chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Traumatic lung injury
Clinical narrative: FELL; panctured lung; Broken ribs; small complication; diagnosed with covid19; A spontaneous report received from a Consumer concerning, 95-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and experienced falling, punctured lung, broken ribs and diagnosed with COVID-19 on 05FEB2021.     The patient's medical history was not included. Patient's concomitant was not included.  On 06JAN2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient daughter-in-law stated that the patient received her first Moderna COVID-19 vaccine on 06JAN2021. Patient daughter-in -law stated that the patient fell the next day and punctured her lung, broke her ribs, and had small complication (unspecified). Patient daughter-in-law stated that the patient was moved to a rehab facility after hospitalization. Patient daughter-in-law stated that the patient was diagnosed with COVID-19 on 05FEB2021. Consent was provided for follow up from safety.    Treatment information was not provided/ unknown  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/ not reported.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation "AFib" - Heart Rate of 150 BPM; A spontaneous report was received from an 87-year-old male patient, who experienced Atrial fibrillation - Heart Rate of 150 BPM.  The patient's medical history included Atrial fibrillation (Afib). Relevant concomitant medication included amiodarone.  The consumer received the first of the two planned doses of mRNA-1273 on 03-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same day, he experienced Atrial fibrillation - Heart Rate of 150 BPM.  No treatment information was provided.  On 04-MAR-2021, the patient received the second of the two planned doses of the mRNA-1273 in an unknown route.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event Atrial fibrillation "AFib" - Heart Rate of 150 BPM was resolved.  The report's causality assessment was not provided for the event.  Follow-up received on 05-MAR-2021 included Atrial fibrillation (Afib) as the consumer's historical condition. Consumer reported that he was in Afib for about 9 days. Doctors changed some of his medications that has helped with his condition. Consumer had his second dose of the vaccine on 04-MAR-2021 and has had no issues with AFib.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: pain near injection site; Vaccine administered a bit higher on arm; A spontaneous report was received from a male patient (unknown age) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain near injection site and vaccine administered a bit higher on arm.  The patient's medical history was not provided. No concomitant product use was reported.  ON 30-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.   The patient stated that he experienced pain near the injection site on left arm. The patient also mentioned that he believes the vaccine was administered a bit high on the arm than where it should have been administered- closer to his shoulder blade. Treatment included Tylenol (acetaminophen) and Advil (ibuprofen).  Action taken with mRNA-1273 was not applicable.  The outcome of the event, pain near injection site, was not recovered. The outcome of the event, vaccine administered a bit higher on arm, was considered recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 026L20A)  with AE reported of injection site pain.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Incorrect dose administered, Injection site pain
Clinical narrative: Only had 0.3ML instead of 0.5ML; Sore arm; Bad headache; Chills; A spontaneous report was received from a 25-years-old female pharmacist (patient) who received Moderna's COVID-19 Vaccine (mRNA-1273) and  experienced only had 0.3ML instead of 0.5ML of vaccine/ incorrect dose administered, headache, chills, and sore arm/ injection site pain.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included spironolactone 50mg.  On 11-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient said she only had 0.3ML instead of 0.5ML. The patient also reported that she had a bad headache and chills the same day after being vaccinated but went well after taking Tyenol. Patient also reported that she had a sore arm. Treatment for the event included paracetamol.   The outcome of event, sore arm, was unknown. The outcome of the events, headache, chills, and only had 0.3ML instead of 0.5ML of vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 030M20A)  with associated AEs reported as headache, chills and sore arm
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Blood pressure measurement, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: out of sorts; dry heaving; so dizzy couldn't see; sweating to death; so dizzy couldn't see; A spontaneous report was received from a consumer who was a 76-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts.  The patient's medical history included stroke and hypertension. Concomitant products included hydrazine and meclizine.  On 01-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01-Mar-2021, the same day of vaccine administration, the patient experienced sweating to death and so dizzy that she could not see. Her husband took her to the emergency room on 02-Mar-2021 and on the way, she was dry heaving. Her blood pressure at the hospital was 127/108.  She stayed in the emergency room for 12 hours and took blood pressure medication hydrazine and Meclizine, which helped. On 03-Mar2021, she reported that she was still out of sorts and lightheaded.  Treatment information for the events was not reported.   Action taken with mRNA-1273 with respect to the events was not reported.  The outcomes of the events, sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts, were considered unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Patient has a history of stroke and hypertension.
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: out of sorts; dry heaving; so dizzy couldn't see; sweating to death; so dizzy couldn't see; A spontaneous report was received from a consumer who was a 76-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts.  The patient's medical history included stroke and hypertension. Concomitant products included hydrazine and meclizine.  On 01-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01-Mar-2021, the same day of vaccine administration, the patient experienced sweating to death and so dizzy that she could not see. Her husband took her to the emergency room on 02-Mar-2021 and on the way, she was dry heaving. Her blood pressure at the hospital was 127/108.  She stayed in the emergency room for 12 hours and took blood pressure medication hydrazine and Meclizine, which helped. On 03-Mar2021, she reported that she was still out of sorts and lightheaded.  Treatment information for the events was not reported.   Action taken with mRNA-1273 with respect to the events was not reported.  The outcomes of the events, sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts, were considered unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Patient has a history of stroke and hypertension.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; A spontaneous report was received from a pharmacist concerning a 73-year-old male patient who developed Bells palsy.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and metoprolol.  On 01 Mar 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   In Mar 2021 (date not specified), the patient developed Bells palsy, and was subsequentlyadmitted to the emergency room/hospital. Treatment included intravenous fluids.  Action taken with mRNA-1273 was not provided.  The outcome of the event, bell's palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Urosepsis
Clinical narrative: 23 days after receiving the vaccine was hospitalized because of an urosepsis; A spontaneous report was received from a other healthcare professional concerning a 70-year-old male patient experienced urosepsis 23 days after receiving the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received the first of the two planned doses of mRNA-1273 on 01-FEB-2021 in unknown arm (Batch: 004M20A)  intramuscularly for prophylaxis of COVID-19 infection.   On 03-MAR-2021, 23 days after receiving the vaccine was hospitalized because of an urosepsis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown.  The assessment was not provided for the event.; Reporter's Comments: The event was consistent with increased risk of complications associated with elderly age of patient. Company assessed the event to be unlikely related to company product.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Burning sensation, Dyspnoea, Hemiparesis, Muscular weakness
Clinical narrative: Bells Palsy; he lost strength in his left face, arm, and leg; Felt nauseous; couldn't breathe; burning sensation from the left side of face from temple to neck; Localized muscle weakness; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bell's palsy, nausea, dyspnea, burning sensation in face and localized muscle weakness.    The patient's medical history included covid-19 . Products known to have been used by the patient, within two weeks prior to the event, not provided.  On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient  felt nauseous and couldn't breathe. The feeling went away so he did not think too much of it. 30 minutes after that, he lost strength in his left face, arm, and leg and diagnosed with Bells Palsy. There was a burning sensation from the left side of his face from  the temple to the neck.  Treatment for the event was not reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event's,reported, was considered not recovered..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Bells Palsy; he lost strength in his left face, arm, and leg; Felt nauseous; couldn't breathe; burning sensation from the left side of face from temple to neck; Localized muscle weakness; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bell's palsy, nausea, dyspnea, burning sensation in face and localized muscle weakness.    The patient's medical history included covid-19 . Products known to have been used by the patient, within two weeks prior to the event, not provided.  On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient  felt nauseous and couldn't breathe. The feeling went away so he did not think too much of it. 30 minutes after that, he lost strength in his left face, arm, and leg and diagnosed with Bells Palsy. There was a burning sensation from the left side of his face from  the temple to the neck.  Treatment for the event was not reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event's,reported, was considered not recovered..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Dysstasia, Nephrolithiasis, Pain
Clinical narrative: Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones).  Patient also reported that patient was having a difficult time breathing.  Treatment for the event included receiving oxygen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones).  Patient also reported that patient was having a difficult time breathing.  Treatment for the event included receiving oxygen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Dyspnoea, Palpitations, Presyncope
Clinical narrative: back pain; difficulty breathing; heart racing; heart hurting; felt like she would pass out; A spontaneous report was received from a consumer who was also a 38-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart racing (palpitations), heart hurting (angina pectoris), difficulty breathing (dyspnea), felt like she would pass out (presyncope) and back pain.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Jan 2021, the patient received the first of two planned doses of mRNA-1273 on (Batch# 043L20A) (route of administration unknown) for prophylaxis of COVID-19 infection.   On 22 Jan 2021, after three weeks post vaccination, the patient reported still having symptoms of her heart racing and hurting, difficulty breathing, felt as if she was going to pass out, and about a week of back pain.   On 12 Feb 2021, the patient went to the emergency room (ER) for heart symptoms. She reported everything was fine at the ER. The patient was to have second dose on 16 Feb 2021 and inquired on whether to have the second dose if experiencing all of these symptoms.  No treatment information was provided..  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Pain in arm; Loss of range of motion in arm; Injected into bursa space in the shoulder joint; A spontaneous report was received from a consumer concerning a 44 year old, male patient who experienced pain in the arm, loss of range of motion in the arm and incorrect route of administration.   The patient's medical history was not provided.  Concomitant medication was not provided.    The patient received their first of two planned doses of mRNA-1273 (Batch: 025J20A) on 31 DEC 2020.    On 02 FEB 2021, approximately the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch : 026L20A) and was injected into bursa space in the shoulder joint for prophylaxis of COVID-19 infection.    On 02 Feb 2021, the patient experienced severe pain in the arm and loss of range of motion in the arm.   The patient was hospitalized on 03 FEB 2021 and released on 04 FEB 2021.  Treatment information was not provided.   Action taken with vaccine was not applicable..  The outcome for pain in the arm, loss of range of motion in the arm was not reported and recovered for incorrect route of administration.; Reporter's Comments: This report refers to a case of Vaccine administration error for mRNA-1273, lot #  026L20A with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Sepsis
Clinical narrative: Kidney stone; patient was also treated for sepsisduring her admission; This spontaneous report from was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was found to have a kidney stone and was treated for sepsis.   The patient was diagnosed with urinary tract infection (UTI) before receiving the first dose of the vaccine. Products known to have been used by patient, within two weeks prior to the event, included antibiotics.   On 08-Feb-2021 the patient received her first dose of mRNA-1273 (Lot number: 011M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.    The patient continued having the UTI after receiving the first dose and was started on antibiotics. The patient was found to have a kidney stone and was admitted to the hospital for kidney stone removal surgery on 24-Feb- 2021. Patient was also treated for sepsis during her admission at the hospital. Patient was scheduled for second dose on 08-Mar-2021 and would like to know if it was okay for her to receive the second dose.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events kidney stones and sepsis were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Condition aggravated, Hepatic enzyme increased, Urticaria, Vaccination site erythema
Clinical narrative: autoimmune hepatitis is triggered; autoimmune hepatitis is triggered/might have triggered the reactivation of the autoimmune hepatitis; liver enzyme are way out of site, very high; welt; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; A spontaneous report was received  from a consumer concerning a 73 year old, female patient who experienced good palm size red hot on her arm but way below the shot, hotness itched, 10 days after vaccine welt returned, liver enzyme way out of site, very high. Doctors say that autoimmune hepatitis is triggered.    The patient's medical history was autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one.  Concomitant product use Estratest, Gabapentin, Omeprazole, Zinc, B50, CoQ10, Coconut oil, and Magnesium.  The patient received their first of two planned doses of mRNA-1273 Batch number [(0 o6)31L20A] on 12Feb2021,  intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient stated she had a reaction to first Moderna vaccine shot and I didn't think it was too bad but she had autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one. On 14Feb2021, second day after vaccine she got a good palm size red hot on her arm but way below the shot. Where shot admin it looked okay. Kind of hot itchy and that lasted one and a half day. Tenth day after vaccine shot this welt came back again and lasted a couple of days.So then when she went to have blood test on Tuesday and mentioned lady taking blood that this red area and told her what happened, and asked her if she had seen this happen and lady mentioned that no. And now she is concerned because she had her blood report back last night, and her liver enzyme are way out of site, very high. Doctors said that autoimmune hepatitis is triggered. Phone with liver doctor. We don't know yet, they suspect that vaccine as autoimmune system is supposed to attack Covid, in fact it might have triggered the reactivation of the autoimmune hepatitis.  Treatment for the event none provided.  The outcome of the events were not resolved.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, a very limited information has been provided for the events-Autoimmune hepatitis, condition aggravated, and hepatic enzyme increased, at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: autoimmune hepatitis is triggered; autoimmune hepatitis is triggered/might have triggered the reactivation of the autoimmune hepatitis; liver enzyme are way out of site, very high; welt; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; palm size red hot on my arm but way below the shot/Kind of hot and itchy; A spontaneous report was received  from a consumer concerning a 73 year old, female patient who experienced good palm size red hot on her arm but way below the shot, hotness itched, 10 days after vaccine welt returned, liver enzyme way out of site, very high. Doctors say that autoimmune hepatitis is triggered.    The patient's medical history was autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one.  Concomitant product use Estratest, Gabapentin, Omeprazole, Zinc, B50, CoQ10, Coconut oil, and Magnesium.  The patient received their first of two planned doses of mRNA-1273 Batch number [(0 o6)31L20A] on 12Feb2021,  intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient stated she had a reaction to first Moderna vaccine shot and I didn't think it was too bad but she had autoimmune diseases and had autoimmune hepatitis in the past, 2017 last one. On 14Feb2021, second day after vaccine she got a good palm size red hot on her arm but way below the shot. Where shot admin it looked okay. Kind of hot itchy and that lasted one and a half day. Tenth day after vaccine shot this welt came back again and lasted a couple of days.So then when she went to have blood test on Tuesday and mentioned lady taking blood that this red area and told her what happened, and asked her if she had seen this happen and lady mentioned that no. And now she is concerned because she had her blood report back last night, and her liver enzyme are way out of site, very high. Doctors said that autoimmune hepatitis is triggered. Phone with liver doctor. We don't know yet, they suspect that vaccine as autoimmune system is supposed to attack Covid, in fact it might have triggered the reactivation of the autoimmune hepatitis.  Treatment for the event none provided.  The outcome of the events were not resolved.  Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, a very limited information has been provided for the events-Autoimmune hepatitis, condition aggravated, and hepatic enzyme increased, at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out on the floor; fainted; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who fainted and passed out on the floor.  The patient's medical history was not provided. Concomitant medications included a blood pressure pill and a thyroid pill.  On 23 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The details of the administration of the first dose were not provided. On 24-Feb-2021, after being awake for 30 minutes, the patient passed out on the floor and fainted.    Treatment information was unknown.  Action taken with study drug was not applicable as the patient had already received both scheduled doses.  The outcome of the events, fainting and passed out on the floor, was resolved on 24 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia; A spontaneous report  was received from a nurse concerning, an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed medically significant event of thrombocytopenia.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of event, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, after receiving vaccine, the patient developed thrombocytopenia. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event of thrombocytopenia, was not provided.; Reporter's Comments: Based on the very limited information provided on the use of the product and the onset of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Kidney infection, Renal cyst
Clinical narrative: kidney infection; cysts on her kidney; she was down and in the bed feeling bad; A spontaneous report was received from a consumer concerning a 51 year old, female patient who developed feeling bad, kidney infection and renal cysts.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 08-JAN-2021, approximately 2 days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    The patient was not feeling great after receiving the vaccine and was in bed.  On 10-JAN-2021, the patient went to the hospital and was admitted for 4 nights, 3 days for a kidney infection.  Cysts on the patient's kidneys were found.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: chills; fatigue; heat from head; sweating; Passed out; A spontaneous report was received from a  51- year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced heat from head, sweating, passing out, chills and fatigue.  The patient's medical history was not provided. No concomitant product use was reported.  On 03-Mar-2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 001211a) intramuscularly for prophylaxis of COVID-19 infection.   On 03-Mar-2021, 4.5 hours after the administration of the vaccine the felt heat from head and was sweating following which the patient passed out. On 04-Mar-2021, it was reported the patient was feeling better despite of experiencing chills and fatigue. Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Headache
Clinical narrative: Headache; extreme fatigue to the point that she could not walk; extreme fatigue to the point that she could not walk; A spontaneous report was received from a Consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Headache, Fatigue and Gait inability.  The patient's medical history was not provided. Relevant concomitant medication was not reported.  On 07 Jan 2021, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.  After first dose the patient did not experience any adverse event. On 04 Feb 2021, prior to the onset of event, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced Headache then extreme Fatigue and Gait inability. Due to these events the patient was hospitalized.  Laboratory details was provided as the physician did some laboratory test, but result was normal.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the events, Headache, Fatigue and Gait inability, was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Bowel movement irregularity, Decreased appetite, Fatigue, Myalgia
Clinical narrative: acute pancreatitis; Pneumonia; edema; fever; fatigue; nausea; bloating; Major bowel movement; loss of appetite; muscle pain; A spontaneous report was received from a unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (Fatigue), fever (Pyrexia), bloating (Abdominal distension), major bowel movement (Bowel movement irregularity), pneumonia (Pneumonia), loss of appetite (Decreased appetite), acute pancreatitis (Pancreatitic acute), edema (Oedema), muscle pain (Myalgia) and nausea (Nausea).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, ramipril, metoprolol succinate, acetylsalicyclic acid and fish oil.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 12L20A) through intramuscularly route of administration in the right upper arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, approximately eight days after the vaccine, patient started experiencing muscle pain, major bowel movements, loss of appetite, bloating and nausea. On 26 Jan 2021,t he patient was hospitalized due to fatigue, fever and some GI issues. Patient was diagnosed with acute pancreatitis, pneumonia, and some edema. Patient said he was tested for COVID-19 multiple time at the hospital and all came back negative. Patient was given some antibiotics and Eliquis for treatment.  On 08 Feb 2021, the patient received their second of two planned doses of mRNA (Lot number:013L20A) intramuscularly for prophylaxis of COVID-19 infection. He did not report any symptom on his second dose.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events were unknown.; Reporter's Comments: The events were consistent with increased risk associated with pancreatitis which was consistent with pancreatic inflammation with unknown etiology. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oedema, Pancreatitis acute, Pneumonia, Pyrexia
Clinical narrative: acute pancreatitis; Pneumonia; edema; fever; fatigue; nausea; bloating; Major bowel movement; loss of appetite; muscle pain; A spontaneous report was received from a unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (Fatigue), fever (Pyrexia), bloating (Abdominal distension), major bowel movement (Bowel movement irregularity), pneumonia (Pneumonia), loss of appetite (Decreased appetite), acute pancreatitis (Pancreatitic acute), edema (Oedema), muscle pain (Myalgia) and nausea (Nausea).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, ramipril, metoprolol succinate, acetylsalicyclic acid and fish oil.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 12L20A) through intramuscularly route of administration in the right upper arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, approximately eight days after the vaccine, patient started experiencing muscle pain, major bowel movements, loss of appetite, bloating and nausea. On 26 Jan 2021,t he patient was hospitalized due to fatigue, fever and some GI issues. Patient was diagnosed with acute pancreatitis, pneumonia, and some edema. Patient said he was tested for COVID-19 multiple time at the hospital and all came back negative. Patient was given some antibiotics and Eliquis for treatment.  On 08 Feb 2021, the patient received their second of two planned doses of mRNA (Lot number:013L20A) intramuscularly for prophylaxis of COVID-19 infection. He did not report any symptom on his second dose.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events were unknown.; Reporter's Comments: The events were consistent with increased risk associated with pancreatitis which was consistent with pancreatic inflammation with unknown etiology. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: acute pancreatitis; Pneumonia; edema; fever; fatigue; nausea; bloating; Major bowel movement; loss of appetite; muscle pain; A spontaneous report was received from a unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (Fatigue), fever (Pyrexia), bloating (Abdominal distension), major bowel movement (Bowel movement irregularity), pneumonia (Pneumonia), loss of appetite (Decreased appetite), acute pancreatitis (Pancreatitic acute), edema (Oedema), muscle pain (Myalgia) and nausea (Nausea).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, ramipril, metoprolol succinate, acetylsalicyclic acid and fish oil.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 12L20A) through intramuscularly route of administration in the right upper arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, approximately eight days after the vaccine, patient started experiencing muscle pain, major bowel movements, loss of appetite, bloating and nausea. On 26 Jan 2021,t he patient was hospitalized due to fatigue, fever and some GI issues. Patient was diagnosed with acute pancreatitis, pneumonia, and some edema. Patient said he was tested for COVID-19 multiple time at the hospital and all came back negative. Patient was given some antibiotics and Eliquis for treatment.  On 08 Feb 2021, the patient received their second of two planned doses of mRNA (Lot number:013L20A) intramuscularly for prophylaxis of COVID-19 infection. He did not report any symptom on his second dose.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events were unknown.; Reporter's Comments: The events were consistent with increased risk associated with pancreatitis which was consistent with pancreatic inflammation with unknown etiology. Company assessed the events to be unlikely related to company product.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: pounding heart, heart rate increased; panic; Total body flushing; Sensation of hot and cold; Shaking; lightheadedness; feelings of passing out; nausea; arm  numbness; extremity tingling; headache; exhaustion; fever; fluctuating blood pressure; racing heart ,heart palpitations; mild flushing; brain fog; A spontaneous report was received from a healthcare professional concerning a 25-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out, nausea, extremity tingling, and arm numbness, headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever.   The patient's medical history, was not provided by the reporter, but patient had a tuberculosis test done in recent days prior to vaccination, reports were  not provided. Concomitant medications reported included vitamin B-12 complex and ibuprofen.  On 04-Mar-2021 at 5:55 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the deltoid for prophylaxis of COVID-19 infection.   On 04 Mar 2021, approximately after 23 minutes after receiving the vaccine patient developed panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out. Patient pulled over and called 9-1-1, and she was taken by ambulance to a nearby hospital. Patient had reported that the symptoms persisted during ambulance transit and continued during her three hour hospital stay. Patient reported to have  development of nausea,  extremity tingling, and arm numbness while being admitted.   Patient reported that a friend of her drove her home from the hospital, and her brother was monitoring her condition. No medicinal treatments were administered at the hospital for the patient.   On 05 Mar 2021, Patient took advil to treat the headache and brain fog that has developed. Patient reported that the symptoms headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever were continuing. As treatment for events no medicinal treatments were administered at the hospital. Patient reported that she had taken ibuprofen to treat a headache and brain fog.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out, nausea, extremity tingling, and arm numbness was unknown and  headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Mobility decreased, Paralysis, Syncope
Clinical narrative: Lost control of muscles; ended up blacking out; could not move; could not talk; A spontaneous report was received from a Consumer concerning about a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Paralysis, Syncope, Mobility decreased and Aphasia.  The patient's medical history was provided as diabetes, dementia as current illness. Relevant concomitant medication was reported as blood thinner for blood clots.  On 08 FEB 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 10 FEB 2021, the patient experienced Paralysis, Syncope, Mobility decreased and Aphasia. Due to these events patient's required hospitalization and on oxygen.  Laboratory details was not provided.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event's Paralysis, Syncope, Mobility decreased, and Aphasia was as unknown.; Reporter's Comments: The events were consistent with increased risk of cerebrovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received from a consumer who was also a 76-years-old female patient, who received Moderna's covid-19 vaccine (mRNA-1273) and who experienced stroke (stroke).  The patient's medical history was not provided. Concomitant medications were not reported.  On 13 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 23 FEB 2021, the patient had a stroke leading to hospitalization. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the event stroke was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.