chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warm to touch; Red and warm to touch; Injection site started to itch; Felt tender; Area along the muscle were the vaccine was administered has a bump; Very severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very severe arm pain), VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site started to itch) and VACCINATION SITE PAIN (Felt tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Renal disease (Kidney Disease).  Concomitant products included RAMIPRIL for Renal disease.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Very severe arm pain). On 09-Jan-2021, the patient experienced VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump) and VACCINATION SITE PAIN (Felt tender). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started to itch). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red and warm to touch). On 09-Jan-2021, PAIN IN EXTREMITY (Very severe arm pain) had resolved. At the time of the report, VACCINATION SITE MASS (Area along the muscle were the vaccine was administered has a bump) and VACCINATION SITE PAIN (Felt tender) had resolved and VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Injection site started to itch) and VACCINATION SITE ERYTHEMA (Red and warm to touch) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pharyngeal swelling, Swollen tongue, Tonsillar hypertrophy
Clinical narrative: Swelling of tongue; swelling of tonsils; swelling of back of his throat; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain), SWOLLEN TONGUE (Swelling of tongue), TONSILLAR HYPERTROPHY (swelling of tonsils) and PHARYNGEAL SWELLING (swelling of back of his throat) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U(or 0)25520-2A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (mold, cats and dust mites).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 13-Jan-2021, the patient experienced SWOLLEN TONGUE (Swelling of tongue), TONSILLAR HYPERTROPHY (swelling of tonsils) and PHARYNGEAL SWELLING (swelling of back of his throat). At the time of the report, ARTHRALGIA (Shoulder pain), SWOLLEN TONGUE (Swelling of tongue), TONSILLAR HYPERTROPHY (swelling of tonsils) and PHARYNGEAL SWELLING (swelling of back of his throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include  Benadryl and Allegra.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia, Swelling
Clinical narrative: Pain; Swelling; Pain down to elbow; Fever of 99 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), ARTHRALGIA (Pain down to elbow) and PYREXIA (Fever of 99 F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  Concomitant products included ACETAMINOPHEN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN (Pain), SWELLING (Swelling), ARTHRALGIA (Pain down to elbow) and PYREXIA (Fever of 99 F). At the time of the report, PAIN (Pain), SWELLING (Swelling), ARTHRALGIA (Pain down to elbow) and PYREXIA (Fever of 99 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Events onset date has been updated and denied consent to contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: High fever 103.7; Shivering; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever 103.7), CHILLS (Shivering) and FATIGUE (Fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PYREXIA (High fever 103.7), CHILLS (Shivering) and FATIGUE (Fatigue). At the time of the report, PYREXIA (High fever 103.7), CHILLS (Shivering) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103.7 high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included paracetamol, ice pack and cold bath as per physician's instructions.   This case was linked to MOD-2021-007917 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Injection site pain, Swelling face
Clinical narrative: Vertigo; Face swollen; Temperature of 99.4F; Arm is very sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Balance disorder since an unknown date. Concurrent medical conditions included Allergy NOS (Allergic to benzodiazepam).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.4 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Benadryl.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; Face swollen; Temperature of 99.4F; Arm is very sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Balance disorder since an unknown date. Concurrent medical conditions included Allergy NOS (Allergic to benzodiazepam).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), SWELLING FACE (Face swollen), BODY TEMPERATURE INCREASED (Temperature of 99.4F), INJECTION SITE PAIN (Arm is very sore) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.4 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Benadryl.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: General malaise; Bit of a runny nose; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), RHINORRHOEA (Bit of a runny nose) and PYREXIA (Mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Condition were reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MALAISE (General malaise), RHINORRHOEA (Bit of a runny nose) and PYREXIA (Mild fever). At the time of the report, MALAISE (General malaise), RHINORRHOEA (Bit of a runny nose) and PYREXIA (Mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds reported.  No treatment reported.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event,  a causal relationship with the event cannot be excluded.  Fever is consistent with the known safety profile of the vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Influenza like illness
Clinical narrative: Got really sick; it was almost like I had the flu; got all the side effects; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Got really sick; it was almost like I had the flu) and ADVERSE EVENT (got all the side effects) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU on 18-Dec-2020.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Got really sick; it was almost like I had the flu) and ADVERSE EVENT (got all the side effects). At the time of the report, INFLUENZA LIKE ILLNESS (Got really sick; it was almost like I had the flu) and ADVERSE EVENT (got all the side effects) outcome was unknown.            Treatment information was not provided.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient Dosage text has been updated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue pruritus
Clinical narrative: Itchiness of tongue; Itchiness of throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONGUE PRURITUS (Itchiness of tongue) and THROAT IRRITATION (Itchiness of throat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Medical history reported as asthma), Allergy to nuts (Medical history reported as allergies to peanuts), Allergy NOS (Medical history reported as allergies) and Migraine NOS (Medical history reported as migraines).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced TONGUE PRURITUS (Itchiness of tongue) and THROAT IRRITATION (Itchiness of throat). At the time of the report, TONGUE PRURITUS (Itchiness of tongue) and THROAT IRRITATION (Itchiness of throat) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events Benadryl and Zyrtec. No relevant concomitant medications were reported 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 event, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Peach, plumps, cherrys, melon). Concomitant products included PROGESTERONE and ACETYLSALICYLIC ACID (ASPIRIN PROTEC) for Pregnancy, FOLIC ACID for an unknown indication.    On 26-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Jun-2020 and the estimated date of delivery was 13-Mar-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2020, Pregnancy test: positive (Positive) Positive.     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.   On ??-???-2020, lab test also included APT down diamniotic; however, the result was negative and RH positive.  Patient had two prior pregnancies.   Patient delivered first neonate on 22-Oct-2009, which resulted in live preterm birth of baby within the duration of 35 weeks with 6 days. Patient delivered second neonate on 18-Dec-2019, which resulted in live preterm birth of baby within the duration of 36 weeks with 6 days.  Number of fetus was found to be one.  Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: Felt just like when she had COVID; 104.8 fever; Chills; Bad headache; A lot of nausea; Just sore initially; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Just sore initially), VACCINATION COMPLICATION (Felt just like when she had COVID), PYREXIA (104.8 fever), CHILLS (Chills) and HEADACHE (Bad headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L(or C)20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020, Colectomy, Ileostomy, Total gastrectomy and Hysterectomy. Concurrent medical conditions included Drug allergy (Morphine, codeine, hydrocodone, butran, dermabond, IV iron sucrose and iron dextran). Concomitant products included GABAPENTIN, CEFIXIME (FLEXERIL [CEFIXIME]), DICYCLOMINE HCL and ESTRADIOL (ESTROGEN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (Just sore initially). On 14-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt just like when she had COVID), PYREXIA (104.8 fever), CHILLS (Chills), HEADACHE (Bad headache) and NAUSEA (A lot of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. In January 2021, PAIN (Just sore initially), VACCINATION COMPLICATION (Felt just like when she had COVID), PYREXIA (104.8 fever), CHILLS (Chills), HEADACHE (Bad headache) and NAUSEA (A lot of nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.8 (High) 104.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-239284, MOD-2021-239284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received and event duration and outcome updated.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Felt just like when she had COVID; 104.8 fever; Chills; Bad headache; A lot of nausea; Just sore initially; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Just sore initially), VACCINATION COMPLICATION (Felt just like when she had COVID), PYREXIA (104.8 fever), CHILLS (Chills) and HEADACHE (Bad headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L(or C)20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020, Colectomy, Ileostomy, Total gastrectomy and Hysterectomy. Concurrent medical conditions included Drug allergy (Morphine, codeine, hydrocodone, butran, dermabond, IV iron sucrose and iron dextran). Concomitant products included GABAPENTIN, CEFIXIME (FLEXERIL [CEFIXIME]), DICYCLOMINE HCL and ESTRADIOL (ESTROGEN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (Just sore initially). On 14-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt just like when she had COVID), PYREXIA (104.8 fever), CHILLS (Chills), HEADACHE (Bad headache) and NAUSEA (A lot of nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. In January 2021, PAIN (Just sore initially), VACCINATION COMPLICATION (Felt just like when she had COVID), PYREXIA (104.8 fever), CHILLS (Chills), HEADACHE (Bad headache) and NAUSEA (A lot of nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.8 (High) 104.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-239284, MOD-2021-239284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received and event duration and outcome updated.; 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (sore arm.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment for event included acetylsalicylic acid.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to touch for all of them; Injection site startedto feel itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch for all of them) and VACCINATION SITE PRURITUS (Injection site startedto feel itchy) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch for all of them) and VACCINATION SITE PRURITUS (Injection site startedto feel itchy). At the time of the report, VACCINATION SITE WARMTH (Warm to touch for all of them) and VACCINATION SITE PRURITUS (Injection site startedto feel itchy) 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.   This case was linked to MOD-2021-003892, MOD-2021-004767, MOD-2021-008393 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling; Itching; Erythema; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythema), VACCINATION SITE SWELLING (Swelling) and PRURITUS (Itching) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Erythema) and PRURITUS (Itching). On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Erythema), VACCINATION SITE SWELLING (Swelling) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up received on 13-Apr-2021 included no new information.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Injection site pain
Clinical narrative: Exposure during pregnancy; Sore at the injection site; Headache; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy), INJECTION SITE PAIN (Sore at the injection site) and HEADACHE (Headache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jun-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy), INJECTION SITE PAIN (Sore at the injection site) and HEADACHE (Headache). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Sore at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24 Aug  2020 the patient received a positive pregnancy test. The patient estimated due date of 06 Jan 2021. There have been no complications or acute illnesses during this pregnancy. Pregnancy ultrasound taken but results have not been provided.Treatment information included Tylenol and Rhogam shot for being blood group  O negative.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: No specific follow-up information recorded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis normal, Gestational diabetes, Glucose tolerance test, Pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1glass/week) on 16-Jun-2020. Concomitant products included METFORMIN for Polycystic ovarian syndrome, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, LEVOTHYROXINE SODIUM (UNITHROID) from 01-Jul-2020 to an unknown date for Thyroid disorder.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-May-2020 and the estimated date of delivery was 26-Feb-2021. On 21-Jun-2020, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  At the time of the report, PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2020, Amniocentesis normal: normal. On 21-Jun-2020, Gestational diabetes: normal. On 21-Jun-2020, Glucose tolerance test: normal. On 21-Jun-2020, Pregnancy test: Positive. On 21-Jun-2020, Ultrasound scan normal: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1glass/week) on 16-Jun-2020. Concomitant products included METFORMIN for Polycystic ovarian syndrome, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, LEVOTHYROXINE SODIUM (UNITHROID) from 01-Jul-2020 to an unknown date for Thyroid disorder.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-May-2020 and the estimated date of delivery was 26-Feb-2021. On 21-Jun-2020, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  At the time of the report, PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2020, Amniocentesis normal: normal. On 21-Jun-2020, Gestational diabetes: normal. On 21-Jun-2020, Glucose tolerance test: normal. On 21-Jun-2020, Pregnancy test: Positive. On 21-Jun-2020, Ultrasound scan normal: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm hurt; Injection site started itching; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Injection site started itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Injection site started itching). At the time of the report, VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Injection site started itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (Discomfort). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.     This case was linked to MOD-2021-007843 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Itching at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itching at the injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O25620A) for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient experienced Itching at the injection site.  The patient was treated with Tranquilizer.  Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event was unknown.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced a non-serious expected event of Injection site pruritus on the same day after receiving their first of two planned doses of mRNA-1273 (Lot #O25620A).  Treatment included Tranquilizer. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Circular red rash around the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Circular red rash around the vaccine) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE RASH (Circular red rash around the vaccine). At the time of the report, INJECTION SITE RASH (Circular red rash around the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth) and VACCINATION SITE REACTION (vaccination site reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth). 14-Jan-2021, the patient experienced VACCINATION SITE REACTION (vaccination site reaction). At the time of the report, INJECTION SITE WARMTH (Injection site warmth) and VACCINATION SITE REACTION (vaccination site reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: face is red flushed; Today (16 Jan 2021) her arm is again red, itchy; Today (16 Jan 2021) her arm is again red, itchy; area of injection site is 4 inch long and 2 inch wide; injection site swelling; arm reaction like redness and swelling but it resolve.; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face is red flushed), INJECTION SITE PRURITUS (Today (16 Jan 2021) her arm is again red, itchy), INJECTION SITE ERYTHEMA (arm reaction like redness and swelling but it resolve.), INJECTION SITE ERYTHEMA (Today (16 Jan 2021) her arm is again red, itchy) and INJECTION SITE SWELLING (area of injection site is 4 inch long and 2 inch wide) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (arm reaction like redness and swelling but it resolve.) and INJECTION SITE SWELLING (injection site swelling). On 16-Jan-2021, the patient experienced FLUSHING (face is red flushed), INJECTION SITE PRURITUS (Today (16 Jan 2021) her arm is again red, itchy), INJECTION SITE ERYTHEMA (Today (16 Jan 2021) her arm is again red, itchy) and INJECTION SITE SWELLING (area of injection site is 4 inch long and 2 inch wide). In January 2021, INJECTION SITE SWELLING (injection site swelling) had resolved. At the time of the report, FLUSHING (face is red flushed), INJECTION SITE PRURITUS (Today (16 Jan 2021) her arm is again red, itchy), INJECTION SITE ERYTHEMA (Today (16 Jan 2021) her arm is again red, itchy) and INJECTION SITE SWELLING (area of injection site is 4 inch long and 2 inch wide) outcome was unknown and INJECTION SITE ERYTHEMA (arm reaction like redness and swelling but it resolve.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant woman received Moderna COVID vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant woman received Moderna COVID vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Spontaneous Abortion) on 20-Feb-2020 and Alcohol use (wine/alcohol occasionally). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-May-2020 and the estimated date of delivery was 06-Feb-2021. On 23-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant woman received Moderna COVID vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-eighth week of the pregnancy.  On 23-Jan-2021, EXPOSURE DURING PREGNANCY (pregnant woman received Moderna COVID vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 14-Sep-2018, patient had a previous pregnancy that ended in live, full-term birth. On 20-Feb-2020, patient had a previous pregnancy that ended in miscarriage.  Estimated date of conception was reported as 16-May-2020. The patient had established prenatal care. It was reported that there was no maternal history of subfertility, complications or acute illness during that pregnancy to date. The patient passed glucose tolerance test.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Spots started to be itchy and now they are spreading to the wrists; Patient started seeing red spots on his both hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Patient started seeing red spots on his both hands) and PRURITUS (Spots started to be itchy and now they are spreading to the wrists) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Mar-2021, the patient experienced RASH MACULAR (Patient started seeing red spots on his both hands). On 16-Mar-2021, the patient experienced PRURITUS (Spots started to be itchy and now they are spreading to the wrists). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Patient started seeing red spots on his both hands) and PRURITUS (Spots started to be itchy and now they are spreading to the wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red circle that was warm; Red circle that was warm; Little itchy on upper (right) arm by the shoulder; Arm was sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Red circle that was warm), VACCINATION SITE PRURITUS (Little itchy on upper (right) arm by the shoulder), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Red circle that was warm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Little itchy on upper (right) arm by the shoulder). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red circle that was warm) and VACCINATION SITE ERYTHEMA (Red circle that was warm). In January 2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 15-Jan-2021, VACCINATION SITE PRURITUS (Little itchy on upper (right) arm by the shoulder) had resolved, VACCINATION SITE PAIN (Arm was sore) had resolved. At the time of the report, VACCINATION SITE WARMTH (Red circle that was warm) and VACCINATION SITE ERYTHEMA (Red circle that was warm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment also included ice.; Sender's Comments: This case concerns a 61 Y/O F with nonserious events of unexpected vaccination site warmth, and expected vaccination site pruritus, vaccination site erythema, and vaccination site pain. Event onset on Day 11 after first dose mRNA-1273. Treated with ibuprofen and hydrocortisone cream. Events resolved or resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling abnormal, Influenza, Malaise
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (Flu), COVID-19 (Tested positive for COVID), FEELING ABNORMAL ( feeling bad), MALAISE (feeling sick) and CHILLS (Started having chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included INFLIXIMAB (REMICADE), LOPERAMIDE HYDROCHLORIDE (IMODIUM) and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced INFLUENZA (Flu) and MALAISE (feeling sick). On 26-Dec-2020, the patient experienced FEELING ABNORMAL ( feeling bad) and CHILLS (Started having chills). On 29-Dec-2020, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, INFLUENZA (Flu), COVID-19 (Tested positive for COVID), FEELING ABNORMAL ( feeling bad), MALAISE (feeling sick) and CHILLS (Started having chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: positive Positive.     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.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection is assessed as unlikely related to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events of flu like, chills, general malaise, a causal relationship cannot be excluded."