chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Loss of hearing in left ear; Ringing in left ear; This spontaneous case was reported by a non-health professional and describes the occurrence of DEAFNESS (Loss of hearing in left ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 040A21A) 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 recorded medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DEAFNESS (Loss of hearing in left ear) (seriousness criterion medically significant) and TINNITUS (Ringing in left ear). At the time of the report, DEAFNESS (Loss of hearing in left ear) and TINNITUS (Ringing in left ear) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the onset date of the reported 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 onset date of the reported events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dizziness, Headache, Pruritus
Clinical narrative: Times are based on amount of time having passed since vaccination   - [ ] 5-10 mins - Itchiness randomly all over body on and off - [ ] 30-40 mins - throat itchiness, felt light headedness, took 2x Zyrtec - [ ] 1 hr - upper back aches - [ ] 2 hrs - left side and left side of chest/lung felt achey - [ ] 2-3 hrs - back and feet feel achey - [ ] 5 hrs - itchy throat returns  - [ ] 6 hrs - sneezing  - [ ] 7 hrs - headache
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Throat irritation
Clinical narrative: Times are based on amount of time having passed since vaccination   - [ ] 5-10 mins - Itchiness randomly all over body on and off - [ ] 30-40 mins - throat itchiness, felt light headedness, took 2x Zyrtec - [ ] 1 hr - upper back aches - [ ] 2 hrs - left side and left side of chest/lung felt achey - [ ] 2-3 hrs - back and feet feel achey - [ ] 5 hrs - itchy throat returns  - [ ] 6 hrs - sneezing  - [ ] 7 hrs - headache
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Chills,, hands very cold extreme tired Friday (about 5 hours after shot) and arm ached from fingers to should blade... shot area red.  Saturday,  Swollen Red Spot on Right Arm at shot site that grew to about three inches  in length and width by Sunday morning, hard lump under red area and hot to touch.  Arm sore, shoulder ache to should blade, major pain from finger to shoulder.  Took Amoxicillin and Claratin, and Tylenol was better by Monday evening.  Chilled Sat and Sun evening around 6pm-10pm...had to cover up and slept....Shot site/arm still three inch red/hard  area but has not gotten any larger is a lighter red and hurts a lot less.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Peripheral coldness
Clinical narrative: Chills,, hands very cold extreme tired Friday (about 5 hours after shot) and arm ached from fingers to should blade... shot area red.  Saturday,  Swollen Red Spot on Right Arm at shot site that grew to about three inches  in length and width by Sunday morning, hard lump under red area and hot to touch.  Arm sore, shoulder ache to should blade, major pain from finger to shoulder.  Took Amoxicillin and Claratin, and Tylenol was better by Monday evening.  Chilled Sat and Sun evening around 6pm-10pm...had to cover up and slept....Shot site/arm still three inch red/hard  area but has not gotten any larger is a lighter red and hurts a lot less.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: immediate reaction; trouble breathing/shortness of breath, sweating, dizziness, hives, nausea, fast heart rate
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: immediate reaction; trouble breathing/shortness of breath, sweating, dizziness, hives, nausea, fast heart rate
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: A lump at injection site roughly the same diameter as a baseball appeared the day after injection. Extremely tender. Red circular coloration about 2.5-3 inches in diameter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Swelling face
Clinical narrative: Pain and swelling in cheeks and around eyes where dermal fillers were previously injected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chest discomfort, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, fatigue, body aches, loss of taste, loss of appetite burning at injection site immediately and hotness around site for three days, heaviness in chest all the way through to back, shortness of breath
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis
Clinical narrative: I got oral thrush 3 days after each covid vaccine.  Used oral thrush lozenges prescribed by dentist
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Eye contusion, Feeling abnormal, Loss of consciousness
Clinical narrative: took 3 steps and just blacked out and passed out; coughing; black eye; didn't remember losing her consciousness; When she sneezes or cough her chest hurts; can't turn over while sleeping at night; she has not gotton back to normal; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) (seriousness criterion medically significant), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotton back to normal). At the time of the report, LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotten back to normal) had not resolved. Not Provided  Treatment information was provided as tylenol. No concomitant information was provided. Patient mentioned she is a vegan no meat, diary, does not take pills. Woke up next morning, she had a black eye, her reading glasses were broken, didn't remember loosing her consciousness.  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.   This case was linked to MOD-2021-076632 (Patient Link).   Reporter did not allow further contact; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Movement disorder
Clinical narrative: took 3 steps and just blacked out and passed out; coughing; black eye; didn't remember losing her consciousness; When she sneezes or cough her chest hurts; can't turn over while sleeping at night; she has not gotton back to normal; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) (seriousness criterion medically significant), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotton back to normal). At the time of the report, LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotten back to normal) had not resolved. Not Provided  Treatment information was provided as tylenol. No concomitant information was provided. Patient mentioned she is a vegan no meat, diary, does not take pills. Woke up next morning, she had a black eye, her reading glasses were broken, didn't remember loosing her consciousness.  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.   This case was linked to MOD-2021-076632 (Patient Link).   Reporter did not allow further contact; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Magnetic resonance imaging, Tinnitus
Clinical narrative: Ringing in ears, anxiety and all symptom that come with anxiety  Stated morning of  April 4th still occurring  Saw my GP and my Gyno they have put me on antidepressants and having an MRI April 30th
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Redness, soreness, itching, and slight swelling at injection point. Left upper arm with slight warmth.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gout, Herpes zoster, Rash
Clinical narrative: On 3/27 I was diagnosed with gout following pain, redness, and swelling in my left foot. I also had pain in my shoulder. The next day I started developing a rash on the right side of my torso on my chest and back. In a follow up appointment with the doctor and a visit to the ER I was diagnosed shingles. I was prescribed acyclovir and indomethicin. The rash has mostly cleared, but pain in both my torso and foot still persists.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Skin irritation, Skin reaction
Clinical narrative: Very achy the next day but my arm continues to worsen 4 days after vaccine. It?s very red and irritated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: I became ill within one day of receiving the second Moderno vaccine. I lost 2 1/2 days of work I received the vaccine on a Friday became sick on Saturday and was not normal again until the next Friday I had fever chills profound fatigue nausea vomiting severe headache it lasted five days. I have never been as sick as I was from any vaccine in my life as I was from that second Moderno vaccine.  I laid in bed for four days. I had mild symptoms from the first vaccine just a mild headache and some fatigue actually better than receiving a flu shot. I have no known prior history of Covid infection.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I became ill within one day of receiving the second Moderno vaccine. I lost 2 1/2 days of work I received the vaccine on a Friday became sick on Saturday and was not normal again until the next Friday I had fever chills profound fatigue nausea vomiting severe headache it lasted five days. I have never been as sick as I was from any vaccine in my life as I was from that second Moderno vaccine.  I laid in bed for four days. I had mild symptoms from the first vaccine just a mild headache and some fatigue actually better than receiving a flu shot. I have no known prior history of Covid infection.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Retching, Vomiting projectile
Clinical narrative: Felt ok had slight headache throughout parts of the day and was sore but worked nothing too bad. Compelled by an act of stupidity to eat a muffin at 10:30pm went to bed around midnight. Woke up around 1am feeling queasy and began projectile vomiting. Evacuated all of that and then had a dry heave and it was over. In all only lasted about 6-7 minutes. I got the sheet I was handed when I was given my vaccine and saw this website. I looked at the chart and saw this did occur with the second dose and  saw that this was relatively common in getting the second shot of the vaccine and just wanted to report it since I?m not about to go to sleep. Checked my temperature and it is around 96 and was around 98 when I was going to bed at around 11pm
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Limb discomfort, Oral mucosal blistering, Pain in extremity
Clinical narrative: Pt developed Red rash on neck and blister in mouth about 6 days after vaccine administration recieved JJ vaccine 08 APR 2021.  reports pressure/pain to bottom of both feet and pain to back of both calves R worse than left.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Ultrasound Doppler, Venogram
Clinical narrative: Pt developed Red rash on neck and blister in mouth about 6 days after vaccine administration recieved JJ vaccine 08 APR 2021.  reports pressure/pain to bottom of both feet and pain to back of both calves R worse than left.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: high blood pressure (230/120); L arm of vaccination site a circle around the area red and blooded; blood pressure high and down, but she has never had the blood; L arm of vaccination site warm to touch; L arm of vaccination site swollen; L arm of vaccination site a circle around the area red and blooded; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure (230/120)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation (Patient reported is common for her to have high and low blood pressure.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSIVE CRISIS (high blood pressure (230/120)) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (L arm of vaccination site a circle around the area red and blooded), BLOOD PRESSURE FLUCTUATION (blood pressure high and down, but she has never had the blood), VACCINATION SITE WARMTH (L arm of vaccination site warm to touch), VACCINATION SITE SWELLING (L arm of vaccination site swollen) and VACCINATION SITE ERYTHEMA (L arm of vaccination site a circle around the area red and blooded). At the time of the report, HYPERTENSIVE CRISIS (high blood pressure (230/120)), VACCINATION SITE HAEMORRHAGE (L arm of vaccination site a circle around the area red and blooded), BLOOD PRESSURE FLUCTUATION (blood pressure high and down, but she has never had the blood), VACCINATION SITE WARMTH (L arm of vaccination site warm to touch), VACCINATION SITE SWELLING (L arm of vaccination site swollen) and VACCINATION SITE ERYTHEMA (L arm of vaccination site a circle around the area red and blooded) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: 230/120 (High) high. On 14-Apr-2021, Blood pressure measurement: 150/80 (High) down to 150/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported taking blood pressure medication. She also indicated that she takes other medications, but no names or indications were provided as patient has been taking them for many years and does not consider them related to the event. No additional treatment medication was provided.  Company comment: 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.; 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Chills, Dyspnoea, Electrocardiogram
Clinical narrative: HISTORY OF PRESENT ILLNESS: 21 yo F p/w midsternal chest burning since 2200 last night. Acute, sharp/burning, constant, mild. No similar prior pain. Reports associated subjective dyspnea. Denies fever, chills, nausea, vomiting, syncope, palpitations, back pain, abdominal pain, weakness/numbness.   Patient states she received the J&J COVID vaccine 3 days ago, and had chills, fatigue and body aches that resolved the following day. She has since been asymptomatic.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: HISTORY OF PRESENT ILLNESS: 21 yo F p/w midsternal chest burning since 2200 last night. Acute, sharp/burning, constant, mild. No similar prior pain. Reports associated subjective dyspnea. Denies fever, chills, nausea, vomiting, syncope, palpitations, back pain, abdominal pain, weakness/numbness.   Patient states she received the J&J COVID vaccine 3 days ago, and had chills, fatigue and body aches that resolved the following day. She has since been asymptomatic.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: COVID ARM - Swollen and hardness at injection site, itchy at injection site
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: after my initial injection swelling and rash went away but about three days after no side effects i had a rash that was about three inches long and one inch wide with a huge mass underneath. four or five hours after the new rash appeared, bruising and a burning sensation started to occur but the rash significantly reduced.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Firm red area around the injection site Red area is warm to the touch and tender
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Eye infection, Viral infection
Clinical narrative: I developed a viral infection in my right eye. My doctor suspects it is the herpes simplex 1 virus. I developed symptoms on Saturday that I thought were consistent with something being stuck in my eye or having a scratch on the surface of my eye. I saw my doctor on Monday and he confirmed that I had a viral eye infection. He believes HSV 1 is the most likely cause. I have never had another symptomatic infection from that virus (no cold sores or other eye infections). I started taking oral valtrex and prescription eye gel drops. I am still taking the medication and will consult with my doctor once I?ve completed the current course of pills.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Intensive care, Laboratory test
Clinical narrative: Patient presented with severe chest pain x 2 1/2 hours, found to have EKG changes consistent with strain, dramatically elevated troponin to 13.2, ultimately peaked at 15.  No pericardial fluid, diagnosed with myocarditis, treated in healthcare facility.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle strain, Myocarditis, Troponin increased
Clinical narrative: Patient presented with severe chest pain x 2 1/2 hours, found to have EKG changes consistent with strain, dramatically elevated troponin to 13.2, ultimately peaked at 15.  No pericardial fluid, diagnosed with myocarditis, treated in healthcare facility.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Chest pain, Congenital arterial malformation, Electrocardiogram, Troponin increased
Clinical narrative: Patient presented with severe chest pain x 2 1/2 hours, found to have EKG changes consistent with strain, dramatically elevated troponin to 13.2, ultimately peaked at 15.  No pericardial fluid, diagnosed with myocarditis, treated in healthcare facility.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Dyspnoea at rest, Rash pruritic, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: my breathing started to get heavy, felt it hard to breathe; I started to develop large hives just above the collar bone; pain in the lymph nodes under her left arm; started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and; little pain at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe) and ANGIOEDEMA (I started to develop large hives just above the collar bone) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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 reported). Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE (FLOVENT HFA).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (little pain at the injection site). On 05-Apr-2021, the patient experienced DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe) (seriousness criterion medically significant), ANGIOEDEMA (I started to develop large hives just above the collar bone) (seriousness criterion medically significant), VACCINATION SITE LYMPHADENOPATHY (pain in the lymph nodes under her left arm) and RASH PRURITIC (started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and). On 05-Apr-2021, VACCINATION SITE PAIN (little pain at the injection site) had resolved. At the time of the report, DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe), ANGIOEDEMA (I started to develop large hives just above the collar bone) and VACCINATION SITE LYMPHADENOPATHY (pain in the lymph nodes under her left arm) outcome was unknown and RASH PRURITIC (started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and) had not resolved.        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 treatment information was provided.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage urinary tract, Product dose omission issue, Urinary retention
Clinical narrative: Patient got scared and did not get his second dose; tried to urinate and could not; passed a clot with some drops of blood; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (tried to urinate and could not) and HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) in a 73-year-old male patient who received mRNA-1273  (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tumor (Malignancy in the tubular tumor in Penis) and Bladder operation (in past 3 months). Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, LISINOPRIL, AMLODIPINE and ESCITALOPRAM for an unknown indication, PRAVASTATIN SODIUM (PRAVASTATIN NA).    On 16-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced URINARY RETENTION (tried to urinate and could not) (seriousness criterion medically significant) and HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) (seriousness criterion medically significant). On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got scared and did not get his second dose). At the time of the report, URINARY RETENTION (tried to urinate and could not), HAEMORRHAGE URINARY TRACT (passed a clot with some drops of blood) and PRODUCT DOSE OMISSION ISSUE (Patient got scared and did not get his second dose) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment medication was not reported.  Based on the current available information and the temporal association between the product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start of the events a causal relationship cannot be excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Head injury, Oxygen saturation, Syncope
Clinical narrative: Covid-19 Pneumonia; Fainted twice and hit his head a few times/Oxygen level went below 53; Hit his head a few times from fainting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (Covid-19 Pneumonia) and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) in an 82-year-old male 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).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (Covid-19 Pneumonia) (seriousness criterion hospitalization) and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) (seriousness criterion hospitalization). an unknown date, the patient experienced HEAD INJURY (Hit his head a few times from fainting). The patient was hospitalized for 15 days due to COVID-19 PNEUMONIA and SYNCOPE. At the time of the report, COVID-19 PNEUMONIA (Covid-19 Pneumonia) outcome was unknown and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) and HEAD INJURY (Hit his head a few times from fainting) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: below 53% (Low) below 53%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and medical history were not reported. The patient felt that he had COVID-19 before he took the vaccine because his family members had it as well.  Company comment: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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cyanosis, Discomfort, Headache, Myalgia
Clinical narrative: PMR; cyanosis of palm of hand; severe pain in shoulders and hips; bad headache; fever; myalgia; extreme discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (PMR) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (myalgia), DISCOMFORT (extreme discomfort), HEADACHE (bad headache) and PYREXIA (fever). On 22-Mar-2021, the patient experienced CYANOSIS (cyanosis of palm of hand) and ARTHRALGIA (severe pain in shoulders and hips). On 29-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA (PMR) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (PMR), MYALGIA (myalgia), DISCOMFORT (extreme discomfort), CYANOSIS (cyanosis of palm of hand), ARTHRALGIA (severe pain in shoulders and hips), HEADACHE (bad headache) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided  Additional and treatment information:On 22MAR2021 cyanosis of palm of hand and severe pain in shoulders and hips which has decrease her ability to perform some of her daily living activities because of the pain. On 29MAR2021 she went to urgent care and was verbally diagnosed with PMR. She stated that the HCP told her it was PMR from the 2nd dose of vaccine but the paperwork stated it was musculoskeletal pain. She was started on a Medrol dosepak and referred to her general practitioner. She saw her GP on 6PAR2021 that confirmed the diagnosis of PMR and prescribed her prednisone. On 13APR2021 she was told to half her prednisone dose and almost all the symptoms are returning. She has a fear of no remission.   This case was linked to MOD-2021-076703 (Patient Link).; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, Pyrexia
Clinical narrative: PMR; cyanosis of palm of hand; severe pain in shoulders and hips; bad headache; fever; myalgia; extreme discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (PMR) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (myalgia), DISCOMFORT (extreme discomfort), HEADACHE (bad headache) and PYREXIA (fever). On 22-Mar-2021, the patient experienced CYANOSIS (cyanosis of palm of hand) and ARTHRALGIA (severe pain in shoulders and hips). On 29-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA (PMR) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (PMR), MYALGIA (myalgia), DISCOMFORT (extreme discomfort), CYANOSIS (cyanosis of palm of hand), ARTHRALGIA (severe pain in shoulders and hips), HEADACHE (bad headache) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided  Additional and treatment information:On 22MAR2021 cyanosis of palm of hand and severe pain in shoulders and hips which has decrease her ability to perform some of her daily living activities because of the pain. On 29MAR2021 she went to urgent care and was verbally diagnosed with PMR. She stated that the HCP told her it was PMR from the 2nd dose of vaccine but the paperwork stated it was musculoskeletal pain. She was started on a Medrol dosepak and referred to her general practitioner. She saw her GP on 6PAR2021 that confirmed the diagnosis of PMR and prescribed her prednisone. On 13APR2021 she was told to half her prednisone dose and almost all the symptoms are returning. She has a fear of no remission.   This case was linked to MOD-2021-076703 (Patient Link).; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, SARS-CoV-2 test positive, Vaccination site erythema
Clinical narrative: episode of passed out; severe allergic reaction at injection site; injection arm is irritating; itchiness; injection arm is hurting; redness; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (episode of passed out) in a 50-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.     Concurrent medical conditions included Blind (patient is legally blind in the left eye). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Seizure, PARACETAMOL (TYLENOL), CYCLOPENTAMINE, ESZOPICLONE, CLONAZEPAM (KLONOPIN), VITAMIN B COMPLEX and CYANOCOBALAMIN (VITAMIN B12 FORTE) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (episode of passed out) (seriousness criterion medically significant), VACCINATION SITE PRURITUS (itchiness), PAIN IN EXTREMITY (injection arm is hurting), IRRITABILITY (injection arm is irritating), INJECTION SITE HYPERSENSITIVITY (severe allergic reaction at injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, LOSS OF CONSCIOUSNESS (episode of passed out) outcome was unknown and VACCINATION SITE PRURITUS (itchiness), PAIN IN EXTREMITY (injection arm is hurting), IRRITABILITY (injection arm is irritating), INJECTION SITE HYPERSENSITIVITY (severe allergic reaction at injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment medication not 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: episode of passed out; severe allergic reaction at injection site; injection arm is irritating; itchiness; injection arm is hurting; redness; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (episode of passed out) in a 50-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.     Concurrent medical conditions included Blind (patient is legally blind in the left eye). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Seizure, PARACETAMOL (TYLENOL), CYCLOPENTAMINE, ESZOPICLONE, CLONAZEPAM (KLONOPIN), VITAMIN B COMPLEX and CYANOCOBALAMIN (VITAMIN B12 FORTE) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (episode of passed out) (seriousness criterion medically significant), VACCINATION SITE PRURITUS (itchiness), PAIN IN EXTREMITY (injection arm is hurting), IRRITABILITY (injection arm is irritating), INJECTION SITE HYPERSENSITIVITY (severe allergic reaction at injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, LOSS OF CONSCIOUSNESS (episode of passed out) outcome was unknown and VACCINATION SITE PRURITUS (itchiness), PAIN IN EXTREMITY (injection arm is hurting), IRRITABILITY (injection arm is irritating), INJECTION SITE HYPERSENSITIVITY (severe allergic reaction at injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment medication not 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.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Surgery
Clinical narrative: event of a surgery; Missed dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SURGERY (event of a surgery) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (event of a surgery) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, SURGERY (event of a surgery) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient intended to receive her second dose on 14-Apr-2021 from pharmacy. The pharmacist recommended her to confirm with Moderna whether she can get her second dose after missing her scheduled dose. Concomitant medications were not reported.  This report refers to a case of missed dose for mRNA-1273.  Very limited information regarding the event of surgery has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: This report refers to a case of missed dose for mRNA-1273.  Very limited information regarding the event of surgery has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Migraine, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: Severe headache; Worst migraine; Excessive vomitting; Patient under 18 given vaccine; Hasn't felt well; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and VOMITING (Excessive vomitting) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 627A21A) 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). Concomitant products included DULOXETINE, CLONIDINE, HYDROXYZINE, AMITRIPTYLINE, RAMELTEON and ETHINYLESTRADIOL, NORGESTIMATE (MONO LINYAH) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MALAISE (Hasn't felt well). On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 given vaccine). On 08-Apr-2021, the patient experienced VOMITING (Excessive vomitting) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant) and MIGRAINE (Worst migraine). On 08-Apr-2021, VOMITING (Excessive vomitting) had resolved. At the time of the report, HEADACHE (Severe headache), MIGRAINE (Worst migraine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 given vaccine) and MALAISE (Hasn't felt well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with fluids, Zofran, Benadryl, Tylenol 800mg and Aspirin for headaches.  Company comment: 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Severe headache; Worst migraine; Excessive vomitting; Patient under 18 given vaccine; Hasn't felt well; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) and VOMITING (Excessive vomitting) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 627A21A) 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). Concomitant products included DULOXETINE, CLONIDINE, HYDROXYZINE, AMITRIPTYLINE, RAMELTEON and ETHINYLESTRADIOL, NORGESTIMATE (MONO LINYAH) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MALAISE (Hasn't felt well). On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 given vaccine). On 08-Apr-2021, the patient experienced VOMITING (Excessive vomitting) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant) and MIGRAINE (Worst migraine). On 08-Apr-2021, VOMITING (Excessive vomitting) had resolved. At the time of the report, HEADACHE (Severe headache), MIGRAINE (Worst migraine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 given vaccine) and MALAISE (Hasn't felt well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with fluids, Zofran, Benadryl, Tylenol 800mg and Aspirin for headaches.  Company comment: 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.