chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Type 1 diabetes mellitus
Clinical narrative: I was diagnosed with type 1 diabetes in 1997. I have never had any complications. On Thursday, 4/15/21, I had a seizure in bed and was taken to the emergency room. While the cause is unknown at this time, and I doubt it is related to the vaccine, I thought I should report it.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Red blotchy and warm at injection site. Feels like a 2 inch knot under the skin. Itches occasionally.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Fatigue, Hypoaesthesia oral, Injection site induration
Clinical narrative: The inside of my mouth felt scalded starting about 20 mins post injection.  The roof of my mouth was numb, my tongue felt burned, and my lips were slightly numb.  I had no swelling or airway restriction.  My tongue still feels slightly burned.  I also had terrible heartburn and digestive problems the first 5-7 days.  I am still very fatigued and the injection site is still tender (the injection felt like I was having a marble injected into my arm).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oral discomfort, Tongue discomfort
Clinical narrative: The inside of my mouth felt scalded starting about 20 mins post injection.  The roof of my mouth was numb, my tongue felt burned, and my lips were slightly numb.  I had no swelling or airway restriction.  My tongue still feels slightly burned.  I also had terrible heartburn and digestive problems the first 5-7 days.  I am still very fatigued and the injection site is still tender (the injection felt like I was having a marble injected into my arm).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Lip swelling nd tingling of lips. No other symptoms.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: I got diagnosed with Cellulitis at the injection site on my left arm. Arm was swollen, inflamed, tender/sore, extremely hot to touch, and itchiness. Prescribed Sulfameth/Trimethoprim 800/160MG TB. The one pill twice a day for 7 days. Most of symptoms have gone away except for a tender/hard lump and itchiness.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: I got diagnosed with Cellulitis at the injection site on my left arm. Arm was swollen, inflamed, tender/sore, extremely hot to touch, and itchiness. Prescribed Sulfameth/Trimethoprim 800/160MG TB. The one pill twice a day for 7 days. Most of symptoms have gone away except for a tender/hard lump and itchiness.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Chills and unwell for 12 hours
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Moderna arm   painful red hot itchy large area on arm 2 inches below jab. Also very painful joint pain especially in hands  wrists and arms  much worse with this second shot  the Moderna arm did not appear with first shot  but joint pain started a few days after  first  shot  now worse pain a few days after second  shot  used  and using cold packs on Moderna arm did  not use anything for joint pain
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 14-Feb-2021 to 01-Apr-2021 due to COVID-19. On 01-Apr-2021, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Patient received Lipitor and "some blood pressure medication" as concomitants.  The patient received the Plasma Therapy as a treatment. Patient still in pretty bad shape, patient wants to know she need to receive second dose or not.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the event is assessed as unlikely related to mRNA-1273.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Petechiae, Skin lesion
Clinical narrative: Petechiae lesion developed on my wrist. It went away in about 3 days.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Pain
Clinical narrative: Sore arm at injection site, continuing through next day. Low grade fever/chills about 12 hours after injection. Significant dizziness, lightheadedness, headache and short fainting episode about 16 hours after injection, then mild headache and body ache throughout the rest of the day.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Sore arm at injection site, continuing through next day. Low grade fever/chills about 12 hours after injection. Significant dizziness, lightheadedness, headache and short fainting episode about 16 hours after injection, then mild headache and body ache throughout the rest of the day.
Age: 59.0
Sex: F
Vaccine: HEPAB, UNK, UNK
Symptoms: Asthenia, Back pain, Ear pain, Headache, Myalgia
Clinical narrative: Headache, earache, muscle aches, weakness, nausea, back pain, cold
Age: 59.0
Sex: F
Vaccine: HEPAB, UNK, UNK
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: Headache, earache, muscle aches, weakness, nausea, back pain, cold
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: When the doctor inserted the needle it disconnected from the hub of the syringe and all the vaccine dripped down patients arm. She removed the needle and gave a new dose in the opposite arm
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: Blood clot in the right leg; Blood clot in the lungs; Blood clot in the hip; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in the hip), THROMBOSIS (Blood clot in the right leg) and PULMONARY EMBOLISM (Blood clot in the lungs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 015L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced THROMBOSIS (Blood clot in the hip) (seriousness criteria hospitalization and medically significant). In March 2021, the patient experienced THROMBOSIS (Blood clot in the right leg) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (Blood clot in the lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 16-Mar-2021 due to PULMONARY EMBOLISM, THROMBOSIS, THROMBOSIS At the time of the report, THROMBOSIS (Blood clot in the hip), THROMBOSIS (Blood clot in the right leg) and PULMONARY EMBOLISM (Blood clot in the lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that 2-3 weeks after receiving the second shot they had a blood clot in the hip and a week later they had a blood clot in the right leg and in the lungs. Patient reports they had to be hospitalized for two nights, in the Medical City Fort Worth Hospital. Patient states they do not have any history of blood clots. Patient mentioned reading online, in forums, that people had taken Pfizer and Moderna vaccines and two weeks after had blood clots and ended in the hospital.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Peripheral swelling, Ultrasound scan
Clinical narrative: Pain in left side groin area with swelling of left calf and foot
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cough, Discomfort, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Left-sided facial numbness/heaviness, some numbness in left arm.  Patient consulted Dr and was advised that this is caused by her immune response.  Spoke to pt again at 659pm and numbness was improving.  Said she did have a choking/coughing spell due to some numbness in her mouth.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS 17 YEARS AND 9 MONTHS AT TIME OF INJECTION.  NOT 18  PER EUA.  NO SIGNS/SYMPTOMS OF ADVERSE EFFECT.   WILL FOLLOW CDC GUIDELINE AND ADMINSTER 2ND MODERNA DOSE AS OFF-LABEL USE.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Thirst
Clinical narrative: Exhaustion, thirst, joint pain, vertigo, headache, chills, Everything was severe.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge, Vertigo
Clinical narrative: Exhaustion, thirst, joint pain, vertigo, headache, chills, Everything was severe.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Felt faint after immunization, fell and hit right side of head, denies LOC. Reports history of vasovagal responses to vaccines. Initial BP 53/40, HR48, 17 minutes later recovered with BP 105/66, left in stable condition
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Headache the night I got the shot and then 2 days after I got a red rash the size of a quarter on my arm at the injection site along with itching and swelling. It went away shortly after (a day) and then returned on day 7 after the shot, this time bigger and lasted 3 days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Feeling abnormal
Clinical narrative: lost most the hearing in the left ear; had a bad day generally; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (lost most the hearing in the left ear) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DEAFNESS UNILATERAL (lost most the hearing in the left ear) (seriousness criterion medically significant) and FEELING ABNORMAL (had a bad day generally). In April 2021, DEAFNESS UNILATERAL (lost most the hearing in the left ear) was resolving. At the time of the report, FEELING ABNORMAL (had a bad day generally) outcome was unknown.            No relevant concomitant medications were reported. The patient confirmed lost most of the hearing in the left ear by a visit to the clinic after a hearing exam was done. The patient stated that he can hear better now but the left ear was not usable and could not use a telephone. It was better now but still not ok and was still "metallic." The patient does not know if 2nd dose had influenced the hearing and stated that he did not have prior history of hearing issues. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Loss of consciousness, Rash
Clinical narrative: Patient received vaccine on Tuesday 4/13/21 and on the following Thursday 4/15/21, she stated that she woke up feeling dizzy and faint.  She stated that she did pass ou and hit her head and that she broke out in a rash all over her body.  She went to the ER where they gave her Solu Medrol, benadryl and pepcid.  She was back at home when she called to make us aware of this.  She said that was feeling better and that the rash was almost gone
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Rash, Rash pruritic
Clinical narrative: Had a pretty severe bloody nose the evening I received my 1st COVID 19 shot. It lasted approx 20 minutes until stopped completely.  It scared me as I don't have bloody noses. I also started developing a pretty bad rash around my belly button on the 3rd day after my shot. It was painful and itchy and I couldnt wear pants that buttoned for about 4 days. It cleared up with some steroid cream I had.  Wasn't sure if these were big enough effects to report but decided to go ahead and do so.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Fatigue, Headache, Pain in extremity
Clinical narrative: 37yo Female, presenting with bilateral foot pain/burning sensation since receiving 2nd COVID moderna vaccination on 4/4. Symptoms also included fever, HA, fatigue, which resolved with exception of still feeling fatigue and foot pain. With the foot pain, has not improved, spends most of day on feet, worse pain at end of day. She also noted about 6 small new bruises from knees down, but was unable to show on video (patient at work), but no bruises on feet. Normal appearing feet, patient feels more swollen. Last CBC 1/2020, normal platelets. Denies CP, SOB, leg swelling, erythema. concern whether neuropathy  is a side effect of vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: 37yo Female, presenting with bilateral foot pain/burning sensation since receiving 2nd COVID moderna vaccination on 4/4. Symptoms also included fever, HA, fatigue, which resolved with exception of still feeling fatigue and foot pain. With the foot pain, has not improved, spends most of day on feet, worse pain at end of day. She also noted about 6 small new bruises from knees down, but was unable to show on video (patient at work), but no bruises on feet. Normal appearing feet, patient feels more swollen. Last CBC 1/2020, normal platelets. Denies CP, SOB, leg swelling, erythema. concern whether neuropathy  is a side effect of vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Injection #1:  Left Deltoid hard and swollen with pain on palpation for 3 weeks.  Heat and massage used to reduce.  Injection #2:  Headache for 5 days, fever, chills, body aches 3 days, nausea 3 days, vomiting 1 day, diarrhea 1 day.  Fatigue 7 days.  Self resolving.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Injection #1:  Left Deltoid hard and swollen with pain on palpation for 3 weeks.  Heat and massage used to reduce.  Injection #2:  Headache for 5 days, fever, chills, body aches 3 days, nausea 3 days, vomiting 1 day, diarrhea 1 day.  Fatigue 7 days.  Self resolving.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Overall itching, no rash
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Cold sweat, Disorientation
Clinical narrative: Severe Fever-like symptoms -- Chills. Disorientation. Cold Sweats. Joint Pain. Stomach Irritation. Nausea.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe Fever-like symptoms -- Chills. Disorientation. Cold Sweats. Joint Pain. Stomach Irritation. Nausea.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Angiogram pulmonary abnormal, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Asthenia
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bilevel positive airway pressure, Biopsy bone marrow normal, Blood fibrinogen increased, Blood glucose increased, Blood immunoglobulin G increased
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood smear test abnormal, Bronchoscopy normal, Chest pain, Echocardiogram abnormal, Ehrlichia test
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Fatigue, Histone antibody negative, Intensive care, Interleukin-2 receptor assay
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis, Neutrophil percentage increased
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count increased, Pleural effusion, Pleuritic pain, Polychromasia, Pulmonary oedema
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory distress, Serum ferritin increased, Shock, Upper respiratory tract infection
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Pallor
Clinical narrative: Patient made an appointment for the COVID-19 vaccine (Pfizer). Patient let us know that he has medical induced anxiety. He has passed out from random medical appointments in the past. Patient was sitting within eye view of the pharmacy. A passing by gentleman said "Dude, are you ok?". I looked over and the gentleman was no longer in his chair. Customer helped gentleman into the chair. The nurse who administered the shot and myself (pharmacist) ran out with the emergency kit. Patient was conscious, but had no color in his face. We gave him water, orange juice, and moist towel for his forehead. Nurse took pulse, it was within normal range. Called 911, EMTs arrived. Patient declined any more help. He walked out of the pharmacy area. Total time of event: 15 minutes.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS 17 YEARS AND 9 MONTHS AT TIME OF INJECTION; NOT AT 18 YEARS OLD PER EUA.  NO ADVERSE EVENTS REPORTED (NO SIGNS/SYMPTONS REPORTED).  WILL FOLLOW CDC GUIDELINES AND ADMINSTER 2ND DOSE OF MODERNA IN 28 DAYS PER OFF USE LABEL.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: DBD blood clot in leg; Arm got little sore; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (DBD blood clot in leg) 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.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm got little sore). On 05-Apr-2021, the patient experienced THROMBOSIS (DBD blood clot in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (DBD blood clot in leg) outcome was unknown and PAIN IN EXTREMITY (Arm got little sore) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reportedly, the patient's sore arm went away pretty fast. The patient received treatment with Xarelto (Rivaroxaban) for blood clot in his leg.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Severe fatigue onset at approx 23 hours post-injection. Nausea onset at approx 44 hours post-injection. Treated with rest and ginger ale.  Symptoms persist 75 hours post-injection.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Ear pain, Headache, Laboratory test
Clinical narrative: Consistent non stop headache, sinus pain and inner ear ache, primarily on the left side of the body/ head.  swollen lymph glands on the left side of the neck.   Pain on sinuses and above eye on the left side of the head.   Headache and ear pain have been present and consistent for 7 days.  Abdominal pain started on day 6 and bloating of the upper abdominal area.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Sinus pain, Urine analysis
Clinical narrative: Consistent non stop headache, sinus pain and inner ear ache, primarily on the left side of the body/ head.  swollen lymph glands on the left side of the neck.   Pain on sinuses and above eye on the left side of the head.   Headache and ear pain have been present and consistent for 7 days.  Abdominal pain started on day 6 and bloating of the upper abdominal area.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Neck pain, Pain
Clinical narrative: Vaccine administered 12 APR about 0830 hours and all fine that day.  Next day (13 APR) my father awoke feeling tired, somewhat sluggish and experienced a little diarrhea. 14 APR, still a hint of diarrhea but now tired and with pain in the back of his neck and his body ached all over, but pain was mild and these conditions lasted through 15 APR 21.  No fever or headache observed.  Today he awoke and felt fine, no additional issues to report but will report anything else should it occur.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Disturbance in attention, Sleep disorder
Clinical narrative: I've had mild tinnitus for 20 years, only noticeable when very quiet, like at night when going to bed, but not severe enough to interfere with sleep. Ten days after the shot it was like someone flipped a switch and suddenly the tinnitus was a lot louder, to the point where it is always audible, even over other noise, and does interfere with sleep and concentration.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Pt complained of numbness at injection site in L arm, radiating down to forearm. BP 151/90, HR89, RR18. No other symptoms or visual changes, self-resolved. Pt discharged in stable condition
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted twice
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Malaise, Nausea, Rash
Clinical narrative: I had a temperature of 104 about four hours after getting the vaccination. I had the temperature for a few hours and then I started feeling nauseous and threw up. I felt terrible the next day with a very bad headache and  five days later I developed a rash on my arms and legs.  It finally subsided but then reoccurred the next day.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I had a temperature of 104 about four hours after getting the vaccination. I had the temperature for a few hours and then I started feeling nauseous and threw up. I felt terrible the next day with a very bad headache and  five days later I developed a rash on my arms and legs.  It finally subsided but then reoccurred the next day.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pain, Pyrexia
Clinical narrative: Fever, body ache, headache, feel heavy in my left arm
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Musculoskeletal stiffness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I was still having arm pain and my left hand clenched and then me left leg went out to the left."; arm became sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (I was still having arm pain and my left hand clenched and then me left leg went out to the left.") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included VITAMIN D3 and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm became sore). On 03-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I was still having arm pain and my left hand clenched and then me left leg went out to the left.") (seriousness criteria hospitalization and medically significant). On 09-Apr-2021, MUSCULOSKELETAL STIFFNESS (I was still having arm pain and my left hand clenched and then me left leg went out to the left.") and PAIN IN EXTREMITY (arm became sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: not provided Results were not mentioned.. On an unknown date, Chest X-ray: not provided Results were not mentioned.. On an unknown date, SARS-CoV-2 test: not provided Results were not mentioned..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wiped the injection site with alcohol took 2 Tylenol and used a heating pad and ice, with no relief. The patient was given IV and hydromorphone was given for pain management. The patient also mentioned that she was otherwise a healthy person, who exercised well, did not eat meat or drink soda. The patient was scheduled for the 2nd dose of Moderna Covid-19 Vaccine on 26-Apr-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tickling in feet
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortage of breath
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram normal, Fibrin D dimer normal, Headache, International normalised ratio normal, Petechiae
Clinical narrative: vaccine info unknown patient with hx of itp resolved 9 years ago. developed very minor petechiae and headache
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Platelet count decreased, Prothrombin level normal
Clinical narrative: vaccine info unknown patient with hx of itp resolved 9 years ago. developed very minor petechiae and headache
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pyrexia
Clinical narrative: High fever 102 degrees Severe headache Chills
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Strong chills, fever of 101.8 for 8 hours (8:30pm-4:30am). Then body aches, fatigue, headache, injection site swelling and soreness, swollen left armpit lymph node for all of 4/16/2021. These symptoms have not yet fully subsided, but I anticipate they will soon. Managing headache with Tylenol.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Strong chills, fever of 101.8 for 8 hours (8:30pm-4:30am). Then body aches, fatigue, headache, injection site swelling and soreness, swollen left armpit lymph node for all of 4/16/2021. These symptoms have not yet fully subsided, but I anticipate they will soon. Managing headache with Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Pallor, Slow response to stimuli
Clinical narrative: Patient in observation area began to feel "fuzzy" after vaccination.  Patients mother stated she has a history of fainting.  Patient was pale, diaphoretic, and limited responsiveness.  PHN place patient on cot and administered oxygen at 6 liters.  Vital signs of 109/73, HR 72, and 98% oxygen.  Patient on oxygen for 10 minutes.  Patient recovered well without concern.  Patient sent home in stable condition with her mother and told to call her MD if she has further concerns.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: fever, headache, body pain, chills, sweating
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea; abdominal pain; Passed out; headache; chills; low grade fever; body aches; Exhaustion; blood pressure was really low; could not sleep that night/it was like if somebody gave me speed; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. -26B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (could not sleep that night/it was like if somebody gave me speed) and NAUSEA (nauseous). On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOTENSION (blood pressure was really low), HEADACHE (headache), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (Exhaustion). On 12-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain). On 13-Apr-2021, the patient experienced DIARRHOEA (diarrhea). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. On 11-Apr-2021, HYPOTENSION (blood pressure was really low), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (Exhaustion) had resolved. At the time of the report, INSOMNIA (could not sleep that night/it was like if somebody gave me speed) and DIARRHOEA (diarrhea) outcome was unknown and ABDOMINAL PAIN (abdominal pain), NAUSEA (nauseous) and HEADACHE (headache) had not resolved. Not Provided          Concomitant  medications were not reported. Treatment medication included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Insomnia, Loss of consciousness, Myalgia, Nausea
Clinical narrative: diarrhea; abdominal pain; Passed out; headache; chills; low grade fever; body aches; Exhaustion; blood pressure was really low; could not sleep that night/it was like if somebody gave me speed; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. -26B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (could not sleep that night/it was like if somebody gave me speed) and NAUSEA (nauseous). On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOTENSION (blood pressure was really low), HEADACHE (headache), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (Exhaustion). On 12-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain). On 13-Apr-2021, the patient experienced DIARRHOEA (diarrhea). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. On 11-Apr-2021, HYPOTENSION (blood pressure was really low), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (Exhaustion) had resolved. At the time of the report, INSOMNIA (could not sleep that night/it was like if somebody gave me speed) and DIARRHOEA (diarrhea) outcome was unknown and ABDOMINAL PAIN (abdominal pain), NAUSEA (nauseous) and HEADACHE (headache) had not resolved. Not Provided          Concomitant  medications were not reported. Treatment medication included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: diarrhea; abdominal pain; Passed out; headache; chills; low grade fever; body aches; Exhaustion; blood pressure was really low; could not sleep that night/it was like if somebody gave me speed; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. -26B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (could not sleep that night/it was like if somebody gave me speed) and NAUSEA (nauseous). On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPOTENSION (blood pressure was really low), HEADACHE (headache), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (Exhaustion). On 12-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal pain). On 13-Apr-2021, the patient experienced DIARRHOEA (diarrhea). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. On 11-Apr-2021, HYPOTENSION (blood pressure was really low), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (Exhaustion) had resolved. At the time of the report, INSOMNIA (could not sleep that night/it was like if somebody gave me speed) and DIARRHOEA (diarrhea) outcome was unknown and ABDOMINAL PAIN (abdominal pain), NAUSEA (nauseous) and HEADACHE (headache) had not resolved. Not Provided          Concomitant  medications were not reported. Treatment medication included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine.  Ultrasound confirmed superficial blood clot from ankle to knee.