chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Incorrect route of product administration
Clinical narrative: A spontaneous report was received from a nurse concerning herself regarding Moderna's COVID-19 vaccine (mRNA-1273) and reported event, got the shots subcutaneous (Incorrect route of drug administration). The patient's medical history was not provided. Concomitant medications were not provided. On an unknown date, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On an unknown date, it was reported that, she got the shots subcutaneous. Treatment information was unknown. She was tested for antibodies and results were negative. Action taken with mRNA-1273 in response to the events was not applicable. At the time of this report, the outcome of the event was considered resolved.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Muscular weakness, Peripheral swelling
Clinical narrative: barely walk; feels like 250 LBS feet,; FATIGUE IN THE LEGS; exhausted quickly; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (barely walk), PERIPHERAL SWELLING (feels like 250 LBS feet,), MUSCULAR WEAKNESS (FATIGUE IN THE LEGS) and FATIGUE (exhausted quickly) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced GAIT DISTURBANCE (barely walk), PERIPHERAL SWELLING (feels like 250 LBS feet,), MUSCULAR WEAKNESS (FATIGUE IN THE LEGS) and FATIGUE (exhausted quickly). At the time of the report, GAIT DISTURBANCE (barely walk), PERIPHERAL SWELLING (feels like 250 LBS feet,), MUSCULAR WEAKNESS (FATIGUE IN THE LEGS) and FATIGUE (exhausted quickly) had not resolved.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus, Pyrexia, Vaccination site pruritus
Clinical narrative: 6 to 8 inch Hive; Rash; Head ache; Fatigue; low grade fever; circular raised hard lump; itchy; pruritic; "Covid Arm"; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021. The most recent information was received on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE URTICARIA (6 to 8 inch Hive), VACCINATION SITE RASH (Rash), HEADACHE (Head ache), FATIGUE (Fatigue) and PYREXIA (low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Arthritis and Allergy. Concomitant products included LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ESTROGEN NOS;PROGESTERONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION ("Covid Arm"). On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (pruritic). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (6 to 8 inch Hive), VACCINATION SITE RASH (Rash), HEADACHE (Head ache), FATIGUE (Fatigue), PYREXIA (low grade fever), VACCINATION SITE SWELLING (circular raised hard lump) and PRURITUS (itchy). On 22-Mar-2021, VACCINATION SITE REACTION ("Covid Arm") had resolved. At the time of the report, VACCINATION SITE URTICARIA (6 to 8 inch Hive), VACCINATION SITE RASH (Rash), HEADACHE (Head ache), FATIGUE (Fatigue), PYREXIA (low grade fever), VACCINATION SITE SWELLING (circular raised hard lump), VACCINATION SITE PRURITUS (pruritic) and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Medication was available.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information added, event outcome changed,action taken changed,medical history,concomitant medication added
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: 6 to 8 inch Hive; Rash; Head ache; Fatigue; low grade fever; circular raised hard lump; itchy; pruritic; "Covid Arm"; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021. The most recent information was received on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE URTICARIA (6 to 8 inch Hive), VACCINATION SITE RASH (Rash), HEADACHE (Head ache), FATIGUE (Fatigue) and PYREXIA (low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Arthritis and Allergy. Concomitant products included LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ESTROGEN NOS;PROGESTERONE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION ("Covid Arm"). On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (pruritic). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (6 to 8 inch Hive), VACCINATION SITE RASH (Rash), HEADACHE (Head ache), FATIGUE (Fatigue), PYREXIA (low grade fever), VACCINATION SITE SWELLING (circular raised hard lump) and PRURITUS (itchy). On 22-Mar-2021, VACCINATION SITE REACTION ("Covid Arm") had resolved. At the time of the report, VACCINATION SITE URTICARIA (6 to 8 inch Hive), VACCINATION SITE RASH (Rash), HEADACHE (Head ache), FATIGUE (Fatigue), PYREXIA (low grade fever), VACCINATION SITE SWELLING (circular raised hard lump), VACCINATION SITE PRURITUS (pruritic) and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Medication was available.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information added, event outcome changed,action taken changed,medical history,concomitant medication added
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oral pain
Clinical narrative: Sore mouth with blisters; Sore mouth with blisters; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL PAIN (Sore mouth with blisters) and ORAL MUCOSAL BLISTERING (Sore mouth with blisters) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ORAL PAIN (Sore mouth with blisters) and ORAL MUCOSAL BLISTERING (Sore mouth with blisters). The patient was treated with AMOXICILLIN ongoing since an unknown date for Symptomatic treatment, at a dose of 500 milligram. At the time of the report, ORAL PAIN (Sore mouth with blisters) and ORAL MUCOSAL BLISTERING (Sore mouth with blisters) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Their arthritis pain improved; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Their arthritis pain improved) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Their arthritis pain improved). At the time of the report, ARTHRALGIA (Their arthritis pain improved) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia oral, Pain in extremity, Peripheral swelling
Clinical narrative: Tiredness, or extremely fatigued; Numb feeling in mouth; Swelling and pain in right arm; Swelling and pain in right arm; Felt panicky; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb feeling in mouth), PERIPHERAL SWELLING (Swelling and pain in right arm), PAIN IN EXTREMITY (Swelling and pain in right arm), FEELING ABNORMAL (Felt panicky) and FATIGUE (Tiredness, or extremely fatigued) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb feeling in mouth), PERIPHERAL SWELLING (Swelling and pain in right arm), PAIN IN EXTREMITY (Swelling and pain in right arm) and FEELING ABNORMAL (Felt panicky). On 19-Mar-2021, the patient experienced FATIGUE (Tiredness, or extremely fatigued). The patient was treated with DEXAMETHASONE on 18-Mar-2021 for Symptomatic treatment, at an unspecified dose and frequency and ACETAMINOPHEN on 18-Mar-2021 for Symptomatic treatment, at an unspecified dose and frequency. On 20-Mar-2021, HYPOAESTHESIA ORAL (Numb feeling in mouth), FEELING ABNORMAL (Felt panicky) and FATIGUE (Tiredness, or extremely fatigued) had resolved. On 24-Mar-2021, PERIPHERAL SWELLING (Swelling and pain in right arm) and PAIN IN EXTREMITY (Swelling and pain in right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        .     Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Night sweats, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), PAIN (body aches), PYREXIA (fever of 101.3F), NAUSEA (nausea) and FATIGUE (tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), PAIN (body aches), PYREXIA (fever of 101.3F), NAUSEA (nausea) and FATIGUE (tiredness). At the time of the report, NIGHT SWEATS (night sweats), PAIN (body aches), PYREXIA (fever of 101.3F), NAUSEA (nausea) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Pre-medicated with Tylenol and Benadryl two hours prior to vaccine and took again six hours after the vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Sore Knee; tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore Knee) and FATIGUE (tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ARTHRALGIA (Sore Knee) and FATIGUE (tired). At the time of the report, ARTHRALGIA (Sore Knee) and FATIGUE (tired) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; Two manufacturers vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INTERCHANGE OF VACCINE PRODUCTS (Two manufacturers vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INTERCHANGE OF VACCINE PRODUCTS (Two manufacturers vaccine). On 18-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INTERCHANGE OF VACCINE PRODUCTS (Two manufacturers vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product reported. No concomitant products reported.; Reporter's Comments: This is a case of vaccine exposure during pregnancy and given both Pfizer vaccine at the first dose and Moderna vaccine with the second dose with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 years old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17 years old) in a 17-year-old male patient 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 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17 years old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021, contains no new information.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pregnancy
Clinical narrative: Resident physician wants to register in the pregnancy form; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PREGNANCY (Resident physician wants to register in the pregnancy form) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    The patient's past medical history included No adverse event, Pregnancy (Live, full-term birth) on 20-Dec-2017 and Abortion (Spontaneous abortion) on 24-Apr-2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) (unknown route) at an unspecified dose. The patient's last menstrual period was on 07-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On an unknown date, the patient experienced PREGNANCY (Resident physician wants to register in the pregnancy form). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) during pregnancy.  At the time of the report, PREGNANCY (Resident physician wants to register in the pregnancy form) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Standard tests are the lab test reported by reporter which is everything normal.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling
Clinical narrative: Swollen arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) 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.    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 PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: needle retracted while giving vaccine; Received close to half of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (needle retracted while giving vaccine) and UNDERDOSE (Received close to half of the vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history).    On 25-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 9:30 AM, the patient experienced SYRINGE ISSUE (needle retracted while giving vaccine) and UNDERDOSE (Received close to half of the vaccine). At the time of the report, SYRINGE ISSUE (needle retracted while giving vaccine) and UNDERDOSE (Received close to half of the vaccine) had resolved. 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.   The reporter stated that the patient received half the amount of the first dose of the COVID-19 vaccine. This was caused by the needle retracting upon administration.   Per medical info provided by Moderna the dose was not repeated since patient received half of the dose. Second dose will be given 28 from first administration.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter information updated from physician to pharmacist, added address.First dose of vaccine date updated from 24th Mar 2021 to 25th Mar 2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: felt kind of dizzy, but kind of weird; felt their balance was totally off and could not walk to the apartment by them selves,; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (felt kind of dizzy, but kind of weird) and BALANCE DISORDER (felt their balance was totally off and could not walk to the apartment by them selves,) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (felt kind of dizzy, but kind of weird) and BALANCE DISORDER (felt their balance was totally off and could not walk to the apartment by them selves,). On 23-Mar-2021, DIZZINESS (felt kind of dizzy, but kind of weird) and BALANCE DISORDER (felt their balance was totally off and could not walk to the apartment by them selves,) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant products included GABAPENTIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication No Treatment information provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site pain
Clinical narrative: found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some; found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some; found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some), RASH PRURITIC (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) and VACCINATION SITE PAIN (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-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 RASH ERYTHEMATOUS (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some), RASH PRURITIC (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) and VACCINATION SITE PAIN (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some). At the time of the report, RASH ERYTHEMATOUS (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some), RASH PRURITIC (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) and VACCINATION SITE PAIN (found a big wide red itch somewhat painful rash on the arm she as injected at the injection site, it later grew some) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sneezing
Clinical narrative: sore arm; sneezing alot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SNEEZING (sneezing alot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and SNEEZING (sneezing alot). At the time of the report, PAIN IN EXTREMITY (sore arm) and SNEEZING (sneezing alot) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she was diagnosed with shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (she was diagnosed with shingles) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included WARFARIN and DILTIAZEM 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 22-Mar-2021, the patient experienced HERPES ZOSTER (she was diagnosed with shingles). At the time of the report, HERPES ZOSTER (she was diagnosed with shingles) had not resolved. Not Provided      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 medication included thyroid medications. Treatment medications included valacyclovir.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling abnormal, Malaise
Clinical narrative: So dizzy; Just don't feel good; just don't feel good.; high temperature, sa high as 101.5; chill; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.), PYREXIA (high temperature, sa high as 101.5) and CHILLS (chill) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.), PYREXIA (high temperature, sa high as 101.5) and CHILLS (chill). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.) and CHILLS (chill) outcome was unknown and PYREXIA (high temperature, sa high as 101.5) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2005, Body temperature: 101.5 (Inconclusive) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: So dizzy; Just don't feel good; just don't feel good.; high temperature, sa high as 101.5; chill; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.), PYREXIA (high temperature, sa high as 101.5) and CHILLS (chill) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.), PYREXIA (high temperature, sa high as 101.5) and CHILLS (chill). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (So dizzy), MALAISE (Just don't feel good), FEELING ABNORMAL (just don't feel good.) and CHILLS (chill) outcome was unknown and PYREXIA (high temperature, sa high as 101.5) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2005, Body temperature: 101.5 (Inconclusive) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphadenopathy, Pain, Swelling
Clinical narrative: "It hurts"; "Like a swollen vein"; Swelling breast; Swelling under left arm, breast and chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("It hurts"), SWELLING ("Like a swollen vein"), BREAST SWELLING (Swelling breast) and LYMPHADENOPATHY (Swelling under left arm, breast and chest) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN ("It hurts"), SWELLING ("Like a swollen vein"), BREAST SWELLING (Swelling breast) and LYMPHADENOPATHY (Swelling under left arm, breast and chest). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of unknown. At the time of the report, PAIN ("It hurts"), SWELLING ("Like a swollen vein"), BREAST SWELLING (Swelling breast) and LYMPHADENOPATHY (Swelling under left arm, breast and chest) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details also include  applied hot compresses on affected areas. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-056054 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04jun2021 and does not contain any new information.; 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: Erythema, Feeling hot, Pruritus, Swelling, Tenderness
Clinical narrative: Redness; swelling the size of tennis ball; itching; warm; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (swelling the size of tennis ball), PRURITUS (itching), FEELING HOT (warm) and TENDERNESS (tenderness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Redness), SWELLING (swelling the size of tennis ball), PRURITUS (itching), FEELING HOT (warm) and TENDERNESS (tenderness). At the time of the report, ERYTHEMA (Redness), SWELLING (swelling the size of tennis ball), PRURITUS (itching), FEELING HOT (warm) and TENDERNESS (tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Put Benadryl and cortisone cream.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pruritus, Rash erythematous
Clinical narrative: Arm Itchy; Arm Red; Rash; headache; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Arm Itchy), ERYTHEMA (Arm Red), RASH ERYTHEMATOUS (Rash), HEADACHE (headache) and FATIGUE (tired) in a 67-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 C-section. Concomitant products included LOSARTAN for an unknown indication.    On 27-Jan-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 PRURITUS (Arm Itchy), ERYTHEMA (Arm Red), RASH ERYTHEMATOUS (Rash), HEADACHE (headache) and FATIGUE (tired). At the time of the report, PRURITUS (Arm Itchy), ERYTHEMA (Arm Red), RASH ERYTHEMATOUS (Rash) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Took Zyrtec an hour before vaccine   This case was linked to MOD21-088590 (E2B Linked Report). This case was linked to MOD-2021-056019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI On 26-May-2021: Non-significant Follow up; Sender's Comments:  MOD21-088590:crosslinked
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. Concomitant product use was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Livedo reticularis, Pain in extremity, Peripheral swelling
Clinical narrative: Palms and fingers of both hands became mottled; Palms and fingers of both hands became puffy; Palms and fingers of both hands turned red; Tiredness; Swelling in upper arm of injection; Pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in upper arm of injection), PAIN IN EXTREMITY (Pain in arm of injection), FATIGUE (Tiredness), ERYTHEMA (Palms and fingers of both hands turned red) and LIVEDO RETICULARIS (Palms and fingers of both hands became mottled) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical historyknown.). Concurrent medical conditions included Drug allergy (Hydrocodone), Drug allergy (Keflex) and Allergy to antibiotic (Amoxicillin.). Concomitant products included MULTIVITAMINS [VITAMINS NOS], TOCOPHERYL ACETATE (VITAMIN E-100), VITAMIN D3, LINOLENIC ACID (OMEGA 3 NATURAL) and ASCORBIC ACID (VITAMIN C CITRUS).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in upper arm of injection) and PAIN IN EXTREMITY (Pain in arm of injection). On 05-Mar-2021, the patient experienced FATIGUE (Tiredness). On 07-Mar-2021, the patient experienced ERYTHEMA (Palms and fingers of both hands turned red), LIVEDO RETICULARIS (Palms and fingers of both hands became mottled) and SKIN SWELLING (Palms and fingers of both hands became puffy). At the time of the report, PERIPHERAL SWELLING (Swelling in upper arm of injection), PAIN IN EXTREMITY (Pain in arm of injection), FATIGUE (Tiredness), ERYTHEMA (Palms and fingers of both hands turned red), LIVEDO RETICULARIS (Palms and fingers of both hands became mottled) and SKIN SWELLING (Palms and fingers of both hands became puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Ice pack, Tylenol. Resolved symptoms
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: Palms and fingers of both hands became mottled; Palms and fingers of both hands became puffy; Palms and fingers of both hands turned red; Tiredness; Swelling in upper arm of injection; Pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in upper arm of injection), PAIN IN EXTREMITY (Pain in arm of injection), FATIGUE (Tiredness), ERYTHEMA (Palms and fingers of both hands turned red) and LIVEDO RETICULARIS (Palms and fingers of both hands became mottled) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical historyknown.). Concurrent medical conditions included Drug allergy (Hydrocodone), Drug allergy (Keflex) and Allergy to antibiotic (Amoxicillin.). Concomitant products included MULTIVITAMINS [VITAMINS NOS], TOCOPHERYL ACETATE (VITAMIN E-100), VITAMIN D3, LINOLENIC ACID (OMEGA 3 NATURAL) and ASCORBIC ACID (VITAMIN C CITRUS).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in upper arm of injection) and PAIN IN EXTREMITY (Pain in arm of injection). On 05-Mar-2021, the patient experienced FATIGUE (Tiredness). On 07-Mar-2021, the patient experienced ERYTHEMA (Palms and fingers of both hands turned red), LIVEDO RETICULARIS (Palms and fingers of both hands became mottled) and SKIN SWELLING (Palms and fingers of both hands became puffy). At the time of the report, PERIPHERAL SWELLING (Swelling in upper arm of injection), PAIN IN EXTREMITY (Pain in arm of injection), FATIGUE (Tiredness), ERYTHEMA (Palms and fingers of both hands turned red), LIVEDO RETICULARIS (Palms and fingers of both hands became mottled) and SKIN SWELLING (Palms and fingers of both hands became puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Ice pack, Tylenol. Resolved symptoms
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Hot to touch; Redness; Injection site pain; Rash 8 days post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), ERYTHEMA (Redness), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE RASH (Rash 8 days post vaccination) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-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) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Rash 8 days post vaccination). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE WARMTH (Hot to touch), ERYTHEMA (Redness), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE RASH (Rash 8 days post vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: tired; pain in his arm; pain all over his body; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his arm), PAIN (pain all over his body), PYREXIA (a little fever) and FATIGUE (tired) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his arm), PAIN (pain all over his body) and PYREXIA (a little fever). On 24-Mar-2021, the patient experienced FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (pain in his arm), PAIN (pain all over his body), PYREXIA (a little fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment 24Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) 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.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Depressed mood, Depression, Fatigue
Clinical narrative: extreme depression lasted me for 2-3 days; arm pain for about 2-3 days; drowsiness; irritable bowel like an upset stomach; irritable bowel like an upset stomach; feeling predominant sadness; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (extreme depression lasted me for 2-3 days), PAIN IN EXTREMITY (arm pain for about 2-3 days), SOMNOLENCE (drowsiness), IRRITABLE BOWEL SYNDROME (irritable bowel like an upset stomach) and ABDOMINAL DISCOMFORT (irritable bowel like an upset stomach) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-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 DEPRESSION (extreme depression lasted me for 2-3 days), PAIN IN EXTREMITY (arm pain for about 2-3 days), SOMNOLENCE (drowsiness), IRRITABLE BOWEL SYNDROME (irritable bowel like an upset stomach), ABDOMINAL DISCOMFORT (irritable bowel like an upset stomach), DEPRESSED MOOD (feeling predominant sadness), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, DEPRESSION (extreme depression lasted me for 2-3 days), PAIN IN EXTREMITY (arm pain for about 2-3 days), SOMNOLENCE (drowsiness), IRRITABLE BOWEL SYNDROME (irritable bowel like an upset stomach), ABDOMINAL DISCOMFORT (irritable bowel like an upset stomach), DEPRESSED MOOD (feeling predominant sadness), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.