chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: 4 days later, she fell and hurt herself; she had a big bruise on right leg; She had open cut on her right leg; term 4 days later, she fell and hurt herself; She had a sore arm after receiving 2nd dose; She had little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg), PAIN (term 4 days later, she fell and hurt herself) and PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-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 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) and PYREXIA (She had little fever). On 14-Mar-2021, the patient experienced FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg) and PAIN (term 4 days later, she fell and hurt herself). At the time of the report, FALL (4 days later, she fell and hurt herself), CONTUSION (she had a big bruise on right leg), WOUND (She had open cut on her right leg), PAIN (term 4 days later, she fell and hurt herself), PAIN IN EXTREMITY (She had a sore arm after receiving 2nd dose) and PYREXIA (She had little fever) outcome was unknown.            No concomitant medication reported   No treatment medication reported  Action taken with mRNA-1273 was not applicable
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Vaccination site erythema, Vaccination site warmth
Clinical narrative: sore throat; felt "crummy".; delayed reaction of hot spots around the injection site; red injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MALAISE (felt "crummy".), VACCINATION SITE WARMTH (delayed reaction of hot spots around the injection site) and VACCINATION SITE ERYTHEMA (red injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 OROPHARYNGEAL PAIN (sore throat), MALAISE (felt "crummy".), VACCINATION SITE WARMTH (delayed reaction of hot spots around the injection site) and VACCINATION SITE ERYTHEMA (red injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), MALAISE (felt "crummy".), VACCINATION SITE WARMTH (delayed reaction of hot spots around the injection site) and VACCINATION SITE ERYTHEMA (red injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Pain in extremity
Clinical narrative: Confusion; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and PAIN IN EXTREMITY (Very sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CONFUSIONAL STATE (Confusion) and PAIN IN EXTREMITY (Very sore arm). At the time of the report, CONFUSIONAL STATE (Confusion) and PAIN IN EXTREMITY (Very sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia
Clinical narrative: (2nd dose) soreness at the injection site; (2nd dose) trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN ((2nd dose) soreness at the injection site) and INSOMNIA ((2nd dose) trouble sleeping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE (Sore arm after first shot of covid-19 vaccine that resolved in two days) on 02-Feb-2021.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN ((2nd dose) soreness at the injection site) and INSOMNIA ((2nd dose) trouble sleeping). At the time of the report, INJECTION SITE PAIN ((2nd dose) soreness at the injection site) and INSOMNIA ((2nd dose) trouble sleeping) outcome was unknown.            medication for diabetes was taken concomitantly by the patient  No treatment information was provided  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: (injection site) very mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ((injection site) very mild arm pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for Immunisation.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced VACCINATION SITE PAIN ((injection site) very mild arm pain).            This case was linked to US-MODERNATX, INC.-MOD-2021-016319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016319:Linked with first dose case
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old twins received Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067052 (Patient Link).; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). On 30-Mar-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter  No treatment reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Hernia repair, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot to the touch; itchy; it started hurting and it was a litlte red; It is red; hernia surgery after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERNIA REPAIR (hernia surgery after first dose), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (it started hurting and it was a litlte red) and VACCINATION SITE ERYTHEMA (It is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included Hernia repair  hernia surgery.) on 01-Mar-2021. Concomitant products included DIGOXIN (DOGOXINE) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced HERNIA REPAIR (hernia surgery after first dose). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (it started hurting and it was a litlte red) and VACCINATION SITE ERYTHEMA (It is red). On 01-Mar-2021, HERNIA REPAIR (hernia surgery after first dose) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (it started hurting and it was a litlte red) and VACCINATION SITE ERYTHEMA (It is red) outcome was unknown.            Concomitant product use also included blood thinners  No treatment information was provided  Action taken with mRNA-1273 was not applicable
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild pain at injection site for 1 1/2 days; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (Mild pain at injection site for 1 1/2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Mild pain at injection site for 1 1/2 days). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Mild pain at injection site for 1 1/2 days) 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.   No concomitant medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2021-064258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064258:2nd dose case
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: sweats; low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) 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 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (sweats), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: vials had been punctured more than 6 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (vials had been punctured more than 6 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (vials had been punctured more than 6 hours). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (vials had been punctured more than 6 hours) 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.   No concomitant product use was reported  No treatment information was provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Myalgia, Oxygen saturation
Clinical narrative: muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk; muscle tight; extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like), MYALGIA (muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk) and MUSCLE TIGHTNESS (muscle tight) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to codene /stantants) and Colitis in 2004. Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN E NOS, CALCIUM, UBIDECARENONE (COQ 10), SALMON OIL, VITAMIN D NOS and MULTI VITAMIN & MINERAL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like). On 26-Feb-2021, the patient experienced MYALGIA (muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk) and MUSCLE TIGHTNESS (muscle tight). At the time of the report, MUSCLE SPASMS (extreme muscle spasm/Right hip muscle spasm (Knife like)/R Neck /L neck muscle spasm/Knife like), MYALGIA (muscle pain/L under shoulder Blade Knife/aching from head to toe like/Get shooting pain and it is on again for 1wk to 2 wk) and MUSCLE TIGHTNESS (muscle tight) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 94 % (normal) 94 and 97 % (normal) 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021.Added patient details, medical history, concomitant medications and outcome of the event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Today at 4am, I had worse headache I have ever had in my entire life. This one wouldn't go away.; I was so nauseated.; arm is sore; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), CHILLS (chills), PYREXIA (fever), HEADACHE (Today at 4am, I had worse headache I have ever had in my entire life. This one wouldn't go away.) and NAUSEA (I was so nauseated.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and PYREXIA (fever). On 31-Mar-2021, the patient experienced HEADACHE (Today at 4am, I had worse headache I have ever had in my entire life. This one wouldn't go away.) and NAUSEA (I was so nauseated.). On 20-Mar-2021, CHILLS (chills) and PYREXIA (fever) had resolved. On 22-Mar-2021, PAIN IN EXTREMITY (arm is sore) had resolved. On 31-Mar-2021, NAUSEA (I was so nauseated.) had resolved. At the time of the report, HEADACHE (Today at 4am, I had worse headache I have ever had in my entire life. This one wouldn't go away.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 07-Jul-2021 included no new information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm turned red from elbow area to her wrist; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned red from elbow area to her wrist) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm turned red from elbow area to her wrist). At the time of the report, ERYTHEMA (Arm turned red from elbow area to her wrist) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-064236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064236:Second dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis
Clinical narrative: headache; dizziness; sweating on forehead; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweating on forehead) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METFORMIN, VITAMIN D3, women's multivitamin, FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON ALPHA LIPOIC ACID), MAGNESIUM, OMEPRAZOLE and ATENOLOL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizziness) and HYPERHIDROSIS (sweating on forehead). On 25-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweating on forehead) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment taken was unknown   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Fever of 102). At the time of the report, PYREXIA (Fever of 102) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in joints) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in joints). At the time of the report, ARTHRALGIA (pain in joints) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and UNK) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IRON FERROUS SULFATE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-May-2021. On 21-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 21-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided          No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 103F-104.4F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever 103F-104.4F). At the time of the report, PYREXIA (fever 103F-104.4F) outcome was unknown. Not Provided. No concomitant product use was reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: low grade fatigue; body pains; fever; felt like she was hit by a truck; DIZZINESS; sweating; blood pressure was low (110/70); heart rate was low; trouble walking; VOMITING; Head was pounding; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)) and HEART RATE DECREASED (heart rate was low) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)), HEART RATE DECREASED (heart rate was low), GAIT DISTURBANCE (trouble walking), VOMITING (VOMITING), HEADACHE (Head was pounding), MYALGIA (body pains) and PYREXIA (fever). On 31-Mar-2021, the patient experienced FATIGUE (low grade fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Mar-2021, FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)), HEART RATE DECREASED (heart rate was low), GAIT DISTURBANCE (trouble walking), VOMITING (VOMITING), HEADACHE (Head was pounding), MYALGIA (body pains) and PYREXIA (fever) had resolved. At the time of the report, FATIGUE (low grade fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: diagnosed APR/2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate decreased, Hyperhidrosis, Hypotension, Myalgia
Clinical narrative: low grade fatigue; body pains; fever; felt like she was hit by a truck; DIZZINESS; sweating; blood pressure was low (110/70); heart rate was low; trouble walking; VOMITING; Head was pounding; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)) and HEART RATE DECREASED (heart rate was low) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)), HEART RATE DECREASED (heart rate was low), GAIT DISTURBANCE (trouble walking), VOMITING (VOMITING), HEADACHE (Head was pounding), MYALGIA (body pains) and PYREXIA (fever). On 31-Mar-2021, the patient experienced FATIGUE (low grade fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Mar-2021, FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)), HEART RATE DECREASED (heart rate was low), GAIT DISTURBANCE (trouble walking), VOMITING (VOMITING), HEADACHE (Head was pounding), MYALGIA (body pains) and PYREXIA (fever) had resolved. At the time of the report, FATIGUE (low grade fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: diagnosed APR/2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: low grade fatigue; body pains; fever; felt like she was hit by a truck; DIZZINESS; sweating; blood pressure was low (110/70); heart rate was low; trouble walking; VOMITING; Head was pounding; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)) and HEART RATE DECREASED (heart rate was low) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)), HEART RATE DECREASED (heart rate was low), GAIT DISTURBANCE (trouble walking), VOMITING (VOMITING), HEADACHE (Head was pounding), MYALGIA (body pains) and PYREXIA (fever). On 31-Mar-2021, the patient experienced FATIGUE (low grade fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Mar-2021, FEELING ABNORMAL (felt like she was hit by a truck), DIZZINESS (DIZZINESS), HYPERHIDROSIS (sweating), HYPOTENSION (blood pressure was low (110/70)), HEART RATE DECREASED (heart rate was low), GAIT DISTURBANCE (trouble walking), VOMITING (VOMITING), HEADACHE (Head was pounding), MYALGIA (body pains) and PYREXIA (fever) had resolved. At the time of the report, FATIGUE (low grade fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: diagnosed APR/2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm (injection site); This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (sore arm (injection site)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm (injection site)). On 28-Feb-2021, INJECTION SITE PAIN (sore arm (injection site)) 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.   concomitant product use was not provided. treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-064269 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064269:Case created for events after first dose of Moderna Vaccine
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he received the 2nd dose outside of the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose outside of the recommended time frame) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose outside of the recommended time frame). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose outside of the recommended time frame) had resolved.            no concomitant medications are reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular, Swelling face
Clinical narrative: localized erythema; Face with little blotches; Face was puffy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face was puffy), ERYTHEMA (localized erythema) and RASH MACULAR (Face with little blotches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SWELLING FACE (Face was puffy) and RASH MACULAR (Face with little blotches). On an unknown date, the patient experienced ERYTHEMA (localized erythema). At the time of the report, SWELLING FACE (Face was puffy) had resolved and ERYTHEMA (localized erythema) and RASH MACULAR (Face with little blotches) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-064222 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-064222:First dose
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: A fever of 100.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (A fever of 100.7) 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 30-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 30-Mar-2021, the patient experienced PYREXIA (A fever of 100.7). At the time of the report, PYREXIA (A fever of 100.7) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) fever of 100.7.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.  The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (a fever of 100.7). At the time of the report, PYREXIA (a fever of 100.7) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter did not allow further contact
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Vaccination site erythema
Clinical narrative: Sore arm; Upset stomach; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, ABDOMINAL DISCOMFORT, and VACCINATION SITE ERYTHEMA in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On 11-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 PAIN IN EXTREMITY, ABDOMINAL DISCOMFORT, and VACCINATION SITE ERYTHEMA. At the time of the report, PAIN IN EXTREMITY, ABDOMINAL DISCOMFORT, and VACCINATION SITE ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   This case was linked to MOD-2021-209267.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Throat irritation
Clinical narrative: Tingling all over her head; Itchy throat; Tingle in her lips as well; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling all over her head), THROAT IRRITATION (Itchy throat) and PARAESTHESIA ORAL (Tingle in her lips as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PARAESTHESIA (Tingling all over her head), THROAT IRRITATION (Itchy throat) and PARAESTHESIA ORAL (Tingle in her lips as well). At the time of the report, PARAESTHESIA (Tingling all over her head), THROAT IRRITATION (Itchy throat) and PARAESTHESIA ORAL (Tingle in her lips as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; 100.3° F fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (100.3° F fever) and FATIGUE (Tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (100.3° F fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), PYREXIA (100.3° F fever) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 100.3 (High) 100.3° F.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Soreness; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PAIN (Soreness), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-061058 (E2B Linked Report).; Sender's Comments:  MOD21-061058:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Nausea. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Nausea, METOPROLOL SUCCINATE (TOPROL) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 22-Mar-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 04-Aug-2021. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 22-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (Itch). On 28-Jan-2021, PRURITUS (Itch) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-032567 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugars are elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugars are elevated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PROCAINE HYDROCHLORIDE (NOVOCAINE) for an unknown indication.    Concurrent medical conditions included Diabetes mellitus (blood sugars are normally well-controlled).   On 28-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 PROCAINE HYDROCHLORIDE (NOVOCAINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugars are elevated). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugars are elevated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) elevated blood sugars.     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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Vomiting
Clinical narrative: Diarrhea; Chills; Body aches; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), MYALGIA (Body aches) and VOMITING (Vomiting) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), MYALGIA (Body aches) and VOMITING (Vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills), MYALGIA (Body aches) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Fatigue, Feeling of body temperature change, Joint swelling
Clinical narrative: Hot and cold; Swelling in abdomen; Swelling in her abdomen, ankles, and feet; Swelling in her abdomen, ankles, and feet; Exhaustion; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ABDOMINAL DISTENSION (Swelling in abdomen), JOINT SWELLING (Swelling in her abdomen, ankles, and feet), PERIPHERAL SWELLING (Swelling in her abdomen, ankles, and feet) and FATIGUE (Exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypertension and Thyroid disorder NOS.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ABDOMINAL DISTENSION (Swelling in abdomen), JOINT SWELLING (Swelling in her abdomen, ankles, and feet), PERIPHERAL SWELLING (Swelling in her abdomen, ankles, and feet), FATIGUE (Exhaustion) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ABDOMINAL DISTENSION (Swelling in abdomen), JOINT SWELLING (Swelling in her abdomen, ankles, and feet), PERIPHERAL SWELLING (Swelling in her abdomen, ankles, and feet), FATIGUE (Exhaustion) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications included diabetes medication,blood pressure medication and thyroid medication (dose recently increased). No treatment information was provided.