chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: At the site of injection is a white mark with 2 red dots; Headache; She was nervous; A metallic taste; Fingers were swollen and red; Fingers were swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (She was nervous), DYSGEUSIA (A metallic taste), PERIPHERAL SWELLING (Fingers were swollen and red), ERYTHEMA (Fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 25-Mar-2021, the patient experienced NERVOUSNESS (She was nervous), DYSGEUSIA (A metallic taste), PERIPHERAL SWELLING (Fingers were swollen and red) and HEADACHE (Headache). 25-Mar-2021, the patient experienced ERYTHEMA (Fingers were swollen and red). On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots). On 25-Mar-2021, NERVOUSNESS (She was nervous) and DYSGEUSIA (A metallic taste) had resolved. On 26-Mar-2021, PERIPHERAL SWELLING (Fingers were swollen and red), ERYTHEMA (Fingers were swollen and red) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) outcome was unknown.            No relevant concomitant medications provided. No relevant treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup was received with NNI
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia
Clinical narrative: joints stiffness; muscle pain; joint pain; Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose), JOINT STIFFNESS (joints stiffness), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 037K20A) for COVID-19 immunisation.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 28-Mar-2021, the patient experienced JOINT STIFFNESS (joints stiffness). On 25-Feb-2021, MUSCULOSKELETAL STIFFNESS (Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) had resolved. At the time of the report, JOINT STIFFNESS (joints stiffness) had not resolved.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under right underarm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (Rash under right underarm) 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 Rash.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Feb-2021, the patient experienced RASH (Rash under right underarm). At the time of the report, RASH (Rash under right underarm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided    This case was linked to US-MODERNATX, INC.-MOD-2021-062527 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062527:Crosslinked case
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Injection site haemorrhage, Pyrexia
Clinical narrative: bleeding under skin; bleeding under skin; big bruises; 2 bruises on right arm; 1 bruise on left arm; 1 bruise on hand; bruises not at injection site; felt dizzy; feels like she has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of INJECTION SITE HAEMORRHAGE (bleeding under skin), CONTUSION (big bruises), CONTUSION (2 bruises on right arm), CONTUSION (1 bruise on left arm) and CONTUSION (1 bruise on hand) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL), CLONAZEPAM, CICLOSPORIN (RESTASIS), ISOSORBIDE, LOSARTAN, FUROSEMIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced the first episode of INJECTION SITE HAEMORRHAGE (bleeding under skin), CONTUSION (big bruises), CONTUSION (2 bruises on right arm), CONTUSION (1 bruise on left arm), CONTUSION (1 bruise on hand), CONTUSION (bruises not at injection site), DIZZINESS (felt dizzy) and PYREXIA (feels like she has a temperature). On an unknown date, the patient experienced the second episode of INJECTION SITE HAEMORRHAGE (bleeding under skin). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 26-Mar-2021, DIZZINESS (felt dizzy) had resolved. At the time of the report, CONTUSION (big bruises), CONTUSION (2 bruises on right arm), CONTUSION (1 bruise on left arm), CONTUSION (1 bruise on hand), CONTUSION (bruises not at injection site), PYREXIA (feels like she has a temperature) and the last episode of INJECTION SITE HAEMORRHAGE (bleeding under skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history and current conditions were not reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 26-Mar-2021, the patient received 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 26-Sep-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: bumps on arm, stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (bumps on arm, stomach and back) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced SKIN REACTION (bumps on arm, stomach and back). At the time of the report, SKIN REACTION (bumps on arm, stomach and back) outcome was unknown.            No Concomitant medication were reported. Treatment medication was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, SARS-CoV-2 test
Clinical narrative: feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (feeling weak). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qd. At the time of the report, ASTHENIA (feeling weak) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0161321A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment taken was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Big Lump under the left Arm (Armpit) about 2" Inches in Size; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Big Lump under the left Arm (Armpit) about 2" Inches in Size) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 27-Mar-2021, the patient experienced AXILLARY MASS (Big Lump under the left Arm (Armpit) about 2" Inches in Size). At the time of the report, AXILLARY MASS (Big Lump under the left Arm (Armpit) about 2" Inches in Size) 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.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty in breathing properly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty in breathing properly) 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 Cancer (cancer survivor) and Lung lobectomy (removal of part of a lung.).    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 DYSPNOEA (difficulty in breathing properly). At the time of the report, DYSPNOEA (difficulty in breathing properly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash is a little bigger today; noticed some rash below the site where they injected; redness; sore arm; raised area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (noticed some rash below the site where they injected), ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE SWELLING (raised area) and RASH (rash is a little bigger today) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ROSUVASTATIN, IBUPROFEN and MORPHINE SULFATE for an unknown indication.    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 VACCINATION SITE RASH (noticed some rash below the site where they injected), ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (raised area). On 26-Mar-2021, the patient experienced RASH (rash is a little bigger today). At the time of the report, VACCINATION SITE RASH (noticed some rash below the site where they injected), ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE SWELLING (raised area) and RASH (rash is a little bigger today) outcome was unknown. 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Bump; Soreness at injection site; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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) (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 26-Mar-2021, the patient experienced VACCINATION SITE MASS (Bump), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE MASS (Bump), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            No concomitant medications were provided.   No treatment details were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Swelling
Clinical narrative: fingers and hands were a little bit swollen; swollen in calves; feels as if her whole body is holding water; left temple is starting to feel like she's getting headache; feet were a tad swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (feet were a tad swollen), PERIPHERAL SWELLING (fingers and hands were a little bit swollen), PERIPHERAL SWELLING (swollen in calves), SWELLING (feels as if her whole body is holding water) and HEADACHE (left temple is starting to feel like she's getting headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN (Z-PAK) for Bronchitis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ASCORBIC ACID (VIT C), VIT D [VITAMIN D NOS], TOCOPHEROL (VIT E [TOCOPHEROL]), ZINC, IRON, PROGESTERONE, TESTOSTERONE, ESTRADIOL (ESTROGEN), VITAMIN B6, UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX), VITAMIN B12 NOS, VITAMIN B [VITAMIN B NOS], MULTIVITAMINS [VITAMINS NOS] and THYROID (NATURE THROID) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PERIPHERAL SWELLING (feet were a tad swollen). On 28-Mar-2021, the patient experienced PERIPHERAL SWELLING (fingers and hands were a little bit swollen), PERIPHERAL SWELLING (swollen in calves), SWELLING (feels as if her whole body is holding water) and HEADACHE (left temple is starting to feel like she's getting headache). At the time of the report, PERIPHERAL SWELLING (feet were a tad swollen), PERIPHERAL SWELLING (fingers and hands were a little bit swollen), PERIPHERAL SWELLING (swollen in calves), SWELLING (feels as if her whole body is holding water) and HEADACHE (left temple is starting to feel like she's getting headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications also included gamma vitamins. The patient had Z-pak for bronchitis 2 weeks ago. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for covid 19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for covid 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: Positive.     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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash pruritic
Clinical narrative: Rash on her left side, back and arm and is itching; Exhausted; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on her left side, back and arm and is itching), FATIGUE (Exhausted), CHILLS (Chills) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04KAZIA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (Exhausted), CHILLS (Chills) and PYREXIA (Fever). On 25-Mar-2021, the patient experienced RASH PRURITIC (Rash on her left side, back and arm and is itching). At the time of the report, RASH PRURITIC (Rash on her left side, back and arm and is itching), FATIGUE (Exhausted), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Neck pain
Clinical narrative: Difficuly Breathing; Dizziness; Neck was hurting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficuly Breathing), DIZZINESS (Dizziness) and NECK PAIN (Neck was hurting) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, CYANOCOBALAMIN (VITAMIN B-12) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Difficuly Breathing), DIZZINESS (Dizziness) and NECK PAIN (Neck was hurting). On 26-Mar-2021, DYSPNOEA (Difficuly Breathing), DIZZINESS (Dizziness) and NECK PAIN (Neck was hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Heart rate: fast (High) fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included IV Fluids.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in Arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in Arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness in Arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR- AE Outcome updated from unknown  to resolved .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching on the Right Arm (Injection Site) after First Vaccine; Rash on the Left arm (Injection Site) after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the Right Arm (Injection Site) after First Vaccine) and VACCINATION SITE RASH (Rash on the Left arm (Injection Site) after First Vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 VACCINATION SITE PRURITUS (Itching on the Right Arm (Injection Site) after First Vaccine) and VACCINATION SITE RASH (Rash on the Left arm (Injection Site) after First Vaccine). On 23-Mar-2021, VACCINATION SITE PRURITUS (Itching on the Right Arm (Injection Site) after First Vaccine) and VACCINATION SITE RASH (Rash on the Left arm (Injection Site) after First Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not specified. No treatment information was provided.   This case was linked to MOD-2021-238125 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021, updated contact information, site of injection (right arm), deleted event arthralgia, added stop dates for events and outcome for events.(Recovered/Resolved)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bowel movement irregularity, Chills, Diarrhoea, Dizziness
Clinical narrative: achiness; water bowel movement; chills; nausea; fever; Dizziness; inability to sleep; inability to rest; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea) and PAIN (achiness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea). On 26-Mar-2021, the patient experienced PAIN (achiness), BOWEL MOVEMENT IRREGULARITY (water bowel movement) and CHILLS (chills). On 24-Mar-2021, DIZZINESS (Dizziness) had resolved. On 26-Mar-2021, PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea), PAIN (achiness), BOWEL MOVEMENT IRREGULARITY (water bowel movement) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101 (High) 101 degrees F.     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.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up received on 24MAY2021, included 2nd dose Moderna vaccine details and events
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pyrexia, Restlessness
Clinical narrative: achiness; water bowel movement; chills; nausea; fever; Dizziness; inability to sleep; inability to rest; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea) and PAIN (achiness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea). On 26-Mar-2021, the patient experienced PAIN (achiness), BOWEL MOVEMENT IRREGULARITY (water bowel movement) and CHILLS (chills). On 24-Mar-2021, DIZZINESS (Dizziness) had resolved. On 26-Mar-2021, PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, INSOMNIA (inability to sleep), RESTLESSNESS (inability to rest), DIARRHOEA (diarrhea), PAIN (achiness), BOWEL MOVEMENT IRREGULARITY (water bowel movement) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101 (High) 101 degrees F.     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.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up received on 24MAY2021, included 2nd dose Moderna vaccine details and events
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old receiving the Moderna vaccine; A spontaneous report  was received from a consumer concerning a 16-years-old Unknown gender of patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of 16 year old receiving the moderna vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) 16 year old receiving the Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 16 year old receiving the moderna vaccine was unknown.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Dizziness; Fever; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information received on 11-MAY-2021 and does not contain any new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: unable to do ususal tasks for any length of time; joint pain; body hurt all over; weakness; body aches; headaches; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and PAIN (body hurt all over) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sepsis (Acute illnesses at the time of vaccination and up to one month before:) from 27-Dec-2020 to 08-Jan-2021, Lupus pneumonitis (start date 1998) and Thyroiditis (start date 2000). Concurrent medical conditions included Diabetes (start date 2007) and Lupus erythematosus (Start date 1993). Concomitant products included METFORMIN, LISINOPRIL, ATORVASTATIN, CLONAZEPAM (KLONOPIN), ESCITALOPRAM OXALATE (LEXAPRO), MELOXICAM, FOMEPIZOLE, FAMOTIDINE and PARACETAMOL (TYLENOL) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), PAIN (body hurt all over) and ASTHENIA (weakness). On an unknown date, the patient experienced VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and ARTHRALGIA (joint pain). At the time of the report, PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), ASTHENIA (weakness) and ARTHRALGIA (joint pain) was resolving and VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and PAIN (body hurt all over) outcome was unknown.            Treatment medication also includes Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: New event added Joint pain having outcome  recovering. Event fatigue, body aches, headache outcome updated to recovering.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: unable to do ususal tasks for any length of time; joint pain; body hurt all over; weakness; body aches; headaches; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and PAIN (body hurt all over) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sepsis (Acute illnesses at the time of vaccination and up to one month before:) from 27-Dec-2020 to 08-Jan-2021, Lupus pneumonitis (start date 1998) and Thyroiditis (start date 2000). Concurrent medical conditions included Diabetes (start date 2007) and Lupus erythematosus (Start date 1993). Concomitant products included METFORMIN, LISINOPRIL, ATORVASTATIN, CLONAZEPAM (KLONOPIN), ESCITALOPRAM OXALATE (LEXAPRO), MELOXICAM, FOMEPIZOLE, FAMOTIDINE and PARACETAMOL (TYLENOL) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), PAIN (body hurt all over) and ASTHENIA (weakness). On an unknown date, the patient experienced VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and ARTHRALGIA (joint pain). At the time of the report, PAIN (body aches), HEADACHE (headaches), FATIGUE (fatigued), ASTHENIA (weakness) and ARTHRALGIA (joint pain) was resolving and VACCINATION COMPLICATION (unable to do ususal tasks for any length of time) and PAIN (body hurt all over) outcome was unknown.            Treatment medication also includes Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: New event added Joint pain having outcome  recovering. Event fatigue, body aches, headache outcome updated to recovering.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration of vaccine past 42 day window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administration of vaccine past 42 day window) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administration of vaccine past 42 day window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administration of vaccine past 42 day window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) 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 28-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 ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided. Treatment details include cortisone injection for shoulder pain.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling on her left arm; Redness on her left arm; Lymph node on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on her left arm), ERYTHEMA (Redness on her left arm) and LYMPHADENOPATHY (Lymph node on her left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling on her left arm), ERYTHEMA (Redness on her left arm) and LYMPHADENOPATHY (Lymph node on her left arm). At the time of the report, PERIPHERAL SWELLING (Swelling on her left arm), ERYTHEMA (Redness on her left arm) and LYMPHADENOPATHY (Lymph node on her left arm) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received and the following was updated: patient's age and date of birth; dose #1 details.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to touch; Arm broke into a rash; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), RASH (Arm broke into a rash) and VACCINATION SITE PRURITUS (Itchy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), RASH (Arm broke into a rash) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), RASH (Arm broke into a rash) and VACCINATION SITE PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: TCR form received on 09-Aug-2021 and  events outcomes updated to recovered/resolved.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Eating disorder symptom, Feeling abnormal, Illness
Clinical narrative: losing weight/lost 30 pounds; lost his taste; he's not eating; was sick; it just may kill him; Very very bitter taste in his mouth/Nothing taste good; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good), WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating) and ILLNESS (was sick) in a 75-year-old male 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.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good). On an unknown date, the patient experienced WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating), ILLNESS (was sick) and FEELING ABNORMAL (it just may kill him). At the time of the report, DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good), WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating), ILLNESS (was sick) and FEELING ABNORMAL (it just may kill him) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 30 Patient stated that he lost 30 pounds of his weight as he was not eating as he couldn't taste anything..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported. Patient stated that he tried home remedies to relieve the symptoms and has spoken with his doctor and has an appointment fixed on 12-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received: added new events and updated events outcome to not recovered/not resolved
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased, Weight fluctuation
Clinical narrative: losing weight/lost 30 pounds; lost his taste; he's not eating; was sick; it just may kill him; Very very bitter taste in his mouth/Nothing taste good; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good), WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating) and ILLNESS (was sick) in a 75-year-old male 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.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good). On an unknown date, the patient experienced WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating), ILLNESS (was sick) and FEELING ABNORMAL (it just may kill him). At the time of the report, DYSGEUSIA (Very very bitter taste in his mouth/Nothing taste good), WEIGHT FLUCTUATION (losing weight/lost 30 pounds), AGEUSIA (lost his taste), EATING DISORDER SYMPTOM (he's not eating), ILLNESS (was sick) and FEELING ABNORMAL (it just may kill him) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 30 Patient stated that he lost 30 pounds of his weight as he was not eating as he couldn't taste anything..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported. Patient stated that he tried home remedies to relieve the symptoms and has spoken with his doctor and has an appointment fixed on 12-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received: added new events and updated events outcome to not recovered/not resolved
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (Sinus infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, FELODIPINE, SIMVASTATIN and ALLOPURINOL for an unknown indication.    On 27-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 SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient experienced sinus infection with no symptoms which was diagnosed during a routine check up the ear, nose and throat.   Treatment included Antibiotics.