical therapy,etc
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Physical examination, X-ray
Clinical narrative: Left Shoulder Pain,left shoulder stiffness,weakness. Treatments include anti inflammatory medications,physical therapy,etc
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache
Clinical narrative: Leg pain, swelling in a specific spot that later bruised
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: injection site soreness, muscle soreness, tiredness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: I had no symptoms 4 days post-vaccine.  Then, 8 days after receiving the vaccine, the injection site swelled again, and became red and itchy.  It looks like a giant bug bite.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Feel winded, short of breath, with moderate physical exertion . ex briskly walking up a long flight of stairs a couple of time wearing a mask caused me to breath every hard. Seems more than normal....I had to keep the mask on  Typically, with heavy physical exertion I would feel this way.  Also, The first time this happened I did feel a little light headed and noticed a higher than normal heart rate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches, fever, chills
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus bilaterally, persistent x 5 days to date.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Anion gap normal, Aspartate aminotransferase increased, Basophil count normal, Bilirubin conjugated decreased
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea decreased, Carbon dioxide normal, Eosinophil count normal, Glomerular filtration rate, Haematocrit normal
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin normal, Lymphocyte count decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Mean platelet volume decreased, Monocyte count, Monocyte count increased, Neutrophil count, Neutrophil count increased
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count increased, Protein total normal, Rash maculo-papular, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: MaculoPapular rash across thighs and lower limbs
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Fever, starting 4/17/21, 5:00 pm, 100.3, reaching a high of 102.9 on 4/18/21 at 6:30 pm, last recording of fever of 99.7  on 4/19/21 at 10:30 am.  Very bad headache starting 4/17/21 at 5:00 pm.  Very painful at injection site starting 4/17/21 at 2:30 pm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Pain, Pain in extremity, Thrombosis
Clinical narrative: Consistent headache - Tylenol or Excedrine relieved Heavy period - began 4 days early. Excessive blood clots and amount of blood.  Left arm pain- unable to move arm without pain x 3 days. Tylenol relieved Fever- began 2 days after. Tylenol reduces fever.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness, vertigo
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Hypertonic bladder, Pollakiuria
Clinical narrative: 48 hours after receiving the vaccine, I started experiencing symptoms of an overactive bladder - had to urinate much more frequently than normal. 72 hours after the vaccine, I had a visible herpes outbreak in the genital region.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe chills, fever, headache, loss of appetite,  extreme fatigued,  night sweats,  Went to UR 3 times and they confirmed bad reaction to vaccine
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Urine analysis
Clinical narrative: Severe chills, fever, headache, loss of appetite,  extreme fatigued,  night sweats,  Went to UR 3 times and they confirmed bad reaction to vaccine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: 12 hours after my 2nd dose of Moderna I felt somewhat nauseated and my abdomen felt sore. 18 hours after 2nd dose I started running a low fever of 100.7. The following day my fever jumped to 102.6 at 2pm and fever continued to return every 3 to 4 hrs. My abdomen aches when I have fever. The following day (Friday night) I went to sleep at 10:30 with a fever of 101, rooks some Tylenol and woke up at 12:30 to a 104.3 fever and severe chills. It took two hours, a cold bath and 4 Advil gel capsules to bring fever down to 101.5. This fever has continued and I still currently have a high fever, all day every day, every 3 to 4 hours.   My body is somewhat achy and I have mild to medium headaches off and on.  I met with a nurse practitioner and she ordered a RESPIRATORY PATHOGEN PANEL WITH COVID-19. I tested negative for all viruses.   I am managing the fever by setting alarms on my phone for every 3-4 hours so I don?t forget to take a fever reducer.  It?s a total nightmare. When will it end?  My appetite is also v small and I am weak. I am truly exhausted from this unending high fever.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 12 hours after my 2nd dose of Moderna I felt somewhat nauseated and my abdomen felt sore. 18 hours after 2nd dose I started running a low fever of 100.7. The following day my fever jumped to 102.6 at 2pm and fever continued to return every 3 to 4 hrs. My abdomen aches when I have fever. The following day (Friday night) I went to sleep at 10:30 with a fever of 101, rooks some Tylenol and woke up at 12:30 to a 104.3 fever and severe chills. It took two hours, a cold bath and 4 Advil gel capsules to bring fever down to 101.5. This fever has continued and I still currently have a high fever, all day every day, every 3 to 4 hours.   My body is somewhat achy and I have mild to medium headaches off and on.  I met with a nurse practitioner and she ordered a RESPIRATORY PATHOGEN PANEL WITH COVID-19. I tested negative for all viruses.   I am managing the fever by setting alarms on my phone for every 3-4 hours so I don?t forget to take a fever reducer.  It?s a total nightmare. When will it end?  My appetite is also v small and I am weak. I am truly exhausted from this unending high fever.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: 12 hours after my 2nd dose of Moderna I felt somewhat nauseated and my abdomen felt sore. 18 hours after 2nd dose I started running a low fever of 100.7. The following day my fever jumped to 102.6 at 2pm and fever continued to return every 3 to 4 hrs. My abdomen aches when I have fever. The following day (Friday night) I went to sleep at 10:30 with a fever of 101, rooks some Tylenol and woke up at 12:30 to a 104.3 fever and severe chills. It took two hours, a cold bath and 4 Advil gel capsules to bring fever down to 101.5. This fever has continued and I still currently have a high fever, all day every day, every 3 to 4 hours.   My body is somewhat achy and I have mild to medium headaches off and on.  I met with a nurse practitioner and she ordered a RESPIRATORY PATHOGEN PANEL WITH COVID-19. I tested negative for all viruses.   I am managing the fever by setting alarms on my phone for every 3-4 hours so I don?t forget to take a fever reducer.  It?s a total nightmare. When will it end?  My appetite is also v small and I am weak. I am truly exhausted from this unending high fever.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Menstruation irregular
Clinical narrative: Extreme stomach cramping and start of painful period despite having birth control that prevents it and not having one for 13 years. Still ongoing.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site mass, Injection site pruritus, Paraesthesia, Swelling
Clinical narrative: 1 hour, pins and needles and joint pain 3 hours itchy lump near injection site 5 hours multiple lumps on arm and torso 5 hours persistant cough
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Ultrasound scan, Vascular rupture
Clinical narrative: When she stands up it still hurts; large broken vessel about the size of a nickle; leg was itching; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of VASCULAR RUPTURE (large broken vessel about the size of a Nickle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Thyroid disorder NOS and Cholesterol.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (leg was itching). On 08-Apr-2021, the patient experienced VASCULAR RUPTURE (large broken vessel about the size of a Nickle) (seriousness criterion medically significant). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (When she stands up it still hurts). At the time of the report, VASCULAR RUPTURE (large broken vessel about the size of a Nickle) and PRURITUS (leg was itching) outcome was unknown and PAIN IN EXTREMITY (When she stands up it still hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Ultrasound scan: abnormal abnormal (abnormal) a large broken vessel about the size of a Nickle.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included acetaminophen.  Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: There is a hot, hard lump on my left arm about 4 inches below the injection spot. Not painful or irritating. Not itchy. Just feels hot inside and out. Have taken ibuprofen. Injection was 2 days ago.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Severe headache  on night of shot and  every day  since Tiredness  daily causing sleep  of up.to 20 hours  per day
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Injection site reaction, Pain
Clinical narrative: Blotchy red rash that itches and feels warm to the touch developed an inch or so below the injection site that covers much of my upper arm.  This first appeared on day 4 after the shot.  I plan to take an anti-histamine to treat the reaction.  I also experienced a slight fever, chills, body aches, and stomach pains lasting about 5-6 hours, starting about 18 hours after my shot.   After that, I had a slight intermittent headache on days 2, 3, and 4 after the shot.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Rash macular, Rash pruritic, Skin warm
Clinical narrative: Blotchy red rash that itches and feels warm to the touch developed an inch or so below the injection site that covers much of my upper arm.  This first appeared on day 4 after the shot.  I plan to take an anti-histamine to treat the reaction.  I also experienced a slight fever, chills, body aches, and stomach pains lasting about 5-6 hours, starting about 18 hours after my shot.   After that, I had a slight intermittent headache on days 2, 3, and 4 after the shot.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: patient received  vaccine at held clinic shortly after complained of chest tightness that she has experienced in the past but more severe. reports hx of seasonal asthma but no rescue inhaler. monitored for 5 minutes with symptoms not improving attempted to call 911 patient refused because she did not want to be billed instead had husband drive general aprox 20 min drive. EMT on site also examined patient and recommended 911 call again patient refused
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA The following morning after receiving my first vaccination, I woke up with a few small hives around various parts of my body. My arms, chest, back, and legs. As the day went on and I moved around, the hives disappeared. Before going to bed, I noticed that my left eye was mildly swollen. The next morning, I woke up and the hives returned. Again, after moving around, the hives went away. Later in the late afternoon and into the evening, I noticed that both of my eyes were swollen and so was my upper lip. I woke up and the hives returned, only one eye was swollen and my lip was swollen. By later in the afternoon, the hives and swelling had just about disappeared. The following morning, I was back to normal with no hives and no swelling around my eyes or lips.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Paraesthesia
Clinical narrative: My lips became numb, then my tongue and the tip of my nose began to tingle.  I took Benadryl about 20 minutes after onset (when I got home), and the tingling stopped within 30 minutes.  The numbness wore off after an hour or so.  I felt normal by evening.  No recurrence.  Headaches that night and over the next day.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: "Covid Arm" large area near injection site red, swollen, and warm to the touch. Same symptoms for my husband and his itches too.