chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lethargy, Nausea, Ocular discomfort
Clinical narrative: pressure build up behind the eyes for 3-4 days; lethargic; sweating; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT, LETHARGY, HYPERHIDROSIS, HEADACHE, and NAUSEA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced OCULAR DISCOMFORT, LETHARGY, HYPERHIDROSIS, HEADACHE, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT had resolved and LETHARGY, HYPERHIDROSIS, HEADACHE, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Movement disorder, Myalgia
Clinical narrative: fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; Patient coudl not standup; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE, NAUSEA, MYALGIA, HEADACHE, and INFLUENZA LIKE ILLNESS in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included TRAMADOL.    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 FATIGUE, NAUSEA, MYALGIA, HEADACHE, INFLUENZA LIKE ILLNESS, VACCINATION SITE PRURITUS and MOVEMENT DISORDER. At the time of the report, FATIGUE, NAUSEA, MYALGIA, HEADACHE, INFLUENZA LIKE ILLNESS, VACCINATION SITE PRURITUS and MOVEMENT DISORDER outcome was unknown. Not Provided          Treatment: Ibuprofen 400mg
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pruritus
Clinical narrative: fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; fatigue, nausea, body aches, headaches, flu like symptoms and itchiness in the injection site; Patient coudl not standup; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE, NAUSEA, MYALGIA, HEADACHE, and INFLUENZA LIKE ILLNESS in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included TRAMADOL.    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 FATIGUE, NAUSEA, MYALGIA, HEADACHE, INFLUENZA LIKE ILLNESS, VACCINATION SITE PRURITUS and MOVEMENT DISORDER. At the time of the report, FATIGUE, NAUSEA, MYALGIA, HEADACHE, INFLUENZA LIKE ILLNESS, VACCINATION SITE PRURITUS and MOVEMENT DISORDER outcome was unknown. Not Provided          Treatment: Ibuprofen 400mg
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Sluggishness
Clinical narrative: Sluggishness; Fever; Body aches and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness), PYREXIA (Fever) and MYALGIA (Body aches and pains) in a patient of an unknown age and gender 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 SLUGGISHNESS (Sluggishness), PYREXIA (Fever) and MYALGIA (Body aches and pains). At the time of the report, SLUGGISHNESS (Sluggishness), PYREXIA (Fever) and MYALGIA (Body aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided    This case was linked to MOD21-035014, MOD21-10588, MOD21-086365, MOD21-086368 (E2B Linked Report). This case was linked to MOD-2021-104083 (Patient Link).; Sender's Comments:  MOD21-035014: MOD21-10588: MOD21-086365: MOD21-086368:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pruritus
Clinical narrative: Itching is now spreading in small blisters down my arm from the shoulder; The location where I received the vaccine was itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itching is now spreading in small blisters down my arm from the shoulder) and VACCINATION SITE PRURITUS (The location where I received the vaccine was itching) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 27A2A2 and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itching is now spreading in small blisters down my arm from the shoulder) and VACCINATION SITE PRURITUS (The location where I received the vaccine was itching). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency; CORTISONE for Itching, at an unspecified dose and frequency and CETIRIZINE 19-Jun-2021 at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itching is now spreading in small blisters down my arm from the shoulder) and VACCINATION SITE PRURITUS (The location where I received the vaccine was itching) had resolved.            No relevant concomitant medications were provided.  Patient had itching and he covered it with a band aid. Two months from the day of reporting, the itching started to spread down from his shoulder in tiny blisters. The patient tried cortisone and other creams, however they did not work. According to the patient, calamine lotion was the only treatment which stopped the itching. Patient used cetirizine and it removed the allergic reaction in 6 days after taking it on June 19th. The blisters merged into 3 plaques the size of a penny; the small ones disappeared. Patient experienced sleepiness and weakness for several days after taking just one pill of cetirizine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional Information received: Updated Event occurred country was changed On 03-Jul-2021: Additional Information received: Updated treatment medication, event outcome and narrative.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Blood glucose fluctuation, Vomiting
Clinical narrative: Blood sugar level fluctuation; Vomiting; aspirations; This spontaneous case was reported by a consumer and describes the occurrence of ASPIRATION (aspirations), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuation) and VOMITING (Vomiting) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03621a and 047b21a) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy, Diabetic, Blood pressure and Acetaminophen.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On 22-Apr-2021, the patient experienced ASPIRATION (aspirations). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuation) and VOMITING (Vomiting). On 20-May-2021, ASPIRATION (aspirations) had resolved. At the time of the report, BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuation) outcome was unknown and VOMITING (Vomiting) had not resolved.            No concomitant medications were reported.   No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment  Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-239195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 and it contain event,allergy; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oral discomfort, Oropharyngeal discomfort, Pruritus, Wheezing
Clinical narrative: wheezing; DIFFICULTY BREATHING; ITCHY; SCRATCHY THROAT; SCRATCHY MOUTH; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing), DYSPNOEA (DIFFICULTY BREATHING), PRURITUS (ITCHY), OROPHARYNGEAL DISCOMFORT (SCRATCHY THROAT) and ORAL DISCOMFORT (SCRATCHY MOUTH) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Scallops) and Adhesive tape allergy (Mastesol).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced WHEEZING (wheezing), DYSPNOEA (DIFFICULTY BREATHING), PRURITUS (ITCHY), OROPHARYNGEAL DISCOMFORT (SCRATCHY THROAT) and ORAL DISCOMFORT (SCRATCHY MOUTH). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Apr-2021 at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) on 29-Apr-2021 at an unspecified dose and frequency. On 30-Apr-2021, WHEEZING (wheezing), DYSPNOEA (DIFFICULTY BREATHING), PRURITUS (ITCHY), OROPHARYNGEAL DISCOMFORT (SCRATCHY THROAT) and ORAL DISCOMFORT (SCRATCHY MOUTH) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication not reported. treatment medication not reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Swelling and rash on arm after 7 days of vaccine dose; Swelling and rash on arm after 7 days of vaccine dose; Injection site welts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling and rash on arm after 7 days of vaccine dose), VACCINATION SITE URTICARIA (Injection site welts) and VACCINATION SITE RASH (Swelling and rash on arm after 7 days of vaccine dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022BUA) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE SWELLING (Swelling and rash on arm after 7 days of vaccine dose) and VACCINATION SITE URTICARIA (Injection site welts). On an unknown date, the patient experienced VACCINATION SITE RASH (Swelling and rash on arm after 7 days of vaccine dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling and rash on arm after 7 days of vaccine dose), VACCINATION SITE URTICARIA (Injection site welts) and VACCINATION SITE RASH (Swelling and rash on arm after 7 days of vaccine dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Medication Was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Eyelid margin crusting, Lacrimation increased
Clinical narrative: Eyes constantly itch; Eyes crustty in the morning; Eyes tear and drip; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Eyes constantly itch), EYELID MARGIN CRUSTING (Eyes crustty in the morning) and LACRIMATION INCREASED (Eyes tear and drip) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced EYE PRURITUS (Eyes constantly itch), EYELID MARGIN CRUSTING (Eyes crustty in the morning) and LACRIMATION INCREASED (Eyes tear and drip). At the time of the report, EYE PRURITUS (Eyes constantly itch), EYELID MARGIN CRUSTING (Eyes crustty in the morning) and LACRIMATION INCREASED (Eyes tear and drip) had not resolved.            No concomitant medication information was provided  No treatment product information was provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Both injections I got Covid Arm; Both injections I got itchy surrounding my injection location; Both injections I got hard welt surrounding my injection location.; hard welt surrounding my injection location; Both injections I got red surrounding my injection location; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Both injections I got Covid Arm), VACCINATION SITE PRURITUS (Both injections I got itchy surrounding my injection location), VACCINATION SITE URTICARIA (Both injections I got hard welt surrounding my injection location.), VACCINATION SITE SWELLING (hard welt surrounding my injection location) and VACCINATION SITE ERYTHEMA (Both injections I got red surrounding my injection location) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfur-based medications).   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE REACTION (Both injections I got Covid Arm), VACCINATION SITE PRURITUS (Both injections I got itchy surrounding my injection location), VACCINATION SITE URTICARIA (Both injections I got hard welt surrounding my injection location.), VACCINATION SITE SWELLING (hard welt surrounding my injection location) and VACCINATION SITE ERYTHEMA (Both injections I got red surrounding my injection location). The patient was treated with ARNICA MONTANA for Vaccination site swelling, at an unspecified dose and frequency. On 06-May-2021, VACCINATION SITE REACTION (Both injections I got Covid Arm), VACCINATION SITE PRURITUS (Both injections I got itchy surrounding my injection location), VACCINATION SITE URTICARIA (Both injections I got hard welt surrounding my injection location.), VACCINATION SITE SWELLING (hard welt surrounding my injection location) and VACCINATION SITE ERYTHEMA (Both injections I got red surrounding my injection location) was resolving.            No concomitant medications were reported.  Other treatment medications taken by patient were took Arnica tablets/Cold & Warm Compresses until the swelling subsided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Weight decreased
Clinical narrative: Loss of weight, shortness of breath; Loss of weight, shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loss of weight, shortness of breath) and DYSPNOEA (Loss of weight, shortness of breath) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced WEIGHT DECREASED (Loss of weight, shortness of breath) and DYSPNOEA (Loss of weight, shortness of breath). At the time of the report, WEIGHT DECREASED (Loss of weight, shortness of breath) and DYSPNOEA (Loss of weight, shortness of breath) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Hands keep going numb; My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore; My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore), HYPOAESTHESIA (Hands keep going numb) and ARTHRALGIA (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Levaquin).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) and ARTHRALGIA (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore). On an unknown date, the patient experienced HYPOAESTHESIA (Hands keep going numb). At the time of the report, PAIN IN EXTREMITY (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) and ARTHRALGIA (My arms, shoulders, hips and legs have severe pain to the point I can't take it anymore) had not resolved and HYPOAESTHESIA (Hands keep going numb) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up received, contains patient demographics (Race), event onset date and outcome for pain in extremity and arthralgia was not recovered and Added new event as numbness in hands
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Rash, Urticaria
Clinical narrative: Extremely itchy; hives, bad rash all over body; Skin and subcutaneous tissue disorders; Bad Rashes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extremely itchy), URTICARIA (hives, bad rash all over body), CONTUSION (Skin and subcutaneous tissue disorders) and RASH (Bad Rashes) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRURITUS (Extremely itchy), URTICARIA (hives, bad rash all over body), CONTUSION (Skin and subcutaneous tissue disorders) and RASH (Bad Rashes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 22-May-2021 to 26-May-2021 for Allergy, at a dose of 10 milligram once a day. On 27-May-2021, PRURITUS (Extremely itchy), URTICARIA (hives, bad rash all over body) and RASH (Bad Rashes) had resolved and CONTUSION (Skin and subcutaneous tissue disorders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After a week of taking the first shot of the Moderna vaccine, patient got hives, bad rashes all over my body which included the chest area, arms, underarms, hips, and the thighs, it was extremely itchy. The patient took one tablet of Zyrtec for Allergy with Cetirizine HCl 10mg/tab per day, 5 days from May 22 to May 26, and the symptom is mostly gone on May 27 but left some large bruises on my hips.  No concomitant medication was provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Dizziness, Ear discomfort, Head discomfort
Clinical narrative: Fullness in ears and head; Ear fullness; Anxiety; inflammation casuing the Tinnitus; Dizziness; brain fog; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears), DIZZINESS (Dizziness), CONFUSIONAL STATE (brain fog), HEAD DISCOMFORT (Fullness in ears and head) and EAR DISCOMFORT (Ear fullness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 020821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Septra). Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) from 01-Jan-2010 to an unknown date for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (Ringing in ears). On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness) and CONFUSIONAL STATE (brain fog). On an unknown date, the patient experienced HEAD DISCOMFORT (Fullness in ears and head), EAR DISCOMFORT (Ear fullness), ANXIETY (Anxiety) and INFLAMMATION (inflammation casuing the Tinnitus). The patient was treated with PREDNISONE (Predensoine) for Inflammation, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in ears), DIZZINESS (Dizziness), CONFUSIONAL STATE (brain fog), HEAD DISCOMFORT (Fullness in ears and head) and EAR DISCOMFORT (Ear fullness) had not resolved and ANXIETY (Anxiety) and INFLAMMATION (inflammation casuing the Tinnitus) outcome was unknown.            The patient had an MRI  for hearing test ,seen by ENT and audiologist ,his hearing was fine .   This case was linked to MOD-2021-265350 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added treatment medication, Added events and updated outcome of events; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Tinnitus
Clinical narrative: Fullness in ears and head; Ear fullness; Anxiety; inflammation casuing the Tinnitus; Dizziness; brain fog; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears), DIZZINESS (Dizziness), CONFUSIONAL STATE (brain fog), HEAD DISCOMFORT (Fullness in ears and head) and EAR DISCOMFORT (Ear fullness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 020821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Septra). Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) from 01-Jan-2010 to an unknown date for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (Ringing in ears). On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness) and CONFUSIONAL STATE (brain fog). On an unknown date, the patient experienced HEAD DISCOMFORT (Fullness in ears and head), EAR DISCOMFORT (Ear fullness), ANXIETY (Anxiety) and INFLAMMATION (inflammation casuing the Tinnitus). The patient was treated with PREDNISONE (Predensoine) for Inflammation, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in ears), DIZZINESS (Dizziness), CONFUSIONAL STATE (brain fog), HEAD DISCOMFORT (Fullness in ears and head) and EAR DISCOMFORT (Ear fullness) had not resolved and ANXIETY (Anxiety) and INFLAMMATION (inflammation casuing the Tinnitus) outcome was unknown.            The patient had an MRI  for hearing test ,seen by ENT and audiologist ,his hearing was fine .   This case was linked to MOD-2021-265350 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added treatment medication, Added events and updated outcome of events; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: warm to the touch; Bruised; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch), CONTUSION (Bruised), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red). On an unknown date, the patient experienced INJECTION SITE WARMTH (warm to the touch) and CONTUSION (Bruised). At the time of the report, INJECTION SITE WARMTH (warm to the touch), CONTUSION (Bruised), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 032A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 since an unknown date. Concurrent medical conditions included Pollen allergy and Dust allergy.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 12-May-2021, PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 103.5 f (High) 103.5 F.         It was reported that 12 hours after the second vaccine dose, the patient experienced fever (temperature 103.5 degree F) that started at 1 AM and lasted till 4PM.  At 4PM, he started to sweat profusely over the next 3 hours as the fever broke. By 8PM, he was back to normal. The seriousness of the side effect was reported unknown. Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation in left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 29-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in left arm) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLAMMATION (Inflammation in left arm). At the time of the report, INFLAMMATION (Inflammation in left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Details regarding concomitant and treatment medications were not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Rash pruritic
Clinical narrative: Itchy rashes on both forearms; Inappropriate dose of drug administered; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rashes on both forearms) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002821A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Oxycodone cause itching).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter once. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter once. On 13-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered). On 15-Mar-2021, the patient experienced RASH PRURITIC (Itchy rashes on both forearms). On 13-Mar-2021, INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) had resolved. At the time of the report, RASH PRURITIC (Itchy rashes on both forearms) had not resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Severe pain at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at vaccination site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-May-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 29-May-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at vaccination site). On 29-May-2021, DIARRHOEA (Diarrhea) had resolved. On 31-May-2021, VACCINATION SITE PAIN (Severe pain at vaccination site) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information included outcome of adverse events were updated to recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vertigo
Clinical narrative: Severe vertigo; Inappropreiate route of administration; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropreiate route of administration) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form once. On an unknown date, the patient experienced VERTIGO (Severe vertigo) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropreiate route of administration). At the time of the report, VERTIGO (Severe vertigo) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropreiate route of administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       Young, healthy male, no significant health history, no allergies, non smoker, occasional drink.  There was no treatment medication reported.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: chest discomfort; shortness of breath; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest discomfort) and DYSPNOEA (shortness of breath) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Coronary disease.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On 10-Apr-2021, the patient experienced CHEST DISCOMFORT (chest discomfort) and DYSPNOEA (shortness of breath). At the time of the report, CHEST DISCOMFORT (chest discomfort) and DYSPNOEA (shortness of breath) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Rash
Clinical narrative: skin rash, headache, body aches, injection site pain; skin rash, headache, body aches, injection site pain; skin rash, headache, body aches, injection site pain; skin rash, headache, body aches, injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (skin rash, headache, body aches, injection site pain), RASH (skin rash, headache, body aches, injection site pain), HEADACHE (skin rash, headache, body aches, injection site pain) and INJECTION SITE PAIN (skin rash, headache, body aches, injection site pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     same reaction to Neosporin ointment, but not to the cream, so I believe it is a nonactive ingredient in the ointment.  Concurrent medical conditions included Drug allergy (Reports allergy to Neosporin ointment bur not to the cream, believes it is a nonactive ingredient in the ointment that causes the reaction.).    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 29-May-2021, the patient experienced PAIN (skin rash, headache, body aches, injection site pain), RASH (skin rash, headache, body aches, injection site pain), HEADACHE (skin rash, headache, body aches, injection site pain) and INJECTION SITE PAIN (skin rash, headache, body aches, injection site pain). At the time of the report, PAIN (skin rash, headache, body aches, injection site pain), RASH (skin rash, headache, body aches, injection site pain), HEADACHE (skin rash, headache, body aches, injection site pain) and INJECTION SITE PAIN (skin rash, headache, body aches, injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant or treatment medications provided by reporter.; 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: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Influenza like illness, Paraesthesia, Peripheral swelling
Clinical narrative: flu like symptoms; left arm swelling; left arm numbness; shortness of breath; left hand & fingers tingling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swelling), HYPOAESTHESIA (left arm numbness), DYSPNOEA (shortness of breath), PARAESTHESIA (left hand & fingers tingling) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination.     The patient's past medical history included Rosacea since an unknown date, Ligament injury and Ankle injury. Concurrent medical conditions included Hypertension, Migraine, Allergy to animals, Allergy to animals, Seasonal allergy, Allergy to feathers, Drug allergy, Drug allergy and Drug allergy.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling), HYPOAESTHESIA (left arm numbness), DYSPNOEA (shortness of breath) and PARAESTHESIA (left hand & fingers tingling). On 12-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with PREDNISONE for Hypoaesthesia and Paraesthesia, at an unspecified dose and frequency; ALBUTEROL for Hypoaesthesia and Shortness of breath, at an unspecified dose and frequency and BENADRYL for Hypoaesthesia and Paraesthesia, at an unspecified dose and frequency. On 10-Apr-2021, PERIPHERAL SWELLING (left arm swelling) and HYPOAESTHESIA (left arm numbness) had resolved. On 16-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 21-Apr-2021, DYSPNOEA (shortness of breath) had resolved. On 10-May-2021, PARAESTHESIA (left hand & fingers tingling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Additional medical history include a Sural nerve injury, and allergy to mold dust mites.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Dyspnoea, Heart rate irregular
Clinical narrative: Shortness of breath; chest pain; irregular heart beat; stomach pain; low back pain; muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), HEART RATE IRREGULAR (irregular heart beat), ABDOMINAL PAIN UPPER (stomach pain) and BACK PAIN (low back pain) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038c21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 01-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), HEART RATE IRREGULAR (irregular heart beat), ABDOMINAL PAIN UPPER (stomach pain), BACK PAIN (low back pain) and MYALGIA (muscle pain). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), HEART RATE IRREGULAR (irregular heart beat), ABDOMINAL PAIN UPPER (stomach pain), BACK PAIN (low back pain) and MYALGIA (muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.; 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. Myalgia is consistent with the product known safety profile.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Shortness of breath; chest pain; irregular heart beat; stomach pain; low back pain; muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), HEART RATE IRREGULAR (irregular heart beat), ABDOMINAL PAIN UPPER (stomach pain) and BACK PAIN (low back pain) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038c21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 01-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), HEART RATE IRREGULAR (irregular heart beat), ABDOMINAL PAIN UPPER (stomach pain), BACK PAIN (low back pain) and MYALGIA (muscle pain). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), HEART RATE IRREGULAR (irregular heart beat), ABDOMINAL PAIN UPPER (stomach pain), BACK PAIN (low back pain) and MYALGIA (muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.; 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. Myalgia is consistent with the product known safety profile.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle abnormal; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle abnormal) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle abnormal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter. Patient missed her menstrual cycle but had crams as usual but no bleeding.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood pressure measurement, Chest pain, Pain in extremity
Clinical narrative: Sharp pain in heart; Sharp pain in left lung; Sharp pain in inner left arm; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Sharp pain in heart), PAIN IN EXTREMITY (Sharp pain in inner left arm) and CHEST PAIN (Sharp pain in left lung) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC: 80777-0273-10) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sharp pain in inner left arm). On an unknown date, the patient experienced ANGINA PECTORIS (Sharp pain in heart) and CHEST PAIN (Sharp pain in left lung). On 02-Jun-2021, PAIN IN EXTREMITY (Sharp pain in inner left arm) had resolved. At the time of the report, ANGINA PECTORIS (Sharp pain in heart) and CHEST PAIN (Sharp pain in left lung) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: other (High) High blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  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.