chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Heart rate increased, Hypoaesthesia, Loss of consciousness, Pain
Clinical narrative: passed out because she was feeling that the world was revolving; shortness of breath when she moves; fast heart beat when she moves; swelling in right leg; Numbness in right leg; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out because she was feeling that the world was revolving) and DYSPNOEA EXERTIONAL (shortness of breath when she moves) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (body ache) and PYREXIA (fever). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out because she was feeling that the world was revolving) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (shortness of breath when she moves) (seriousness criterion medically significant), HEART RATE INCREASED (fast heart beat when she moves), PERIPHERAL SWELLING (swelling in right leg) and HYPOAESTHESIA (Numbness in right leg). On 29-Mar-2021, PAIN (body ache) and PYREXIA (fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out because she was feeling that the world was revolving), DYSPNOEA EXERTIONAL (shortness of breath when she moves), HEART RATE INCREASED (fast heart beat when she moves), PERIPHERAL SWELLING (swelling in right leg) and HYPOAESTHESIA (Numbness in right leg) outcome was unknown.            No concomitant medication were not provided.  The patient was treated with PARACETAMOL (TYLENOL) and METOPROLOL.  Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: passed out because she was feeling that the world was revolving; shortness of breath when she moves; fast heart beat when she moves; swelling in right leg; Numbness in right leg; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out because she was feeling that the world was revolving) and DYSPNOEA EXERTIONAL (shortness of breath when she moves) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (body ache) and PYREXIA (fever). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out because she was feeling that the world was revolving) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (shortness of breath when she moves) (seriousness criterion medically significant), HEART RATE INCREASED (fast heart beat when she moves), PERIPHERAL SWELLING (swelling in right leg) and HYPOAESTHESIA (Numbness in right leg). On 29-Mar-2021, PAIN (body ache) and PYREXIA (fever) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out because she was feeling that the world was revolving), DYSPNOEA EXERTIONAL (shortness of breath when she moves), HEART RATE INCREASED (fast heart beat when she moves), PERIPHERAL SWELLING (swelling in right leg) and HYPOAESTHESIA (Numbness in right leg) outcome was unknown.            No concomitant medication were not provided.  The patient was treated with PARACETAMOL (TYLENOL) and METOPROLOL.  Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Facial paralysis) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patients treatment information included steroids.; Sender'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.  At the time of the report the patient's second dose was not yet delayed (per medical advice)  so no event captured associated with late second dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Myalgia, Pneumonia, Pyrexia, Syncope
Clinical narrative: Pneumonia; Fainting; Vomiting; Fever; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SYNCOPE (Fainting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), VOMITING (Vomiting), PYREXIA (Fever) and MYALGIA (Muscle aches and pains). On 23-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PNEUMONIA (Pneumonia) had not resolved and SYNCOPE (Fainting), VOMITING (Vomiting) and MYALGIA (Muscle aches and pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: revealed pneumonia (Inconclusive) Revealed pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pneumonia; Fainting; Vomiting; Fever; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SYNCOPE (Fainting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), VOMITING (Vomiting), PYREXIA (Fever) and MYALGIA (Muscle aches and pains). On 23-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PNEUMONIA (Pneumonia) had not resolved and SYNCOPE (Fainting), VOMITING (Vomiting) and MYALGIA (Muscle aches and pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: revealed pneumonia (Inconclusive) Revealed pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Head injury, Loss of consciousness, Nausea, White blood cell count increased
Clinical narrative: Passed out; Hit her head 3 times; White Blood Cell Increased; Bloody nose that would not stop; Felt nauseated; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and HEAD INJURY (Hit her head 3 times) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes since an unknown date. Concomitant products included POTASSIUM, VITAMIN D3, TRAMADOL, LEVOTHYROXINE, METOLAZONE, SPIRONOLACTONE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), HEAD INJURY (Hit her head 3 times) (seriousness criterion hospitalization), EPISTAXIS (Bloody nose that would not stop) and NAUSEA (Felt nauseated). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (White Blood Cell Increased). The patient was hospitalized from 17-Mar-2021 to 24-Mar-2021 due to HEAD INJURY and LOSS OF CONSCIOUSNESS. On 17-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out), HEAD INJURY (Hit her head 3 times), EPISTAXIS (Bloody nose that would not stop) and NAUSEA (Felt nauseated) had resolved. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White Blood Cell Increased) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  After hospitalization patient was started with Januvia, Pregabalin, Potassium chloride, Torsemibe, Metoprolol, Levemir insulin  Company comment:Based on the current available information and the temporal association between the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product and the start date of the events a causal relationship cannot be excluded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Haemorrhage, Pain in extremity, Vision blurred
Clinical narrative: Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On 05-Apr-2021, the patient experienced  blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm.  The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were given No lab details was provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: may have had a heart attack; pressure in her chestuncomfortable feeling which lasted for a week; 6 short chest pains that felt like something was moving in her chest; felt really bad; tired/worn out; chills; a fever all night; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (may have had a heart attack) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills) and PYREXIA (a fever all night). On 08-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (may have had a heart attack) (seriousness criterion medically significant), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 08-Mar-2021 to 13-Mar-2021 for Heart attack, at a dose of UNK UNK, bid. On 11-Mar-2021, MYOCARDIAL INFARCTION (may have had a heart attack), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week), FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills), PYREXIA (a fever all night) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest) had resolved.            Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Pyrexia
Clinical narrative: may have had a heart attack; pressure in her chestuncomfortable feeling which lasted for a week; 6 short chest pains that felt like something was moving in her chest; felt really bad; tired/worn out; chills; a fever all night; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (may have had a heart attack) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills) and PYREXIA (a fever all night). On 08-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (may have had a heart attack) (seriousness criterion medically significant), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 08-Mar-2021 to 13-Mar-2021 for Heart attack, at a dose of UNK UNK, bid. On 11-Mar-2021, MYOCARDIAL INFARCTION (may have had a heart attack), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week), FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills), PYREXIA (a fever all night) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest) had resolved.            Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of consciousness, Palpitations, Vomiting
Clinical narrative: shortly after as she was driving home she felt like she was going to black out had to stop the car; had heart palpitations; was sick for about 5 days; shortly after as she was driving home she felt like she was going to black out had to stop the car and began to vomit; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (shortly after as she was driving home she felt like she was going to black out had to stop the car) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus infection. Concurrent medical conditions included Inner ear disorder.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (shortly after as she was driving home she felt like she was going to black out had to stop the car) (seriousness criterion medically significant), PALPITATIONS (had heart palpitations), ILLNESS (was sick for about 5 days) and VOMITING (shortly after as she was driving home she felt like she was going to black out had to stop the car and began to vomit). On 24-Feb-2021, LOSS OF CONSCIOUSNESS (shortly after as she was driving home she felt like she was going to black out had to stop the car) and VOMITING (shortly after as she was driving home she felt like she was going to black out had to stop the car and began to vomit) had resolved. On 01-Mar-2021, ILLNESS (was sick for about 5 days) had resolved. At the time of the report, PALPITATIONS (had heart palpitations) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications were reported.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.  Vomiting is consistent to the known safety profile of mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Gastric disorder
Clinical narrative: Bell's palsy; Gastric distress; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant) and GASTRIC DISORDER (Gastric distress). At the time of the report, FACIAL PARALYSIS (Bell's palsy) and GASTRIC DISORDER (Gastric distress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On an unspecified date, 4-5 days later, the patient had gastric distress and 8 days later, patient had Bell's palsy (diagnosed by a doctor 10 days post vaccination). He was prescribed with Prednisone for 1 week.  This case concerns a male of unknown age with a serious unexpected event of facial paralysis and a nonserious unexpected event of gastric distress. Event onset 8 days after first dose mRNA-1273. Treated with prednisone. Event outcome unknown. Based on 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.; Sender's Comments: This case concerns a male of unknown age with a serious unexpected event of facial paralysis and a nonserious unexpected event of gastric distress. Event onset 8 days after first dose mRNA-1273. Treated with prednisone. Event outcome unknown. Based on 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Head discomfort, Headache, Insomnia
Clinical narrative: Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received   COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy.   On 06-Apr-2021, the patient received first dose  (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown.               Treatment was not reported/ unknown.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received   COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy.   On 06-Apr-2021, the patient received first dose  (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown.               Treatment was not reported/ unknown.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Loss of consciousness
Clinical narrative: passed out twice; was very weak; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) in a female patient of an unknown age who received  COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).   On an unknown date, the patient received second dose of Vaccine (Intramuscular) 1 dosage form. On an unknown date, received first dose  (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), ASTHENIA (was very weak) and DIZZINESS (dizzy). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), ASTHENIA (was very weak) and DIZZINESS (dizzy) outcome was unknown.         Concomitant product use was not provided.  Treatment information was not provided.  Reportedly, two days after experiencing the events, the patient was able to walk five miles a day like she used to do in the mornings.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information is required.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Diarrhea; Dizzy; Feels weakness; feeling really weird; Feels hot and cold; Feeling very cold, an unusual cold; Muscle pain, it's an incredible pain; Headache; Blood pressure is 35 above normal and somedays lower (109 mm Hg); First dose on her "left hand"; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First dose on her "left hand"). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy), ASTHENIA (Feels weakness), FEELING ABNORMAL (feeling really weird), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), FEELING COLD (Feeling very cold, an unusual cold), MYALGIA (Muscle pain, it's an incredible pain) and HEADACHE (Headache). On 17-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First dose on her "left hand") had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy), ASTHENIA (Feels weakness), FEELING ABNORMAL (feeling really weird), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), FEELING COLD (Feeling very cold, an unusual cold), MYALGIA (Muscle pain, it's an incredible pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient reported that only with a hair dryer could they get warm. Each day is worse and wanted to know when it will end. The patient said they had a blood test, previous to the vaccination because they gained weight, and it was normal. Treatment for the events included paracetamol, ibuprofen and cold showers.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling of body temperature change, Headache, Incorrect route of product administration, Myalgia
Clinical narrative: Diarrhea; Dizzy; Feels weakness; feeling really weird; Feels hot and cold; Feeling very cold, an unusual cold; Muscle pain, it's an incredible pain; Headache; Blood pressure is 35 above normal and somedays lower (109 mm Hg); First dose on her "left hand"; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First dose on her "left hand"). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy), ASTHENIA (Feels weakness), FEELING ABNORMAL (feeling really weird), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), FEELING COLD (Feeling very cold, an unusual cold), MYALGIA (Muscle pain, it's an incredible pain) and HEADACHE (Headache). On 17-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First dose on her "left hand") had resolved. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure is 35 above normal and somedays lower (109 mm Hg)), DIARRHOEA (Diarrhea), DIZZINESS (Dizzy), ASTHENIA (Feels weakness), FEELING ABNORMAL (feeling really weird), FEELING OF BODY TEMPERATURE CHANGE (Feels hot and cold), FEELING COLD (Feeling very cold, an unusual cold), MYALGIA (Muscle pain, it's an incredible pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient reported that only with a hair dryer could they get warm. Each day is worse and wanted to know when it will end. The patient said they had a blood test, previous to the vaccination because they gained weight, and it was normal. Treatment for the events included paracetamol, ibuprofen and cold showers.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Pyrexia
Clinical narrative: Covid Pneumonia; High fevers; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Covid Pneumonia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leukemia.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 PNEUMONIA (Covid Pneumonia) (seriousness criteria hospitalization and medically significant) and PYREXIA (High fevers). At the time of the report, COVID-19 PNEUMONIA (Covid Pneumonia) and PYREXIA (High fevers) outcome was unknown.            Hospitalization- treatment with remdesivir x 2 courses and other unknown monoclonal antibodies. Is on oxygen.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: excruciating headache at the top, left side of head; muscle pain; unusual heart rhythm; Pain Worsened; fever; chills; joint pain; arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (unusual heart rhythm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt). On 04-Apr-2021, the patient experienced ARRHYTHMIA (unusual heart rhythm) (seriousness criterion medically significant), PAIN (Pain Worsened), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 05-Apr-2021, the patient experienced HEADACHE (excruciating headache at the top, left side of head). On 05-Apr-2021, PYREXIA (fever) outcome was unknown. At the time of the report, ARRHYTHMIA (unusual heart rhythm), PAIN (Pain Worsened), VACCINATION SITE PAIN (arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (excruciating headache at the top, left side of head) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events included aspirin.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: excruciating headache at the top, left side of head; muscle pain; unusual heart rhythm; Pain Worsened; fever; chills; joint pain; arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (unusual heart rhythm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt). On 04-Apr-2021, the patient experienced ARRHYTHMIA (unusual heart rhythm) (seriousness criterion medically significant), PAIN (Pain Worsened), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 05-Apr-2021, the patient experienced HEADACHE (excruciating headache at the top, left side of head). On 05-Apr-2021, PYREXIA (fever) outcome was unknown. At the time of the report, ARRHYTHMIA (unusual heart rhythm), PAIN (Pain Worsened), VACCINATION SITE PAIN (arm was sore/entire arm was in excruciating pain like pain of 9.5/10/ muscle and joint pain/arm continued to hurt), CHILLS (chills), ARTHRALGIA (joint pain), HEADACHE (excruciating headache at the top, left side of head) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events included aspirin.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cholecystitis, Intestinal obstruction
Clinical narrative: bowel obstruction; enflamed gallbladder; GI issues; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INTESTINAL OBSTRUCTION (bowel obstruction) and CHOLECYSTITIS (enflamed gallbladder) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (GI issues). On an unknown date, the patient experienced INTESTINAL OBSTRUCTION (bowel obstruction) (seriousness criteria hospitalization and medically significant) and CHOLECYSTITIS (enflamed gallbladder) (seriousness criterion medically significant). At the time of the report, INTESTINAL OBSTRUCTION (bowel obstruction), CHOLECYSTITIS (enflamed gallbladder) and ABDOMINAL DISCOMFORT (GI issues) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Fatigue, Pain in extremity
Clinical narrative: wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts; "serious pain in arm"; fatigue for "weeks"; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer (Stage 4 breast cancer). Concomitant products included EVEROLIMUS (AFINITOR) for an unknown indication.   On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY ("serious pain in arm") and FATIGUE (fatigue for "weeks"). On 11-Mar-2021, the patient experienced BREAST CANCER (wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts) (seriousness criterion medically significant). On 08-Mar-2021, PAIN IN EXTREMITY ("serious pain in arm") had resolved. In March 2021, FATIGUE (fatigue for "weeks") had resolved. At the time of the report, BREAST CANCER (wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter states patient saw her doctor Tuesday and no new MRI was done. In 2 weeks she goes back for follow up regarding side effects she experienced. Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-071245 (E2B Linked Report).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. MOD-2021-071245:Crosslink (MOD21-071889)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vascular graft
Clinical narrative: bypass surgery after the first dose; Second dose past 36 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR GRAFT (bypass surgery after the first dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery bypass graft on 16-Mar-2021. Concomitant products included METFORMIN, CLOPIDOGREL BISULFATE (PLAVIX), ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VASCULAR GRAFT (bypass surgery after the first dose) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose past 36 days after first dose). At the time of the report, VASCULAR GRAFT (bypass surgery after the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose past 36 days after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bled a lot at injection site during administration (left arm); This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled a lot at injection site during administration (left arm)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 024A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 07-Apr-2021, the patient stated that after her 2nd dose, her left arm bled a lot at the injection site and blood ran down her arm and the patient was concerned if the vaccine came out through the blood and if she received the full dose?  On 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bled a lot at injection site during administration (left arm)) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bled a lot at injection site during administration (left arm)) outcome was unknown. Not Provided     No relevant concomitant medication were provided. No treatment information was provided.; Sender's Comments: This is a case or injection site bleeding during administration of mRNA-1273.  Based on the available information, a causal association between the product administration and the event cannot be excluded.