chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Upper RT arm hurts, head ache, neck ache, aches & pains - especially joints,  very tired,  generally feel like I have the flu. Ear Temp at 99.7
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Intracranial pressure increased
Clinical narrative: Extreme inter cranial pressure, headache
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: Jan 12, I noticed a small reddened area about an inch and some swelling. nurse told me to draw around the border of it. It progressed over to a bigger area on the 13th - and spread more - it ended up being 3 or 4 inches. Spreading, red, and warm, and swollen. It didn't affect use of arm.  Swollen glands on the 14th. doctor (workman's comp dr) - on 15th of January - gave me some Prednisone - so Saturday, 16th, I had sore throat, swollen glands and worst headache I had in my whole life -  I had taken one Prednisone and the evening I stopped taking Prednisone because I thought the headache was result of it.  Original spot was fading on the 15th.   I started to get shooting pains on sternum area and clavicle. Evening of 18th,  I noticed rash on left shoulder and a little tiny blister on my sternal notch. I  had I talked to Dr  on 19th and he thought it was Shingles. I saw my regular  health dr - my regular PCP Dr on 20th of January  - He prescribed - Acyclovir and Gabapentin - for shingles. I had a very wicked case of singles. I contacted Moderna about  and February 3rd, 2021. Shingles was still happening at time of second dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Rash, Skin warm, Swelling
Clinical narrative: Jan 12, I noticed a small reddened area about an inch and some swelling. nurse told me to draw around the border of it. It progressed over to a bigger area on the 13th - and spread more - it ended up being 3 or 4 inches. Spreading, red, and warm, and swollen. It didn't affect use of arm.  Swollen glands on the 14th. doctor (workman's comp dr) - on 15th of January - gave me some Prednisone - so Saturday, 16th, I had sore throat, swollen glands and worst headache I had in my whole life -  I had taken one Prednisone and the evening I stopped taking Prednisone because I thought the headache was result of it.  Original spot was fading on the 15th.   I started to get shooting pains on sternum area and clavicle. Evening of 18th,  I noticed rash on left shoulder and a little tiny blister on my sternal notch. I  had I talked to Dr  on 19th and he thought it was Shingles. I saw my regular  health dr - my regular PCP Dr on 20th of January  - He prescribed - Acyclovir and Gabapentin - for shingles. I had a very wicked case of singles. I contacted Moderna about  and February 3rd, 2021. Shingles was still happening at time of second dose.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Severe chills, headache, mild nausea and diarrhea, and fatigue.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After receiving vaccination patient stated a rash developed on arm and stomach. Facility called ambulance and patient was taken to hospital for observation
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Hypoaesthesia, Impaired work ability
Clinical narrative: I began feeling dizzy and nauseous about 2 hours after injection and tried to lie down but was unable to rest. I felt like I had taken adrenaline or steroids and couldn?t sleep that might. The next morning I did not want to get out of bed. My body, particular along my spine, was in so much pain that I began crying. On Monday I called in sick to work. I had almost total numbness in my left arm arm, hand, and upper body. Periodically my heart would race and feel as if was about to beat out of my chest. I started to black out in the grocery store and continue feel dizzy and weak. This is my second day off of work and I have only gotten out of bed to perform essential tasks. I am nauseated and am having trouble eating. I feel like I?ve been run over by several cars and can?t feel my left pinkie. I don?t remember ever feeling this bad for any past illness.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Pain, Palpitations, Sleep disorder
Clinical narrative: I began feeling dizzy and nauseous about 2 hours after injection and tried to lie down but was unable to rest. I felt like I had taken adrenaline or steroids and couldn?t sleep that might. The next morning I did not want to get out of bed. My body, particular along my spine, was in so much pain that I began crying. On Monday I called in sick to work. I had almost total numbness in my left arm arm, hand, and upper body. Periodically my heart would race and feel as if was about to beat out of my chest. I started to black out in the grocery store and continue feel dizzy and weak. This is my second day off of work and I have only gotten out of bed to perform essential tasks. I am nauseated and am having trouble eating. I feel like I?ve been run over by several cars and can?t feel my left pinkie. I don?t remember ever feeling this bad for any past illness.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: I began feeling dizzy and nauseous about 2 hours after injection and tried to lie down but was unable to rest. I felt like I had taken adrenaline or steroids and couldn?t sleep that might. The next morning I did not want to get out of bed. My body, particular along my spine, was in so much pain that I began crying. On Monday I called in sick to work. I had almost total numbness in my left arm arm, hand, and upper body. Periodically my heart would race and feel as if was about to beat out of my chest. I started to black out in the grocery store and continue feel dizzy and weak. This is my second day off of work and I have only gotten out of bed to perform essential tasks. I am nauseated and am having trouble eating. I feel like I?ve been run over by several cars and can?t feel my left pinkie. I don?t remember ever feeling this bad for any past illness.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Oral pain, Pain in extremity
Clinical narrative: extend amounts of pain in the head, mouth, legs inability to walk
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Throat irritation
Clinical narrative: On same side as vaccine (left side), patient had numbness in lips and cheek. Also reported a scratchy throat.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Malaise, Pain of skin
Clinical narrative: flu like symptoms, loss of appetite, tired, general malaise, skin on stomach hurts
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Elbow and knee joint pain
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Decreased appetite, Dyspnoea
Clinical narrative: First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the next 8 days she felt sleepy and achy. Reports felt ok couple of days. Friday 3/5/2021 she had a fever, loss of appetite, chills, for 24 hours. Sunday night had trouble breathing SOB. used humidifier. Chest felt tight. minor cough, symptoms similar to asthma.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: First 48 hours reports felt fine. Sunday am felt achy and tired. Took advil and aspirin. Reports the next 8 days she felt sleepy and achy. Reports felt ok couple of days. Friday 3/5/2021 she had a fever, loss of appetite, chills, for 24 hours. Sunday night had trouble breathing SOB. used humidifier. Chest felt tight. minor cough, symptoms similar to asthma.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pyrexia, Rash
Clinical narrative: About 26 hours (a Friday afternoon) after the 2nd COVID shot, I suddenly began to feel bad and found I had 2.5 degrees of fever.  My shoulder where the shot occurred became painful and a pinkish rash formed there.  The temp rose to 3.5 degrees over the next seven hours and remained that high until mid morning Saturday.  Then it oscillated between 1.0 and 3.0 degrees until Sunday morning.  Finally it began to fall and reached normal Sunday afternoon around 4 pm.  The rash disappeared on Monday and the shoulder pain stopped on Tuesday.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash starting under the breast area around to the side and up to the armpit on both sides of body
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Herpes zoster, Pain
Clinical narrative: Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain
Clinical narrative: Upset stomach, severe chills, body aches lasting about 8 hours. Then, fatigue lasting through the following day.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: 20 minutes after the vaccination I had an itchy throat and had the urge to cough. I asked if I could use my inhaler. Nurse took me to a room with a doctor. I used my inhaler. The doctor suggested Benadryl. Discussion about me driving home. I declined the shot as the doctor was concerned about me driving. I said I would take Benadryl at home. We waited 15 minutes more and I was released. I used Benadryl and my inhaler during the rest of the day.  Both day1 and day 2,  I was coughing on and off. Day three I feel better.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Multiple pregnancy, Nausea, Vaccination complication
Clinical narrative: Extreme fatigue and nausea   6w6d pregnant at time of vaccine   2 previous healthy full term pregnancies
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray normal, Cough
Clinical narrative: Coughing about 15 minutes after vaccine, eacalated  to asthma exacerbation; given benadryl, used albuterol 2 puffs, no response.  Taken to ED and given 2 duo-nebs, 40 mg prednisone, chest xray. Dischargedbhome
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: 1st administration of vaccine on 2/22. Onset of Bell's Palsy on 3/3. Saw primary doctor on 3/4 and neurologist on 3/5 who acknowledged condition and put me on steroids and an antiviral. Rescheduled my second shot which were to be administered on 3/5 as per primary doctor recommendation.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: High Fever from 101.5 the next morning after second vaccine to 103 degrees.  Body aches/chills...took Tylenols and advil every 5-6 hours.  arm pain...very sore...used ice pack in the evening and same tylenols/advil as for fever.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Pain, Pyrexia
Clinical narrative: Body aches, HA, Fever, unable to come in for next shift
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Livedo reticularis, Pyrexia, Rash, Rash erythematous
Clinical narrative: 2/3/2021: Within the first 24 hours patient c/o fever, headache and rash to bilateral legs.  (Patient took Benadryl prior to receiving vaccine).  2/9/2021:  Patient states she has rash on bilateral legs with mottling that was worse then before. She states the rash spots blistered and are no longer painful, but still present, like little red dots at almost every hair follicle. 3/9/2021: Patient states the red bumps/rash is still present with mottling on bilateral lower legs; however, they are not painful and do not itch at this time.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: 2/3/2021: Within the first 24 hours patient c/o fever, headache and rash to bilateral legs.  (Patient took Benadryl prior to receiving vaccine).  2/9/2021:  Patient states she has rash on bilateral legs with mottling that was worse then before. She states the rash spots blistered and are no longer painful, but still present, like little red dots at almost every hair follicle. 3/9/2021: Patient states the red bumps/rash is still present with mottling on bilateral lower legs; however, they are not painful and do not itch at this time.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea, ongoing since day after injection
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Diarrhoea, Erythema, Headache
Clinical narrative: Fever 106, chills, body ache, bone pain, headache, vomiting, diarrhea, pangs in the arm, red arm coloration intense pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 106, chills, body ache, bone pain, headache, vomiting, diarrhea, pangs in the arm, red arm coloration intense pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Fatigue,  nausea vomiting,  muscle pain joint pain, headache,  stuffy nose
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Fatigue,  nausea vomiting,  muscle pain joint pain, headache,  stuffy nose
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of MMR-II that was administered to a patient / that vaccine was 10 days post expiry; The patient has not experienced anyside effects; This non-valid spontaneous report was received from a certified medical assistant referring to an unspecified patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unknown date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported) reconstituted with sterile diluent (lot number and expiration date were not provided). The medical assistant reported that vaccine was 10 days post expiry and that the patient had not experienced any side effects.  This is a non-valid case due tothe lack of patient's identifiers.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient who was administered their first ROTATEQ dose at 16 weeks; This spontaneous report was received from a registered nurse and refers to a 16-week-old infant patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-MAR-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (product administered to patient of inappropriate age).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Muscle fatigue, Rhabdomyolysis
Clinical narrative: Muscle break down; Loss of strength; Easy fatigue-ability of the muscles; A spontaneous report  was received from a Healthcare Professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events loss of strength, muscle break down, easy fatigue-ability of the muscles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, after the first dose of mRNA-1273  patient experienced loss of strength, muscle break down, easy fatigue-ability of the muscles.  Treatment details received for the event was not provided Action taken with mRNA-1273 in response to the events was not reported.   The events, outcome of events include loss of strength, muscle break down, mild rhabdo, easy fatigue-ability of the muscles was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Lost consciousness; A spontaneous report, was received from a pharmacist, concerning a patient of unknown age and gender, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced loss of consciousness.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unknown date, prior to the onset of the event, the patient received their unknown planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, the pharmacist stated that they had a possible adverse reaction where patient lost consciousness shortly after receiving the vaccine. The patient was transported to the hospital by emergency medical services (EMS). Treatment information was not provided/unknown.     Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event, loss of consciousness, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of loss of consciousness, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough
Clinical narrative: Bronchitis; Cough; A spontaneous report was received from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bronchitis and cough.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 003L20A) intramuscularly for prophylaxis of COVID-19 infection.   On Unknown date, the patient have bad lungs and developed bronchitis which is considered as Medically Significant Event and cough.  Treatment for the events included antibiotics for 6 days, albuterol, Pertussin AC and Z-Pack.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, bronchitis and cough, was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dyspnoea, Fatigue, Mobility decreased
Clinical narrative: Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received from a consumer concerning a 79 years old, female patient who received Moderna (mRNA-1273) vaccine and experienced couldn't get up/mobility decreased, couldn't breathe/dyspnoea , lost voice/aphonia and felt very tired/fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Feb 2021, approximately three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) in the left arm for prophylaxis of COVID-19 infection.    15 Feb 2021, the patient couldn't breathe, felt very tired, lost her voice, couldn't get up, and was hospitalized following a visit to urgent care. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, Dyspnoea, Fatigue, Aphonia, Movement disorder and Hospitalization was unknown.; Reporter's Comments: This case concerns a 79-year-old female who was hospitalized with serious unexpected events of dyspnea, mobility decreased, and aphonia and a serious expected event of fatigue.  The events occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Facial paralysis
Clinical narrative: Bell's Palsy; voice was sort of ugly; A spontaneous report was received from a consumer who is a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis.  The patient's medical history included hypertension, triple bypass, operation in stomach and intestine and depression. No relevant concomitant medications were reported.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient stated he woke up at 0800 and noticed his voice sounded ugly. When he looked in the mirror his face looked crooked. The patient went to the hospital and was diagnosed with Bell's palsy. The patient stated he was discharged home the following day. He was given unspecified steroids.  Treatment information included unspecified steroids.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis, were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stone; A spontaneous report was received from a consumer, concerning a 68-years old female patient, who was administered Moderna's COVID-19 vaccine and developed kidney stones.   The patient's medical history was not provided. The patient was not taking any concomitant medications.  On 20 Jan 2021, approximately 30 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) in the right arm for prophylaxis of COVID-19 infection.   The patient stated that she went to Emergency room (ER) on 18 Feb 2021 for kidney stone. The patient was treated with flomax, tylenol with codeine, motrin 600mg, zofran ODT. The patient wanted to know if she can still take her Flomax and get 2nd dose.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, kidney stone was unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected event of Nephrolithiasis.   The events occurred 30 days after the first dose of mRNA-1273. Treated with Flomax, Tylenol with Codeine, Motrin, Zofran. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal faeces, Haematochezia, Muscle twitching
Clinical narrative: Bloody stool; Stool with bad rotten egg smell to it; Stomach started rolling; Facial tremors around right eye; A spontaneous report was received from a consumer concerning a female patient of 70 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced facial tremors around right eye, stomach started rolling, bloody stool  and stool with bad rotten egg smell.   The patients medical history included asthmatic spasmodic dysphonia. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received their first of two planned dose of mRNA-1273 (Lot number: 042L20A) vaccine in the left arm for prophylaxis of COVID-19 infection. On 24 Feb 2021, the patient received their second of two planned dose of mRNA-1273 (Lot number: 011A21A) vaccine in the left arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, approximately 5 hours after receiving the second dose, the patient's stomach started rolling, and she experienced bloody stool with bad rotten egg smell and facial tremors around right eye. Treatment information for the events included Tylenol.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome for the events was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Fatigue
Clinical narrative: Possible Stroke; Unable to speak/Lack of pronunciations; Fatigue; A spontaneous report was received from a health care professional concerning 75-years old male patient who experienced stroke (Cerebrovascular accident), unable to speak/ lack of pronunciations (Speech disorder) and fatigue (Fatigue).  The patient's medical history included heart attack. Concomitant medications included included Metoprolol, HCTZ, Irbesartan, and Aspirin.  On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L201A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 05 Feb 2021, approximately four days prior to the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 06 Feb 2021, the patient experienced fatigue.  On 09 Feb 2021, the patient experienced the events stroke and unable to speak/ lack of pronunciations. The events resulted in hospitalisation as seriousness criteria. The patient was admitted to the hospital on 09 Feb 2021. The patient was moved to ICU for 24 hours, and was the patient was discharged from Hospital on 11 Feb 2021. Treatment for the event included Eliquis and 80 mg chewable aspirin.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable.  The events stroke, unable to speak/ lack of pronunciations and fatigue were considered as recovered/resolved.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient has a pre-existing history of heart attack which is a strong confounder for the reported CVA and speech disorder. Fatigue is consistent with the known safety profile of the vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Pain, Sinusitis
Clinical narrative: Chest cold; Bad sinus and chest cold; Sore from head to toe; A spontaneous report was received from a reporter(consumer) concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest cold/lower respiratory tract infection, bad sinus/sinusitis and sore from head to toe/pain.  The patient's medical history was not provided. No concomitant product use was reported.  On 18 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 20 Feb 2021, the reporter stated the patient had severe side effects. The patient had a bad sinus and chest cold and felt sore from head to their toes.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, chest cold/lower respiratory tract infection, bad sinus/sinusitis and sore from head to toe/pain, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI (Urinary Tract Infection); A spontaneous report was received from a 79-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI).  The patient's current history included fibromyalgia and lymphoma. No relevant concomitant medications were reported.  On 30 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch No.007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date (weeks after the vaccination), the patient experienced urinary tract infection after receiving first dose of vaccination. On an unspecified date, she also reported that she felt better.  Action taken with mRNA-1273 in response to the event was unknown.  The event, urinary tract infection, was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.  Elderly age, female gender and underlying lymphoma are considered risk factors.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Dysarthria, Facial discomfort, Facial paralysis, Lacrimation increased
Clinical narrative: bell's palsy or could of had a stroke; mouth drooping; speech was a little slurred; could not smile, could not open mouth to eat; right eye started tearing up and was watery; A spontaneous report  was received from a consumer concerning a 55 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   On 05-FEB-2021, prior to the onset of the events, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05-FEB-2021, the patient experienced Lacrimation increased. On 06-FEB-2021, the patient experienced Facial paralysis (mouth drooping), Facial discomfort. On 08-FEB-2021, the patient experienced Facial paralysis. The patient reported that he went to the doctor who said it could be bell's palsy or could had a stroke, and recommend he go to hospital to have it checked. The Patient reported that he has not gone to the hospital at the time of this report.  No Laboratory details were provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the event's Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blindness, Corneal abrasion, Herpes zoster
Clinical narrative: Losing eyesight in one eye; Has scratched cornea; She developed Bell's Palsy; She developed shingles; A spontaneous report was received from a relative concerning a  91-year old,  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles, Bell's Palsy, losing eyesight in one eye, and scratched cornea.  The patient's medical history included blind in one eye after laser surgery. Concomitant medications include vitamin d, equate arthritis medicine, losartan potassium, and eye vitamins.  On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly  for prophylaxis of COVID-19 infection.   On 09 Feb 2021, the patient developed shingles and Bell's Palsy. The patient was in the process of losing eyesight in one eye, on the side affected by the Bell's Palsy. The patient also has a scratched cornea. The patient went to the emergency room on 12 Feb 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events of shingles Bell's Palsy cannot be excluded.  However, causality with scratched cornea and losing eyesight in one eye is unlikely.  The scratch is most likely due to a trauma and can impair vision. No further information is expected and follow up consent was denied.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Hypoaesthesia, Paraesthesia
Clinical narrative: Blood pressure was 180/101; numbness on whole left side of body; tingling; A spontaneous report was received from a consumer concerning a 68 years-old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and  hospitalized for blood pressure that was 180/101 and experienced numbness on whole left side of body, and tingling.  The patient's medical history included hypertension, allergies to penicillin, IV contrast (highly allergic, has to be pre-medicated if uses it 2-3 days before), and sulfa, and unspecified issues with sodium. Concomitant product use included blood pressure medication.    On 24 Feb 2021 at 09:45 am, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, approximately 2 hours after receiving the dose at 11:00 am, the patient's left side started going numb. The patient went home at 02:30 pm and took some Motrin, but still had numbness and tingling. At around 07:00 pm same day, the patient reported blood pressure was 180/101 beats per minute. Patient reported taking prescribed blood pressure medicine prior to getting the vaccine on 24 Feb 2021 and Motrin after the vaccination on 24 Feb 2021 in order to stop the numbness.   In the morning of 25 Feb 2021, patient's blood pressure was very high until 04:00 am; therefore, patient went to the emergency room (ER).  At the hospital, they were very concerned about patient's blood pressure because it remained high. The patient thought the numbness and tingling would stop but they didn't. Patient denied numbness in arms; but felt it in legs and all up left side. Due to prior "issues with sodium", patient had to be treated for sodium levels at the hospital. Patient was discharged out of the hospital on 26 Feb 2021. All tests came back normal. Numbness on side and tingling went away. The patient believed reaction was due to the vaccine even though it was temporary.   Treatment information included Motrin.   Action taken with mRNA-1273 in response to the events is not reported.   The events blood pressure was 180/101, numbness on whole left side of body, and tingling were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events approximately 2 hours after receiving the dose, a causal relationship cannot be excluded. However, patient's hx of hypertension, allergies to penicillin, IV contrast and sulfa, and issues with sodium are confounding factors that may play a possible contributory role providing an alternative explanation.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following:  things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy,  passed out, and a bit of an ache in her injection arm.  The patient's medical history was not provided. No concomitant medications were reported.    On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved.    The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following:  things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy,  passed out, and a bit of an ache in her injection arm.  The patient's medical history was not provided. No concomitant medications were reported.    On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved.    The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Chills, Pyrexia, Vaccination site erythema
Clinical narrative: Cellulitis on chest; Swollen; Tender; Red; Chills; Fever; A spontaneous report was received from a consumer concerning a 96 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, fever, chills and injection site swelling, tenderness, and redness.  The patient's medical history included serving as an employee, episodes of days with fever, feeding tube, Pulmonary issues and cellulitis on arm.. Concomitant medication included triamcinolone acetonide cream 0.1%, Tessalon and Robitussin.    On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in his left arm for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient experienced injection site swelling, tenderness, and redness.  On 24 Feb 2021, the patient experienced chills. Vital signs included a temperature of 103.9 degrees Fahrenheit.  Also, his sputum had some blood in it.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events cannot be excluded. Fever, chills injection site swelling, tenderness and redness are consistent with the known safety profile of the mRNA-1273 vaccine.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Cellulitis on chest; Swollen; Tender; Red; Chills; Fever; A spontaneous report was received from a consumer concerning a 96 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, fever, chills and injection site swelling, tenderness, and redness.  The patient's medical history included serving as an employee, episodes of days with fever, feeding tube, Pulmonary issues and cellulitis on arm.. Concomitant medication included triamcinolone acetonide cream 0.1%, Tessalon and Robitussin.    On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in his left arm for prophylaxis of COVID-19 infection.  On an undisclosed date, the patient experienced injection site swelling, tenderness, and redness.  On 24 Feb 2021, the patient experienced chills. Vital signs included a temperature of 103.9 degrees Fahrenheit.  Also, his sputum had some blood in it.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events cannot be excluded. Fever, chills injection site swelling, tenderness and redness are consistent with the known safety profile of the mRNA-1273 vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Colitis, Urinary tract infection
Clinical narrative: UTI; Anemia; Colitis; A spontaneous report was received from a healthcare professional concerning a 77 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed anemia, colitis and Urinary Tract Infection (UTI).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 039k208) on 29 Dec 2020. On 26 Jan 2021, approximately 6 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 019K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient had a hospital visit for anemia and colitis for which patient was admitted and was discharged on 04 Feb 2021.The patient was again admitted to the hospital on 22 Feb 2021, for UTI and was at the hospital at the time of reporting.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.; Reporter's Comments: Very limited information has been provided for this cases Although, a temporal association exist between the product use and the reported events of anemia and colitis, critical details such as the patient's medical history concomitant medication list lacking.  Urinary tract infection is of an infective etiology as  such a causal relationship is unlikely.
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Facial bones fracture, Pain, Rib fracture
Clinical narrative: Broken nose; Rib fracture; Body ache; everything turned cloudy; A report from was received from a 66 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced everything turned cloudy, and his car crashed, suffered a broken nose, rib fracture and body ache.  Patient's medical history and concomitant medications were not reported.    On 24-Feb-2021 the patient received his second dose of mRNA-1273 (Lot number: 012L20A) injection intramuscularly in his left arm for prophylaxis of COVID-19 infection. On 25-Feb-2021, the patient crashed into a fire truck while driving. The patient "totalled" his Feb-2021, the patient was home with body aching everywhere  The events broken nose and rib fracture and  were medically significant.  Action taken with mRNA-1273 was not applicable.  Patient was treated with Ultram (tramadol hcl) 50mg and Skelaxin (metaxalone) 800 mg.  Outcome for the event of body ache was not recovered/not resolved and for all other events the outcome was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.