chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: felt like a mac truck ran over him; Chills; Low graded fever; Fatigue; Muscle Ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like a mac truck ran over him), CHILLS (Chills), PYREXIA (Low graded fever), FATIGUE (Fatigue) and MYALGIA (Muscle Ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Low graded fever), FATIGUE (Fatigue) and MYALGIA (Muscle Ache). On an unknown date, the patient experienced FEELING ABNORMAL (felt like a mac truck ran over him). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt like a mac truck ran over him), CHILLS (Chills), PYREXIA (Low graded fever), FATIGUE (Fatigue) and MYALGIA (Muscle Ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-038141 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-038141:wife case
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder sore) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ARTHRALGIA (shoulder sore). At the time of the report, ARTHRALGIA (shoulder sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received. Significant FU. AE Outcome and patient gender and age group added. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder sore) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ARTHRALGIA (shoulder sore). At the time of the report, ARTHRALGIA (shoulder sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received. Significant FU. AE Outcome and patient gender and age group added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Intense itching at injection site; Slight swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Intense itching at injection site) and VACCINATION SITE SWELLING (Slight swelling at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Intense itching at injection site) and VACCINATION SITE SWELLING (Slight swelling at injection site). At the time of the report, VACCINATION SITE PRURITUS (Intense itching at injection site) and VACCINATION SITE SWELLING (Slight swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.  The patient reported that it was annoying, like an insect bite.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was given both doses of the vaccine in the wrong location; A spontaneous report was received from a consumer concerning a female patient of an unknown age who was administered Moderna's COVID-19 vaccine (mRNA-1273) and reported that patient was given both doses of the vaccine in the wrong location/inappropriate route of vaccination.  The patient's medical history and concomitant medications were not reported.  The patient received (dates not provided) her both first and second of two planned doses of mRNA-1273 (batch number: unknown) for the prophylaxis of COVID-19 infection.  The patient was given both doses of the vaccine in the wrong location. One was administered too high and the other too low. The patient thought it was not as effective and may need to restart the vaccination series.  Action taken with mRNA-1273 in response to the event was not applicable.; Reporter's Comments: This report refers to a case of Inappropriate route of vaccination for mRNA-1273, lot# unknown, with no associated adverse events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: huge raised swollen bump on injection site which was hot to touch; also total 3 swollen lymph nodes in armpit and on the collar bone area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (huge raised swollen bump on injection site which was hot to touch) and LYMPHADENOPATHY (also total 3 swollen lymph nodes in armpit and on the collar bone area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE SWELLING (huge raised swollen bump on injection site which was hot to touch) and LYMPHADENOPATHY (also total 3 swollen lymph nodes in armpit and on the collar bone area). At the time of the report, VACCINATION SITE SWELLING (huge raised swollen bump on injection site which was hot to touch) outcome was unknown and LYMPHADENOPATHY (also total 3 swollen lymph nodes in armpit and on the collar bone area) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She took Heat pack & Ice pack as treatment for the event occurred .
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Limb discomfort, Myalgia
Clinical narrative: The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (arm discomfort) and MYALGIA (muscle aches). On 08-Mar-2021, the patient experienced AGEUSIA (losing sense of taste and smell) and ANOSMIA (losing sense of taste and smell). At the time of the report, LIMB DISCOMFORT (arm discomfort), MYALGIA (muscle aches), AGEUSIA (losing sense of taste and smell) and ANOSMIA (losing sense of taste and smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Pyrexia, Tremor
Clinical narrative: Second shot I had mild fever; mild right shoulder pain.; flulike symptoms; Shaking; chills/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flulike symptoms), TREMOR (Shaking), CHILLS (chills/severe chills), PYREXIA (Second shot I had mild fever) and ARTHRALGIA (mild right shoulder pain.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No medical history was provided by the reporter.  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 INFLUENZA LIKE ILLNESS (flulike symptoms), TREMOR (Shaking) and CHILLS (chills/severe chills). On an unknown date, the patient experienced PYREXIA (Second shot I had mild fever) and ARTHRALGIA (mild right shoulder pain.). On 09-Mar-2021, INFLUENZA LIKE ILLNESS (flulike symptoms), TREMOR (Shaking) and CHILLS (chills/severe chills) had resolved. At the time of the report, PYREXIA (Second shot I had mild fever) and ARTHRALGIA (mild right shoulder pain.) outcome was unknown. No concomitant medications reported. No Treatments were reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: added fever. shoulder pain.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Rash pruritic, Swelling
Clinical narrative: Shoulder and arm down to the elbow were very big in size like a bodybuilder; developed a really itchy rash; pain and swelling; pain and swelling; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Shoulder and arm down to the elbow were very big in size like a bodybuilder), RASH PRURITIC (developed a really itchy rash), SWELLING (pain and swelling) and PAIN (pain and swelling) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation.     Concomitant products included EZETIMIBE (ZETIA), CANDESARTAN, TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN 81), FINASTERIDE (PROSCAR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced JOINT SWELLING (Shoulder and arm down to the elbow were very big in size like a bodybuilder), RASH PRURITIC (developed a really itchy rash), SWELLING (pain and swelling) and PAIN (pain and swelling). On 04-Mar-2021, RASH PRURITIC (developed a really itchy rash) had resolved. At the time of the report, JOINT SWELLING (Shoulder and arm down to the elbow were very big in size like a bodybuilder) and PAIN (pain and swelling) outcome was unknown and SWELLING (pain and swelling) had resolved.            Treatment medication included allegra (antihistamine)   This case was linked to US-MODERNATX, INC.-MOD-2021-038157 (E2B Linked Report). This case was linked to MOD-2021-069722, MOD-2021-069722 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 7-May-2021 added outcome of events swelling and itch subsided after several days; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-038157:Wife's case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site pruritus
Clinical narrative: very itchy at injection site; a rash at injection site 1.5 inch; (deep pink) redness; slightly light headed; black and blue at the injection site; numbness at the injection site; light pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slightly light headed), VACCINATION SITE DISCOLOURATION (black and blue at the injection site), INJECTION SITE HYPOAESTHESIA (numbness at the injection site), INJECTION SITE PAIN (light pain at injection site) and INJECTION SITE RASH (a rash at injection site 1.5 inch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN (ADVIL 12 HOUR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (slightly light headed), VACCINATION SITE DISCOLOURATION (black and blue at the injection site), INJECTION SITE HYPOAESTHESIA (numbness at the injection site) and INJECTION SITE PAIN (light pain at injection site). On 08-Mar-2021, the patient experienced INJECTION SITE RASH (a rash at injection site 1.5 inch) and INJECTION SITE ERYTHEMA ((deep pink) redness). On an unknown date, the patient experienced INJECTION SITE PRURITUS (very itchy at injection site). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (slightly light headed), INJECTION SITE HYPOAESTHESIA (numbness at the injection site), INJECTION SITE PAIN (light pain at injection site) and INJECTION SITE PRURITUS (very itchy at injection site) outcome was unknown, VACCINATION SITE DISCOLOURATION (black and blue at the injection site) had resolved and INJECTION SITE RASH (a rash at injection site 1.5 inch) and INJECTION SITE ERYTHEMA ((deep pink) redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included Centrum. Treatment details also included cold compresses.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site discolouration
Clinical narrative: very itchy at injection site; a rash at injection site 1.5 inch; (deep pink) redness; slightly light headed; black and blue at the injection site; numbness at the injection site; light pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slightly light headed), VACCINATION SITE DISCOLOURATION (black and blue at the injection site), INJECTION SITE HYPOAESTHESIA (numbness at the injection site), INJECTION SITE PAIN (light pain at injection site) and INJECTION SITE RASH (a rash at injection site 1.5 inch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN (ADVIL 12 HOUR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (slightly light headed), VACCINATION SITE DISCOLOURATION (black and blue at the injection site), INJECTION SITE HYPOAESTHESIA (numbness at the injection site) and INJECTION SITE PAIN (light pain at injection site). On 08-Mar-2021, the patient experienced INJECTION SITE RASH (a rash at injection site 1.5 inch) and INJECTION SITE ERYTHEMA ((deep pink) redness). On an unknown date, the patient experienced INJECTION SITE PRURITUS (very itchy at injection site). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIZZINESS (slightly light headed), INJECTION SITE HYPOAESTHESIA (numbness at the injection site), INJECTION SITE PAIN (light pain at injection site) and INJECTION SITE PRURITUS (very itchy at injection site) outcome was unknown, VACCINATION SITE DISCOLOURATION (black and blue at the injection site) had resolved and INJECTION SITE RASH (a rash at injection site 1.5 inch) and INJECTION SITE ERYTHEMA ((deep pink) redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included Centrum. Treatment details also included cold compresses.
Sex: F
Vaccine: COVID19
Symptoms: Salivary gland enlargement, Skin burning sensation
Clinical narrative: Severe burning on the left side of the neck; Swelling of the salivary glands on the left side of her face which still have not resolved; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Severe burning on the left side of the neck) and SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands on the left side of her face which still have not resolved) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Severe burning on the left side of the neck) and SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands on the left side of her face which still have not resolved). At the time of the report, SKIN BURNING SENSATION (Severe burning on the left side of the neck) and SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands on the left side of her face which still have not resolved) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided Treatment information was not provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: next day red spot and beat red; started itching really bad; arm swollen the size of a grapefruit; very warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (next day red spot and beat red), PRURITUS (started itching really bad), PERIPHERAL SWELLING (arm swollen the size of a grapefruit) and FEELING HOT (very warm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ERYTHEMA (next day red spot and beat red), PRURITUS (started itching really bad), PERIPHERAL SWELLING (arm swollen the size of a grapefruit) and FEELING HOT (very warm). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (next day red spot and beat red), PRURITUS (started itching really bad), PERIPHERAL SWELLING (arm swollen the size of a grapefruit) and FEELING HOT (very warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR was received and Does not Contains any new information
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach Ache; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Ache) and DIARRHOEA (Diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation.     No medical history provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, LISINOPRIL for Hypertension.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Ache) and DIARRHOEA (Diarrhea) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: updated event to recovered/resolved.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Rash, Skin disorder
Clinical narrative: Very hot rash on forehead, stomach, wrist, elbow, shoulder, and thigh; Suddenly had rash; Sunburns type skin changes all over the body; First 'Red Flush" was on knees, wrist, elbows, and stomach, lasted approximately three hours; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Sunburns type skin changes all over the body), FLUSHING (First 'Red Flush" was on knees, wrist, elbows, and stomach, lasted approximately three hours), RASH (Very hot rash on forehead, stomach, wrist, elbow, shoulder, and thigh) and RASH (Suddenly had rash) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced SKIN DISORDER (Sunburns type skin changes all over the body) and FLUSHING (First 'Red Flush" was on knees, wrist, elbows, and stomach, lasted approximately three hours). On an unknown date, the patient experienced RASH (Very hot rash on forehead, stomach, wrist, elbow, shoulder, and thigh) and RASH (Suddenly had rash). At the time of the report, SKIN DISORDER (Sunburns type skin changes all over the body), FLUSHING (First 'Red Flush" was on knees, wrist, elbows, and stomach, lasted approximately three hours), RASH (Very hot rash on forehead, stomach, wrist, elbow, shoulder, and thigh) and RASH (Suddenly had rash) outcome was unknown.            No concomitant products were reported. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Event added; 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
Sex: M
Vaccine: COVID19
Symptoms: Ammonia, Ammonia increased, Blood sodium, Blood sodium increased, Body temperature
Clinical narrative: Disorientation; Sodium level high; Ammonia level was high; influenza positive; fever(100F); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (Disorientation), BLOOD SODIUM INCREASED (Sodium level high), AMMONIA INCREASED (Ammonia level was high), INFLUENZA VIRUS TEST POSITIVE (influenza positive) and PYREXIA (fever(100F)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, FUROSEMIDE (FUROSIMIDE), ATORVASTATIN, POTASSIUM CHLORIDE, OMEPRAZOLE, GARLIC [ALLIUM SATIVUM], VITAMIN D3 and FENOFIBRATE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DISORIENTATION (Disorientation), BLOOD SODIUM INCREASED (Sodium level high), AMMONIA INCREASED (Ammonia level was high), INFLUENZA VIRUS TEST POSITIVE (influenza positive) and PYREXIA (fever(100F)). The patient was treated with LACTULOSE ongoing since an unknown date for Disorientation, at a dose of UNK dosage form. At the time of the report, DISORIENTATION (Disorientation), BLOOD SODIUM INCREASED (Sodium level high), AMMONIA INCREASED (Ammonia level was high), INFLUENZA VIRUS TEST POSITIVE (influenza positive) and PYREXIA (fever(100F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Ammonia: high. On 07-Mar-2021, Blood sodium: high. On 07-Mar-2021, Body temperature: 100.     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.
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Influenza virus test positive, Pyrexia
Clinical narrative: Disorientation; Sodium level high; Ammonia level was high; influenza positive; fever(100F); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (Disorientation), BLOOD SODIUM INCREASED (Sodium level high), AMMONIA INCREASED (Ammonia level was high), INFLUENZA VIRUS TEST POSITIVE (influenza positive) and PYREXIA (fever(100F)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, FUROSEMIDE (FUROSIMIDE), ATORVASTATIN, POTASSIUM CHLORIDE, OMEPRAZOLE, GARLIC [ALLIUM SATIVUM], VITAMIN D3 and FENOFIBRATE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DISORIENTATION (Disorientation), BLOOD SODIUM INCREASED (Sodium level high), AMMONIA INCREASED (Ammonia level was high), INFLUENZA VIRUS TEST POSITIVE (influenza positive) and PYREXIA (fever(100F)). The patient was treated with LACTULOSE ongoing since an unknown date for Disorientation, at a dose of UNK dosage form. At the time of the report, DISORIENTATION (Disorientation), BLOOD SODIUM INCREASED (Sodium level high), AMMONIA INCREASED (Ammonia level was high), INFLUENZA VIRUS TEST POSITIVE (influenza positive) and PYREXIA (fever(100F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Ammonia: high. On 07-Mar-2021, Blood sodium: high. On 07-Mar-2021, Body temperature: 100.     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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Facial pain, Nervous system disorder, Noninfective gingivitis, Pain
Clinical narrative: sores on her face; sores on her mouth; open ulcer/lesions in the vagina; severe burning; Sores on her gums; Very painful; affects nervous system; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning) and NONINFECTIVE GINGIVITIS (Sores on her gums) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning), NONINFECTIVE GINGIVITIS (Sores on her gums), PAIN (Very painful) and NERVOUS SYSTEM DISORDER (affects nervous system).   At the time of the report, FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning), NONINFECTIVE GINGIVITIS (Sores on her gums), PAIN (Very painful) and NERVOUS SYSTEM DISORDER (affects nervous system) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Vaginal lesion
Clinical narrative: sores on her face; sores on her mouth; open ulcer/lesions in the vagina; severe burning; Sores on her gums; Very painful; affects nervous system; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning) and NONINFECTIVE GINGIVITIS (Sores on her gums) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning), NONINFECTIVE GINGIVITIS (Sores on her gums), PAIN (Very painful) and NERVOUS SYSTEM DISORDER (affects nervous system).   At the time of the report, FACIAL PAIN (sores on her face), STOMATITIS (sores on her mouth), VAGINAL LESION (open ulcer/lesions in the vagina), BURNING SENSATION (severe burning), NONINFECTIVE GINGIVITIS (Sores on her gums), PAIN (Very painful) and NERVOUS SYSTEM DISORDER (affects nervous system) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination complication
Clinical narrative: bit of a reaction; spike fever(101.5); nauseous for 2 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (bit of a reaction), PYREXIA (spike fever(101.5)) and NAUSEA (nauseous for 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No medical history was provided by the reporter.     On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (bit of a reaction), PYREXIA (spike fever(101.5)) and NAUSEA (nauseous for 2 days). At the time of the report, VACCINATION COMPLICATION (bit of a reaction), PYREXIA (spike fever(101.5)) and NAUSEA (nauseous for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; the achiness in my lower back has increased; mild headache; mild fever that ran up to 101F; achiness in joints; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (the achiness in my lower back has increased), HEADACHE (mild headache), PYREXIA (mild fever that ran up to 101F) and ARTHRALGIA (achiness in joints) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (the achiness in my lower back has increased), HEADACHE (mild headache), PYREXIA (mild fever that ran up to 101F) and ARTHRALGIA (achiness in joints). On 06-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (mild fever that ran up to 101F) and ARTHRALGIA (achiness in joints) had resolved. At the time of the report, BACK PAIN (the achiness in my lower back has increased) and HEADACHE (mild headache) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Chills, Eye swelling, Ocular discomfort, Pain
Clinical narrative: Fluid around the eye had really puffed up; started having chills; Body aches; Whole area around their eye was swollen; Fluid had gathered up around that area; Eyelids were swollen; Eyelid had inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen) and BLEPHARITIS (Eyelid had inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (3 weeks ago) and Cancer surgery (Skin Cancer removed(right eye was not affected) had stitches both internal and external (internal were removed).Recovering fine.). Concurrent medical conditions included Penicillin allergy and Drug allergy (Levaquin). Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body aches), EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen), BLEPHARITIS (Eyelid had inflammation) and CHILLS (started having chills). On an unknown date, the patient experienced PERIORBITAL SWELLING (Fluid around the eye had really puffed up). The patient was treated with PREDNISONE (ophthalmic) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, PAIN (Body aches) and CHILLS (started having chills) had resolved. On 12-Mar-2021, EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen), BLEPHARITIS (Eyelid had inflammation) and PERIORBITAL SWELLING (Fluid around the eye had really puffed up) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include prednisone eyedrop. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Event outcome changed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling of eyelid
Clinical narrative: Fluid around the eye had really puffed up; started having chills; Body aches; Whole area around their eye was swollen; Fluid had gathered up around that area; Eyelids were swollen; Eyelid had inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen) and BLEPHARITIS (Eyelid had inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (3 weeks ago) and Cancer surgery (Skin Cancer removed(right eye was not affected) had stitches both internal and external (internal were removed).Recovering fine.). Concurrent medical conditions included Penicillin allergy and Drug allergy (Levaquin). Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Body aches), EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen), BLEPHARITIS (Eyelid had inflammation) and CHILLS (started having chills). On an unknown date, the patient experienced PERIORBITAL SWELLING (Fluid around the eye had really puffed up). The patient was treated with PREDNISONE (ophthalmic) ongoing since an unknown date at an unspecified dose and frequency. On 07-Mar-2021, PAIN (Body aches) and CHILLS (started having chills) had resolved. On 12-Mar-2021, EYE SWELLING (Whole area around their eye was swollen), OCULAR DISCOMFORT (Fluid had gathered up around that area), SWELLING OF EYELID (Eyelids were swollen), BLEPHARITIS (Eyelid had inflammation) and PERIORBITAL SWELLING (Fluid around the eye had really puffed up) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include prednisone eyedrop. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Event outcome changed.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Tongue disorder
Clinical narrative: dry mouth; thick tongue; difficulty shallowing; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth), TONGUE DISORDER (thick tongue) and DYSPHAGIA (difficulty shallowing) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     Concomitant products included CARVEDILOL (CARVEDIOL) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DRY MOUTH (dry mouth), TONGUE DISORDER (thick tongue) and DYSPHAGIA (difficulty shallowing). On 02-Mar-2021, DRY MOUTH (dry mouth), TONGUE DISORDER (thick tongue) and DYSPHAGIA (difficulty shallowing) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events are reported as Sudafed.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (had a body rash/ like covid arm but all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-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 08-Mar-2021, the patient experienced RASH (had a body rash/ like covid arm but all over his body). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (had a body rash/ like covid arm but all over his body) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-06-2021 contains non-significant information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breath odour, Dysgeusia, Eating disorder, Nausea, Oral discomfort
Clinical narrative: can't eat; smells it when she breaths; Smell is nauseating; she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins; she has metallic taste and smell; everything smells and tastes like metal; she as a weird aluminum foil foul smell in her mouth.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal), ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.), EATING DISORDER (can't eat) and BREATH ODOUR (smells it when she breaths) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had loss of smell and tastes like metal). Concurrent medical conditions included Ulcerative colitis and Colitis (interstitial colitis). Concomitant products included OXYBUTYNIN and ALMOTRIPTAN MALATE (ALMOGRAN) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal) and ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.). On 08-Mar-2021, the patient experienced EATING DISORDER (can't eat), BREATH ODOUR (smells it when she breaths) and NAUSEA (Smell is nauseating). At the time of the report, DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal), ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.), EATING DISORDER (can't eat), BREATH ODOUR (smells it when she breaths) and NAUSEA (Smell is nauseating) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included natural holistic remedy tea with ginger and turmeric. Also, said her sister gave her a natural holistic remedy.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: can't eat; smells it when she breaths; Smell is nauseating; she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins; she has metallic taste and smell; everything smells and tastes like metal; she as a weird aluminum foil foul smell in her mouth.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal), ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.), EATING DISORDER (can't eat) and BREATH ODOUR (smells it when she breaths) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had loss of smell and tastes like metal). Concurrent medical conditions included Ulcerative colitis and Colitis (interstitial colitis). Concomitant products included OXYBUTYNIN and ALMOTRIPTAN MALATE (ALMOGRAN) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal) and ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.). On 08-Mar-2021, the patient experienced EATING DISORDER (can't eat), BREATH ODOUR (smells it when she breaths) and NAUSEA (Smell is nauseating). At the time of the report, DYSGEUSIA (she has metallic taste and smell; everything smells and tastes like metal\Everything tastes gross; smell and tastes like coins), PAROSMIA (she has metallic taste and smell; everything smells and tastes like metal), ORAL DISCOMFORT (she as a weird aluminum foil foul smell in her mouth.), EATING DISORDER (can't eat), BREATH ODOUR (smells it when she breaths) and NAUSEA (Smell is nauseating) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included natural holistic remedy tea with ginger and turmeric. Also, said her sister gave her a natural holistic remedy.