chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Urinary tract infection, Vaccination complication
Clinical narrative: urinary tract infection; Got really sick; Chills; Fever/ high temperature; Feeling really tired; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), VACCINATION COMPLICATION (Got really sick), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and PYREXIA (Fever/ high temperature) in a 74-year-old male 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.     No Medical History information was reported.   On 23-Feb-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) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Got really sick), CHILLS (Chills), PYREXIA (Fever/ high temperature) and FATIGUE (Feeling really tired). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection), VACCINATION COMPLICATION (Got really sick), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills), PYREXIA (Fever/ high temperature) and FATIGUE (Feeling really tired) outcome was unknown.            This case was linked to MOD-2021-032266 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-032266:Crosslinked case
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: urinary tract infection; Got really sick; Chills; Fever/ high temperature; Feeling really tired; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection), VACCINATION COMPLICATION (Got really sick), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills) and PYREXIA (Fever/ high temperature) in a 74-year-old male 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.     No Medical History information was reported.   On 23-Feb-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) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Got really sick), CHILLS (Chills), PYREXIA (Fever/ high temperature) and FATIGUE (Feeling really tired). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection), VACCINATION COMPLICATION (Got really sick), VACCINATION SITE PAIN (Vaccination site pain), CHILLS (Chills), PYREXIA (Fever/ high temperature) and FATIGUE (Feeling really tired) outcome was unknown.            This case was linked to MOD-2021-032266 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-032266:Crosslinked case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse event with both my vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event with both my vaccinations) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event with both my vaccinations). At the time of the report, VACCINATION COMPLICATION (adverse event with both my vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-034126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received updated reporter contact, patient demographic and suspect dosage details.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chattering of teeth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) and CHILLS (Chattering of teeth) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chattering of teeth). On 03-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, CHILLS (Chattering of teeth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-058511 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow-up information received on 22 MAR 2021 and does not contain any new information. On 25-Mar-2021: Follow-up information received on 25 MAR 2021 and does not contain any new information. On 23-Jun-2021: Patient demography and vaccine route of administration was updated.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Site of injection has red mark; Site of injection is itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Site of injection has red mark) and VACCINATION SITE PRURITUS (Site of injection is itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Site of injection has red mark) and VACCINATION SITE PRURITUS (Site of injection is itching). At the time of the report, VACCINATION SITE ERYTHEMA (Site of injection has red mark) and VACCINATION SITE PRURITUS (Site of injection is itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Tinnitus
Clinical narrative: ringing in her ear; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ear) and INJECTION SITE PAIN (injection site pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced TINNITUS (ringing in her ear) and INJECTION SITE PAIN (injection site pain). At the time of the report, TINNITUS (ringing in her ear) and INJECTION SITE PAIN (injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram
Clinical narrative: Sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore left shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Sore left shoulder). At the time of the report, ARTHRALGIA (Sore left shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Computerised tomogram: unknown (Inconclusive) Cat scan done using IV contrast and iodine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Illness, Retching
Clinical narrative: horribly ill/Felt very sick; started with dry heaves; feeling of weakness; Had to get to bed right away; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (horribly ill/Felt very sick), RETCHING (started with dry heaves), ASTHENIA (feeling of weakness) and BEDRIDDEN (Had to get to bed right away) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder disease and COPD. Concomitant products included BUDESONIDE, MOMETASONE FUROATE (ASMANEX), METOPROLOL, FUROSEMIDE, CLOPIDOGREL, METOLAZONE, POTASSIUM, MONTELUKAST, SIMVASTATIN and ALPRAZOLAM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ILLNESS (horribly ill/Felt very sick), RETCHING (started with dry heaves), ASTHENIA (feeling of weakness) and BEDRIDDEN (Had to get to bed right away). At the time of the report, ILLNESS (horribly ill/Felt very sick), RETCHING (started with dry heaves), ASTHENIA (feeling of weakness) and BEDRIDDEN (Had to get to bed right away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-043746, MOD-2021-034069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non Significant
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Lip swelling
Clinical narrative: trouble breathing; Fast heart rate; top lip was swollen; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (Fast heart rate), LIP SWELLING (top lip was swollen) and DYSPNOEA (trouble breathing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart rate) and LIP SWELLING (top lip was swollen). On an unknown date, the patient experienced DYSPNOEA (trouble breathing). At the time of the report, HEART RATE INCREASED (Fast heart rate), LIP SWELLING (top lip was swollen) and DYSPNOEA (trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity, Peripheral swelling, Skin exfoliation
Clinical narrative: Swelling in the arm; Pain in the arm; Scaling of skin between elbow and wrist; Itchiness in the arm; Redness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Pain in the arm), SKIN EXFOLIATION (Scaling of skin between elbow and wrist), INJECTION SITE PRURITUS (Itchiness in the arm) and INJECTION SITE ERYTHEMA (Redness in the arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included POTASSIUM CHLORIDE (K-TAB) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Pain in the arm), SKIN EXFOLIATION (Scaling of skin between elbow and wrist), INJECTION SITE PRURITUS (Itchiness in the arm) and INJECTION SITE ERYTHEMA (Redness in the arm). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling in the arm), PAIN IN EXTREMITY (Pain in the arm), SKIN EXFOLIATION (Scaling of skin between elbow and wrist), INJECTION SITE PRURITUS (Itchiness in the arm) and INJECTION SITE ERYTHEMA (Redness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes patient rubbed Epsom salt body cream and aloe Vera cream
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm sore; body ache; temperature of 102°; chillS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), MYALGIA (body ache), PYREXIA (temperature of 102°) and CHILLS (chillS) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore), MYALGIA (body ache), PYREXIA (temperature of 102°) and CHILLS (chillS). At the time of the report, PAIN IN EXTREMITY (arm sore), MYALGIA (body ache), PYREXIA (temperature of 102°) and CHILLS (chillS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE PAIN (Arm is a little achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE PAIN (Arm is a little achy). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and VACCINATION SITE PAIN (Arm is a little achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  No concomitant medications were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOVASTATIN, FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], VITAMIN D3, VITAMIN B12 NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), MAGNESIUM and POTASSIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-033801 (E2B Linked Report).; Sender's Comments:  MOD-2021-033801:same reporter, different patient and event
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: Sore arm; feeling cold; sweating; insomnia; headache; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia) and HEADACHE (headache) in a 64-year-old male 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 COVID-19 from 08-Sep-2020 to 15-Nov-2020 and Permanent cardiac pacemaker insertion. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports contracting pneumonia post COVID-19 infection in September.Patient reports findings of a blood clot during his previous COVID-19 illness, and necessity to have a pacemaker inserted
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Sore arm; feeling cold; sweating; insomnia; headache; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia) and HEADACHE (headache) in a 64-year-old male 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 COVID-19 from 08-Sep-2020 to 15-Nov-2020 and Permanent cardiac pacemaker insertion. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports contracting pneumonia post COVID-19 infection in September.Patient reports findings of a blood clot during his previous COVID-19 illness, and necessity to have a pacemaker inserted
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Medical History was provided by Reporter No Concomitant Medications were  provided by Reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Pruritus, Vaccination site pain
Clinical narrative: a little painful and itchy; a little painful and itchy; irregular bright red area on her arm; it hurts not just in the skin but in the muscle as well.; Initially, she had pain in the injection site for 24 hours which then went away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little painful and itchy), PRURITUS (a little painful and itchy), ERYTHEMA (irregular bright red area on her arm), MYALGIA (it hurts not just in the skin but in the muscle as well.) and VACCINATION SITE PAIN (Initially, she had pain in the injection site for 24 hours which then went away) in a 65-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.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Initially, she had pain in the injection site for 24 hours which then went away). On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little painful and itchy), PRURITUS (a little painful and itchy), ERYTHEMA (irregular bright red area on her arm) and MYALGIA (it hurts not just in the skin but in the muscle as well.). On 23-Feb-2021, VACCINATION SITE PAIN (Initially, she had pain in the injection site for 24 hours which then went away) had resolved. At the time of the report, PAIN IN EXTREMITY (a little painful and itchy), PRURITUS (a little painful and itchy), ERYTHEMA (irregular bright red area on her arm) and MYALGIA (it hurts not just in the skin but in the muscle as well.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Medical History was provided by Reporter No Concomitant Medications were  provided by Reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscular weakness, Peripheral swelling
Clinical narrative: swollen arm; leg weakness; red arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (leg weakness) and ERYTHEMA (red arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCORTISONE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (leg weakness) and ERYTHEMA (red arm). At the time of the report, PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (leg weakness) and ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient (gravida 5, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vertigo
Clinical narrative: weakness; dizziness; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness) and VERTIGO (vertigo) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness) and VERTIGO (vertigo) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain in the arm of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in the arm of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 582726) 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) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain in the arm of the vaccine). At the time of the report, VACCINATION SITE PAIN (Severe pain in the arm of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS ("Flu like illness") and MYALGIA (Body Aches) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-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 INFLUENZA LIKE ILLNESS ("Flu like illness") and MYALGIA (Body Aches). At the time of the report, INFLUENZA LIKE ILLNESS ("Flu like illness") and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: DIZZINESS/LIGHT HEADEDNESS; SORE ARM; FELT TERRIBLE; RASH; HEADACHE; FEVER; was unable to get up from couch; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIZZINESS/LIGHT HEADEDNESS), PAIN IN EXTREMITY (SORE ARM), MALAISE (FELT TERRIBLE), RASH (RASH) and HEADACHE (HEADACHE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis since an unknown date. Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, PROPRANOLOL for Blood pressure abnormal, VITAMINS NOS, OMEPRAZOLE and LORATADINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM), MALAISE (FELT TERRIBLE), RASH (RASH), HEADACHE (HEADACHE), PYREXIA (FEVER) and FATIGUE (was unable to get up from couch). On 27-Feb-2021, the patient experienced DIZZINESS (DIZZINESS/LIGHT HEADEDNESS). At the time of the report, DIZZINESS (DIZZINESS/LIGHT HEADEDNESS), PAIN IN EXTREMITY (SORE ARM), MALAISE (FELT TERRIBLE), RASH (RASH), HEADACHE (HEADACHE), PYREXIA (FEVER) and FATIGUE (was unable to get up from couch) had not resolved.            Treatment information included staying hydrated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: DIZZINESS/LIGHT HEADEDNESS; SORE ARM; FELT TERRIBLE; RASH; HEADACHE; FEVER; was unable to get up from couch; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIZZINESS/LIGHT HEADEDNESS), PAIN IN EXTREMITY (SORE ARM), MALAISE (FELT TERRIBLE), RASH (RASH) and HEADACHE (HEADACHE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis since an unknown date. Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, PROPRANOLOL for Blood pressure abnormal, VITAMINS NOS, OMEPRAZOLE and LORATADINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM), MALAISE (FELT TERRIBLE), RASH (RASH), HEADACHE (HEADACHE), PYREXIA (FEVER) and FATIGUE (was unable to get up from couch). On 27-Feb-2021, the patient experienced DIZZINESS (DIZZINESS/LIGHT HEADEDNESS). At the time of the report, DIZZINESS (DIZZINESS/LIGHT HEADEDNESS), PAIN IN EXTREMITY (SORE ARM), MALAISE (FELT TERRIBLE), RASH (RASH), HEADACHE (HEADACHE), PYREXIA (FEVER) and FATIGUE (was unable to get up from couch) had not resolved.            Treatment information included staying hydrated.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dysphonia
Clinical narrative: Confusion; Taking in a lower voice than normal; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and DYSPHONIA (Taking in a lower voice than normal) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion) and DYSPHONIA (Taking in a lower voice than normal). On 03-Mar-2021, CONFUSIONAL STATE (Confusion) and DYSPHONIA (Taking in a lower voice than normal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Off label use
Clinical narrative: defer second dose of vaccine; contracted COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (contracted COVID-19) and OFF LABEL USE (defer second dose of vaccine) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (contracted COVID-19). On an unknown date, the patient experienced OFF LABEL USE (defer second dose of vaccine). At the time of the report, COVID-19 (contracted COVID-19) and OFF LABEL USE (defer second dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received monoclonal antibodies infusion approximately 17-Feb-2021 or 18-Feb-2021. No concomitant medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Email from reporter: no idea what this is regarding.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Malaise, Pyrexia
Clinical narrative: chills; felt very tired; was freezing cold and shaking; freezing cold and shaking; severe fever with rigors; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking) and PYREXIA (severe fever with rigors) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking), PYREXIA (severe fever with rigors) and MALAISE (not feeling well). At the time of the report, CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking), PYREXIA (severe fever with rigors) and MALAISE (not feeling well) outcome was unknown. Not Provided          Treatment and concomitant medications were not provided by reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: chills; felt very tired; was freezing cold and shaking; freezing cold and shaking; severe fever with rigors; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking) and PYREXIA (severe fever with rigors) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking), PYREXIA (severe fever with rigors) and MALAISE (not feeling well). At the time of the report, CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking), PYREXIA (severe fever with rigors) and MALAISE (not feeling well) outcome was unknown. Not Provided          Treatment and concomitant medications were not provided by reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got first dose on 18Jan2021 and still has not gotten the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got first dose on 18Jan2021 and still has not gotten the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got first dose on 18Jan2021 and still has not gotten the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got first dose on 18Jan2021 and still has not gotten the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 041L20A, with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; A spontaneous case report was received from  a consumer concerning himself  who experienced rash at the injection site.      The patient's past medical history included no adverse event.     The patient received first  of two planned doses of mRNA-1273 (Moderna COVID-19 Vaccine) intramuscularly on 1 Feb 2021 for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash at the injection site.  At the time of the report, the outcome of the event rash at the injection site had not resolved.     No treatment information was provided.   The action taken with mRNA-1273 in response to the event was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache). In February 2021, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaginal infection
Clinical narrative: vaginal infection; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL INFECTION (vaginal infection) 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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, 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 experienced VAGINAL INFECTION (vaginal infection). At the time of the report, VAGINAL INFECTION (vaginal infection) outcome was unknown.            Patient was taking an antibiotic for a vaginal infection that she mentioed started prior to her first dose of the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Musculoskeletal stiffness
Clinical narrative: Slight headache; Injection arm being really sore, when she rises it it feels tight in the inside, she always has a feeling of discomfort in the arm; Difficulty breathing; Fast heartbeat; Felt lightheaded; Stiffness on her right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat), DIZZINESS (Felt lightheaded), MUSCULOSKELETAL STIFFNESS (Stiffness on her right shoulder) and HEADACHE (Slight headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat), DIZZINESS (Felt lightheaded), MUSCULOSKELETAL STIFFNESS (Stiffness on her right shoulder) and VACCINATION SITE PAIN (Injection arm being really sore, when she rises it it feels tight in the inside, she always has a feeling of discomfort in the arm). On 03-Mar-2021, the patient experienced HEADACHE (Slight headache). On 02-Mar-2021, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat), DIZZINESS (Felt lightheaded) and MUSCULOSKELETAL STIFFNESS (Stiffness on her right shoulder) had resolved. On 03-Mar-2021, HEADACHE (Slight headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm being really sore, when she rises it it feels tight in the inside, she always has a feeling of discomfort in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received contains No New Information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight headache; Injection arm being really sore, when she rises it it feels tight in the inside, she always has a feeling of discomfort in the arm; Difficulty breathing; Fast heartbeat; Felt lightheaded; Stiffness on her right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat), DIZZINESS (Felt lightheaded), MUSCULOSKELETAL STIFFNESS (Stiffness on her right shoulder) and HEADACHE (Slight headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat), DIZZINESS (Felt lightheaded), MUSCULOSKELETAL STIFFNESS (Stiffness on her right shoulder) and VACCINATION SITE PAIN (Injection arm being really sore, when she rises it it feels tight in the inside, she always has a feeling of discomfort in the arm). On 03-Mar-2021, the patient experienced HEADACHE (Slight headache). On 02-Mar-2021, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat), DIZZINESS (Felt lightheaded) and MUSCULOSKELETAL STIFFNESS (Stiffness on her right shoulder) had resolved. On 03-Mar-2021, HEADACHE (Slight headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm being really sore, when she rises it it feels tight in the inside, she always has a feeling of discomfort in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received contains No New Information
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash at injection site; Swelling at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products were reported. No Treatment information was reported.