chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient told me as I was setting up a Covid vaccine event on 4/15/21 when she told me she is not sure if she had an adverse reaction to the vaccine.  She normally get heart palpations under control maybe once every month or two, but after the 1st vaccination she noticed she gets the palpations every week instead. Then on 2nd vaccination 3/28/21 she started getting it palpitations every other day.   It doesn't seem as often and it has not kept her from doing her normal activities.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt faint and his father caught him before he fell, sat in chair for >30 minutes. Had an ice bag to use against head and to chew on ice chips.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site pustule, Injection site warmth
Clinical narrative: the patient says the area of injection is very hot to the touch, somewhat itchy, red, and some small pustules. The redness started on the evening of 4/14/21 and has gotten bigger since. She had a less severe reaction to the first show which she received in the left arm one month prior.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Pain
Clinical narrative: Severe body aches, weak, dizzy,  fever, runny nose,  chills, sweating for 5 days with ongoing continued weakness.  Call doctor, was advised to take OTC painkiller. It did not relieve the symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Severe body aches, weak, dizzy,  fever, runny nose,  chills, sweating for 5 days with ongoing continued weakness.  Call doctor, was advised to take OTC painkiller. It did not relieve the symptoms.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope
Clinical narrative: Pt experienced syncope with flushing and sweating, BP 98/59, HR52, RR18. Outcome not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium increased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Cardiac failure
Clinical narrative: Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Condition aggravated, Dyspnoea, Lung opacity, N-terminal prohormone brain natriuretic peptide increased
Clinical narrative: Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pneumonia, Pulmonary oedema, SARS-CoV-2 test negative
Clinical narrative: Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Chills, Diarrhoea
Clinical narrative: Appendicitis; Chills; Stomach pain; Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of APPENDICITIS (Appendicitis) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 reported). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.  On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (Chills), ABDOMINAL PAIN (Stomach pain) and DIARRHOEA (Diarrhea). On 05-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized for 2 days due to APPENDICITIS. The patient was treated with Surgery (appendectomy) for Appendicitis. On 06-Apr-2021, APPENDICITIS (Appendicitis), CHILLS (Chills), ABDOMINAL PAIN (Stomach pain) and DIARRHOEA (Diarrhea) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: The patient said that his arm feels numb.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 years and 11 months, he will be 18 on 5-11-2021. I talked to dad, we will vaccinate on his 18 birthday. Our policy is to report  to vaers due to age under 18.  Please let me know if anything I can do. Thanks
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Patient received the COVID-19 shot (Moderna) on 03/23/21 and has been having a severe arm pain from the site of injection. She was checked by her Dr and was told that she is having a nerve pain as a result of the vaccination. She just called the pharmacy today on 04/16/2021 to report the adverse events as advised by her Doctor. According to the patient she is taking the Gabapentin 300 mg  prescribed by her Dr and it is helping her with the pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Dizziness, Dyspnoea, Hyperthyroidism, Pruritus
Clinical narrative: Aside from the usual, I had sudden weight loss, intense itching, and was out f breath easily and sometimes dizzy. It now has been diagnosed as hyperthyroid. I am undergoing more diagnosis now.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Weight decreased
Clinical narrative: Aside from the usual, I had sudden weight loss, intense itching, and was out f breath easily and sometimes dizzy. It now has been diagnosed as hyperthyroid. I am undergoing more diagnosis now.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hot flush, Pain
Clinical narrative: Began with mild headache and chills a few hours after the shot. Next morning had a fever of 101.5 that the max dose of Tylenol brought down to 99.5. Experienced chills, mild tremor (similar to low blood sugar feeling), body aches, and loss of appetite. The fever still persists at present, (approx 32 hours after vaccine, and 26 hours after symptom onset), and remains stable at 99.5. Rather than chills, I have have been having hot flashes for the past 2 hours.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Began with mild headache and chills a few hours after the shot. Next morning had a fever of 101.5 that the max dose of Tylenol brought down to 99.5. Experienced chills, mild tremor (similar to low blood sugar feeling), body aches, and loss of appetite. The fever still persists at present, (approx 32 hours after vaccine, and 26 hours after symptom onset), and remains stable at 99.5. Rather than chills, I have have been having hot flashes for the past 2 hours.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Laboratory test
Clinical narrative: Had moderate dizziness starting on 4/10 in the morning . Dizziness has not resolved as of 4/16.   Very debilitating.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Fatigue, Nausea, Vertigo
Clinical narrative: Fatigue, vertigo/balance problems, nausea, diarrhea
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Monoplegia, Paraesthesia
Clinical narrative: possible stroke; small clot that went through and resolved on its own; Loss use of left leg/couldn't use her leg; tingling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Familial hypercholesterolemia, Peripheral arterial disease and Stent placement (has stents in her iliac ery). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SERTRALINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criterion hospitalization), THROMBOSIS (small clot that went through and resolved on its own) (seriousness criterion hospitalization), MONOPLEGIA (Loss use of left leg/couldn't use her leg) (seriousness criterion hospitalization) and PARAESTHESIA (tingling in left arm) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 28-Mar-2021 due to CEREBROVASCULAR ACCIDENT, MONOPLEGIA, PARAESTHESIA and THROMBOSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: Inconclusive. In March 2021, Magnetic resonance imaging: Inconclusive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was provided.   Patient reports an MRI and CT scan was done, and she was informed that they suspected she had a small cot that went through and resolved on its own.  Company Comment: Based on the temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patient's hx of familial hypercholesterolemia, peripheral arterial disease and stent placement are confounding factors that may play a possible contributory role.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: possible stroke; small clot that went through and resolved on its own; Loss use of left leg/couldn't use her leg; tingling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Familial hypercholesterolemia, Peripheral arterial disease and Stent placement (has stents in her iliac ery). Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SERTRALINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criterion hospitalization), THROMBOSIS (small clot that went through and resolved on its own) (seriousness criterion hospitalization), MONOPLEGIA (Loss use of left leg/couldn't use her leg) (seriousness criterion hospitalization) and PARAESTHESIA (tingling in left arm) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 28-Mar-2021 due to CEREBROVASCULAR ACCIDENT, MONOPLEGIA, PARAESTHESIA and THROMBOSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (possible stroke), THROMBOSIS (small clot that went through and resolved on its own), MONOPLEGIA (Loss use of left leg/couldn't use her leg) and PARAESTHESIA (tingling in left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: Inconclusive. In March 2021, Magnetic resonance imaging: Inconclusive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was provided.   Patient reports an MRI and CT scan was done, and she was informed that they suspected she had a small cot that went through and resolved on its own.  Company Comment: Based on the temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patient's hx of familial hypercholesterolemia, peripheral arterial disease and stent placement are confounding factors that may play a possible contributory role.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Thrombosis
Clinical narrative: Pt started having headaches on 3/20/21. He was playing golf with a cardiologist and he recommended that he see his doctor.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 102 fever for 24 hours, body aches & fatigue for 48 hours
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Dizziness
Clinical narrative: Dizzyness Lightheaded Nausea  Muscle pain Nerve pain Joint pain (especially in my hips, legs, knees, ankles) Possible fever/low grade Felt hot while having chills/shivering uncontrollably  Headache  Nose, ear, and eye stuffed up/closed on the opposide side of the shot arm.  Throat itchy and felt like it was closing up at times.  Achey entire body. Keep feeling like i have to pee Peeing alot more than usual in terms of times and amount Stomach ache Spine and lower back pain on the left side Neck pain on the left side Sore throat  Left leg pain more than right leg.  Numbness and tingling in my hands and arms. More so in the left side than the right. Unable to hold a pen and write at one point *happened on wednesday* During wednesday. Had that weird pain in arm.  Started as numbness and tingling then a hot pain ive never felt before when on the very left side of my chest area up/down into my arm and down the one side of the arm and into my ring and pinkie fingers. Felt like i was in a crushing bear hug and couldnt breath Then later the same type of pain entered my left leg. Not as serve pain/feeling in chest during the leg episode Today around 740 had the same pain (none in chest) in my right leg as described above Sudical thoughts/feelings. I know its not a right thought. Feels like when i had a reaction to another medication
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear congestion, Feeling hot, Grip strength decreased, Headache
Clinical narrative: Dizzyness Lightheaded Nausea  Muscle pain Nerve pain Joint pain (especially in my hips, legs, knees, ankles) Possible fever/low grade Felt hot while having chills/shivering uncontrollably  Headache  Nose, ear, and eye stuffed up/closed on the opposide side of the shot arm.  Throat itchy and felt like it was closing up at times.  Achey entire body. Keep feeling like i have to pee Peeing alot more than usual in terms of times and amount Stomach ache Spine and lower back pain on the left side Neck pain on the left side Sore throat  Left leg pain more than right leg.  Numbness and tingling in my hands and arms. More so in the left side than the right. Unable to hold a pen and write at one point *happened on wednesday* During wednesday. Had that weird pain in arm.  Started as numbness and tingling then a hot pain ive never felt before when on the very left side of my chest area up/down into my arm and down the one side of the arm and into my ring and pinkie fingers. Felt like i was in a crushing bear hug and couldnt breath Then later the same type of pain entered my left leg. Not as serve pain/feeling in chest during the leg episode Today around 740 had the same pain (none in chest) in my right leg as described above Sudical thoughts/feelings. I know its not a right thought. Feels like when i had a reaction to another medication
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Nasal congestion, Neck pain, Oropharyngeal pain
Clinical narrative: Dizzyness Lightheaded Nausea  Muscle pain Nerve pain Joint pain (especially in my hips, legs, knees, ankles) Possible fever/low grade Felt hot while having chills/shivering uncontrollably  Headache  Nose, ear, and eye stuffed up/closed on the opposide side of the shot arm.  Throat itchy and felt like it was closing up at times.  Achey entire body. Keep feeling like i have to pee Peeing alot more than usual in terms of times and amount Stomach ache Spine and lower back pain on the left side Neck pain on the left side Sore throat  Left leg pain more than right leg.  Numbness and tingling in my hands and arms. More so in the left side than the right. Unable to hold a pen and write at one point *happened on wednesday* During wednesday. Had that weird pain in arm.  Started as numbness and tingling then a hot pain ive never felt before when on the very left side of my chest area up/down into my arm and down the one side of the arm and into my ring and pinkie fingers. Felt like i was in a crushing bear hug and couldnt breath Then later the same type of pain entered my left leg. Not as serve pain/feeling in chest during the leg episode Today around 740 had the same pain (none in chest) in my right leg as described above Sudical thoughts/feelings. I know its not a right thought. Feels like when i had a reaction to another medication
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Suicidal ideation, Throat irritation, Throat tightness
Clinical narrative: Dizzyness Lightheaded Nausea  Muscle pain Nerve pain Joint pain (especially in my hips, legs, knees, ankles) Possible fever/low grade Felt hot while having chills/shivering uncontrollably  Headache  Nose, ear, and eye stuffed up/closed on the opposide side of the shot arm.  Throat itchy and felt like it was closing up at times.  Achey entire body. Keep feeling like i have to pee Peeing alot more than usual in terms of times and amount Stomach ache Spine and lower back pain on the left side Neck pain on the left side Sore throat  Left leg pain more than right leg.  Numbness and tingling in my hands and arms. More so in the left side than the right. Unable to hold a pen and write at one point *happened on wednesday* During wednesday. Had that weird pain in arm.  Started as numbness and tingling then a hot pain ive never felt before when on the very left side of my chest area up/down into my arm and down the one side of the arm and into my ring and pinkie fingers. Felt like i was in a crushing bear hug and couldnt breath Then later the same type of pain entered my left leg. Not as serve pain/feeling in chest during the leg episode Today around 740 had the same pain (none in chest) in my right leg as described above Sudical thoughts/feelings. I know its not a right thought. Feels like when i had a reaction to another medication
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, chills & fever, headache and muscle aches which lasted for 2 days
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Chills, Dyspnoea, Fatigue
Clinical narrative: tested positive for COVID19; Headache; Fever; Fatigue; Chills; Secondary bronchitis and bacterial infection; Sore throat; Sweats; And could not breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Secondary bronchitis and bacterial infection) in a 48-year-old female patient 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 relevant medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced BRONCHITIS (Secondary bronchitis and bacterial infection) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweats), DYSPNOEA (And could not breathe through her nose), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 14-Mar-2021, the patient experienced COVID-19 (tested positive for COVID19). On 14-Mar-2021, COVID-19 (tested positive for COVID19) had resolved. At the time of the report, BRONCHITIS (Secondary bronchitis and bacterial infection), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweats), DYSPNOEA (And could not breathe through her nose), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, COVID-19: positive (Positive) positive.         This case was linked to MODERNATX, INC.-MOD-2021-074973 (E2B Linked Report).; Sender's Comments: Based on the known etiology of covid-19, , the event ofSARS-CoV-2 test positive and bronchitis is assessed as unlikely. Based on temporal association between the use of the product and onset of the other events of sore throat, headache, fever, fatigue, chills, sweats,  dyspnea , injection site as hot and she developed a large red oval rash on her shoulder, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-074973:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Oropharyngeal pain, Pyrexia
Clinical narrative: tested positive for COVID19; Headache; Fever; Fatigue; Chills; Secondary bronchitis and bacterial infection; Sore throat; Sweats; And could not breathe through her nose; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Secondary bronchitis and bacterial infection) in a 48-year-old female patient 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 relevant medical history reported).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced BRONCHITIS (Secondary bronchitis and bacterial infection) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweats), DYSPNOEA (And could not breathe through her nose), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 14-Mar-2021, the patient experienced COVID-19 (tested positive for COVID19). On 14-Mar-2021, COVID-19 (tested positive for COVID19) had resolved. At the time of the report, BRONCHITIS (Secondary bronchitis and bacterial infection), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweats), DYSPNOEA (And could not breathe through her nose), HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, COVID-19: positive (Positive) positive.         This case was linked to MODERNATX, INC.-MOD-2021-074973 (E2B Linked Report).; Sender's Comments: Based on the known etiology of covid-19, , the event ofSARS-CoV-2 test positive and bronchitis is assessed as unlikely. Based on temporal association between the use of the product and onset of the other events of sore throat, headache, fever, fatigue, chills, sweats,  dyspnea , injection site as hot and she developed a large red oval rash on her shoulder, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-074973:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually improving
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Presyncope
Clinical narrative: Patient had vasovagal response to vaccine, no loss of consciousness, but did have flushing/sweating. BP 109/67, HR68, RR15. Patient discharged in stable condition.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count, Glycosylated haemoglobin, Tinnitus
Clinical narrative: Developed strong tinnitus in left ear, which continues to this day (4/16/21).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syringe issue
Clinical narrative: Administration failure - vaccine product leaked from the syringe as dose was being given. Less than half was administered to patient. Due to it being less than half administered, we followed CDC COVID-19 Vaccine Administration Errors and Deviations protocols as outlined (https://www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations.pdf) and patient was given dose again.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Eleven days after receiving the dose, he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Eleven days after receiving the dose, he died) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 21-Feb-2021 The patient died on 21-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Unknown          Action taken with mRNA-1273 in response to the event was not applicable.  Prior to the patient's receiving his first dose of the Moderna Covid-19 vaccine series, wife reported that he was hospitalized for Covid-19 infection for three weeks. While hospitalized, he was treated for Covid-19 infection with medications unknown to her and was very sick on a ventilator in the ICU. He was then discharged to a rehab facility for several weeks and moved to a nursing home for additional rehab. Eleven days after receiving the dose, he died on 21 Feb 2021. He had been getting along well and working on coming home prior to receiving the first dose.  Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Early menstrual spotting/bleeding and cramping. I am on the 3 month birth control pill and have never experienced spotting this early into a pack.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth began shortly after the second dose and has continued.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Skin sensitisation
Clinical narrative: Fatigue, headache, body aches, chills, and skin sensitivity
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Fever of 103.3F that lasted 24 hours beginning 6pm on April 14th Violent shaking chills that lasted 18 hours beginning 10pm on April 14th Swollen lymph glands and sore throat Nausea beginning 8pm on April 14th, lasted 36 hours  Headache that is ongoing for more than 48 hours beginning within 2 hours of vaccination Feeling unable to warm up beginning 2 hours post vaccination and lasting until 9pm on April 14th Painful aching joints lasted 36 hours beginning 5pm on April 15th Fatigue began within 2 hours of vaccination, is ongoing more than 48 hours post vaccination
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever of 103.3F that lasted 24 hours beginning 6pm on April 14th Violent shaking chills that lasted 18 hours beginning 10pm on April 14th Swollen lymph glands and sore throat Nausea beginning 8pm on April 14th, lasted 36 hours  Headache that is ongoing for more than 48 hours beginning within 2 hours of vaccination Feeling unable to warm up beginning 2 hours post vaccination and lasting until 9pm on April 14th Painful aching joints lasted 36 hours beginning 5pm on April 15th Fatigue began within 2 hours of vaccination, is ongoing more than 48 hours post vaccination
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: About a week after the vaccine the lymph gland in my armpit on the same arm that I received the shot swelled up about half the size of a golf ball. Also had some fatigue that seemed to accompany this, though that could have been a coincidence with many late night interruptions to my sleep schedule because of on-call responsibilities at that time.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fall, Neck pain, Pain, Pyrexia
Clinical narrative: neck is all sore; Fainted; aching all over; Fall; temperature was 100; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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 reported).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 9:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced FALL (Fall) and PYREXIA (temperature was 100). On 06-Apr-2021 at 6:00 AM, the patient experienced PAIN (aching all over). On 06-Apr-2021 at 3:30 PM, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On 07-Apr-2021, the patient experienced NECK PAIN (neck is all sore). At the time of the report, SYNCOPE (Fainted), NECK PAIN (neck is all sore), PAIN (aching all over), FALL (Fall) and PYREXIA (temperature was 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 100 (High) 100.         No concomitant medications were reported.  On 06 Apr2021 at 6, the patient got up because she was aching all over. The patient fainted (medically significant) on the kitchen floor at about 3:30. Her temperature was 100. Her neck was all sore today 07 Apr 2021, so she was not sure if that was from the fall. Patient stated that she took some pain reliever on 06 Apr 2021.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-069995 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: neck is all sore; Fainted; aching all over; Fall; temperature was 100; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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 reported).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 9:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced FALL (Fall) and PYREXIA (temperature was 100). On 06-Apr-2021 at 6:00 AM, the patient experienced PAIN (aching all over). On 06-Apr-2021 at 3:30 PM, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On 07-Apr-2021, the patient experienced NECK PAIN (neck is all sore). At the time of the report, SYNCOPE (Fainted), NECK PAIN (neck is all sore), PAIN (aching all over), FALL (Fall) and PYREXIA (temperature was 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 100 (High) 100.         No concomitant medications were reported.  On 06 Apr2021 at 6, the patient got up because she was aching all over. The patient fainted (medically significant) on the kitchen floor at about 3:30. Her temperature was 100. Her neck was all sore today 07 Apr 2021, so she was not sure if that was from the fall. Patient stated that she took some pain reliever on 06 Apr 2021.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-069995 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: VASOVAGO PATIENT C/O DIZZINESS.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Nausea
Clinical narrative: Experienced nausea starting about 15 hours after the injection.  Went home to rest.  Started feeling fatigue, then temperature went up.  At about 20 hours after injection, temperature peaked at 101 Fahrenheit.  When I woke up the next morning, at about 34 hours after injection, most of the symptoms had disappeared or lessened.  Three days later, I still occasionally experience mild nausea.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed shingles ten days after the Covid injection. Dr. treated with an anti viral medication. Developed a rash under left arm and across left breast in area where I had radiation treatment for breast cancer. The rash lasted for three weeks.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler abnormal
Clinical narrative: DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fatigue, mild fever,  general body aches, pain at injection site and opposite arm (oddly), mild chills, headache, nausea
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fatigue, mild fever,  general body aches, pain at injection site and opposite arm (oddly), mild chills, headache, nausea
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site reaction, Pain, Rash erythematous
Clinical narrative: That night I had chills and bar ache but recovered.  On April 14th I developed a red rash on my arm where I received the shot.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual cycle began 8 days early with unusual heaviness and cramping.  Menstrual cycle has been normal for years.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Flushing, Headache, Hyperhidrosis
Clinical narrative: After about 5 minutes patient started to feel dizzy, light headed and nauseous. After a few more minutes she started to have a headache and chest paints.  Her face was flushed and sweaty. She was transferred by EMS to the hospital.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: After about 5 minutes patient started to feel dizzy, light headed and nauseous. After a few more minutes she started to have a headache and chest paints.  Her face was flushed and sweaty. She was transferred by EMS to the hospital.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness bilateral, Decreased appetite, Dizziness, Headache
Clinical narrative: Bruise approximately 1.5? in diameter at injection site & swelling, very sore shoulder muscle for next 2-3 days; Pulsating tinnitus  in right ear started 3/29/21; dizziness started 3/31/21 or 4/1/21;  headaches  and construction of facial muscles around right eye began 4-5 days after injection;  4/4/21 dizziness was accompanied by feeling of nausea and loss of appetite  Visited ENT on 4/5/21.  Audiologist assessed loss of hearing in both ears
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling, Magnetic resonance imaging head, Myalgia, Nausea
Clinical narrative: Bruise approximately 1.5? in diameter at injection site & swelling, very sore shoulder muscle for next 2-3 days; Pulsating tinnitus  in right ear started 3/29/21; dizziness started 3/31/21 or 4/1/21;  headaches  and construction of facial muscles around right eye began 4-5 days after injection;  4/4/21 dizziness was accompanied by feeling of nausea and loss of appetite  Visited ENT on 4/5/21.  Audiologist assessed loss of hearing in both ears
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bruise approximately 1.5? in diameter at injection site & swelling, very sore shoulder muscle for next 2-3 days; Pulsating tinnitus  in right ear started 3/29/21; dizziness started 3/31/21 or 4/1/21;  headaches  and construction of facial muscles around right eye began 4-5 days after injection;  4/4/21 dizziness was accompanied by feeling of nausea and loss of appetite  Visited ENT on 4/5/21.  Audiologist assessed loss of hearing in both ears
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Patient had syncope and sweating, BP 141/84, HR87, RR18. Given OJ and monitored, patient was stable and discharged in stable condition
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hot flush, Pyrexia, Vomiting
Clinical narrative: Fever, chills, hot flashes, throwing up, diarrhea, slowed armpit lymph nodes
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Antiphospholipid antibodies, Beta-2 glycoprotein antibody, Fibrin D dimer, Full blood count
Clinical narrative: Sudden onset left calf pain 4/2, increasing swelling and pain, presented for evaluation 4/9, SVT and DVT noted on ultrasound same day, started on Eliquis to manage clot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Prothrombin time, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Sudden onset left calf pain 4/2, increasing swelling and pain, presented for evaluation 4/9, SVT and DVT noted on ultrasound same day, started on Eliquis to manage clot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Sudden onset left calf pain 4/2, increasing swelling and pain, presented for evaluation 4/9, SVT and DVT noted on ultrasound same day, started on Eliquis to manage clot.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid normal, Ataxia, Carotid artery occlusion, Computerised tomogram head normal
Clinical narrative: PT BECAME SYMPTOMATIC 2 HRS POST VACCINE: DIZZY, UNSTEAD GAIT, BILAT ATAXIA, VOMITING. NEUROLOGY RECOMMENDED TPA FOR ACUTE CVA, ADMINISTERED ALTEPLASE WITH SYMTOM RESOLUTION.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Magnetic resonance imaging, Vomiting
Clinical narrative: PT BECAME SYMPTOMATIC 2 HRS POST VACCINE: DIZZY, UNSTEAD GAIT, BILAT ATAXIA, VOMITING. NEUROLOGY RECOMMENDED TPA FOR ACUTE CVA, ADMINISTERED ALTEPLASE WITH SYMTOM RESOLUTION.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Cerebrovascular accident, Computerised tomogram head normal, Dizziness, Gait disturbance
Clinical narrative: PT BECAME SYMPTOMATIC 2 HRS POST VACCINE: DIZZY, UNSTEAD GAIT, BILAT ATAXIA, VOMITING. NEUROLOGY RECOMMENDED TPA FOR ACUTE CVA, ADMINISTERED ALTEPLASE WITH SYMTOM RESOLUTION.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Sinusitis, Spinal osteoarthritis, Stenosis, Vomiting
Clinical narrative: PT BECAME SYMPTOMATIC 2 HRS POST VACCINE: DIZZY, UNSTEAD GAIT, BILAT ATAXIA, VOMITING. NEUROLOGY RECOMMENDED TPA FOR ACUTE CVA, ADMINISTERED ALTEPLASE WITH SYMTOM RESOLUTION.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: Stroke
Sex: F
Vaccine: COVID19
Symptoms: Brain stem thrombosis
Clinical narrative: Died of clots in brain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM THROMBOSIS (Died of clots in brain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced BRAIN STEM THROMBOSIS (Died of clots in brain) (seriousness criteria death and medically significant). The patient died on 30-Jan-2021. The reported cause of death was Brain stem thrombosis. It is unknown if an autopsy was performed.            This is a 76 year-old, who received mRNA-1273 Vaccine) and died 8 days after receiving first dose of vaccine and subsequently experienced brain stem thrombosis. No medical hx or conmeds were provided.  The reported cause of death was brain stem thrombosis. Very limited information has been reported at this time. Further information is expected.   This case was linked to MOD21-075103, US-MODERNATX, INC.-MOD-2021-075124 (Linked Report).; Sender's Comments: This is a 76 year-old, who received mRNA-1273 Vaccine) and died 8 days after receiving first dose of vaccine and subsequently experienced brain stem thrombosis. No medical hx or conmeds were provided.  The reported cause of death was brain stem thrombosis. Very limited information has been reported at this time. Further information is expected. MOD21-075103: US-MODERNATX, INC.-MOD-2021-075124:Patient's brother in law case; Reported Cause(s) of Death: brain stem thrombosis
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Dry throat, Eye pain, Headache
Clinical narrative: Symptoms first occurred approximately 26 hours after injection (4:30 pm following day).  Initial symptom was mild headache progressively increasing in severity with pain between the eyes and at top of left eyeball. Pain in both shoulder joints, swollen fingers, inability to sleep, dry throat, abdominal pain in liver & spleen, pain in mouth, nausea, vomiting. Symptoms lasted approximately 14 hours until 6 am.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Oral pain, Peripheral swelling, Vomiting
Clinical narrative: Symptoms first occurred approximately 26 hours after injection (4:30 pm following day).  Initial symptom was mild headache progressively increasing in severity with pain between the eyes and at top of left eyeball. Pain in both shoulder joints, swollen fingers, inability to sleep, dry throat, abdominal pain in liver & spleen, pain in mouth, nausea, vomiting. Symptoms lasted approximately 14 hours until 6 am.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal, Subarachnoid haemorrhage, Ultrasound scan
Clinical narrative: Benign perimesencephalic subarachnoid brain hemorrhage requiring ER visit, hospitalization, physical therapy plus follow up care.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse events reported. We realized after we had administered the vaccine to the patient that he was only 15 years old.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Flushing, Tremor
Clinical narrative: Within one to two minutes after receiving the vaccination her face flushed extremely red quickly followed by severe dizziness. She was shaking and having a difficult time breathing. She was provided a place to sit and a bottle of water.  Her blood pressure was 140/85.  The flushing started to fade and breathing became less difficult. Within 45 minutes she was feeling well enough to head home.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Eye pain, Eyelid rash, Herpes zoster, Lip pain
Clinical narrative: I started feeling twinges of pain on my lip inside the roof of my mouth and in the corner of my eye on Friday April 9th. This got progressively worse through weekend and I started having a rash or raised bumps in those areas. On Monday April 12th I saw my dermatologist and was diagnosed with shingles.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption, Oral pain, Rash papular
Clinical narrative: I started feeling twinges of pain on my lip inside the roof of my mouth and in the corner of my eye on Friday April 9th. This got progressively worse through weekend and I started having a rash or raised bumps in those areas. On Monday April 12th I saw my dermatologist and was diagnosed with shingles.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pregnancy test negative
Clinical narrative: Delayed menstrual cycle, no treatment, negative Home pregnancy test on 4/15/21. Date of expected period start 4/8/21. We use natural family planning and my normal mental cycles are regular.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Patient had flushing/sweating and dizziness, BP 112/71, HR91, RR16. No documentation of outcome
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Biopsy lung normal, Computerised tomogram thorax abnormal, Diffuse alveolar damage, Dyspnoea
Clinical narrative: patient was doing well as outpatient with no significant issues post-allogeneic hematopoietic cell transplant.  Received 1st Moderna COVID19 vaccine on 2/3/2021.  Developed a rash, biopsy showed lichenoid dermatitis, but no other symptoms after that first shot.  Received 2nd Moderna COVID19 vaccine on 3/12/21 and rash persisted (may or may not have worsened, hard to know from patient report) and the patient presented to medical attention on 3/23/21 acutely short of breath and hypoxic, after being able to exercise (walk 2 miles every other day, etc) prior.  Found to have biopsy proven lymphocytic interstitial pneumonitis with diffuse alveolar damage/ARDS requiring supplemental oxygen.  Started on systemic steroids without response.  Also with concurrent mild transaminitis.  From prior recent labs, LFTs were normal prior to presentation with hypoxia.