chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     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 (pain) and PYREXIA (fever). At the time of the report, PAIN (pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The reporter did not provide an assessment for the events, fever and pain.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM, ASCORBIC ACID (VITAMIN C ASC ACID), VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    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 PYREXIA (fever). On 21-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4. On 21-Jan-2021, Body temperature: 100.2.     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.   Patient took acetaminophen to relieve her symptoms
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypersensitivity, Hypoaesthesia, Malaise
Clinical narrative: Allergic reaction to vaccine; Arm went numb; arm cold; arm tingly; Lightheaded/Dizziness; very weak; Felt like death; Nausea; Muscles hurt/was in a lot of body pain; developed a rash in the arm; Vision fuzziness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly) and DIZZINESS (Lightheaded/Dizziness) in a 32-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold) and PARAESTHESIA (arm tingly). 15-Jan-2021, the patient experienced DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), MALAISE (Felt like death), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain). In January 2021, the patient experienced VISION BLURRED (Vision fuzziness) and RASH (developed a rash in the arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly), DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), VISION BLURRED (Vision fuzziness), MALAISE (Felt like death), RASH (developed a rash in the arm), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was give shots of diphenhydramine for treatment   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Paraesthesia, Peripheral coldness, Rash
Clinical narrative: Allergic reaction to vaccine; Arm went numb; arm cold; arm tingly; Lightheaded/Dizziness; very weak; Felt like death; Nausea; Muscles hurt/was in a lot of body pain; developed a rash in the arm; Vision fuzziness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly) and DIZZINESS (Lightheaded/Dizziness) in a 32-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold) and PARAESTHESIA (arm tingly). 15-Jan-2021, the patient experienced DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), MALAISE (Felt like death), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain). In January 2021, the patient experienced VISION BLURRED (Vision fuzziness) and RASH (developed a rash in the arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly), DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), VISION BLURRED (Vision fuzziness), MALAISE (Felt like death), RASH (developed a rash in the arm), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was give shots of diphenhydramine for treatment   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Allergic reaction to vaccine; Arm went numb; arm cold; arm tingly; Lightheaded/Dizziness; very weak; Felt like death; Nausea; Muscles hurt/was in a lot of body pain; developed a rash in the arm; Vision fuzziness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly) and DIZZINESS (Lightheaded/Dizziness) in a 32-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold) and PARAESTHESIA (arm tingly). 15-Jan-2021, the patient experienced DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), MALAISE (Felt like death), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain). In January 2021, the patient experienced VISION BLURRED (Vision fuzziness) and RASH (developed a rash in the arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction to vaccine), HYPOAESTHESIA (Arm went numb), PERIPHERAL COLDNESS (arm cold), PARAESTHESIA (arm tingly), DIZZINESS (Lightheaded/Dizziness), ASTHENIA (very weak), VISION BLURRED (Vision fuzziness), MALAISE (Felt like death), RASH (developed a rash in the arm), NAUSEA (Nausea) and MYALGIA (Muscles hurt/was in a lot of body pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was give shots of diphenhydramine for treatment   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: About 5 to 8 cm diameter redness around the injection site; About 5 to 8 cm diameter pruritus around the injection site; About 5 to 8 cm diameter swelling around the injection site; A spontaneous report was received from a physician concerning a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed about 5 to 8 cm diameter pruritus around the injection site/vaccination site erythema/vaccination site swelling/vaccination site pruritus.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, post vaccination, the reporter stated the patient developed about 5 to 8 cm diameter pruritus around the injection site.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, about 5 to 8 cm diameter pruritus around the injection site/vaccination site erythema/vaccination site swelling/vaccination site pruritus, were considered unknown.  Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Oropharyngeal discomfort
Clinical narrative: side effects in her ear and throat; side effects in her ear and throat; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (side effects in her ear and throat) and OROPHARYNGEAL DISCOMFORT (side effects in her ear and throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (side effects in her ear and throat) and OROPHARYNGEAL DISCOMFORT (side effects in her ear and throat). At the time of the report, EAR DISORDER (side effects in her ear and throat) and OROPHARYNGEAL DISCOMFORT (side effects in her ear and throat) 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
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: lowgrade fever of 99.9; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (lowgrade fever of 99.9) and VACCINATION SITE PAIN (arm was sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (lowgrade fever of 99.9) and VACCINATION SITE PAIN (arm was sore). On 17-Jan-2021, PYREXIA (lowgrade fever of 99.9) and VACCINATION SITE PAIN (arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: very very swollen; every day more red, more red, more red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (very very swollen) and VACCINATION SITE ERYTHEMA (every day more red, more red, more red) 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 08-Jan-2021 at 6:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (very very swollen) and VACCINATION SITE ERYTHEMA (every day more red, more red, more red). At the time of the report, VACCINATION SITE SWELLING (very very swollen) and VACCINATION SITE ERYTHEMA (every day more red, more red, more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication list was not provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced LIP SWELLING (swollen lips). At the time of the report, LIP SWELLING (swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash pruritic
Clinical narrative: r ash on both left and right arm; shivering; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (r ash on both left and right arm) and CHILLS (shivering) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced RASH PRURITIC (r ash on both left and right arm) and CHILLS (shivering). At the time of the report, RASH PRURITIC (r ash on both left and right arm) and CHILLS (shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter'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. Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 29-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy details.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: hot to touch; big lump; pain in her arm; swelling; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (hot to touch), INJECTION SITE MASS (big lump), INJECTION SITE SWELLING (swelling) and INJECTION SITE PAIN (pain in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling). On 19-Jan-2021, the patient experienced INJECTION SITE WARMTH (hot to touch), INJECTION SITE MASS (big lump) and INJECTION SITE PAIN (pain in her arm). At the time of the report, INJECTION SITE WARMTH (hot to touch), INJECTION SITE MASS (big lump), INJECTION SITE SWELLING (swelling) and INJECTION SITE PAIN (pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Sore arm; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included SERTRALINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Jun-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Fatigue; Site of the injection was red and hot; Site of the injection was is itchy; Mild reaction that went away; Site of the injection was very swollen; Site of the injection was hot; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Mild reaction that went away), VACCINATION SITE WARMTH (Site of the injection was hot), VACCINATION SITE PRURITUS (Site of the injection was is itchy), VACCINATION SITE SWELLING (Site of the injection was very swollen) and VACCINATION SITE ERYTHEMA (Site of the injection was red and hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Allergy to animal (Cats), Food allergy (many fruits), Pollen allergy, Hypertension since 1995 and Cholesterol since 1996. Concomitant products included LISINOPRIL for Cholesterol, SIMVASTATIN from 1995 to an unknown date for Hypertension.  On 12-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Site of the injection was hot), VACCINATION SITE PRURITUS (Site of the injection was is itchy), VACCINATION SITE SWELLING (Site of the injection was very swollen) and VACCINATION SITE ERYTHEMA (Site of the injection was red and hot). On 22-Jan-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE REACTION (Mild reaction that went away). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 25-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE REACTION (Mild reaction that went away), VACCINATION SITE WARMTH (Site of the injection was hot), VACCINATION SITE PRURITUS (Site of the injection was is itchy), VACCINATION SITE SWELLING (Site of the injection was very swollen) and VACCINATION SITE ERYTHEMA (Site of the injection was red and hot) had resolved. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  This case was linked to MOD-2021-088993 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-PAR-2021 Contains patient demographic details updated, other relevant history was updated, dosage information was updated, concomitant medications was updated, treatment information was updated, events was updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Fatigue; Site of the injection was red and hot; Site of the injection was is itchy; Mild reaction that went away; Site of the injection was very swollen; Site of the injection was hot; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Mild reaction that went away), VACCINATION SITE WARMTH (Site of the injection was hot), VACCINATION SITE PRURITUS (Site of the injection was is itchy), VACCINATION SITE SWELLING (Site of the injection was very swollen) and VACCINATION SITE ERYTHEMA (Site of the injection was red and hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concurrent medical conditions included Allergy to animal (Cats), Food allergy (many fruits), Pollen allergy, Hypertension since 1995 and Cholesterol since 1996. Concomitant products included LISINOPRIL for Cholesterol, SIMVASTATIN from 1995 to an unknown date for Hypertension.  On 12-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Site of the injection was hot), VACCINATION SITE PRURITUS (Site of the injection was is itchy), VACCINATION SITE SWELLING (Site of the injection was very swollen) and VACCINATION SITE ERYTHEMA (Site of the injection was red and hot). On 22-Jan-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE REACTION (Mild reaction that went away). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 25-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE REACTION (Mild reaction that went away), VACCINATION SITE WARMTH (Site of the injection was hot), VACCINATION SITE PRURITUS (Site of the injection was is itchy), VACCINATION SITE SWELLING (Site of the injection was very swollen) and VACCINATION SITE ERYTHEMA (Site of the injection was red and hot) had resolved. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  This case was linked to MOD-2021-088993 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-PAR-2021 Contains patient demographic details updated, other relevant history was updated, dosage information was updated, concomitant medications was updated, treatment information was updated, events was updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: hot to the touch; her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot; raised circle shape around the injection site, red; red splotched-like hives above the injection site; when she does the Epley Maneuver she got dizzy and stayed dizzy; felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), DIZZINESS (when she does the Epley Maneuver she got dizzy and stayed dizzy), FATIGUE (felt a little tired), VACCINATION SITE PRURITUS (her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot) and VACCINATION SITE ERYTHEMA (raised circle shape around the injection site, red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Jan-2021, the patient experienced FATIGUE (felt a little tired). On 10-Jan-2021, the patient experienced DIZZINESS (when she does the Epley Maneuver she got dizzy and stayed dizzy). On 16-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot), VACCINATION SITE ERYTHEMA (raised circle shape around the injection site, red) and VACCINATION SITE URTICARIA (red splotched-like hives above the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), DIZZINESS (when she does the Epley Maneuver she got dizzy and stayed dizzy), FATIGUE (felt a little tired), VACCINATION SITE PRURITUS (her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot), VACCINATION SITE ERYTHEMA (raised circle shape around the injection site, red) and VACCINATION SITE URTICARIA (red splotched-like hives above the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Reporter contact information, patient information, Dose-1 date and events updated in details.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: hot to the touch; her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot; raised circle shape around the injection site, red; red splotched-like hives above the injection site; when she does the Epley Maneuver she got dizzy and stayed dizzy; felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), DIZZINESS (when she does the Epley Maneuver she got dizzy and stayed dizzy), FATIGUE (felt a little tired), VACCINATION SITE PRURITUS (her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot) and VACCINATION SITE ERYTHEMA (raised circle shape around the injection site, red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Jan-2021, the patient experienced FATIGUE (felt a little tired). On 10-Jan-2021, the patient experienced DIZZINESS (when she does the Epley Maneuver she got dizzy and stayed dizzy). On 16-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot), VACCINATION SITE ERYTHEMA (raised circle shape around the injection site, red) and VACCINATION SITE URTICARIA (red splotched-like hives above the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), DIZZINESS (when she does the Epley Maneuver she got dizzy and stayed dizzy), FATIGUE (felt a little tired), VACCINATION SITE PRURITUS (her arm, at the injection site was very itchy, raised circle shape around the injection site, red, hot), VACCINATION SITE ERYTHEMA (raised circle shape around the injection site, red) and VACCINATION SITE URTICARIA (red splotched-like hives above the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Reporter contact information, patient information, Dose-1 date and events updated in details.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: vaccination site itching; Rash around the injection site; Injection site felt warm; burning at site of vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Injection site felt warm), VACCINATION SITE PAIN (burning at site of vaccination), VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE RASH (Rash around the injection site) in a 34-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 Hyperthyroidism. Concurrent medical conditions included Food allergy (Allergies to gluten).    On 29-Dec-2020 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Injection site felt warm) and VACCINATION SITE PAIN (burning at site of vaccination). On 30-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE RASH (Rash around the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site felt warm), VACCINATION SITE PAIN (burning at site of vaccination), VACCINATION SITE PRURITUS (vaccination site itching) and VACCINATION SITE RASH (Rash around the 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 medications were reported.   No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance
Clinical narrative: Serious pain in the right hip; chills; can barely walk; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (can barely walk), ARTHRALGIA (Serious pain in the right hip) and CHILLS (chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 089120A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced GAIT DISTURBANCE (can barely walk). On an unknown date, the patient experienced ARTHRALGIA (Serious pain in the right hip) and CHILLS (chills). At the time of the report, GAIT DISTURBANCE (can barely walk) and ARTHRALGIA (Serious pain in the right hip) outcome was unknown and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Glossodynia, Headache, Maternal exposure during pregnancy, Myalgia
Clinical narrative: Received Vaccine while pregnant; Fever; Body aches; Chills; Headache; Tongue Hurt; Arm hurt; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-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.     The patient's past medical history included Heart disease, unspecified, COVID-19 (Suffered from Covid-19) in November 2020, Gestational diabetes, Pregnancy (Live,full-term birth) on 20-Aug-2008 and Pregnancy (Live,full-term birth) on 17-Feb-2010.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 07-Feb-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), GLOSSODYNIA (Tongue Hurt) and PAIN IN EXTREMITY (Arm hurt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant) outcome was unknown. On 01-Jan-2021, PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), GLOSSODYNIA (Tongue Hurt) and PAIN IN EXTREMITY (Arm hurt) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details was reported. She was 9 months pregnant and was about to deliver on 26 Jan 2021. She had three previous pregnancies of which two were live and full term birth on 20 Aug 2008 and 17 Feb 2010.; Reporter's Comments: This is a case of product exposure during pregnancy with associated non-serious AEs (fever, chills, body ache, headache, arm and tongue pain) for this 41-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Received Vaccine while pregnant; Fever; Body aches; Chills; Headache; Tongue Hurt; Arm hurt; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-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.     The patient's past medical history included Heart disease, unspecified, COVID-19 (Suffered from Covid-19) in November 2020, Gestational diabetes, Pregnancy (Live,full-term birth) on 20-Aug-2008 and Pregnancy (Live,full-term birth) on 17-Feb-2010.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 07-Feb-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), GLOSSODYNIA (Tongue Hurt) and PAIN IN EXTREMITY (Arm hurt). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Received Vaccine while pregnant) outcome was unknown. On 01-Jan-2021, PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), GLOSSODYNIA (Tongue Hurt) and PAIN IN EXTREMITY (Arm hurt) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details was reported. She was 9 months pregnant and was about to deliver on 26 Jan 2021. She had three previous pregnancies of which two were live and full term birth on 20 Aug 2008 and 17 Feb 2010.; Reporter's Comments: This is a case of product exposure during pregnancy with associated non-serious AEs (fever, chills, body ache, headache, arm and tongue pain) for this 41-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Tachycardia; mild rash on the back; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and RASH (mild rash on the back) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia) and RASH (mild rash on the back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown and RASH (mild rash on the back) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l80a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Blood Thinners for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a patient and describes the occurrence of   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 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hypersensitivity, Myalgia
Clinical narrative: No medical history provided by the reporter.  Concomitant products included METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and INSULIN for an unknown indication.    On 20-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 HYPERSENSITIVITY (Allergies acting bad), MYALGIA (Body aches / muscle aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F). On 22-Jan-2021, PYREXIA (Fever 101F) had resolved. At the time of the report, HYPERSENSITIVITY (Allergies acting bad) and MYALGIA (Body aches / muscle aches) had resolved and CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101.0 (High) °F. On 22-Jan-2021, Body temperature: 98.0 (normal) °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took ibuprofen for the treatment of the events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: No medical history provided by the reporter.  Concomitant products included METFORMIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) and INSULIN for an unknown indication.    On 20-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 HYPERSENSITIVITY (Allergies acting bad), MYALGIA (Body aches / muscle aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F). On 22-Jan-2021, PYREXIA (Fever 101F) had resolved. At the time of the report, HYPERSENSITIVITY (Allergies acting bad) and MYALGIA (Body aches / muscle aches) had resolved and CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101.0 (High) °F. On 22-Jan-2021, Body temperature: 98.0 (normal) °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took ibuprofen for the treatment of the events.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Pain
Clinical narrative: On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced EYE SWELLING (Swelling of right eye), ERYTHEMA (Redness) and PAIN (Pain). At the time of the report, EYE SWELLING (Swelling of right eye), ERYTHEMA (Redness) and PAIN (Pain) outcome was unknown.            No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-157104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional information included no new information. On 25-Jun-2021: Non-significant follow up appended
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swollen; warm to touch; area was red; itching on injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (itching on injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to touch) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Cefzil).    On 07-Jan-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching on injection site). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (area was red). On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to touch). At the time of the report, VACCINATION SITE PRURITUS (itching on injection site), VACCINATION SITE ERYTHEMA (area was red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to touch) 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 reported.   The patient was using Benadryl cream as treatment for the events.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin burning sensation, Vaccination site pain
Clinical narrative: chest warm in the back and front.like sunburn; pain in the arm; fever; A spontaneous report was received from a physician concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, skin burning sensation and pyrexia.  The patient's medical history was not provided . No relevant concomitant medications was reported.  On 7-jan-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number : 011j20A) intramuscularly for the prophylaxis of COVID-19 infection.  On the same day, the patient experienced pain in the injection site , chest warm and fever during 48 hrs. Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of report, the outcome of the events, pain at injection site, fever and chest warm was unknown; 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. Further information has been requested