chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Not feeling well; Bad cold; No sense of smell; Ear is hurting; lingering symptoms about month ago; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Not feeling well), NASOPHARYNGITIS (Bad cold), ANOSMIA (No sense of smell), EAR PAIN (Ear is hurting) and VACCINATION COMPLICATION (lingering symptoms about month ago) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), NASOPHARYNGITIS (Bad cold), ANOSMIA (No sense of smell), EAR PAIN (Ear is hurting) and VACCINATION COMPLICATION (lingering symptoms about month ago). At the time of the report, MALAISE (Not feeling well), NASOPHARYNGITIS (Bad cold), ANOSMIA (No sense of smell), EAR PAIN (Ear is hurting) and VACCINATION COMPLICATION (lingering symptoms about month ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non-significant follow-up appended. On 29-Jul-2021: Significant Follow  up
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red patch (like a sun burn) which was also dry and scaly; Swollen left arm from shoulder to elbow; Itching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red patch (like a sun burn) which was also dry and scaly), PERIPHERAL SWELLING (Swollen left arm from shoulder to elbow), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 054C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, OMEPRAZOLE, METOPROLOL, LOSARTAN and ATORVASTATIN for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Sore arm). On 26-May-2021, the patient experienced ERYTHEMA (red patch (like a sun burn) which was also dry and scaly), PERIPHERAL SWELLING (Swollen left arm from shoulder to elbow) and VACCINATION SITE PRURITUS (Itching). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red patch (like a sun burn) which was also dry and scaly), PERIPHERAL SWELLING (Swollen left arm from shoulder to elbow), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Sore arm) outcome was unknown.            Other treatment information included, antihistamine cream was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pyrexia
Clinical narrative: Chest pain; Heaviness in chest; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), CHEST DISCOMFORT (Heaviness in chest) and PYREXIA (Fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Heaviness in chest). 04-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, CHEST PAIN (Chest pain), CHEST DISCOMFORT (Heaviness in chest) and PYREXIA (Fever) had resolved.            Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-090437 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: I'm feeling like I'm going to throw up; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (I'm feeling like I'm going to throw up) and NAUSEA (Nausea) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (I'm feeling like I'm going to throw up) and NAUSEA (Nausea). At the time of the report, VOMITING (I'm feeling like I'm going to throw up) and NAUSEA (Nausea) outcome was unknown.            no concomitant and treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: My right inner ear has hot flashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (My right inner ear has hot flashes) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (My right inner ear has hot flashes). At the time of the report, HOT FLUSH (My right inner ear has hot flashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient took the second dose as well. The patient had no adverse reactions and was doing find now. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received on 25 Jul 2021. The event outcome was updated. The reporter details were updated and second dose details added.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: myocarditis and pericarditis over the course of 5-6 weeks after the vaccines was given
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Drug hypersensitivity, Fatigue, Somnolence
Clinical narrative: Severe Debilitating chronic fatigue onset after vaccine has only gotten worse. unsure how to treat
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Extremity numbness, tingling, pins and needles.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Musculoskeletal stiffness, Nausea, Pallor
Clinical narrative: 15:50/Patient felt weak, nauseous, pale and has stiff fingers after vaccine administered  Assessed by RN and EMT Medical Staff. 02 - 98%   HR 59   BP 110/77 Remained awake, alert and oriented, very conversational No shortness of breath 16:00/Patient walked to personal car and sat comfortably and in air conditioned vehicle. 02 - 97%  HR77   BP 120/82 16:30/Patient departed with his wife driving thier vehicle after waiting and relaxing for 30 minutes.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Physical examination, Vertigo
Clinical narrative: I was doing the dishes at night as usual and all at once I felt off balance and the room started to spin...I had to sit down and it was still spinning...this went on for about 45 seconds. I have never had vertigo prior and don't even remember having dizziness ever in my life. I did have a cup of green tea just prior but I have had green tea before. Of course, I cannot say what caused this, but I can say that it was most unusual and frightening and given the close proximity in time to when I had my dose of Moderna it is possible that it was a side reaction of it. My Dr. said it was of a benign nature, sometimes an ear crystal dislodges and causes dizziness, but that it could have been from the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Human chorionic gonadotropin negative, Intermenstrual bleeding, Oligomenorrhoea, Ovarian cyst, Ultrasound scan vagina
Clinical narrative: Always have had regular cycles- never missed a period unless pregnant, never issues with infertility. I have 4 children. After receiving my first dose of Covid-19 vaccination, I had a heavy menstrual cycle. After the 2nd dose- I had 1 very light day of spotting instead of a normal menstrual period. The second following month, again, I had only one day of light spotting. I am now on my 3rd month and have had no menstrual cycle at all. I am not pregnant. The only change is the Covid-19 vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: On 15 Aug 21 at approx 2000 I had tightness in the chest, shortness of breath (SOB) , mild fatigue, and muscle pain in the right shoulder, legs and back.  On the 16 Aug 21 at approx 0930 while at work the symptoms got worse so I went home.  My PCP who told me to go to the Emergency Room.  I did not go.  I stayed at home in the bed.  On the 19 Aug 21 the tightness and (SOB) resolved; however, the fatigue got worse along with exhaustion, sore throat and a pounding headache.  At 1500 I saw  NP for clinic.  He ordered Loratadine 1 x a day and Butalbital/Acetaminophen/Caff 1 q 4 hrs prn.  I still have a headache.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: On 15 Aug 21 at approx 2000 I had tightness in the chest, shortness of breath (SOB) , mild fatigue, and muscle pain in the right shoulder, legs and back.  On the 16 Aug 21 at approx 0930 while at work the symptoms got worse so I went home.  My PCP who told me to go to the Emergency Room.  I did not go.  I stayed at home in the bed.  On the 19 Aug 21 the tightness and (SOB) resolved; however, the fatigue got worse along with exhaustion, sore throat and a pounding headache.  At 1500 I saw  NP for clinic.  He ordered Loratadine 1 x a day and Butalbital/Acetaminophen/Caff 1 q 4 hrs prn.  I still have a headache.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypophagia, Migraine, Retching, Vomiting
Clinical narrative: Extreme migraine on right side of head, vomiting/ dry heaving, unable to even keep down water, diarrhea, unable to do anything but try to sleep for 3 days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Pain
Clinical narrative: Within 3 hours of getting the johnson and johnson shot, I was in bed with a high fever (101.0).  I had chills, a massive headache, sensitivity to light, aching all over, no energy, and just wanted to sleep.  This went on for 3 days of up and down temperatures and chills.  Could not get out of bed and don't remember much of the 3 days.  Tried to drink lots of water and took Acetaminophen every 3 hours if I was awake.  I have never felt so bad in my life because I am a person who rarely gets sick.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Somnolence
Clinical narrative: Within 3 hours of getting the johnson and johnson shot, I was in bed with a high fever (101.0).  I had chills, a massive headache, sensitivity to light, aching all over, no energy, and just wanted to sleep.  This went on for 3 days of up and down temperatures and chills.  Could not get out of bed and don't remember much of the 3 days.  Tried to drink lots of water and took Acetaminophen every 3 hours if I was awake.  I have never felt so bad in my life because I am a person who rarely gets sick.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Product dose omission issue
Clinical narrative: 70 Days after First Shot, No Second Shot; Caller's wife got the first dose 8 weeks ago and wants to now get the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Caller's wife got the first dose 8 weeks ago and wants to now get the second dose.) and PRODUCT DOSE OMISSION ISSUE (70 Days after First Shot, No Second Shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Caller's wife got the first dose 8 weeks ago and wants to now get the second dose.). On 11-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (70 Days after First Shot, No Second Shot). On 02-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Caller's wife got the first dose 8 weeks ago and wants to now get the second dose.) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (70 Days after First Shot, No Second Shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported. It was reported that patient didn't receive second dose due to procrastination.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up received contact information and information on Adverse event updated
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Broke out into rash and welts all over stomach, back, chest, and spreading to underarms and pelvis area.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness bilateral, Dizziness, Lip blister, Magnetic resonance imaging head abnormal, Subdural haematoma
Clinical narrative: I had my first shot of Pfizer vaccine on 1/27/2021 and my second shot on 2/17/2021. About a few days after my second shot, I began to have some blisters on my lips, but I did not take Valtrex for fear that it might compromise the vaccine's effectiveness.  On 2/28/2021, I had a sudden bilateral hearing loss, along with dizziness and vomiting. I was rushed to the emergency room, where it was diagnosed as vestibular neuronitis, and might be due to the vaccine stirring up some immune system.  I was given a 12-day prednisone regimen. The dizziness and vomiting were gone the day I started the prednisone, but the bilateral hearing loss did not recover. On 3/24 a head MRI was performed and it demonstrated subdural hematoma.  The question I have is that might the 2/28 events be triggered by the Covid vaccine I received, directly or indirectly. If there was such a possibility, what measures should be taken to prevent or to minimize the possibility for it to happen again with future booster shots?
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Vestibular neuronitis, Vomiting
Clinical narrative: I had my first shot of Pfizer vaccine on 1/27/2021 and my second shot on 2/17/2021. About a few days after my second shot, I began to have some blisters on my lips, but I did not take Valtrex for fear that it might compromise the vaccine's effectiveness.  On 2/28/2021, I had a sudden bilateral hearing loss, along with dizziness and vomiting. I was rushed to the emergency room, where it was diagnosed as vestibular neuronitis, and might be due to the vaccine stirring up some immune system.  I was given a 12-day prednisone regimen. The dizziness and vomiting were gone the day I started the prednisone, but the bilateral hearing loss did not recover. On 3/24 a head MRI was performed and it demonstrated subdural hematoma.  The question I have is that might the 2/28 events be triggered by the Covid vaccine I received, directly or indirectly. If there was such a possibility, what measures should be taken to prevent or to minimize the possibility for it to happen again with future booster shots?
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: Knot that is hot to touch at injection site
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: I have a small red rash on my right cheek. This started about 8 hours after I received my vaccine. It has been a little itchy but seems to be improving on its own.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Electric shock sensation
Clinical narrative: Brain zaps A  startling  ,painless, wave of  sensation throughout my brain .  The sensation stops me in my tracks and I?m briefly confused  but quickly reorient .
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Disturbance in attention, Dizziness, Flushing, Vision blurred
Clinical narrative: I became flush and felt a cold sweat come over me, I was in mid conversation with a fellow employee when he asked me a question and I was unable to answer due to a lapse in my ability to form a complete thought. I then felt the room getting dark and narrowing quickly, it was then I realized I was in the process of ?passing out?. I don't believe I passed all the way out,  although the next thing I remembers was  hearing my charge nurse, asking me a series of questions while I had my legs elevated and I was lying down on the break room couch with a blood pressure cuff on my left arm and a pulse-ox on my right index finger.  I was having trouble focusing my eye sight on one object.  My blood pressure during the event hit numbers of 210/190 but slowly subsided over the course of a couple hours. I still was dizzy when attempting to ambulate with assistance for the remainder of the day. It took a full two days for me to finally return to normal. My wife came and picked me up from work where I left my personal vehicle as well as my personal belongings secured in my locker until I was able to retrieve them on Saturday.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Angiogram, CSF test, Cerebral palsy, Cytogenetic analysis, Developmental delay
Clinical narrative: Pt was a healthy and developmentally normal 6 month old. She received her regular 2, 4, and 6 month vaccinations. She had no immediate reactions to any vaccines. Her last set of vaccinations was 7/27/20.  She was in her usual state of health until 8/12/20 when she acutely developed seizures that progressed into status epilepticus and encephalopathy.  She was also found to be febrile and hypoglycemic on presentation. She spent about two weeks admitted and required multiple different anti-epileptic agents to combat her seizures.  She has not had any further seizures since that hospitalization.  She is improving but now carries a diagnosis of cerebral palsy and significant developmental delay.    All work up (infectious, metabolic, genetic) has essentially been unrevealing/undiagnostic thus far so etiology is unclear.  Neurologist favors infectious/viral etiology, but no pathogen was identified.   It is unclear whether vaccinations were related to these events or not but given lack of known etiology, cannot completely exclude the possibility.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram, Encephalopathy, Hypoglycaemia, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Pt was a healthy and developmentally normal 6 month old. She received her regular 2, 4, and 6 month vaccinations. She had no immediate reactions to any vaccines. Her last set of vaccinations was 7/27/20.  She was in her usual state of health until 8/12/20 when she acutely developed seizures that progressed into status epilepticus and encephalopathy.  She was also found to be febrile and hypoglycemic on presentation. She spent about two weeks admitted and required multiple different anti-epileptic agents to combat her seizures.  She has not had any further seizures since that hospitalization.  She is improving but now carries a diagnosis of cerebral palsy and significant developmental delay.    All work up (infectious, metabolic, genetic) has essentially been unrevealing/undiagnostic thus far so etiology is unclear.  Neurologist favors infectious/viral etiology, but no pathogen was identified.   It is unclear whether vaccinations were related to these events or not but given lack of known etiology, cannot completely exclude the possibility.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Seizure, Status epilepticus
Clinical narrative: Pt was a healthy and developmentally normal 6 month old. She received her regular 2, 4, and 6 month vaccinations. She had no immediate reactions to any vaccines. Her last set of vaccinations was 7/27/20.  She was in her usual state of health until 8/12/20 when she acutely developed seizures that progressed into status epilepticus and encephalopathy.  She was also found to be febrile and hypoglycemic on presentation. She spent about two weeks admitted and required multiple different anti-epileptic agents to combat her seizures.  She has not had any further seizures since that hospitalization.  She is improving but now carries a diagnosis of cerebral palsy and significant developmental delay.    All work up (infectious, metabolic, genetic) has essentially been unrevealing/undiagnostic thus far so etiology is unclear.  Neurologist favors infectious/viral etiology, but no pathogen was identified.   It is unclear whether vaccinations were related to these events or not but given lack of known etiology, cannot completely exclude the possibility.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Injection site mass
Clinical narrative: Within 3 hours of shot developed a large ball upper left arm and a red rash that spread throughout upper arm. Had a low grade fever, diarrhea loss of appetite for 4 days. On the 8th day the rash returned and had severe vomiting, fever, chills, loss of energy that lasted 6 days
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Within 3 hours of shot developed a large ball upper left arm and a red rash that spread throughout upper arm. Had a low grade fever, diarrhea loss of appetite for 4 days. On the 8th day the rash returned and had severe vomiting, fever, chills, loss of energy that lasted 6 days
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dizziness, Dyspnoea, Headache
Clinical narrative: Patient came in with Chest pain, SOB, dizziness, headache, tachycardia following 1st dose Pfizer vaccine. Diagnosis: subsegmental pulmonary embolism in right lower lobe.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Tachycardia
Clinical narrative: Patient came in with Chest pain, SOB, dizziness, headache, tachycardia following 1st dose Pfizer vaccine. Diagnosis: subsegmental pulmonary embolism in right lower lobe.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Patient came in with Chest pain, SOB, dizziness, headache, tachycardia following 1st dose Pfizer vaccine. Diagnosis: subsegmental pulmonary embolism in right lower lobe.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Noninfective encephalitis
Clinical narrative: Patient came in with Chest pain, SOB, dizziness, headache, tachycardia following 1st dose Pfizer vaccine. Diagnosis: subsegmental pulmonary embolism in right lower lobe.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Heart rate increased, Palpitations, Pyrexia
Clinical narrative: Heart Palpitations, increased heart rate greater than 20 bpm of baseline,  chills within 30 minutes post administration. Benadryl taken within 30 minutes of symptom onset.  Weakness and chills 12 hours after administration.  Fever of 100.6 and chills 24-36 hours post administration.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Circumoral swelling, Swelling face
Clinical narrative: At approximately minute 13 in the 15 minutes of observation after receiving the vaccine my face started to swell around my mouth. Blood pressure was elevated (150/100) and I was observed for about 40 minutes until blood pressure was within normal limits and facial swelling subsided.  No treatment was given other than the observation and several blood pressure readings.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered patient under age of 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered patient under age of 18) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered patient under age of 18). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered patient under age of 18) 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.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: Extreme lower back pain. Throbbing pain not improving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Cough, Dyspnoea, Musculoskeletal chest pain
Clinical narrative: Shortness of breath, severe chest pain, debilitating pain with inability to take deep breaths, visit to ER - all tests came back negative and patient was sent home. continued to experience bouts of severe pain in the chest, left side rib cage, back left shoulder for two weeks, dry cough appeared on day 3 and developed into a severe cough, sleep disrupted, acute symptoms subsided after two weeks, and breathing returned to normal after one month. Use of ibuprofen helped relieve the pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Sleep disorder
Clinical narrative: Shortness of breath, severe chest pain, debilitating pain with inability to take deep breaths, visit to ER - all tests came back negative and patient was sent home. continued to experience bouts of severe pain in the chest, left side rib cage, back left shoulder for two weeks, dry cough appeared on day 3 and developed into a severe cough, sleep disrupted, acute symptoms subsided after two weeks, and breathing returned to normal after one month. Use of ibuprofen helped relieve the pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Rash, Rash vesicular
Clinical narrative: Allergic rash, with blisters,  all over body Still seeking medical care , have been given steroid, benadryl, pepsid hydoxzine,steroid cream, oatmeal baths
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: severe nose bleeds; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EPISTAXIS (severe nose bleeds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced EPISTAXIS (severe nose bleeds). At the time of the report, EPISTAXIS (severe nose bleeds) outcome was unknown.            Treatment information were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Respiratory symptom
Clinical narrative: have symptoms and have been exposed to covid; Having upper respiratory symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (have symptoms and have been exposed to covid) and RESPIRATORY SYMPTOM (Having upper respiratory symptoms) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (have symptoms and have been exposed to covid) and RESPIRATORY SYMPTOM (Having upper respiratory symptoms). At the time of the report, EXPOSURE TO SARS-COV-2 (have symptoms and have been exposed to covid) and RESPIRATORY SYMPTOM (Having upper respiratory symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment information was provided no concomitant medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: sick; COVID positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and SARS-COV-2 TEST POSITIVE (COVID positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced ILLNESS (sick) and SARS-COV-2 TEST POSITIVE (COVID positive). At the time of the report, ILLNESS (sick) and SARS-COV-2 TEST POSITIVE (COVID positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment mediation were reported.  Patient informed that he had  sick for 9days he think he had covid  will a test so a positive reading now that he is better.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash that moved all over my body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that moved all over my body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced RASH (Rash that moved all over my body). At the time of the report, RASH (Rash that moved all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: warmth at injection site and spread across forearm; redness at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site and spread across forearm) and VACCINATION SITE ERYTHEMA (redness at injection site ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth at injection site and spread across forearm) and VACCINATION SITE ERYTHEMA (redness at injection site ). At the time of the report, VACCINATION SITE WARMTH (warmth at injection site and spread across forearm) and VACCINATION SITE ERYTHEMA (redness at injection site ) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Feeling abnormal, Myalgia
Clinical narrative: Cough; Feel horrible; no appetite; Sneezing; Just sleeping in Bed; Fever; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing) and SOMNOLENCE (Just sleeping in Bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), SOMNOLENCE (Just sleeping in Bed), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), SOMNOLENCE (Just sleeping in Bed), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sneezing, Somnolence
Clinical narrative: Cough; Feel horrible; no appetite; Sneezing; Just sleeping in Bed; Fever; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing) and SOMNOLENCE (Just sleeping in Bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), SOMNOLENCE (Just sleeping in Bed), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), FEELING ABNORMAL (Feel horrible), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), SOMNOLENCE (Just sleeping in Bed), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: bad joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (bad joint pain) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (bad joint pain). At the time of the report, ARTHRALGIA (bad joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: vaccine site itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccine site itch) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (vaccine site itch). At the time of the report, VACCINATION SITE PRURITUS (vaccine site itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Joint swelling, Oedema peripheral, Thrombosis
Clinical narrative: The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down; The patient experienced on the right leg from the knee to foot was swelling; Feeling as if clot is coming up; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down), JOINT SWELLING (The patient experienced on the right leg from the knee to foot was swelling), COUGH (Coughing) and THROMBOSIS (Feeling as if clot is coming up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 038B71A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included SPIRONOLACTONE and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced COUGH (Coughing). On an unknown date, the patient experienced OEDEMA PERIPHERAL (The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down), JOINT SWELLING (The patient experienced on the right leg from the knee to foot was swelling) and THROMBOSIS (Feeling as if clot is coming up). At the time of the report, OEDEMA PERIPHERAL (The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down), COUGH (Coughing) and THROMBOSIS (Feeling as if clot is coming up) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: No specific follow-up information recorded. On 02-Jun-2021: Follow up
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Loss of appetite; Nausea; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (Fever) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PYREXIA (Fever). On 29-May-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and NAUSEA (Nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Body temperature: 102 degree (High) 102 degree.         No concomitant medications were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: large rash at the injection site; sore arm muscle at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (large rash at the injection site) and VACCINATION SITE PAIN (sore arm muscle at the injection site) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (large rash at the injection site) and VACCINATION SITE PAIN (sore arm muscle at the injection site). At the time of the report, VACCINATION SITE RASH (large rash at the injection site) and VACCINATION SITE PAIN (sore arm muscle at the injection site) 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.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: skin reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reaction). At the time of the report, SKIN REACTION (skin reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 49 days since 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (49 days since 1st dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (49 days since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (49 days since 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (bad headaches). At the time of the report, HEADACHE (bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact