chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Hallucination, Head discomfort
Clinical narrative: balance was weird; left side of head, above my ear felt like something inside my head popped and liquid drained; felt really terrible; she thought that maybe she was hallucinating; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (she thought that maybe she was hallucinating) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dyslexia and Thyroid associated orbitopathy (Unspecified Allergies).   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible). On an unknown date, the patient experienced HALLUCINATION (she thought that maybe she was hallucinating) (seriousness criterion medically significant). On 12-Feb-2021, HALLUCINATION (she thought that maybe she was hallucinating), BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible) had resolved.            No treatment medications were provided.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ear) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bicuspid aortic valve, Cholesterol total abnormal NOS and Tinnitus. Concomitant products included ROSUVASTATIN, METOPROLOL, UBIDECARENONE (CO-ENZYME Q10) and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TINNITUS (Ringing in my ear) (seriousness criterion medically significant). At the time of the report, TINNITUS (Ringing in my ear) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Prednisone, four tablets per day for five days. Approximately 30 to 45 minutes post administration of the vaccine, the patient experienced ringing in his ear.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of tinnitus, a causal relationship cannot be excluded. Prior medical history of tinnitus is considered a risk factor.   This case was linked to MOD21-072080, US-MODERNATX, INC.-MOD-2021-071450 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of tinnitus, a causal relationship cannot be excluded. Prior medical history of tinnitus is considered a risk factor. MOD21-072080:Crosslink US-MODERNATX, INC.-MOD-2021-071450:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Circumoral oedema, Fatigue, Lip oedema, Malaise
Clinical narrative: worsening bilateral infraorbital edema; perioral edema; upper lip edema; mid-cheeks swelling and inflammation; malaise; fever; fatigue; myalgias; This literature-non-study case was reported in a literature article and describes the occurrence of ORBITAL OEDEMA (worsening bilateral infraorbital edema) in a 36-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.   LITERATURE REFERENCE: Oral angiotensin-converting enzyme inhibitors for treatment of delayed inflammatory reaction to dermal hyaluroninc acid fillers following COVID-19 vaccination-a model for inhibition of angiotensin II-induced cutaneous inflammation. 2021:63-68     The patient's past medical history included Skin cosmetic procedure (she was injected with 1 mL of Voluma 1 in the bilateral tear troughs) in November 2019 and Lip cosmetic procedure (she was injected with 1 mL of Juvederm Ultra in the upper and lower part of the lips) in November 2019.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced ORBITAL OEDEMA (worsening bilateral infraorbital edema) (seriousness criterion medically significant) and CIRCUMORAL OEDEMA (perioral edema). December 2020, the patient experienced LIP OEDEMA (upper lip edema) and SWELLING FACE (mid-cheeks swelling and inflammation). December 2020, the patient experienced MALAISE (malaise), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (myalgias). At the time of the report, ORBITAL OEDEMA (worsening bilateral infraorbital edema), CIRCUMORAL OEDEMA (perioral edema), LIP OEDEMA (upper lip edema) and SWELLING FACE (mid-cheeks swelling and inflammation) had resolved and MALAISE (malaise), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (myalgias) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Body temperature: 38.8 (High) 38.8 degrees Celsius.     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.   Treatment for the events included Cetirizine 20mg and oral lisinopril 5mg QD. Historic use of corticosteroids was noted.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: Myalgia, Orbital oedema, Pyrexia, Swelling face
Clinical narrative: worsening bilateral infraorbital edema; perioral edema; upper lip edema; mid-cheeks swelling and inflammation; malaise; fever; fatigue; myalgias; This literature-non-study case was reported in a literature article and describes the occurrence of ORBITAL OEDEMA (worsening bilateral infraorbital edema) in a 36-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.   LITERATURE REFERENCE: Oral angiotensin-converting enzyme inhibitors for treatment of delayed inflammatory reaction to dermal hyaluroninc acid fillers following COVID-19 vaccination-a model for inhibition of angiotensin II-induced cutaneous inflammation. 2021:63-68     The patient's past medical history included Skin cosmetic procedure (she was injected with 1 mL of Voluma 1 in the bilateral tear troughs) in November 2019 and Lip cosmetic procedure (she was injected with 1 mL of Juvederm Ultra in the upper and lower part of the lips) in November 2019.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced ORBITAL OEDEMA (worsening bilateral infraorbital edema) (seriousness criterion medically significant) and CIRCUMORAL OEDEMA (perioral edema). December 2020, the patient experienced LIP OEDEMA (upper lip edema) and SWELLING FACE (mid-cheeks swelling and inflammation). December 2020, the patient experienced MALAISE (malaise), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (myalgias). At the time of the report, ORBITAL OEDEMA (worsening bilateral infraorbital edema), CIRCUMORAL OEDEMA (perioral edema), LIP OEDEMA (upper lip edema) and SWELLING FACE (mid-cheeks swelling and inflammation) had resolved and MALAISE (malaise), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (myalgias) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Body temperature: 38.8 (High) 38.8 degrees Celsius.     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.   Treatment for the events included Cetirizine 20mg and oral lisinopril 5mg QD. Historic use of corticosteroids was noted.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included unspecified antibiotics. 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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: delayed onset cellulitis at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (delayed onset cellulitis at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Vaccination site cellulitis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced CELLULITIS (delayed onset cellulitis at the site of injection) (seriousness criterion medically significant). At the time of the report, CELLULITIS (delayed onset cellulitis at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Patient visited to the emergency room on 8 Apr 2021.   Reporter did not allow further contact; 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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Pain in extremity
Clinical narrative: The day after the shot pain in her chest, "pain in her heart"; The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CARVEDILOL, AMLODIPINE, ISOSORBIDE and METFORMIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") (seriousness criterion medically significant) and PAIN IN EXTREMITY (The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days). At the time of the report, ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") and PAIN IN EXTREMITY (The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that these events occurred even before receiving the vaccine every once in a while. Treatment information was not provided.  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.; 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. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Hypertension, Pain in extremity
Clinical narrative: Anaphylactic reaction; Blood pressure high; Could not breathe; Pain in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERTENSION (Blood pressure high) and DYSPNOEA (Could not breathe) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031b21a) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD. Concurrent medical conditions included Allergy (receives four shots a week for his allergies).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm). On 05-Apr-2021, the patient experienced DYSPNOEA (Could not breathe) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure high) (seriousness criterion hospitalization). The patient was hospitalized on 06-Apr-2021 due to ANAPHYLACTIC REACTION, DYSPNOEA and HYPERTENSION. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERTENSION (Blood pressure high), DYSPNOEA (Could not breathe) and PAIN IN EXTREMITY (Pain in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment of the events included steroids and blood pressure medication.  Additional information:Patient stated he had some pain in his arm. Patient states on 4-5-2021 he could not breathe. Patient states on 4-6-2021 he went to emergency room. Patient stated he was in the intensive care unit for 3 days. Patient stated he was given steroids and blood pressure medicine because his blood pressure was high. Patient stated he was told he had an anaphylactic reaction. Patient stated that the doctor thought it was something he ate. Patient state he has a history of COPD and allergies and receives four shots a week for his allergies. Patient stated he will get itching around his mouth from eating chicken but doesn't believe his symptoms was from food.  Company comment:Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Dizziness, Fatigue, Injection site reaction, Pain
Clinical narrative: injection site reaction that was like cellulitis; felt lightheaded; injection site reaction; body aches; severe fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CELLULITIS (injection site reaction that was like cellulitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites).   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CELLULITIS (injection site reaction that was like cellulitis) (seriousness criterion medically significant), DIZZINESS (felt lightheaded), INJECTION SITE REACTION (injection site reaction), PAIN (body aches) and FATIGUE (severe fatigue). At the time of the report, CELLULITIS (injection site reaction that was like cellulitis), DIZZINESS (felt lightheaded), INJECTION SITE REACTION (injection site reaction), PAIN (body aches) and FATIGUE (severe fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment reported included Keflex(cefalexin)  for 2 days.   This case was linked to MOD-2021-073420 (Patient Link).; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected injection site reaction, pain, dizziness and expected fatigue. Event onset with unknown latency after first dose mRNA-1273. Events ongoing. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye haemorrhage, Heart rate increased, Hypertension
Clinical narrative: Experienced very high blood pressure/blood pressure was 190/119; The blood vessel broke in her left eye/ there was blood in half of her eyes; Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119), EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease and Colitis. Concomitant products included MESALAMINE for Crohn's disease and Colitis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119) (seriousness criterion hospitalization), EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) (seriousness criterion hospitalization) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119) had resolved and EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate  was 150 and she did not even feel it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 141/90. On 16-Mar-2021, Blood pressure measurement: 136/84. On 17-Mar-2021, Blood pressure measurement: 140/91. On 22-Mar-2021, Blood pressure measurement: 155/94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported to be treated with beta blockers and test were performed and came out "okay". No further information regarding test results or types of tests was provided.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Chills, Dizziness, Loss of consciousness, Malaise
Clinical narrative: break her ankle; nausea; shaking chills; she fell and passed out; severe dizziness; did not feel her self as well for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she fell and passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (she fell and passed out) (seriousness criterion medically significant), DIZZINESS (severe dizziness), MALAISE (did not feel her self as well for a couple of days), NAUSEA (nausea) and CHILLS (shaking chills). On an unknown date, the patient experienced ANKLE FRACTURE (break her ankle). On 04-Feb-2021, LOSS OF CONSCIOUSNESS (she fell and passed out) had resolved, DIZZINESS (severe dizziness) and NAUSEA (nausea) outcome was unknown. At the time of the report, MALAISE (did not feel her self as well for a couple of days), ANKLE FRACTURE (break her ankle) and CHILLS (shaking chills) outcome was unknown. Not Provided          No treatment information was provided. No relevant concomitant medications was provided.  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. Further information has been requested.; 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. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: break her ankle; nausea; shaking chills; she fell and passed out; severe dizziness; did not feel her self as well for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she fell and passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (she fell and passed out) (seriousness criterion medically significant), DIZZINESS (severe dizziness), MALAISE (did not feel her self as well for a couple of days), NAUSEA (nausea) and CHILLS (shaking chills). On an unknown date, the patient experienced ANKLE FRACTURE (break her ankle). On 04-Feb-2021, LOSS OF CONSCIOUSNESS (she fell and passed out) had resolved, DIZZINESS (severe dizziness) and NAUSEA (nausea) outcome was unknown. At the time of the report, MALAISE (did not feel her self as well for a couple of days), ANKLE FRACTURE (break her ankle) and CHILLS (shaking chills) outcome was unknown. Not Provided          No treatment information was provided. No relevant concomitant medications was provided.  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. Further information has been requested.; 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. Further information has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Fatigue, Hypoglycaemia, Vaccination site pain
Clinical narrative: seemed to almost fall asleep and become unconscious like; hypoglycemia; some fatigue; sore arm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). On 04-Apr-2021, the patient experienced FATIGUE (some fatigue). On 07-Apr-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) (seriousness criterion medically significant) and HYPOGLYCAEMIA (hypoglycemia). At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (seemed to almost fall asleep and become unconscious like) and HYPOGLYCAEMIA (hypoglycemia) had resolved and VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (some fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. On 03-Apr-2021, patient took Tylenol for the sore arm. On 09-Apr-2021, patient went to his doctor. He got some blood work done. His A1c was fine, his fasting glucose level was fine. Doctor doesn't think it's diabetes but had an episode of hypoglycemia. He also did not rule out possible side effect of the vaccine. He has not had another episode since then. Caller is asking if there have been any other reports of hypoglycemic episodes and also asking if Moderna would recommend getting the second dose given the reaction he had with the first dose.   This case was linked  ( Linked Report).; 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: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Productive cough, Wound infection
Clinical narrative: patient hit the leg and the wound infected; dry cough; throat ache; cold; very little phlegm; This spontaneous case was reported by a consumer and describes the occurrence of WOUND INFECTION (patient hit the leg and the wound infected) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced COUGH (dry cough), OROPHARYNGEAL PAIN (throat ache), NASOPHARYNGITIS (cold) and PRODUCTIVE COUGH (very little phlegm). On 05-Apr-2021, the patient experienced WOUND INFECTION (patient hit the leg and the wound infected) (seriousness criterion medically significant). At the time of the report, WOUND INFECTION (patient hit the leg and the wound infected), COUGH (dry cough), OROPHARYNGEAL PAIN (throat ache), NASOPHARYNGITIS (cold) and PRODUCTIVE COUGH (very little phlegm) outcome was unknown.        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.   Patient is taking antibiotics for wound infecting. Treatment taking  for high blood pressure and diabetes.  This case refers to a 72-year old female patient with relevant history of Diabetes who experienced wound infection, cough, Nasopharyngitis and Productive cough following the administration of Covid-19 vaccine and was assessed as Possibly Related to study drug.  The event of Nasopharyngitis could be caused by viral or bacterial infection.  Wound infection was due to the patient hitting her leg.  The underlying history of Diabetes subjects her to higher risk of infections and poor wound healing.; Sender's Comments: This case refers to a 72-year old female patient with relevant history of Diabetes who experienced wound infection, cough, Nasopharyngitis and Productive cough following the administration of Covid-19 vaccine and was assessed as Possibly Related to study drug.  The event of Nasopharyngitis could be caused by viral or bacterial infection.  Wound infection was due to the patient hitting her leg.  The underlying history of Diabetes subjects her to higher risk of infections and poor wound healing.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Inappropriate schedule of product administration, Nausea
Clinical narrative: 48 days post first vaccine and has not received the second dose; Weak; Underweight; Nausea; Dry Heaving; Upper Respiratory Infection; Fainted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and CHILLS (Chills). On 16-Mar-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), DYSPNOEA (Dry Heaving) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose), ASTHENIA (Weak) and UNDERWEIGHT (Underweight). On 23-Feb-2021, SYNCOPE (Fainted) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. On 06-Apr-2021, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection) had resolved. On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose) had resolved. At the time of the report, DYSPNOEA (Dry Heaving), ASTHENIA (Weak), UNDERWEIGHT (Underweight) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She reported that she Fainted, and had chills, after the first vaccine. About 2-3 weeks after Vaccination she had an Upper Respiratory Infection with Negative COVID Test. She had Nausea, and Dry heaving since then. She feels Weak and Underweight. Today 12APR2021 and 48 days post first vaccine, She has not recovered from her upper respiratory infection. MD and Cardiologist told her to get the second vaccine. She wants to receive the second vaccine but she would like to delay it more, until she feels 100% well.  Patient had a pneumonia shot and Flu shot SEP2020.; Sender's Comments: This case concerns a 92-year-old female with a serious unexpected event of syncope, and nonserious unexpected upper respiratory tract infection, dyspnea, asthenia, underweight, inappropriate schedule of product administration and expected chills, nausea. Event onset the same day as first dose mRNA-1273. Events resolved. 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: 91.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope, Underweight, Upper respiratory tract infection
Clinical narrative: 48 days post first vaccine and has not received the second dose; Weak; Underweight; Nausea; Dry Heaving; Upper Respiratory Infection; Fainted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and CHILLS (Chills). On 16-Mar-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), DYSPNOEA (Dry Heaving) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose), ASTHENIA (Weak) and UNDERWEIGHT (Underweight). On 23-Feb-2021, SYNCOPE (Fainted) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. On 06-Apr-2021, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection) had resolved. On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose) had resolved. At the time of the report, DYSPNOEA (Dry Heaving), ASTHENIA (Weak), UNDERWEIGHT (Underweight) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She reported that she Fainted, and had chills, after the first vaccine. About 2-3 weeks after Vaccination she had an Upper Respiratory Infection with Negative COVID Test. She had Nausea, and Dry heaving since then. She feels Weak and Underweight. Today 12APR2021 and 48 days post first vaccine, She has not recovered from her upper respiratory infection. MD and Cardiologist told her to get the second vaccine. She wants to receive the second vaccine but she would like to delay it more, until she feels 100% well.  Patient had a pneumonia shot and Flu shot SEP2020.; Sender's Comments: This case concerns a 92-year-old female with a serious unexpected event of syncope, and nonserious unexpected upper respiratory tract infection, dyspnea, asthenia, underweight, inappropriate schedule of product administration and expected chills, nausea. Event onset the same day as first dose mRNA-1273. Events resolved. 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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, Thrombosis
Clinical narrative: blood clot in his pulmonary artery and several others in his legs; blood clot pulmonary artery; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) and PULMONARY EMBOLISM (blood clot pulmonary artery) in an 82-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.     Family history included Factor V deficiency, Factor II deficiency and MTHFR deficiency.    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 THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) (seriousness criteria hospitalization prolonged and medically significant), PULMONARY EMBOLISM (blood clot pulmonary artery) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in his pulmonary artery and several others in his legs), PULMONARY EMBOLISM (blood clot pulmonary artery) and DYSPNOEA (shortness of breath) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. 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: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia (No special treatment for leukemia received.) and White blood cell count (10000 points). Concomitant products included PRAVASTATIN and GEMFIBROZIL for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown. Not Provided          Patient was treated with Levaquin, IV hydration with magnesium.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Headache, Malaise, Sinusitis, Tinnitus
Clinical narrative: Sinus infection got worse; Headache; Lost hearing; Had bothering tinnitus; All her body feels sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Lost hearing) in an 84-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 Allergy (Allergy to Vaccine NOS). Concurrent medical conditions included Diabetes.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DEAFNESS (Lost hearing) (seriousness criterion medically significant), TINNITUS (Had bothering tinnitus), MALAISE (All her body feels sick) and HEADACHE (Headache). On an unknown date, the patient experienced SINUSITIS (Sinus infection got worse). At the time of the report, DEAFNESS (Lost hearing), TINNITUS (Had bothering tinnitus), MALAISE (All her body feels sick), SINUSITIS (Sinus infection got worse) and HEADACHE (Headache) outcome was unknown.            No concomitant medicines reported. Treatment information included unspecified antibiotic, diphenhydramine and prednisone. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.  Action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Gait disturbance
Clinical narrative: blood clots in the heart; had no energy, very weak, extremely weak; irregular heartbeats; couldn't walk very good; shortness of breath; coughing; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (blood clots in the heart), ASTHENIA (had no energy, very weak, extremely weak) and HEART RATE IRREGULAR (irregular heartbeats) in a 55-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 Tumor and Arrhythmia. Concurrent medical conditions included Heart disease, unspecified in 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), COUGH (coughing), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 01-Apr-2021, the patient experienced ASTHENIA (had no energy, very weak, extremely weak) (seriousness criterion hospitalization) and GAIT DISTURBANCE (couldn't walk very good). On 09-Apr-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeats) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (blood clots in the heart) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Apr-2021 to sometime in April 2021 due to HEART RATE IRREGULAR, then from 05-Apr-2021 to sometime in April 2021 due to INTRACARDIAC THROMBUS, and then from 09-Apr-2021 to sometime in April 2021 due to ASTHENIA. On 25-Mar-2021, CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, INTRACARDIAC THROMBUS (blood clots in the heart), ASTHENIA (had no energy, very weak, extremely weak), HEART RATE IRREGULAR (irregular heartbeats), GAIT DISTURBANCE (couldn't walk very good), DYSPNOEA (shortness of breath), COUGH (coughing) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was placed on unknown medication to help dissolve blood clots for one or two months.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Intracardiac thrombus, Nausea, Vomiting
Clinical narrative: blood clots in the heart; had no energy, very weak, extremely weak; irregular heartbeats; couldn't walk very good; shortness of breath; coughing; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (blood clots in the heart), ASTHENIA (had no energy, very weak, extremely weak) and HEART RATE IRREGULAR (irregular heartbeats) in a 55-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 Tumor and Arrhythmia. Concurrent medical conditions included Heart disease, unspecified in 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), COUGH (coughing), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 01-Apr-2021, the patient experienced ASTHENIA (had no energy, very weak, extremely weak) (seriousness criterion hospitalization) and GAIT DISTURBANCE (couldn't walk very good). On 09-Apr-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeats) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (blood clots in the heart) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Apr-2021 to sometime in April 2021 due to HEART RATE IRREGULAR, then from 05-Apr-2021 to sometime in April 2021 due to INTRACARDIAC THROMBUS, and then from 09-Apr-2021 to sometime in April 2021 due to ASTHENIA. On 25-Mar-2021, CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, INTRACARDIAC THROMBUS (blood clots in the heart), ASTHENIA (had no energy, very weak, extremely weak), HEART RATE IRREGULAR (irregular heartbeats), GAIT DISTURBANCE (couldn't walk very good), DYSPNOEA (shortness of breath), COUGH (coughing) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was placed on unknown medication to help dissolve blood clots for one or two months.  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