chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site pain
Clinical narrative: I am sitting and sweating; delayed reaction from the vaccine; hot flashes; slight cough; seemed like I had a sinus infection; Chills; had the normal redness; had the normal pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (hot flashes), COUGH (slight cough), SINUSITIS (seemed like I had a sinus infection), HYPERHIDROSIS (I am sitting and sweating) and TYPE IV HYPERSENSITIVITY REACTION (delayed reaction from the vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A03A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (had the normal redness) and VACCINATION SITE PAIN (had the normal pain in the arm). On 28-Mar-2021, the patient experienced HOT FLUSH (hot flashes), COUGH (slight cough), SINUSITIS (seemed like I had a sinus infection) and CHILLS (Chills). On an unknown date, the patient experienced HYPERHIDROSIS (I am sitting and sweating) and TYPE IV HYPERSENSITIVITY REACTION (delayed reaction from the vaccine). At the time of the report, HOT FLUSH (hot flashes), COUGH (slight cough), SINUSITIS (seemed like I had a sinus infection), HYPERHIDROSIS (I am sitting and sweating), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction from the vaccine), VACCINATION SITE ERYTHEMA (had the normal redness), VACCINATION SITE PAIN (had the normal pain in the arm) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test negative: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient was advised to take tylenol and alternate with Aleve by doctor as treatment medication.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: muscle pain; joint pain; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 021B21A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for Osteopenia.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Vaccination site pruritus
Clinical narrative: itching on injection site; muscle pain; fatigue; "real dizziness"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching on injection site), MYALGIA (muscle pain), FATIGUE (fatigue) and DIZZINESS ("real dizziness") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching on injection site), MYALGIA (muscle pain), FATIGUE (fatigue) and DIZZINESS ("real dizziness"). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (itching on injection site), MYALGIA (muscle pain), FATIGUE (fatigue) and DIZZINESS ("real dizziness") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       physician advised not to take second vaccine shot.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; fever; could not find a place to receive the second vaccine; could not find a place to receive the second vaccine; This spontaneous case was reported by a physician and describes the occurrence of RHINORRHOEA (runny nose), PYREXIA (fever), PRODUCT ADMINISTRATION INTERRUPTED (could not find a place to receive the second vaccine) and PRODUCT AVAILABILITY ISSUE (could not find a place to receive the second vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (could not find a place to receive the second vaccine) and PRODUCT AVAILABILITY ISSUE (could not find a place to receive the second vaccine). On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHINORRHOEA (runny nose) and PYREXIA (fever). On 26-Jul-2021, RHINORRHOEA (runny nose) and PYREXIA (fever) had resolved. At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (could not find a place to receive the second vaccine) and PRODUCT AVAILABILITY ISSUE (could not find a place to receive the second vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Patient got the second dose after the recommended window.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received Added second dose details, events of second dose, outcome of the event.updated reporter details.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not reported. Treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05 Aug 2021, Updated outcome for the events from unknown to recovered/resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Palpitations, Visual impairment
Clinical narrative: heart palpitation; visual bubble in right eye; stomach pain as reaction for any food; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual bubble in right eye), ABDOMINAL PAIN UPPER (stomach pain as reaction for any food) and PALPITATIONS (heart palpitation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VISUAL IMPAIRMENT (visual bubble in right eye) and ABDOMINAL PAIN UPPER (stomach pain as reaction for any food). On 17-Feb-2021, the patient experienced PALPITATIONS (heart palpitation). On 17-Feb-2021, VISUAL IMPAIRMENT (visual bubble in right eye) had resolved. On 18-Feb-2021, PALPITATIONS (heart palpitation) had resolved. On 02-Apr-2021, ABDOMINAL PAIN UPPER (stomach pain as reaction for any food) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Pepcid and strict diet to be followed
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore Arm; Shot burned as the fluid was going into my arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Shot burned as the fluid was going into my arm) and PAIN IN EXTREMITY (Sore Arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Shot burned as the fluid was going into my arm) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Shot burned as the fluid was going into my arm) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: It's a little warm sometimes to the touch; It was itchy; 3-4 days after slight redness at the injection site of 2 and a half inches diameter; Twinch in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twinch in the shoulder), VACCINATION SITE WARMTH (It's a little warm sometimes to the touch), VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE ERYTHEMA (3-4 days after slight redness at the injection site of 2 and a half inches diameter) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCLE TWITCHING (Twinch in the shoulder). On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH (It's a little warm sometimes to the touch), VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE ERYTHEMA (3-4 days after slight redness at the injection site of 2 and a half inches diameter). On 24-Mar-2021, MUSCLE TWITCHING (Twinch in the shoulder) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's a little warm sometimes to the touch), VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE ERYTHEMA (3-4 days after slight redness at the injection site of 2 and a half inches diameter) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: tooth infection, described as some bacteria got inside the tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (tooth infection, described as some bacteria got inside the tooth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TOOTH INFECTION (tooth infection, described as some bacteria got inside the tooth). The patient was treated with CLINDAMYCIN for Tooth infection, at an unspecified dose and frequency. At the time of the report, TOOTH INFECTION (tooth infection, described as some bacteria got inside the tooth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Paralysis
Clinical narrative: Approxamatly 12 hours after injection and after going to bed I awoke to a severe headache.  I attempted to get out of bed but realized I could not lift my head off the pillow.  I attempted to reach the phone by my bed side but found that  I was almost totally  paralyzed  neck,  both arms and shoulders to the point that I could not get out of bed to call 911 for help.  I believe I was Simi conscious on and off for approximately 8 hours.  at some point during the night I fell back asleep.  When I awoke at approximately 11:00 am I was able to get out of bed with extreme difficulty and pain in my entire body.  The symptoms took almost two weeks to go away however the headache continued for almost a month.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles on eye, progressed to inside mouth (after clinic visit). Prescribed anti-viral Valtrex tablet. Also short of breath, but all other vitals were normal
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Patient was immunized 2 days ago on 08/19/2021.  Today, 08/21/2021, wife indicates patient has one issue, loss of taste.  No loss of smell. No fever.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Pyrexia
Clinical narrative: Subjective fevers, chills, nausea, chest tightness that are improving with time and Tylenol
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Pericarditis
Clinical narrative: Pericarditis that has been unsuccessfully treated with Ibuprofen and Colchizine. Currently I am taking a steroid.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Back pain, Condition aggravated, Gastrooesophageal reflux disease
Clinical narrative: Back pain and abdominal pain/discomfort/reflux. All started the day after vaccine.  I?m still experiencing these symptoms even 6 weeks post vaccine, some days are worse than others.  I?ve taken Motrin and reflux medication as needed. I?m planning to see a doctor for my stomach this next week. I?be also started seeing a chiropractor for my back pain.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: The next day my hands got stiff 3 times and the next day 4 times. I had cramps in my legs for 3 days.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Frequent bowel movements, Micturition urgency, Pollakiuria
Clinical narrative: 17 hours later developed urinary frequency, urgency, and suprapublic and low back aching, multiple stools, exhaustion, and low grade fever.  Fever rose to 103 through rest of morning.  Saw Urgent-Care NP at 2:30 p.m.  (signed in 11:30 a.m.)  Urine only microscopic hematuria (not new finding) and no evidence bacterial infection.  Started on Macrodantin empirically while await culture. Fever resolved on antipyretics (tylenol).  Slept rest of day and through the night.  Much better in morning of August 20, with resolution GU symptoms and aching.  Urine culture negative/antibiotics discontinued.  Back to normal by August 20th evening.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suprapubic pain, Urine analysis
Clinical narrative: 17 hours later developed urinary frequency, urgency, and suprapublic and low back aching, multiple stools, exhaustion, and low grade fever.  Fever rose to 103 through rest of morning.  Saw Urgent-Care NP at 2:30 p.m.  (signed in 11:30 a.m.)  Urine only microscopic hematuria (not new finding) and no evidence bacterial infection.  Started on Macrodantin empirically while await culture. Fever resolved on antipyretics (tylenol).  Slept rest of day and through the night.  Much better in morning of August 20, with resolution GU symptoms and aching.  Urine culture negative/antibiotics discontinued.  Back to normal by August 20th evening.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Herpes ophthalmic, Skin lesion
Clinical narrative: Diagnosed with Herpes Zoster Opthalmicus. First symptom-eye pain, 3/9/2021, followed by lesions above eye, forehead p, across scalp, 3/13-14/2021. All left side.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching
Clinical narrative: Pfizer vaccine.  Twitching ... facial, legs, hands.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Vasculitis, Vasodilatation
Clinical narrative: Pronounced blood vessels in both hands.  Blue hands due to vasculitis that lasted for 10 minutes.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed shingles approx 10 days after first dose of Moderna vaccine.  Visit with dr, given prescription for prolonged prednisone taper, acyclovir, and Tylenol 3. Rash cleared up around 8/21/2021
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash spreading all over back, torso, both arms
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Painful, visible swelling in left armpit
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discharge, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Hives throughout body within 1-2 hours after shot, continued for about 3 days consistently. Arm also swelled about 2 inches around injection site within 2 hours, it continued to swell to about 3.5 inches around injection site over the next 36hours. Hives continued on & off about 3 more days. Injection site stayed swollen. On day 7-8 hives & swelling seemed to lessen, but on day 9, swelling/pain/discomfort got much worse & hives returned on & off throughout body. I then went to our local urgent care.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate irregular, Hypotension
Clinical narrative: Around 8pm tightness of chest and difficulty taking deep breathes was noticed - took Benadryl and symptoms eased. Upon waking was lightheaded and took blood pressure irregular heartbeat detected. Low blood pressure, dizziness  and irregular heartbeat detected for around a month then self corrected.  Was able to see pcp who suggested I see neurologist. Neurologist appointment in September 2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia, Pain in extremity
Clinical narrative: I was awoken at 6:00am with a pain in my left armpit and extreme numbness along the outside of my upper left arm from the shoulder to the elbow. I had been sleeping on my back and my arm was not pinched or compressed in any way.  I got up and walked around while moving my arm in circular motions. The numbness turned to pain that went down the outside of my left forearm. I used a 2 lb weight to do some exercises with my left arm. After about 15 minutes I took 2 Advil and kept rotating my left arm and massaging it. After one half hour the numbness and pain went away.  Then at 8:45pm the same day while sitting upright, the same symptoms as described above began again, only this time more intense. I took 2 Advil right away and massaged my left arm and rotated it around. After 45 minutes, the pain and numbness subsided.  So far these symptoms have not returned again.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Low grade fever 99.5 for 2 days. "Covid arm"- swelling, hot to touch, redness, itching, sore to raise arm, chills
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm
Clinical narrative: Low grade fever 99.5 for 2 days. "Covid arm"- swelling, hot to touch, redness, itching, sore to raise arm, chills
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional distress
Clinical narrative: Emotional distress
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oxygen consumption, Pain in extremity, Paraesthesia oral, Tachycardia
Clinical narrative: Tachycardia was very bad; Low grade headache; Lips was tingling/Tongue tingling; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 03-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia was very bad), HEADACHE (Low grade headache), PARAESTHESIA ORAL (Lips was tingling/Tongue tingling) and PAIN IN EXTREMITY (Sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Apr-2021, the patient experienced HEADACHE (Low grade headache), PARAESTHESIA ORAL (Lips was tingling/Tongue tingling) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced TACHYCARDIA (Tachycardia was very bad). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, TACHYCARDIA (Tachycardia was very bad), HEADACHE (Low grade headache), PARAESTHESIA ORAL (Lips was tingling/Tongue tingling) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Oxygen consumption: 94 Decreased. On an unknown date, Oxygen consumption: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was included acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received on 02 Aug 2021, The follow-up document contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain
Clinical narrative: Flank Pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Within 6 weeks of my 2nd Modern COVID-19 vaccine, I experienced intense itching on my whole face. The lymph nodes in my neck were very swollen and tender, I had a sore throat, and I was exhausted. I went 2 times that week, with the 2nd visit being who suspected lupus. She prescribed prednisone and hydroxyzine for the itching, which continued for more than a month. referred me. I had my first visit, and my lab work is not supporting a lupus diagnosis.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Systemic lupus erythematosus
Clinical narrative: Within 6 weeks of my 2nd Modern COVID-19 vaccine, I experienced intense itching on my whole face. The lymph nodes in my neck were very swollen and tender, I had a sore throat, and I was exhausted. I went 2 times that week, with the 2nd visit being who suspected lupus. She prescribed prednisone and hydroxyzine for the itching, which continued for more than a month. referred me. I had my first visit, and my lab work is not supporting a lupus diagnosis.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Micrographic skin surgery, Pathology test, Squamous cell carcinoma
Clinical narrative: Squamous cell cancer on left face. Mohs procedure on 3/2021. Follow up on may1 st
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes under left arm swelling and causing discomfort and slight pain
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dyspnoea, Fatigue
Clinical narrative: Fatigue dizzy spells some shortness of breath
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT CAME IN AND SAID SHE WAS HERE FOR HER SECOND COVID VACCINE. WHEN LOOKING AT VACCINE CARD, THE FIRST VACCINE DATE WAS INCORRECTLY SEEN, SO WE THOUGHT SHE WAS DUE FOR HER VACCINE. AFTER ADMINSTERING, WE REALIZED IT WAS 1 WEEK EARLY FOR THE VACCINE. ORIGINAL VACCINE 8/8/21, DUE DATE WOULD HAVE BEEN 8/29/21, BUT SHE GOT VACCIN ON 8/21/21
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient caregiver reported her mom  had dizziness and felt seated at 9 am the day posterior to the second dose of covid vaccine. She stated she recovered fast from symptoms.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Rash macular
Clinical narrative: Within 6 hours of the vaccine, red spots that looked like pyoderma gangrenosum appeared on both feet and legs all the way up to lower thighs.  On August 21st, patient experienced muscle weakness in legs and arms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient feels pain on her left arm and complained about it. She was assessed with 2 RNs and refused EMS. Instruction was given to patient.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia
Clinical narrative: Anosmia - could not smell coffee; Some times the flavors are off/could not taste; Some body aches; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Anosmia - could not smell coffee), AGEUSIA (Some times the flavors are off/could not taste) and MYALGIA (Some body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ANOSMIA (Anosmia - could not smell coffee), AGEUSIA (Some times the flavors are off/could not taste) and MYALGIA (Some body aches). On 03-Apr-2021, MYALGIA (Some body aches) had resolved. At the time of the report, ANOSMIA (Anosmia - could not smell coffee) and AGEUSIA (Some times the flavors are off/could not taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Lip swelling, Pruritus, Urticaria
Clinical narrative: Headache, Full body hives, itching, mouth numbness with top lip swelling.  Hives still present as of this date 08/21/21. Lip swelling resolved with Benadryl.  Urgent care visit- recommended Benadryl every 4 hrs, go directly to ED if mouth numbness or lip swelling occur again.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate increased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site on left arm hard red swollen. Heart has been fast & having frequent palpitations/ uneven rhythm
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Injection site on left arm hard red swollen. Heart has been fast & having frequent palpitations/ uneven rhythm
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Moderna Covid-19 Vaccine EUA  On the day of the vaccine my arm (where the vaccine was injected) started to hurt in the evening. That night I was laying in bed and when I moved it felt as if the muscle was hanging off my arm. The next day the pain was worse and my arm was very swollen and looked like a ball where they injected the vaccine. My arm was also red and felt hot. My joints hurt and I felt tired. Throughout the day the redness began to travel down my arm to my elbow. I couldn't move my arm or do anything with it due to the pain. I took 1K miligrams of Tylenol with breakfast that day and felt a relief in joint pain and I didn't feel tired anymore. That Monday my arm began to itch sometimes. The pain, redness, and swelling was still there. On Thursday there was less swelling and less redness. To this day my arm is still itchy sometimes and still a bit red.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Muscle discomfort, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Moderna Covid-19 Vaccine EUA  On the day of the vaccine my arm (where the vaccine was injected) started to hurt in the evening. That night I was laying in bed and when I moved it felt as if the muscle was hanging off my arm. The next day the pain was worse and my arm was very swollen and looked like a ball where they injected the vaccine. My arm was also red and felt hot. My joints hurt and I felt tired. Throughout the day the redness began to travel down my arm to my elbow. I couldn't move my arm or do anything with it due to the pain. I took 1K miligrams of Tylenol with breakfast that day and felt a relief in joint pain and I didn't feel tired anymore. That Monday my arm began to itch sometimes. The pain, redness, and swelling was still there. On Thursday there was less swelling and less redness. To this day my arm is still itchy sometimes and still a bit red.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: Moderna Covid-19 Vaccine EUA  On the day of the vaccine my arm (where the vaccine was injected) started to hurt in the evening. That night I was laying in bed and when I moved it felt as if the muscle was hanging off my arm. The next day the pain was worse and my arm was very swollen and looked like a ball where they injected the vaccine. My arm was also red and felt hot. My joints hurt and I felt tired. Throughout the day the redness began to travel down my arm to my elbow. I couldn't move my arm or do anything with it due to the pain. I took 1K miligrams of Tylenol with breakfast that day and felt a relief in joint pain and I didn't feel tired anymore. That Monday my arm began to itch sometimes. The pain, redness, and swelling was still there. On Thursday there was less swelling and less redness. To this day my arm is still itchy sometimes and still a bit red.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Limb discomfort, Malaise, Myalgia
Clinical narrative: felt sick; not feeling well; headache; njection site showed very red blotches; rm hurt for a while from where she had her vaccine; hurting got more itchy for 1 day; nauseous; fever of 100.8'F; every muscle hurt; arm hurt again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (rm hurt for a while from where she had her vaccine), PRURITUS (hurting got more itchy for 1 day), VACCINATION SITE ERYTHEMA (njection site showed very red blotches), LIMB DISCOMFORT (arm hurt again) and ILLNESS (felt sick) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced LIMB DISCOMFORT (arm hurt again). On 25-Mar-2021, the patient experienced PYREXIA (fever of 100.8'F) and MYALGIA (every muscle hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (rm hurt for a while from where she had her vaccine), PRURITUS (hurting got more itchy for 1 day), VACCINATION SITE ERYTHEMA (njection site showed very red blotches), ILLNESS (felt sick), MALAISE (not feeling well), HEADACHE (headache) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 350 mg. At the time of the report, PAIN IN EXTREMITY (rm hurt for a while from where she had her vaccine), PRURITUS (hurting got more itchy for 1 day), VACCINATION SITE ERYTHEMA (njection site showed very red blotches), LIMB DISCOMFORT (arm hurt again), ILLNESS (felt sick), MALAISE (not feeling well), HEADACHE (headache), PYREXIA (fever of 100.8'F), MYALGIA (every muscle hurt) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pruritus, Pyrexia, Vaccination site erythema
Clinical narrative: felt sick; not feeling well; headache; njection site showed very red blotches; rm hurt for a while from where she had her vaccine; hurting got more itchy for 1 day; nauseous; fever of 100.8'F; every muscle hurt; arm hurt again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (rm hurt for a while from where she had her vaccine), PRURITUS (hurting got more itchy for 1 day), VACCINATION SITE ERYTHEMA (njection site showed very red blotches), LIMB DISCOMFORT (arm hurt again) and ILLNESS (felt sick) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced LIMB DISCOMFORT (arm hurt again). On 25-Mar-2021, the patient experienced PYREXIA (fever of 100.8'F) and MYALGIA (every muscle hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (rm hurt for a while from where she had her vaccine), PRURITUS (hurting got more itchy for 1 day), VACCINATION SITE ERYTHEMA (njection site showed very red blotches), ILLNESS (felt sick), MALAISE (not feeling well), HEADACHE (headache) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 350 mg. At the time of the report, PAIN IN EXTREMITY (rm hurt for a while from where she had her vaccine), PRURITUS (hurting got more itchy for 1 day), VACCINATION SITE ERYTHEMA (njection site showed very red blotches), LIMB DISCOMFORT (arm hurt again), ILLNESS (felt sick), MALAISE (not feeling well), HEADACHE (headache), PYREXIA (fever of 100.8'F), MYALGIA (every muscle hurt) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Diarrhea; Sweating in the middle of the night like someone pour a glass in bed; High body temperature but the temperature was not consistent and eventually went away; Severe pain from the bones and muscle; Shivering at night; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating in the middle of the night like someone pour a glass in bed), PYREXIA (High body temperature but the temperature was not consistent and eventually went away), MYALGIA (Severe pain from the bones and muscle) and CHILLS (Shivering at night) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating in the middle of the night like someone pour a glass in bed), PYREXIA (High body temperature but the temperature was not consistent and eventually went away), MYALGIA (Severe pain from the bones and muscle) and CHILLS (Shivering at night). At the time of the report, DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating in the middle of the night like someone pour a glass in bed), PYREXIA (High body temperature but the temperature was not consistent and eventually went away), MYALGIA (Severe pain from the bones and muscle) and CHILLS (Shivering at night) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant products usage were not reported by the reporter.  No treatment medication were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20a and 038a21a) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VITAMIN B6, DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 29-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            Treatment information was not provided. Action taken for Moderna  COVID-19 Vaccine was not applicable. Patient was right now on her 1st trimester.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Body ache; Head ache; Felt tired; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), PYREXIA (Had a fever), HEADACHE (Head ache) and FATIGUE (Felt tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (Had a fever). On 30-Mar-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Head ache) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), PYREXIA (Had a fever), HEADACHE (Head ache) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         Concomitant products included blood pressure medication and cholesterol medication.  Action taken with mRNA-1273 in response to the events was not Applicable.  Patient reported that she still has the headache and tiredness. Patient also reported that she did not had these symptoms with her first dose.   Treatment information included paracetamol.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications not provided. Treatment information unknown. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered and she also received the dose.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Haematuria
Clinical narrative: peeing blood; back really hurts; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (peeing blood) and BACK PAIN (back really hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HAEMATURIA (peeing blood) and BACK PAIN (back really hurts). At the time of the report, HAEMATURIA (peeing blood) and BACK PAIN (back really hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator.  Treatment of these events were not provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: lost of taste; change of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost of taste) and TASTE DISORDER (change of taste) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced AGEUSIA (lost of taste) and TASTE DISORDER (change of taste). On 28-Mar-2021, AGEUSIA (lost of taste) and TASTE DISORDER (change of taste) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.