chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some amount leaked into his left arm; Some amount leaked into his left arm; A spontaneous report  was received from a Healthcare professional concerning a 70-year-old, male patient, who felt some amount of vaccine leaked into his left arm.  On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 014M20A) in left arm for the prophylaxis of COVID-19 infection.   while administering the Moderna Covid-19 vaccine, patient felt some amount leaked into his left arm.   Action taken with mRNA-1273 in response to the events was not reported.    Outcome of the event experienced vaccine underdose which is unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue of Moderna mRNA-1273,  with no associated AEs.  Causality for the medication error is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Exposure via skin contact
Clinical narrative: Some of the vaccine leaked out of arm; Leaked out of arm; A spontaneous report was received from a consumer who was a female patient of unknown age, who received Moderna's covid-19 vaccine(mRNA-1273) and some of the vaccine leaked out of her arm.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 24-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:unknown) for prophylaxis of COVID-19 infection.   During the vaccination, some of the vaccine leaked out of her arm.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, vaccine leaked out, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of accidental underdose and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Somnolence, Vaccination site pain
Clinical narrative: feels sleepy; arm is sensitive; received the second dose 52 days after the first one; A spontaneous report was received from a consumer concerning a 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: received the second dose 52 days after the first one (inappropriate schedule of product administration), feels sleepy (somnolence), arm is sensitive (vaccination site pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041120A) for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 001A121A) for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event received the second dose 52 days after the first one . On 24 Feb 2021, the patient experienced the events feels sleepy and arm is sensitive.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  On 23 Feb 2021 the outcome of events received the second dose 52 days after the first one was resolved. The outcome of events, feels sleepy and arm is sensitive was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 001A121A for the second dose) with associated AEs reported as sleepy and injection site pain 1 day after vaccination. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Peripheral coldness, Syncope
Clinical narrative: Fainted; Sweating; Vision was blurry; It went "black; Whole skin feels cold; Felt something weird on her body; vision was sparkly; Chills; A spontaneous report was received from a Consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird.  The patient's medical history was not provided. Products known to have been used by patient, with in two weeks prior to the event, included levothyroxine, lisinopril, amlodipine, omeprazole, atorvastatin, baby-aspirin, lisinopril hydrochlorothiazide.  On 2-Jan-2021, patient received the first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly at right arm . On 28-Jan -2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly at right arm for prophylaxis of COVID-19 infection.   On 21-Feb-2021, the patient experienced the events felt something weird on her body. sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. Treatment information was not provided.   The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable   The outcome of events, felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Fainted; Sweating; Vision was blurry; It went "black; Whole skin feels cold; Felt something weird on her body; vision was sparkly; Chills; A spontaneous report was received from a Consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird.  The patient's medical history was not provided. Products known to have been used by patient, with in two weeks prior to the event, included levothyroxine, lisinopril, amlodipine, omeprazole, atorvastatin, baby-aspirin, lisinopril hydrochlorothiazide.  On 2-Jan-2021, patient received the first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly at right arm . On 28-Jan -2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly at right arm for prophylaxis of COVID-19 infection.   On 21-Feb-2021, the patient experienced the events felt something weird on her body. sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. Treatment information was not provided.   The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable   The outcome of events, felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird 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.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: administered it  in an improper location on his arm; A spontaneous report was received from a healthcare professional (wife of the patient) for a male patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) in an improper location on his arm/ Inappropriate route of vaccination.  The patient's medical history was not provided. No concomitant product use was reported.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The individual who administered the vaccination administered it in an improper location on his arm. The reporter knew that some IM vaccinations can have reduce efficacy if administered outside of the muscular region and was wanting to ensure that the patient would be receiving full coverage from this 1st dose of vaccination. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, received Moderna's COVID-19 vaccine (mRNA-1273) in an improper location on his arm, was considered resolved on 24 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Multiple patients were administered double doses in their 1st dose; A spontaneous report was received from a HCP concerning a  patient, of unspecified age and gender, who received  Moderna's COVID-19 vaccine(mRNA-1273) and experienced accidental overdose.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273(Lot/batch:unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was administered with double doses of 1 milliliter of the Moderna vaccine (more than recommended amount) from one syringe.  No lab reports  were provided. Treatment information was unknown.  Action taken with mRNA-1273  in response to the event was not reported.  At the time of the report, outcome of the event accidental overdose was considered resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental overdose without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; A spontaneous report was received from a healthcare professional concerning their patient, of unknown age, female patient who developed shingles/herpes zoster, open sores/ulcer.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on unknown date at the unknown injection site for prophylaxis of COVID-19 infection.   The patient experienced shingles and open sores. Treatment of the events included Valtrex.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events shingles and open sores 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, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine administered with temperature deviation; A spontaneous report was received from a healthcare professional (HCP) concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect product storage/administered with a temperature deviation.  The patient's medical history was not provided. No concomitant product use was reported.  On 26 Jan2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 26-Jan-2021, the vaccine which was initially frozen had a 45 minute excursion when was left out of the freezer, at the room temperature (approximately 65 degrees Fahrenheit) and was put back into the freezer (-23 degrees Fahrenheit). No adverse events were reported.   Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, incorrect product storage was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product storage error for  mRNA-1273 (Lot number: unknown) with no associated AEs.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect route of product administration, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Vaccine was administered in the side of her arm and not in her deltoid muscle; Pain; Nausea; Headache; Injection site swelling; redness 2 inches below the injection site; A spontaneous report was received from a 64 year old  female nurse, regarding herself who received second  dose of Moderna Covid-19 vaccine and experienced nausea, headache, injection site swelling, redness 2 inches below the site , pain and injection given on the side of arm instead of deltoid.  The patient's medical history included Covid-19 infection from 13-JAN-2021 to 22-Jan-2021. Her concomitant medications were not provided. No information on allergies.   On 27-JAN-2021, prior to the onset of events, the patient received 2nd of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot#011M20A).   On 27 Jan 2021,  the patient states that vaccine was given on side of her left arm instead of deltoid muscle. On the same day, she experienced nausea, headache, injection site swelling, redness 2 inches below the injection site and pain.  Action taken with the vaccine is not applicable as the individual completed 2 doses.  The outcome of the event, injection given on the side of arm instead of deltoid, was considered recovered/resolved on 27 Jan 2021.   The outcome of the event, nausea, was considered resolved on 28-JAN-2021  The outcome of the event, headache, injection site swelling, redness, pain, were considered not recovered/no 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.   The causality for the event incorrect route of vaccine administration is assessed as Not Applicable
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Vaccine was administered in the side of her arm and not in her deltoid muscle; Pain; Nausea; Headache; Injection site swelling; redness 2 inches below the injection site; A spontaneous report was received from a 64 year old  female nurse, regarding herself who received second  dose of Moderna Covid-19 vaccine and experienced nausea, headache, injection site swelling, redness 2 inches below the site , pain and injection given on the side of arm instead of deltoid.  The patient's medical history included Covid-19 infection from 13-JAN-2021 to 22-Jan-2021. Her concomitant medications were not provided. No information on allergies.   On 27-JAN-2021, prior to the onset of events, the patient received 2nd of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot#011M20A).   On 27 Jan 2021,  the patient states that vaccine was given on side of her left arm instead of deltoid muscle. On the same day, she experienced nausea, headache, injection site swelling, redness 2 inches below the injection site and pain.  Action taken with the vaccine is not applicable as the individual completed 2 doses.  The outcome of the event, injection given on the side of arm instead of deltoid, was considered recovered/resolved on 27 Jan 2021.   The outcome of the event, nausea, was considered resolved on 28-JAN-2021  The outcome of the event, headache, injection site swelling, redness, pain, were considered not recovered/no 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.   The causality for the event incorrect route of vaccine administration is assessed as Not Applicable
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Mental impairment, Myocardial infarction
Clinical narrative: Severe Allergic reaction; Heart attack; Neurological issues was unable to think straight; Extreme inflammatory response; A spontaneous report  was received from a consumer and  physician concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight.  The patient's medical history was not reported by the reporter. Concomitant medication was not reported.  On 22 Jan 2021, 15 minutes prior to the onset of the event, the patient received first of the two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, 15 minutes after the vaccination, patient had a severe allergic reaction. Patient had extreme inflammatory response, heart attack, neurological issues was unable to think straight, urinator catheter placed in on sight as fluid build and kept coming out, pulled out 1500ml. Patient was hospitalized 22 Jan 2021 through 24 Jan 2021. Laboratory information at the time of event was not provided.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight 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: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Haemorrhage intracranial, Oxygen saturation
Clinical narrative: Intercranial hemorrhage/brain bleed; Chills; Fatigue; Really bad shortness of breath; A spontaneous report was received from a pharmacist regarding a 64-year-old female consumer, unknown race, and ethnicity, who experienced intracranial hemorrhage, chills, fatigue, and dyspnoea.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Feb 2021, prior to the onset of symptoms, the patient received one of her two planned doses of mRNA-1273  vaccine intramuscularly for the prophylaxis of Covid-19 infection (Batch# 023M20A).   On 22 Feb 2021, 7 hours post-vaccination, the patient developed symptoms of chills, fatigue, and a "really bad" shortness of breath with a pulse oximetry reading of 81% on room air.   On 23 Feb 2021, the patient was hospitalzed and subsequently transferred to a sister hospital for an intracranial hemorrhage/brain bleed. Lab investigations and treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, intracranial hemorrhage/brain bleed, chills, fatigue, and shortness of breath, was unknown at the time of the report.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; A Spontaneous report  was received from a pharmacy intern concerning a patient (age and gender unknown), who experienced a heart attack/myocardial infarction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of symptoms, the patient received one of their two planned doses (dose number not provided) of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, 8 days after vaccine administration, the patient experienced a heart attack. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, heart attack, was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender with a serious unexpected event of myocardial infarction.  The event occurred 8 days after first dose mRNA-1273. Treatment not reported. Event outcome unknown. Very limited information regarding this event has been provided at this time.  Further information has been requested.  Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Atrial flutter, Night sweats, Pericarditis
Clinical narrative: Pericarditis; Atrium flutter; Extremely anemic; Night sweats; A spontaneous report was received from a consumer  concerning a male patient who experienced pericarditis, atrium flutter/atrial flutter, became extremely anemic/anaemia, and developed night sweats.   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 sucralfate, mesalazine, metoprolol, escitalopram oxalate, colesevelam hydrochloride, multivitamin, vitamin D3, vitamin B 12 and fluocinonide.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch# 029K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, the same day as the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch# 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient presented to the emergency room with severe chest pain across his entire chest and entire jaw that was exacerbated when he took a breath. A pulmonary function test and electrocardiogram were performed (results not provided). The patient was admitted to the hospital with pericarditis and discharged 3 days later. Treatment included colchicine.  In Feb 2021 (date not specified), the patient experienced night sweats and had a blood test (result not provided) that showed extreme anemia. The patient also developed atrial flutter. Treatment for atrial flutter included cardiac ablation and apixaban.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, pericarditis and atrium flutter, was considered not recovered. The outcome of the events, anemia and night sweats 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 events, a causal relationship cannot be excluded. The patient's medical history of taking colchicine can be contributory to the Anemia.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: unmonitored doses were administered; A spontaneous report was received from a Healthcare Professional concerning patients who received Moderna's COVID-19 vaccine (mRNA-1273) where unmonitored doses were administered to people (product storage error)  On an unknown date, the HCP reports about administering  mRNA-1273 (Lot number: 029L20A)  and mRNA-1273  (Lot number:007M20A) where unmonitored doses were administered to people.   The HCP reports that the Moderna vaccine shipment arrived at the pharmacy on 19Jan2021, and to her knowledge they were stored in the refrigerator. But the pharmacy staff did not take any temperature documentation prior to 27Jan2021. The fridge was observed at 49 degree F on 27Jan2021. She is contacting the manufacture (Moderna) and to see whether Moderna supports the continued use of these vaccine without prior temperature monitoring.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.; Reporter's Comments: This report refers to a case of product storage error (temperature excursion)  for mRNA-1273, lot # 029L20A and 007M20A with no associated AEs.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chills, Decreased appetite, Diarrhoea haemorrhagic, Fatigue
Clinical narrative: Bloody diarrhea; Loss of appetite; Skin on her back started to peel; Lower intestine is sore; Feeling queasy; chills; Fever of 101.1F that took about 3 days to break; Soreness at the injection site; Tired; A spontaneous report was received from a consumer concerning a 62 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site and tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.      On 10 FEB 2021 prior to the onset of the events, the patient received her second dose of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly for prophylaxis of COVID-19 infection.    On  unknown date, the patient experienced the events   feeling queasy, loss of appetite, nausea, lower intestine is sore, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired and  on unknown date event bloody diarrhea as medically significant serious criteria.   Laboratory details were not provided.    Treatment medication included Baby Aspirin.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Skin exfoliation, Vaccination site pain
Clinical narrative: Bloody diarrhea; Loss of appetite; Skin on her back started to peel; Lower intestine is sore; Feeling queasy; chills; Fever of 101.1F that took about 3 days to break; Soreness at the injection site; Tired; A spontaneous report was received from a consumer concerning a 62 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site and tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.      On 10 FEB 2021 prior to the onset of the events, the patient received her second dose of two planned doses of mRNA-1273 (lot/batch:041L20A) intramuscularly for prophylaxis of COVID-19 infection.    On  unknown date, the patient experienced the events   feeling queasy, loss of appetite, nausea, lower intestine is sore, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired and  on unknown date event bloody diarrhea as medically significant serious criteria.   Laboratory details were not provided.    Treatment medication included Baby Aspirin.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events feeling queasy, loss of appetite, nausea, lower intestine is sore, bloody diarrhea, fever of 101.1F that took about 3 days to break, skin on her back started to peel, soreness at the injection site, tired 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: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram, Lack of spontaneous speech, Musculoskeletal chest pain
Clinical narrative: Pleurisy; sharp, severe pain in the rib area under the arm where I had had the injection; Pressure in my lungs have risen, but not high enough to be medicated; Impossible to take a deep breath; Could barely communicate; Daytime oxygen levels were in the 88-89% level during the day.; A Spontaneous report was received from a consumer who was also a 70 year old , female  patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, pressure in my lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased.   The patient's medical history included bronchitis and supplemental oxygen at night.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, approximately two hours before the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Feb 2021, approximately two hours after receiving the vaccine, the patient experienced sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased two hours later. At the emergency room, blood tests, rib X-ray, and computerized tomography (CT) of the lungs were done.  The CR scan showed some changes, which the radiologist said could be asthma or chronic bronchitis.  The patient spent the next three weeks on supplemental oxygen during the day.  On 23 Feb 2021, an echocardiogram indicated that pressure in her lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased.  Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event of developed sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, "pressure in my lungs have risen, but not high enough to be medicated"/ Pulmonary arterial pressure increased were not reported. The outcome of the event, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, was considered recovered/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.; Sender's Comments:  MOD-2021-029767:Patient's friend
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Pleurisy, Pulmonary arterial pressure increased
Clinical narrative: Pleurisy; sharp, severe pain in the rib area under the arm where I had had the injection; Pressure in my lungs have risen, but not high enough to be medicated; Impossible to take a deep breath; Could barely communicate; Daytime oxygen levels were in the 88-89% level during the day.; A Spontaneous report was received from a consumer who was also a 70 year old , female  patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, pressure in my lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased.   The patient's medical history included bronchitis and supplemental oxygen at night.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, approximately two hours before the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Feb 2021, approximately two hours after receiving the vaccine, the patient experienced sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased two hours later. At the emergency room, blood tests, rib X-ray, and computerized tomography (CT) of the lungs were done.  The CR scan showed some changes, which the radiologist said could be asthma or chronic bronchitis.  The patient spent the next three weeks on supplemental oxygen during the day.  On 23 Feb 2021, an echocardiogram indicated that pressure in her lungs have risen, but not high enough to be medicated/ Pulmonary arterial pressure increased.  Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event of developed sharp, severe pain in the rib area under the arm "where I had had the injection"/ Musculoskeletal chest pain, impossible to take a deep breath/ Dyspnoea , could barely communicate/ Lack of spontaneous speech, pleurisy, "pressure in my lungs have risen, but not high enough to be medicated"/ Pulmonary arterial pressure increased were not reported. The outcome of the event, daytime oxygen levels were in the 88-89% level during the day/ Oxygen saturation decreased, was considered recovered/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.; Sender's Comments:  MOD-2021-029767:Patient's friend
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infection; A regulatory authority report was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ear infection. The patient's medical history, as provided by the reporter, included ear infection. Concomitant medications were not reported.  On 25 Feb 2021, approximately one days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, prior to receiving mRNA-1273, the patient felt ear infection with medically significant. Treatment for the events included steroids shots.  Action taken with mRNA-1273 in response to the events was not reported.   The event, ear infection was considered unknown outcome event on 26 Feb 2021.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Loss of consciousness
Clinical narrative: Unconsciousness; Feeling discomfort within a few minutes after the vaccination; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced of feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the event, patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death.  Treatment information for event unconsciousness included resuscitate via cardiopulmonary resuscitation with no success.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event unconsciousness was fatal and patient died.; Reporter's Comments: This is a case of death of a 78-year-old, female patient who experienced   within a few minutes of product use who experienced feeling of discomfort and became unconscious and subsequently expired. Based on the current available information, a strong temporal association between the product use and onset of the events, a causal relationship with the events cannot be excluded. However, critical details such as the patient's medical history and actual cause of death is lacking.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Hot flush, Hypersensitivity, Hypoacusis
Clinical narrative: Major allergic reaction to the shot; Heat all over her body; Foggy head; Heavy right arm; Shooting pain under the breast; Left ear and face itching, itching spread all over body; Clogged ears; A spontaneous report was received from a 69-year old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced major allergic reaction to the shot, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears.   The patient's medical history included asthma and anaphylactic shock with Sulfa medication. No relevant concomitant medications were reported.   The patient received the first of two planned doses of mRNA-1273, (Lot/Batch No. 031M20A) on 26-Feb-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.    The patient reported after her first shot, she did stay in the office for 30 minutes and after she left within the hour after receiving the shot, she had a major allergic reaction. The patient felt heat all over her body, foggy head, right arm was heavy, shooting pain under breast, felt ear and face was itching. Then itching spread all over the body, and ears clogged up. As soon as itching spread, she took four Benadryl (diphenhydramine) 25mg each and used Dulera (mometasone-formoterol) asthma inhaler to prevent the reaction. She did not have a rash and did not have difficulty breathing because of the medicines that she took. The patient does not know if she can take the second shot because she fears having anaphylactic shock.   Treatment for the events included Benadryl 25mg Capsules.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the events major allergic reaction to the shot, I fear having anaphylactic shock, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears were 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: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus
Clinical narrative: Major allergic reaction to the shot; Heat all over her body; Foggy head; Heavy right arm; Shooting pain under the breast; Left ear and face itching, itching spread all over body; Clogged ears; A spontaneous report was received from a 69-year old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced major allergic reaction to the shot, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears.   The patient's medical history included asthma and anaphylactic shock with Sulfa medication. No relevant concomitant medications were reported.   The patient received the first of two planned doses of mRNA-1273, (Lot/Batch No. 031M20A) on 26-Feb-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.    The patient reported after her first shot, she did stay in the office for 30 minutes and after she left within the hour after receiving the shot, she had a major allergic reaction. The patient felt heat all over her body, foggy head, right arm was heavy, shooting pain under breast, felt ear and face was itching. Then itching spread all over the body, and ears clogged up. As soon as itching spread, she took four Benadryl (diphenhydramine) 25mg each and used Dulera (mometasone-formoterol) asthma inhaler to prevent the reaction. She did not have a rash and did not have difficulty breathing because of the medicines that she took. The patient does not know if she can take the second shot because she fears having anaphylactic shock.   Treatment for the events included Benadryl 25mg Capsules.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the events major allergic reaction to the shot, I fear having anaphylactic shock, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears were 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Dizziness, Fall, Lethargy, Nausea
Clinical narrative: Dizziness; Severe vertigo; Fell in yoga class; Lethargic; Feel run down; Nausea; A spontaneous report was received from other healthcare professional, concerning a 48 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, severe vertigo (vertigo), fell in yoga class (fall), nausea, lethargic (lethargy), feel run down (depressed mood), and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of events, the patient received the second of planned doses of mRNA-1273 (Batch number: 13M20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 03 Feb 2021, same day, the patient experienced nausea, dizziness, severe vertigo, having a fall in yoga class, lethargy, & feels run down. The patient went to urgent care, and then the emergency room (ER). An electrocardiogram (EKG) and a computerised tomography (CT) scan were done with no results provided. The patient was given ondansetron and meclizine.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, dizziness, severe vertigo, fell in yoga class, nausea, lethargic, feel run down, and nausea 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Dizziness; Severe vertigo; Fell in yoga class; Lethargic; Feel run down; Nausea; A spontaneous report was received from other healthcare professional, concerning a 48 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, severe vertigo (vertigo), fell in yoga class (fall), nausea, lethargic (lethargy), feel run down (depressed mood), and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of events, the patient received the second of planned doses of mRNA-1273 (Batch number: 13M20A), intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 03 Feb 2021, same day, the patient experienced nausea, dizziness, severe vertigo, having a fall in yoga class, lethargy, & feels run down. The patient went to urgent care, and then the emergency room (ER). An electrocardiogram (EKG) and a computerised tomography (CT) scan were done with no results provided. The patient was given ondansetron and meclizine.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, dizziness, severe vertigo, fell in yoga class, nausea, lethargic, feel run down, and nausea 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: Fall, Hypoaesthesia, Nerve injury
Clinical narrative: Had a fall; The lower part of her body was without feeling; There was a lot of damage to the nerves; A spontaneous report was received from a consumer for a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized as she had a fall and the lower part of her body was without feeling, and there was a lot damage to the nerves.  The patient's medical history included a back surgery. No concomitant product use was reported.  On 15 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   02 Feb 2021, approximately 17 days after receiving the vaccine, she had been hospitalized as had a fall and the lower part of her body was without feeling. She had previous back surgery, so there was a lot damage to the nerves and she was still presently in rehab. She could not receive her second dose because of hospitalization.  The treatment medication was not reported.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the event(s) for which she had a fall and the lower part of her body was without feeling, and there was a lot damage to the nerves were 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: F
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, Fall, Multiple fractures, SARS-CoV-2 test
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.