chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Illness, Product administration interrupted, Pyrexia
Clinical narrative: sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page; Felt very sick; Fever; Bones ached horribly for three days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page), BONE PAIN (Bones ached horribly for three days) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 twice before receiving the shot). Concurrent medical conditions included COPD.    On 08-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 PRODUCT ADMINISTRATION INTERRUPTED (sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page), BONE PAIN (Bones ached horribly for three days) and PYREXIA (Fever). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (sent home from second dose, told too soon, unsuccessful at rescheduling appointment, no appointments on CDC page), BONE PAIN (Bones ached horribly for three days) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Prolonged adverse reaction) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Prolonged adverse reaction). At the time of the report, VACCINATION COMPLICATION (Prolonged adverse reaction) outcome was unknown. There is no relevant treatment and concomitant medications provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient name and contact information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Left arm red circle rounding; looks like broken vessels; Left arm itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Left arm red circle rounding; looks like broken vessels) and VACCINATION SITE PRURITUS (Left arm itching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant therapy, VITAMINS NOS for an unknown indication.    On 18-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 VACCINATION SITE ERYTHEMA (Left arm red circle rounding; looks like broken vessels) and VACCINATION SITE PRURITUS (Left arm itching). At the time of the report, VACCINATION SITE ERYTHEMA (Left arm red circle rounding; looks like broken vessels) and VACCINATION SITE PRURITUS (Left arm itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included pressure medication (not specified). No treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Nausea
Clinical narrative: Increased back pain; Felt nauseous, never threw up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Increased back pain) and NAUSEA (Felt nauseous, never threw up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain, Fish allergy and Seafood allergy (Allergy to shrimp).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BACK PAIN (Increased back pain) and NAUSEA (Felt nauseous, never threw up). In January 2021, NAUSEA (Felt nauseous, never threw up) had resolved. At the time of the report, BACK PAIN (Increased back pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used includes epidurals. This patient is seen by a Orthopedic doctor for his history of back pain. Treatment information was not provided.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive after getting the vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Patient tested positive after getting the vaccine). At the time of the report, COVID-19 (Patient tested positive after getting the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Injection site warmth, Lip swelling
Clinical narrative: blotchy rash from shoulder to elbow; swelling of  lips; nausea; nausea; Diarrhea; red raised skin at injection site; injection site was itchy; Injection site warm to touch; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy), INJECTION SITE WARMTH (Injection site warm to touch) and the first episode of NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE and LEVONORGESTREL (MIRENA) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm soreness). On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy) and INJECTION SITE WARMTH (Injection site warm to touch). On 27-Jan-2021, the patient experienced the first episode of NAUSEA (nausea) and DIARRHOEA (Diarrhea). On 01-Feb-2021, the patient experienced RASH (blotchy rash from shoulder to elbow), LIP SWELLING (swelling of  lips) and the second episode of NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 21-Jan-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 28-Jan-2021, INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy), INJECTION SITE WARMTH (Injection site warm to touch) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, RASH (blotchy rash from shoulder to elbow), LIP SWELLING (swelling of  lips) and the last episode of NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes: Cold Compress
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: blotchy rash from shoulder to elbow; swelling of  lips; nausea; nausea; Diarrhea; red raised skin at injection site; injection site was itchy; Injection site warm to touch; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy), INJECTION SITE WARMTH (Injection site warm to touch) and the first episode of NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE and LEVONORGESTREL (MIRENA) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm soreness). On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy) and INJECTION SITE WARMTH (Injection site warm to touch). On 27-Jan-2021, the patient experienced the first episode of NAUSEA (nausea) and DIARRHOEA (Diarrhea). On 01-Feb-2021, the patient experienced RASH (blotchy rash from shoulder to elbow), LIP SWELLING (swelling of  lips) and the second episode of NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 21-Jan-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 28-Jan-2021, INJECTION SITE ERYTHEMA (red raised skin at injection site), INJECTION SITE PRURITUS (injection site was itchy), INJECTION SITE WARMTH (Injection site warm to touch) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, RASH (blotchy rash from shoulder to elbow), LIP SWELLING (swelling of  lips) and the last episode of NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes: Cold Compress
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Vaccination site pain, Vaccination site swelling, White blood cell count
Clinical narrative: did not show any antibodies after the first shot; injection site was very very swelling; injection site very uncomfortable; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (did not show any antibodies after the first shot), VACCINATION SITE SWELLING (injection site was very very swelling) and VACCINATION SITE PAIN (injection site very uncomfortable) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (did not show any antibodies after the first shot), VACCINATION SITE SWELLING (injection site was very very swelling) and VACCINATION SITE PAIN (injection site very uncomfortable). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (did not show any antibodies after the first shot), VACCINATION SITE SWELLING (injection site was very very swelling) and VACCINATION SITE PAIN (injection site very uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: negative. In January 2021, White blood cell count: okay, no infection Okay, no infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant therapy included heart pills. The reporter stated very very scary episode after two weeks of received the vaccine. Doctor put patient on antibiotic but really did not help, so patient was put on more stronger penicillin.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/throbbing and hurting arm), PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), PRURITUS (arm was itchy) and FEELING HOT (arm was hot/real hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm/throbbing and hurting arm). On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), PRURITUS (arm was itchy), FEELING HOT (arm was hot/real hot), RASH (arm rash (raised bumps)) and HEADACHE (terrible headache). On 22-Jan-2021, PAIN IN EXTREMITY (sore arm/throbbing and hurting arm) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), PRURITUS (arm was itchy), FEELING HOT (arm was hot/real hot), RASH (arm rash (raised bumps)) and HEADACHE (terrible headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product reported by the reporter. No treatment medication reported by the reporter. The patient reported on 29-Jan-2021. arm was throbbing, hurting and very hot.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/throbbing and hurting arm), PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), PRURITUS (arm was itchy) and FEELING HOT (arm was hot/real hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm/throbbing and hurting arm). On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), PRURITUS (arm was itchy), FEELING HOT (arm was hot/real hot), RASH (arm rash (raised bumps)) and HEADACHE (terrible headache). On 22-Jan-2021, PAIN IN EXTREMITY (sore arm/throbbing and hurting arm) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), PRURITUS (arm was itchy), FEELING HOT (arm was hot/real hot), RASH (arm rash (raised bumps)) and HEADACHE (terrible headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product reported by the reporter. No treatment medication reported by the reporter. The patient reported on 29-Jan-2021. arm was throbbing, hurting and very hot.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Rash on the left arm; Large red area; very warm almost hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the left arm), INJECTION SITE ERYTHEMA (Large red area) and INJECTION SITE WARMTH (very warm almost hot to touch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced RASH (Rash on the left arm), INJECTION SITE ERYTHEMA (Large red area) and INJECTION SITE WARMTH (very warm almost hot to touch). At the time of the report, RASH (Rash on the left arm), INJECTION SITE ERYTHEMA (Large red area) and INJECTION SITE WARMTH (very warm almost hot to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Rash on her arm; Itchy Sensation Rash - Near Injection Site; Red Rash - Near Injection Site/ Bright Red, Triangular Shaped Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy Sensation Rash - Near Injection Site), RASH (Rash on her arm) and INJECTION SITE RASH (Red Rash - Near Injection Site/ Bright Red, Triangular Shaped Rash - Near Injection Site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE RASH (Red Rash - Near Injection Site/ Bright Red, Triangular Shaped Rash - Near Injection Site). On 28-Jan-2021, the patient experienced RASH PRURITIC (Itchy Sensation Rash - Near Injection Site). On an unknown date, the patient experienced RASH (Rash on her arm). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form. On 23-Jan-2021, INJECTION SITE RASH (Red Rash - Near Injection Site/ Bright Red, Triangular Shaped Rash - Near Injection Site) had resolved. At the time of the report, RASH PRURITIC (Itchy Sensation Rash - Near Injection Site) and RASH (Rash on her arm) 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 medications were provided. Other treatment included antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received and added new event.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Pain in extremity
Clinical narrative: Red splotch all the way around the injection site, about 2 inches long; Little headache that lasted about an hour/ Mild Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red splotch all the way around the injection site, about 2 inches long), HEADACHE (Little headache that lasted about an hour/ Mild Headache) and PAIN IN EXTREMITY (Sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Allergy. Concurrent medical conditions included BPH since 1990 and GERD. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, FINASTERIDE and DOXAZOSIN for BPH, RABEPRAZOLE and FAMOTIDINE for GERD.   On 14-Jan-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (Little headache that lasted about an hour/ Mild Headache) and PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red splotch all the way around the injection site, about 2 inches long). On 14-Jan-2021, HEADACHE (Little headache that lasted about an hour/ Mild Headache) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red splotch all the way around the injection site, about 2 inches long) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 19 Apr 2021 includes patient details; height, weight, race ethnicity details.Current condition; BPH, GERD, allergies.Concomitant medication; rabeprazole, famotidine, finasteride, doxazosin and Flonase.The mild red splotch with no real rash or itching or anything else just a red splotch that the patient experienced caused no issues and faded away in about five days.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild Headache) and VACCINATION SITE PAIN (Sore Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Mild Headache) and VACCINATION SITE PAIN (Sore Arm). At the time of the report, HEADACHE (Mild Headache) and VACCINATION SITE PAIN (Sore Arm) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event were  not provided.  No laboratory investigations were provided. The Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Arm was hurting; A spontaneous report was received from a consumer concerning her husband a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was hurting/ limb discomfort.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch: 0280L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient's arm hurts. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, arm was hurting was unknown.; Sender's Comments:  MOD21-035070:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Nausea, Presyncope, Pyrexia
Clinical narrative: I don't know if I fainted or passed out found myself lying on the floor; woke up sick to my stomach; fever; I felt really cold; i felt very cold; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I don't know if I fainted or passed out found myself lying on the floor), NASOPHARYNGITIS (I felt really cold), CHILLS (i felt very cold), NAUSEA (woke up sick to my stomach) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included SIMVASTATIN, LISINOPRIL and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (I felt really cold) and CHILLS (i felt very cold). On 19-Feb-2021, the patient experienced PRESYNCOPE (I don't know if I fainted or passed out found myself lying on the floor), NAUSEA (woke up sick to my stomach) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (I don't know if I fainted or passed out found myself lying on the floor), NASOPHARYNGITIS (I felt really cold), CHILLS (i felt very cold), NAUSEA (woke up sick to my stomach) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-187096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-Significant follow up appended to AER. Concomitant medication was updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Vaccination site erythema, Vaccination site rash
Clinical narrative: Headache; Rash - Near Injection Site; Redness - Near Injection Site; Swelling (hardness) - Near Injection Site; Hot to Touch Sensation - Near Injection Site; Joint pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), ARTHRALGIA (Joint pain), HEADACHE (Headache) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Respiratory disorder.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (Joint pain). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), HEADACHE (Headache), VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), HEADACHE (Headache), VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Headache; Rash - Near Injection Site; Redness - Near Injection Site; Swelling (hardness) - Near Injection Site; Hot to Touch Sensation - Near Injection Site; Joint pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), ARTHRALGIA (Joint pain), HEADACHE (Headache) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Respiratory disorder.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (Joint pain). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), HEADACHE (Headache), VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), HEADACHE (Headache), VACCINATION SITE RASH (Rash - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling (hardness) - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: small nodule to injection site; Itching worsened; Itching in the arm  of injection; Redness in the arm of injection; Sore in the arm of injection; swelling in the arm of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection) and VACCINATION SITE PAIN (Sore in the arm of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 307K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Dec-2020 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021 at 12:24 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection). The patient was treated with IBUPROFEN (oral) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of 1 dosage form. On 12-Jan-2021, VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection) to be possibly related.    It was noted per follow-up report that the patient had a delayed topical reaction to the TB skin test.   This case was linked to MOD-2021-031261, MOD-2021-027551, MOD-2021-025815, MOD-2021-028822, MOD-2021-028858 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow-up ADR form received and contained first and second dose details, concomitant/treatment medications, event onset and resolution dates, medical history and causality.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Myalgia
Clinical narrative: I was so weak; couldn't move in the morning; temperature 100.8; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I was so weak), BODY TEMPERATURE INCREASED (temperature 100.8), CHILLS (chills), MYALGIA (body ache) and FATIGUE (couldn't move in the morning) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History Reported.).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature 100.8), CHILLS (chills) and MYALGIA (body ache). On 25-Jan-2021, the patient experienced ASTHENIA (I was so weak) and FATIGUE (couldn't move in the morning). On 25-Jan-2021, FATIGUE (couldn't move in the morning) had resolved. On 26-Jan-2021, ASTHENIA (I was so weak) had resolved. On 28-Jan-2021, BODY TEMPERATURE INCREASED (temperature 100.8), CHILLS (chills) and MYALGIA (body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomintant Medications were not provided.  Treatment medication were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: fatigue; little swollen in appearance; little swollen in appearance; Arm Soreness that is tolerable; A spontaneous report was received from a consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness that is tolerable, arm soreness became worse day by day, a little swollen in appearance, fatigue.  The patient's medical history was not provided. Concomitant medications reported were Losartan for hypertension, Amlodipine for hypertension, Atorvastatin for cholesterol for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) arm soreness that is tolerable. On 12 Feb 2021, the patient experienced the event(s) arm soreness became worse day by day, a little swollen in appearance. On an unknown date, the patient experienced the event(s) fatigue.  Treatment details included Took Tylenol and Advil, Cool pad.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm soreness that is tolerable, arm soreness became worse day by day, a little swollen in appearance, fatigue was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Incomplete course of vaccination
Clinical narrative: tested positive for covid-19 after first dose of vaccine.; headaches; Second dose over 42 days later; A spontaneous report  was received from a consumer, concerning herself, a 38-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced tested positive for COVID-19 after first dose of vaccine headache, and second dose over 42 days later.  The patient's medical history, as provided by the reporter, included migraines. Concomitant medications were unknown.    On 24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route  in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced tested positive for COVID-19 after first dose of vaccine and headache. Treatment for the events included vitamin C and hot teas  On 22 Feb 2021, over 42 days had passed since her first dose, and she had not scheduled her second planned dose yet.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tested positive for COVID-19 after first dose of vaccine, headaches, and second dose over 42 days later, was unknown.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown with associated AEs: headache and COVID positive test. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: rash at the site of injection; that area is red; that area is hard; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at the site of injection, that area is red, that area is hard.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) rash at the site of injection, that area is red, that area is hard.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash at the site of injection, that area is red, that area is hard was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: chills; swelling; headache; dizziness; soreness; still fuggy, can have a clear head, little dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), SWELLING (swelling), HEADACHE (headache) and DIZZINESS (dizziness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHILLS (chills), SWELLING (swelling), HEADACHE (headache), DIZZINESS (dizziness), MYALGIA (soreness) and DIZZINESS (still fuggy, can have a clear head, little dizzy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Jan-2021, PYREXIA (fever) outcome was unknown. At the time of the report, CHILLS (chills), SWELLING (swelling), HEADACHE (headache), DIZZINESS (dizziness), MYALGIA (soreness) and DIZZINESS (still fuggy, can have a clear head, little dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: chills; swelling; headache; dizziness; soreness; still fuggy, can have a clear head, little dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), SWELLING (swelling), HEADACHE (headache) and DIZZINESS (dizziness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHILLS (chills), SWELLING (swelling), HEADACHE (headache), DIZZINESS (dizziness), MYALGIA (soreness) and DIZZINESS (still fuggy, can have a clear head, little dizzy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Jan-2021, PYREXIA (fever) outcome was unknown. At the time of the report, CHILLS (chills), SWELLING (swelling), HEADACHE (headache), DIZZINESS (dizziness), MYALGIA (soreness) and DIZZINESS (still fuggy, can have a clear head, little dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Dizziness; Stomach aches; Headache; Nausea; Fever which ranged from 103.8-104.5F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach aches), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever which ranged from 103.8-104.5F) in a 49-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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach aches), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever which ranged from 103.8-104.5F) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) had not resolved and ABDOMINAL PAIN UPPER (Stomach aches), HEADACHE (Headache), PYREXIA (Fever which ranged from 103.8-104.5F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: ranged from 103.8-104.5 f (abnormal) Ranged from 103.8-104.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Experienced dizziness about 5 minutes after getting the vaccine.  Not feeling well the same evening due to stomach aches, dizziness, headache, and she could not get out of bed the next day. Concomitant medication use not reported. Treatment: Acetaminophen (TYLENOL) and ibuprofen which did not break the fever.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Dizziness; Stomach aches; Headache; Nausea; Fever which ranged from 103.8-104.5F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach aches), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever which ranged from 103.8-104.5F) in a 49-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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach aches), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever which ranged from 103.8-104.5F) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) had not resolved and ABDOMINAL PAIN UPPER (Stomach aches), HEADACHE (Headache), PYREXIA (Fever which ranged from 103.8-104.5F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: ranged from 103.8-104.5 f (abnormal) Ranged from 103.8-104.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Experienced dizziness about 5 minutes after getting the vaccine.  Not feeling well the same evening due to stomach aches, dizziness, headache, and she could not get out of bed the next day. Concomitant medication use not reported. Treatment: Acetaminophen (TYLENOL) and ibuprofen which did not break the fever.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache, Injection site pain, Pain
Clinical narrative: Pain at injection site; Headache; Body ache; Painful stomach ache; Upset stomach; A spontaneous report was received from a consumer concerning a 29-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, headache, body ache, painful stomach ache, upset stomach.  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 21 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 02020M20A) via unknown route for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced the event(s) pain at injection site, headache, body ache, painful stomach ache, upset stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain at injection site, headache, body ache, painful stomach ache, upset stomach was unknown.