chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, fever of 101 and chills
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Echocardiogram, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: Vibrating from my waist to my neck; Atrial fibrillation; Really tired; Felt lousy; Extreme thirst; I've lost 8 lbs from the last month or two; A spontaneous report was received from an consumer concerning a 70 years old, female patient who experienced atrial fibrillation, tired out, vibrating from waist to neck, felt lousy, extreme thirst and lost 8 lbs last month.    The patient's medical history was not provided.    Concomitant product use was none by the reporter.   On 01 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027L20A) in left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) in left arm for prophylaxis of COVID-19 infection.     The patient experienced the events tired since an unknown date in Feb 2021; vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month all since 06 Feb 2021. The patient was hospitalized on 06 Feb 2021 and was discharged on 07 Feb 2021.  Laboratory investigations included echocardiogram which "turned out ok" and EKG "was ok" both performed on an unknown date in Feb 2021.  Treatment for the event included diltiazem and Eliquis both since an unknown date for an unknown indication.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events felt very tired, vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month were 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Tremor, Weight decreased
Clinical narrative: Vibrating from my waist to my neck; Atrial fibrillation; Really tired; Felt lousy; Extreme thirst; I've lost 8 lbs from the last month or two; A spontaneous report was received from an consumer concerning a 70 years old, female patient who experienced atrial fibrillation, tired out, vibrating from waist to neck, felt lousy, extreme thirst and lost 8 lbs last month.    The patient's medical history was not provided.    Concomitant product use was none by the reporter.   On 01 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027L20A) in left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) in left arm for prophylaxis of COVID-19 infection.     The patient experienced the events tired since an unknown date in Feb 2021; vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month all since 06 Feb 2021. The patient was hospitalized on 06 Feb 2021 and was discharged on 07 Feb 2021.  Laboratory investigations included echocardiogram which "turned out ok" and EKG "was ok" both performed on an unknown date in Feb 2021.  Treatment for the event included diltiazem and Eliquis both since an unknown date for an unknown indication.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events felt very tired, vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month were 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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: FEVER, CHILLS, HEADACHE, JOINT ACHES, MUSCLE ACHES, NAUSEA, SKIN HURT ON CHEST
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia
Clinical narrative: FEVER, CHILLS, HEADACHE, JOINT ACHES, MUSCLE ACHES, NAUSEA, SKIN HURT ON CHEST
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram normal, Platelet count decreased, Platelet transfusion
Clinical narrative: Platelets dropped to 1 by March 14,  Treated with 2 infusions of platelets and IG drip with prednisone.  Platelet count rose to 35 on March 16 and was released from hospital.  Platelet count at 165 on march 19, 2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Moderna arm?sore arm resolved 3 days after vaccination but then returned 8 days after injection
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Fatigue, Feeling abnormal, Mood altered, Pyrexia
Clinical narrative: Developed a fever and fatigue six days after vaccination (10/6/2020). Fever resolved by 10/13/2020 but took about 6 weeks until his mood and energy were back to baseline.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Due to an error in mixing, the patient received diluent only
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: my doctor said it is an Olecranon Bursitis. where my left elbow has a fluid knot on it. it came up after i left the area of my shot. it has no pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis
Clinical narrative: Bell's Palsy on the right side of the face; A spontaneous report was received from an consumer who was also a 70 years old, female patient who experienced Bell's Palsy on the right side of the face (facial paresis).    The medical history of patient's family included Half-brother with Bell's Palsy since an unknown date. Concomitant product use was not provided by the reporter.   On 03 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 05 Mar 2021, the patient experienced the event facial paresis. Symptoms included: she could not blink her right eye, could not move right side of mouth and droopy right side of face.  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 event, was not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Discomfort, Fatigue
Clinical narrative: Fever of 101.3 across 24 hours, alternating chills and sweats, severe muscle and joint pain and discomfort, fatigue, nausea, loss of appetite.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 101.3 across 24 hours, alternating chills and sweats, severe muscle and joint pain and discomfort, fatigue, nausea, loss of appetite.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Gastric disorder, Headache
Clinical narrative: I had my 2nd shot in the evening of  Feb 13.  On Sunday in the mid afternoon around 2, I started experiencing chills and aches. I didn't feel like eating at all. I ate a little in the evening but I mainly slept the last half of the day. I took 2 Tylenol ever 4 hours and kept on that and took a Tylenol PM when I finally gave up and went to bed. Then next 3 days, throughout all these days, Mon - Wed, I had an excruciating headache and more joint pain especially in my ankles.  My headaches came from the back of my lower neck to my forehead. My entire shoulder was  sore the entire time.  I had a low grade fever only on Monday (Day 2). The injection site was red and warm to the touch the entire time. It was also very itchy and a tiny bit swollen and with a little bit of maybe a rash? I experienced chills on the first 2 days after my injection. Today is day 5 and I still continue to have gastric issues, not really wanting to eat even though I have been feeling hungry, a bit queasy throughout the 5 days. I drank peppermint tea through the past 5 days as it was the only thing that felt good in my body.  On Tuesday after too much stomach upsets, I chose to eat the BRATY and only ate bananas, yogurt, very finely chopped apples, and crackers. By Wed, I more hungry to tried to eat light and a not a lot. Today Friday, Day 5, I chose to eat some Soup and that seems OK. I still have a headache but not as severe as on Day 2 and 3. My injection site is starting to look normal.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: I had my 2nd shot in the evening of  Feb 13.  On Sunday in the mid afternoon around 2, I started experiencing chills and aches. I didn't feel like eating at all. I ate a little in the evening but I mainly slept the last half of the day. I took 2 Tylenol ever 4 hours and kept on that and took a Tylenol PM when I finally gave up and went to bed. Then next 3 days, throughout all these days, Mon - Wed, I had an excruciating headache and more joint pain especially in my ankles.  My headaches came from the back of my lower neck to my forehead. My entire shoulder was  sore the entire time.  I had a low grade fever only on Monday (Day 2). The injection site was red and warm to the touch the entire time. It was also very itchy and a tiny bit swollen and with a little bit of maybe a rash? I experienced chills on the first 2 days after my injection. Today is day 5 and I still continue to have gastric issues, not really wanting to eat even though I have been feeling hungry, a bit queasy throughout the 5 days. I drank peppermint tea through the past 5 days as it was the only thing that felt good in my body.  On Tuesday after too much stomach upsets, I chose to eat the BRATY and only ate bananas, yogurt, very finely chopped apples, and crackers. By Wed, I more hungry to tried to eat light and a not a lot. Today Friday, Day 5, I chose to eat some Soup and that seems OK. I still have a headache but not as severe as on Day 2 and 3. My injection site is starting to look normal.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I had my 2nd shot in the evening of  Feb 13.  On Sunday in the mid afternoon around 2, I started experiencing chills and aches. I didn't feel like eating at all. I ate a little in the evening but I mainly slept the last half of the day. I took 2 Tylenol ever 4 hours and kept on that and took a Tylenol PM when I finally gave up and went to bed. Then next 3 days, throughout all these days, Mon - Wed, I had an excruciating headache and more joint pain especially in my ankles.  My headaches came from the back of my lower neck to my forehead. My entire shoulder was  sore the entire time.  I had a low grade fever only on Monday (Day 2). The injection site was red and warm to the touch the entire time. It was also very itchy and a tiny bit swollen and with a little bit of maybe a rash? I experienced chills on the first 2 days after my injection. Today is day 5 and I still continue to have gastric issues, not really wanting to eat even though I have been feeling hungry, a bit queasy throughout the 5 days. I drank peppermint tea through the past 5 days as it was the only thing that felt good in my body.  On Tuesday after too much stomach upsets, I chose to eat the BRATY and only ate bananas, yogurt, very finely chopped apples, and crackers. By Wed, I more hungry to tried to eat light and a not a lot. Today Friday, Day 5, I chose to eat some Soup and that seems OK. I still have a headache but not as severe as on Day 2 and 3. My injection site is starting to look normal.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Awoke on morning of 3/18/2021 (48 hours after the vaccine) with florid generalized rash, most notable on neck, bilateral forearms and umbilicus. No itch, swelling or pain associated with the rash. Rash extended to include upper arms and (R) cheek and (L) 5th toe. The rash had been preceded by left upper arm pain, headaches, joint aches and pains, chills, nausea and fatigue. These symptoms started about 10 hours after the vaccine and continued for 24 hours. By the following afternoon, 3/17/2021 (29 hours after the vaccine), fever of 100.8. Patient took an Advil PM on the evening of 3/17/2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Awoke on morning of 3/18/2021 (48 hours after the vaccine) with florid generalized rash, most notable on neck, bilateral forearms and umbilicus. No itch, swelling or pain associated with the rash. Rash extended to include upper arms and (R) cheek and (L) 5th toe. The rash had been preceded by left upper arm pain, headaches, joint aches and pains, chills, nausea and fatigue. These symptoms started about 10 hours after the vaccine and continued for 24 hours. By the following afternoon, 3/17/2021 (29 hours after the vaccine), fever of 100.8. Patient took an Advil PM on the evening of 3/17/2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient called our onsite registered nurse on 18MAR21 to report an itchy, red raised rash at the injection site (left deltoid).  Patient also reports a headache.  Patient was advised to take Benadryl and Ibuprofen and will follow-up with onsite nurse as needed.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis
Clinical narrative: After 1st vaccine , patient had mild ptosis to left eyelid that was intermittent.  After the 2nd dose on 1/27/21, patient had more pronounced ptosis to left eyelid, worsening after approximately 3 weeks.  The patient is experiencing improvement at this time, but seems to be aggravated with seasonal pollen experience.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Urticaria
Clinical narrative: Approximately 2 hours after receiving vaccine, patient states her back started burning and she broke out in hive on back and both arms. She self-treated with benadryl for duration of hive (2 days).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypotension, Loss of consciousness, Pallor, Visual impairment
Clinical narrative: Patient passed out and fell to the floor after standing up from a chair about 5-10 minutes after vaccine. She had low blood pressure, was pale, and had difficulty seeing clearly. EMS came to the scene to evaluate and her blood pressure recovered and she went home. She did not go to the emergency room, was just treated by EMS. She remained conscious and breathing and did not require CPR.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Injection site induration, Injection site rash, Rash, Sensation of foreign body
Clinical narrative: At time of the shot nurse noticed an immediate bump at the injection site. Patient then started to have rash down arm.  Ice was applied. Benadryl 25 mg was given.  At the time no throat issues.  Patient drinking water without difficulties.  Rash progressed to neck area.  Patient then complained of lump in throat.  Additional 25mg Benadryl given.  Patient also very anxious and says gets hives and feel lump in throat with that.  Patients rash started to improve and lump resolved.  Rash almost resolved by time of leaving.  Patient felt much better and refused hospital transport.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: I felt extremely foggy headed. It was like I was struggling to put thoughts together at times. Also, it was like I was having trouble focusing on and off. The foggy headed last mainly the first day of vaccination, then some on the second day after.  This happened about 15 minutes after receiving the vaccine.  Also, exhausted feeling on and off the first night of vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: At 13:55 on 3/19/21 patient received 1st Pfizer vaccine to left arm. At 14:05 on 3/19/21 patient developed itching to bilateral lower and upper arms. Denies shortness of breath, denies trouble breathing, denies chest pain, denies hives.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vertigo
Clinical narrative: Headache, vertigo, and no strength
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large round, red, hot, circle around injection site.  Doctor advised to take Advil and benedril
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Blood pressure increased, Blood urea increased, Chest X-ray normal
Clinical narrative: Patient was seen in our ER on 3/8. She stated that she had received her Johnson/Johnson COVID Vaccine on Thursday (3/4/21) and since then, had been experiencing body aches, chills, fever, fatigue, headache, n/v/d. She was admitted for treatment with IV fluids and supportive meds for the n/v/d. On 3/9, she was still feeling very ill. Fever and chills had improved but she was still not tolerating PO. BP was also elevated ranging from 142/82 to 206/80. She was also diagnosed with AKI. BUN was 51, Cr 3.26. By 3/11, she was feeling a little better but kidney function continued to deteriorate. BUN was 53, Cr 4.39. The physician decided she should be transferred to a higher level facility for her AKI on CKD. However, there were no beds available. So she remained at our facility awaiting transfer. Around 1900 that night, she experienced a bout of hypotension and decreased urine output. Chest xray was normal. EKG was NSR. She was eventually transferred to another hospital on 3/12 at 1300.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: Patient was seen in our ER on 3/8. She stated that she had received her Johnson/Johnson COVID Vaccine on Thursday (3/4/21) and since then, had been experiencing body aches, chills, fever, fatigue, headache, n/v/d. She was admitted for treatment with IV fluids and supportive meds for the n/v/d. On 3/9, she was still feeling very ill. Fever and chills had improved but she was still not tolerating PO. BP was also elevated ranging from 142/82 to 206/80. She was also diagnosed with AKI. BUN was 51, Cr 3.26. By 3/11, she was feeling a little better but kidney function continued to deteriorate. BUN was 53, Cr 4.39. The physician decided she should be transferred to a higher level facility for her AKI on CKD. However, there were no beds available. So she remained at our facility awaiting transfer. Around 1900 that night, she experienced a bout of hypotension and decreased urine output. Chest xray was normal. EKG was NSR. She was eventually transferred to another hospital on 3/12 at 1300.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Patient was seen in our ER on 3/8. She stated that she had received her Johnson/Johnson COVID Vaccine on Thursday (3/4/21) and since then, had been experiencing body aches, chills, fever, fatigue, headache, n/v/d. She was admitted for treatment with IV fluids and supportive meds for the n/v/d. On 3/9, she was still feeling very ill. Fever and chills had improved but she was still not tolerating PO. BP was also elevated ranging from 142/82 to 206/80. She was also diagnosed with AKI. BUN was 51, Cr 3.26. By 3/11, she was feeling a little better but kidney function continued to deteriorate. BUN was 53, Cr 4.39. The physician decided she should be transferred to a higher level facility for her AKI on CKD. However, there were no beds available. So she remained at our facility awaiting transfer. Around 1900 that night, she experienced a bout of hypotension and decreased urine output. Chest xray was normal. EKG was NSR. She was eventually transferred to another hospital on 3/12 at 1300.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment, Urine output decreased, Vomiting
Clinical narrative: Patient was seen in our ER on 3/8. She stated that she had received her Johnson/Johnson COVID Vaccine on Thursday (3/4/21) and since then, had been experiencing body aches, chills, fever, fatigue, headache, n/v/d. She was admitted for treatment with IV fluids and supportive meds for the n/v/d. On 3/9, she was still feeling very ill. Fever and chills had improved but she was still not tolerating PO. BP was also elevated ranging from 142/82 to 206/80. She was also diagnosed with AKI. BUN was 51, Cr 3.26. By 3/11, she was feeling a little better but kidney function continued to deteriorate. BUN was 53, Cr 4.39. The physician decided she should be transferred to a higher level facility for her AKI on CKD. However, there were no beds available. So she remained at our facility awaiting transfer. Around 1900 that night, she experienced a bout of hypotension and decreased urine output. Chest xray was normal. EKG was NSR. She was eventually transferred to another hospital on 3/12 at 1300.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Contusion, Feeling abnormal, Injection site bruising, Injection site pain
Clinical narrative: Patient came in 3/18/21 to inform us that she had an adverse event to the flu shot she received on 10/15/2020.  She says that when she receieved the vaccine  she felt "something weird where she was injected".  She said that she did not think too much of it until later when she had a bruise at the injection site.  She said that the bruise later extended and she had a series of bruises going up  a line on her deltoid muscle.  Her nurse friends told her that a nerve might have been hit during administration of the flu shot.  She said that ever since she has had issues with her left arm, feeling pain in that left shoulder.  They have given her steroid shots and at one point were going to do suregery on her rotator cuff but they found nothing to be wrong with it so canceled that procedure.  She says that her shoulder is still sore up to today and that she just started regaining strength in her arm.  According to the patient, she did not do anything to her arm (hit it, etc) and the only connection is the flu shot.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Pt received vaccine at 1025,waiting to finish his 15 min observation.At10:38 pt called the RN observer because he felt lightheaded. RN came to help him ,30 sec later, pt fainted and loss consciousness for about 10 sec. Assisted to the floor in T-position. 911 called.Pt regained consciousness, BP and O2 saturation monitored. Initial BP 102/57, 10:46 107/62,10:50 115/72,10:56 131/74. 10 Pt is alert, sat up in a chair.911 arrived
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site rash, Pain
Clinical narrative: Expected sore arm...no more than first vaccine. Chills/aches and headache on Day #1, lessened but continuing on Day #2. Continuing tiredness, some chills and  headache Day #3.  Rash developing around site increasing throughout first week, including  itchy body rash on torso, with less on upper legs and face that worsened after first couple of days. Remaining headache on mornings of Days #5 and #6. I am reporting on Day #6. Rash remains but is not worsening. None of these symptoms are of a serious nature. I am reporting for record keeping purposes only.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Expected sore arm...no more than first vaccine. Chills/aches and headache on Day #1, lessened but continuing on Day #2. Continuing tiredness, some chills and  headache Day #3.  Rash developing around site increasing throughout first week, including  itchy body rash on torso, with less on upper legs and face that worsened after first couple of days. Remaining headache on mornings of Days #5 and #6. I am reporting on Day #6. Rash remains but is not worsening. None of these symptoms are of a serious nature. I am reporting for record keeping purposes only.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Vomiting
Clinical narrative: Back ache, chills, vomiting  and diarreau
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: I noticed that the left side of my face was feeling numb while I was working mid afternoon on Tuesday, March 16.  The feeling was similar to a novacaine shot that a dentist would give for a cavity.  This feeling has been continuous for 3 day and I noticed my left upper lip was feeling numb to the touch as well.  The heaviness is felt in the  cheekbone area, the area below my left nostril, and down to my jaw on the left side of my face.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Due to error in mixing, the patient only received the diluent
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Severe headaches, chills, muscle aches onset with 3 hours and lasting 36 hours
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Oxygen saturation decreased
Clinical narrative: low oxygen; Weakness; A spontaneous report was received from a consumer concerning a 83-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced weakness, lack of efficacy and low oxygen.  The patient's medical history was included COVID 19,Pacemaker 20 years ago and Kidney Disease. Products known to have been used by the patient were not reported.  The patient received the first of two planned doses of mRNA-1273 (Batch number : 030L20A) on 22-Jan-2021.  On 1-Feb-2021, the patient experienced weakness, lack of efficacy and tested positive for COVID 19.   On 05 -Feb-2021, he was admitted in a hospital and treated with vitamin C, D, zinc cough.   On 15-Feb -2021, patient was discharged from the hospital.  On 03-Mar-2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 002A21A), intramuscularly for prophylaxis of COVID-19 infection.  On 5-Mar -021, the patient experienced  low oxygen levels and admitted to a new hospital. Patient was consuming increasing supplemental oxygen as treatment.   No relevant laboratory details were included.   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, experienced weakness, lack of efficacy and low oxygen were considered not recovered/ 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 events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Chest X-ray abnormal, Chills, Computerised tomogram, Computerised tomogram abnormal
Clinical narrative: Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Lung infiltration, Neutrophil count increased, Palpitations
Clinical narrative: Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Platelet count decreased, Pulmonary oedema, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Euphoric mood
Clinical narrative: I had a sense of being high. euphoric and also giddy, feeling silly.    Some brain fog.   No medical treatment. After 24 to 48 hours the symptoms subsided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swollen lip and chin about 12 hours after vaccine; doctor has advised to try Tylenol PM
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Dizziness, Fatigue, Pollakiuria, Pyrexia
Clinical narrative: Fever,  tiredness,  weak, dizziness , frequent urinating
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Within 5 min of receiving the vaccine injection, pt complained of being dizzy. EMT's on site took BP and found it to be significantly elevated. EMT's called the local clinic and spoke to the PA on duty. They advised the EMT's to transport the pt to the hospital for treatment.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: SYNCOPE REACTION , DEVELOPED 10 MINS POST IM INJECTION
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: Swollen lymph node in left armpit appeared 3/14, does not respond to heating pad, ice, ibuprofen, still bothering with same amount of pain and tenderness on 3/19. On 3/19, a rash appeared at the injection site approximately the size of a half-dollar, raised, red, and itchy.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit appeared 3/14, does not respond to heating pad, ice, ibuprofen, still bothering with same amount of pain and tenderness on 3/19. On 3/19, a rash appeared at the injection site approximately the size of a half-dollar, raised, red, and itchy.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired quality of life, Tinnitus
Clinical narrative: Sudden onset of tinnitus in my left ear 2 days after shot. Ongoing buzzing that has never happened before and is almost constant and affecting quality of life. Mild headache after vaccine want away before tinnitus started about 36-48 hours after shot. It has now been going on for 5 days.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness, Physical examination, Tinnitus
Clinical narrative: Still experiencing tinnitis & hearing loss 3 weeks after 2nd Moderna vaccine.  I had an audiologist test my hearing and a physical exam by Dr. on March 4, 2021.  No treatment
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dysphonia, Pruritus, Throat tightness
Clinical narrative: Patient reported it was hard to swallow and had throat tightness and itching. She thought her voice was different. Patient evaluated with. Was given Epi and Benadryl. Continued to cough. EMS called and patient transported to Emergency Room for further evaluation.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: SYNCOPE
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Back pain, Chest discomfort, Choking sensation, Fatigue
Clinical narrative: Lose lot of blood; Vein broken; Flu like symptoms; Neck is like a balloon; Pressure in the heart; Pain in the back; Severe headache; Fatigue; Felt like being choked; Side effects after 20 days; Neck swollen; Neck hard; Pressure in the neck; Allergic reaction; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported. On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003M20A) for prophylaxis of COVID-19 infection.  Patient received the vaccine on 10 Feb 2021 and reports that the doctor said not to take the second dose as they have had an allergic reaction. After 20 days reports adverse side effects. Reports neck was swollen and hard. Had severe headache and pressure in the neck. Felt the feeling of rigidness in the neck like she was being choked. Later the caller got into an accident and was in the urgent care for 5 days. The caller is unsure if this is related to the vaccine and reports a broken vein and loss of lot of blood due to the accident. Caller felt flu like symptoms after visiting the urgent care and said neck was swelling like a balloon. Felt pressure in the heart, pain in the back and fatigue. Treatment for the events as reported by the caller were Advil and 2 or 3 Claritin but says has stopped Claritin cause was feeling worse. No Lab tests mentioned but says she is scheduled to take a COVID-19 test. Action taken with mRNA-1273 in response to the events was withdrawn as per her HCP. The events, had an accident that caused loss of blood and broken vein and felt like being choked, was considered as medically significant. The outcome of the events, side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue, was 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: Haemorrhage, Headache, Hypersensitivity, Influenza like illness, Neck pain
Clinical narrative: Lose lot of blood; Vein broken; Flu like symptoms; Neck is like a balloon; Pressure in the heart; Pain in the back; Severe headache; Fatigue; Felt like being choked; Side effects after 20 days; Neck swollen; Neck hard; Pressure in the neck; Allergic reaction; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported. On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003M20A) for prophylaxis of COVID-19 infection.  Patient received the vaccine on 10 Feb 2021 and reports that the doctor said not to take the second dose as they have had an allergic reaction. After 20 days reports adverse side effects. Reports neck was swollen and hard. Had severe headache and pressure in the neck. Felt the feeling of rigidness in the neck like she was being choked. Later the caller got into an accident and was in the urgent care for 5 days. The caller is unsure if this is related to the vaccine and reports a broken vein and loss of lot of blood due to the accident. Caller felt flu like symptoms after visiting the urgent care and said neck was swelling like a balloon. Felt pressure in the heart, pain in the back and fatigue. Treatment for the events as reported by the caller were Advil and 2 or 3 Claritin but says has stopped Claritin cause was feeling worse. No Lab tests mentioned but says she is scheduled to take a COVID-19 test. Action taken with mRNA-1273 in response to the events was withdrawn as per her HCP. The events, had an accident that caused loss of blood and broken vein and felt like being choked, was considered as medically significant. The outcome of the events, side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue, was 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: Nuchal rigidity, Swelling, Vein rupture
Clinical narrative: Lose lot of blood; Vein broken; Flu like symptoms; Neck is like a balloon; Pressure in the heart; Pain in the back; Severe headache; Fatigue; Felt like being choked; Side effects after 20 days; Neck swollen; Neck hard; Pressure in the neck; Allergic reaction; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue.  The patient's medical history was not provided. Concomitant medications were not reported. On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003M20A) for prophylaxis of COVID-19 infection.  Patient received the vaccine on 10 Feb 2021 and reports that the doctor said not to take the second dose as they have had an allergic reaction. After 20 days reports adverse side effects. Reports neck was swollen and hard. Had severe headache and pressure in the neck. Felt the feeling of rigidness in the neck like she was being choked. Later the caller got into an accident and was in the urgent care for 5 days. The caller is unsure if this is related to the vaccine and reports a broken vein and loss of lot of blood due to the accident. Caller felt flu like symptoms after visiting the urgent care and said neck was swelling like a balloon. Felt pressure in the heart, pain in the back and fatigue. Treatment for the events as reported by the caller were Advil and 2 or 3 Claritin but says has stopped Claritin cause was feeling worse. No Lab tests mentioned but says she is scheduled to take a COVID-19 test. Action taken with mRNA-1273 in response to the events was withdrawn as per her HCP. The events, had an accident that caused loss of blood and broken vein and felt like being choked, was considered as medically significant. The outcome of the events, side effects after 20 days, neck swollen, neck hard, accident that caused broken vein and loss of lot of blood, headache, pressure in the neck, rigidness in the neck, felt like being choked, allergic reaction, flu like symptoms, neck is like a balloon, pressure in the heart, pain in the back and fatigue, was 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Headache chills dizzy nausea fatigue and pain  48hours
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache chills dizzy nausea fatigue and pain  48hours
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Renal pain
Clinical narrative: I have had Pain and soreness throughout the entire left side of my body.. and very sore left side kidney area pain. the pain runs from the side up through my arm and into my neck
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 8 days after the Maderna Vaccine I developed Shingles. I had a Shingles vaccine 2015
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Itching all over body and red splotches on chest. This began about 30 minutes after the shot. The red splotches are gone after an hour and the itching is still  occurring but minor now.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Progress Notes Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All    COVID VACCINE CLINIC     Date:  3/17/2021                                                                                               Subjective Patient is a 49 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience tingling sensation along recent surgical incision and along both sides (had full knee replacement on March 9th). She also has "burning" going down the left leg from her knee down to foot. She denied all other symptoms.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , increased swelling, rapid progression of symptoms, respiratory distress and skin changes.   Of note, she had not taken her medications this morning, which includes lisinopril. She had physical therapy this morning as well. She states that they iced her knee at the end of her session.     ALLERGY REVIEW OF SYSTEMS:  All other systems negative    Left knee bandaged, wrapped with ace bandage. She also has compression socks on.:  Tingling sensation along surgical incision on left knee and down both sides of same incision.  Burning pain down left leg from knee to foot.:   Previous Reactions: None to first covid vaccine.    Objective    Vitals Vitals:   03/17/21 1113 03/17/21 1129 BP: (!) 129/90 126/70 Pulse: 81 72 SpO2: 97% 100%    Physical Exam Vitals reviewed.  Constitutional:      Appearance: She is obese. She is not ill-appearing, toxic-appearing or diaphoretic.  HENT:     Head: Normocephalic.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal:     Cervical back: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal. Behavior is cooperative.        Thought Content: Thought content normal.        Judgment: Judgment normal.       Assessment/Plan  Treatment included: no therapy Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Symptoms likely related to ice therapy done at physical therapy prior to coming into vaccine clinic. Symptoms were resolving, back to her baseline when she left. Encouraged to notify surgeon or primary care provider if symptoms return or become worrisome.    Electronically Signed 3/17/2021 11:30 AM
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Heart rate increased, Lymphadenopathy, Nausea
Clinical narrative: Horrible headache started a few hours after injection with nausea, but backed off by next morning. By Saturday, the headache was back with the nausea and I began feeling very itchy. When I woke on Sunday, I had hives and a rash all over my face and most of my left side, which is the side I got my shot. Called Dr Monday and was sent to urgent care, who then sent me to the ER. Heart rate was high, hives, rash, headaches, nausea, swollen eyes and face, swollen lymph nodes
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Horrible headache started a few hours after injection with nausea, but backed off by next morning. By Saturday, the headache was back with the nausea and I began feeling very itchy. When I woke on Sunday, I had hives and a rash all over my face and most of my left side, which is the side I got my shot. Called Dr Monday and was sent to urgent care, who then sent me to the ER. Heart rate was high, hives, rash, headaches, nausea, swollen eyes and face, swollen lymph nodes
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Significant (2X normal) swelling in two fingers on right hand with dark red/blue areas 1-1.5cm in diameter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypersomnia
Clinical narrative: tested positive for COVID-19 virus; Patient slept day and night for 3 days after the vaccination; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and slept day and night for 3 days/hypersomnia and tested positive for COVID-19 virus.  The patient's current medical condition included COVID-19 since 05MAR2021.  Concomitant medication history was not provided.  On 25JAN2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch not available) intramuscularly for prophylaxis  of COVID-19 infection.  On 29JAN2021, following the vaccine administration, the patient slept day and night for 3 days after the vaccination, was taken to the hospital, where he tested positive for COVID-19 virus. Patient was still in the hospital at the time of this reporting and he tested positive for COVID-19 again on 05MAR2021.   Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events, hypersomnia and COVID-19 were 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. However , the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 positive test after vaccination, is unlikely related to mRNA-1273.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient passed away within 60 days of receiving the COVID vaccine series
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This is the second dose. It was given too early.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: 09:24 am: Pt received vaccine 09:38 am: Pt complained of numbness of mouth (palate ) 09:40 am:  8 oz water given to pt.  b/p 150/80, p73, r20, o2 sat = 98% 10:05 am:  Pt states that he feels better ("mild numbness").  Pt discharged.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Due to error in mixing, the patient only received diluent