chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Very fatigued; Threw up; Headache; Couldn't get out of bed; Severe chills; Chattering teeth; Body aches; Pain on joints of her hands; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches) and ARTHRALGIA (Pain on joints of her hands) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches), ARTHRALGIA (Pain on joints of her hands), VOMITING (Threw up) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced FATIGUE (Very fatigued). On 01-Apr-2021, ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches), ARTHRALGIA (Pain on joints of her hands), VOMITING (Threw up) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Very fatigued) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included ibuprofen.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: Very fatigued; Threw up; Headache; Couldn't get out of bed; Severe chills; Chattering teeth; Body aches; Pain on joints of her hands; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches) and ARTHRALGIA (Pain on joints of her hands) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches), ARTHRALGIA (Pain on joints of her hands), VOMITING (Threw up) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced FATIGUE (Very fatigued). On 01-Apr-2021, ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches), ARTHRALGIA (Pain on joints of her hands), VOMITING (Threw up) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Very fatigued) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included ibuprofen.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive
Clinical narrative: positive ANA titer; This spontaneous case was reported by a consumer and describes the occurrence of ANTINUCLEAR ANTIBODY POSITIVE (positive ANA titer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ANTINUCLEAR ANTIBODY POSITIVE (positive ANA titer). At the time of the report, ANTINUCLEAR ANTIBODY POSITIVE (positive ANA titer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: Prior to the shot - ANA positive 1 in 320 dilution. One month after the first shot - ANA positive 1 in 640 dilution..         Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: 20 weeks Pregnant patient got first dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (20 weeks Pregnant patient got first dose of Moderna vaccine) in a 30-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Miscarriage at 6 weeks) on 12-Oct-2017, Pregnancy (live full term birth) on 21-Feb-2019 and Alcoholism (1/week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Oct-2020 and the estimated date of delivery was 03-Aug-2021. On 18-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (20 weeks Pregnant patient got first dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (20 weeks Pregnant patient got first dose of Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2020, Pregnancy test: unknown (Positive) Positive. On an unknown date, Ultrasound scan: unknown (Inconclusive) MONITORING FOR MARGINAL PREVIA.     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 medications provided by the reporter.  Patient was positive to pregnancy on 03DEC2021 and no. of fetuses were one and patient reported the complication during the pregnancy was monitoring for marginal previa during ultrasounds.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Lymph node pain
Clinical narrative: she felt a little better but didn't have energy to walk to the car.; her arm got a little sore, hard; her arm got a little sore, hard; total fatigue; a headache that kept getting worse and worse through the day; lymph nodes was very sore; extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.), VACCINATION SITE INDURATION (her arm got a little sore, hard) and VACCINATION SITE PAIN (her arm got a little sore, hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), VACCINATION SITE INDURATION (her arm got a little sore, hard), VACCINATION SITE PAIN (her arm got a little sore, hard), FATIGUE (total fatigue) and HEADACHE (a headache that kept getting worse and worse through the day). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.). On 31-Mar-2021, HEADACHE (a headache that kept getting worse and worse through the day) had resolved. On 01-Apr-2021, FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.) had resolved. At the time of the report, LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), VACCINATION SITE INDURATION (her arm got a little sore, hard), VACCINATION SITE PAIN (her arm got a little sore, hard) and FATIGUE (total fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: she felt a little better but didn't have energy to walk to the car.; her arm got a little sore, hard; her arm got a little sore, hard; total fatigue; a headache that kept getting worse and worse through the day; lymph nodes was very sore; extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.), VACCINATION SITE INDURATION (her arm got a little sore, hard) and VACCINATION SITE PAIN (her arm got a little sore, hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), VACCINATION SITE INDURATION (her arm got a little sore, hard), VACCINATION SITE PAIN (her arm got a little sore, hard), FATIGUE (total fatigue) and HEADACHE (a headache that kept getting worse and worse through the day). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.). On 31-Mar-2021, HEADACHE (a headache that kept getting worse and worse through the day) had resolved. On 01-Apr-2021, FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.) had resolved. At the time of the report, LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), VACCINATION SITE INDURATION (her arm got a little sore, hard), VACCINATION SITE PAIN (her arm got a little sore, hard) and FATIGUE (total fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Mild flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu-like symptoms) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu-like symptoms). The patient was treated with PARACETAMOL (TYLENOL) for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Patient has taken 2 Tylenol for the treatment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: left eye seemed a little swollen; left eye seemed red; left eye had itchiness; kind of soreness in the left eye/left eye had some pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN, EYE SWELLING, OCULAR HYPERAEMIA, and EYE PRURITUS in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced EYE PAIN. On 02-Mar-2021, the patient experienced EYE SWELLING, OCULAR HYPERAEMIA, and EYE PRURITUS. At the time of the report, EYE PAIN, EYE SWELLING, OCULAR HYPERAEMIA and EYE PRURITUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Fatigue; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Blood Pressure medications.  No treatment taken.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Feeling cold, Headache
Clinical narrative: 3 minutes later he almost fainted after getting the vaccine; shortness of breath; sweating profusely; cold all over the body; felt like he was about to explode; left arm was sore; headaches on both sides of the head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (3 minutes later he almost fainted after getting the vaccine), DYSPNEA (shortness of breath), HYPERHIDROSIS (sweating profusely), FEELING COLD (cold all over the body) and FEELING ABNORMAL (felt like he was about to explode) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (3 minutes later he almost fainted after getting the vaccine), DYSPNEA (shortness of breath), HYPERHIDROSIS (sweating profusely), FEELING COLD (cold all over the body), FEELING ABNORMAL (felt like he was about to explode), VACCINATION SITE PAIN (left arm was sore) and HEADACHE (headaches on both sides of the head). On 03-Apr-2021, VACCINATION SITE PAIN (left arm was sore) had resolved. At the time of the report, DIZZINESS (3 minutes later he almost fainted after getting the vaccine), DYSPNEA (shortness of breath), HYPERHIDROSIS (sweating profusely), FEELING COLD (cold all over the body), FEELING ABNORMAL (felt like he was about to explode) and HEADACHE (headaches on both sides of the head) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Water was the Treatment Medication.  The patient received the vaccine at 9:30am and stated exactly 3 minutes later he almost fainted after getting the vaccine. He started to experience shortness of breath, cold all over the body like when you are about to faint and sweating profusely; His left arm was sore for next 2-3 days and has also been having headaches on both sides of the head. He stated after he started sweating he asked the nurse for some water and felt better after drinking water.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vaccination site pain
Clinical narrative: 3 minutes later he almost fainted after getting the vaccine; shortness of breath; sweating profusely; cold all over the body; felt like he was about to explode; left arm was sore; headaches on both sides of the head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (3 minutes later he almost fainted after getting the vaccine), DYSPNEA (shortness of breath), HYPERHIDROSIS (sweating profusely), FEELING COLD (cold all over the body) and FEELING ABNORMAL (felt like he was about to explode) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (3 minutes later he almost fainted after getting the vaccine), DYSPNEA (shortness of breath), HYPERHIDROSIS (sweating profusely), FEELING COLD (cold all over the body), FEELING ABNORMAL (felt like he was about to explode), VACCINATION SITE PAIN (left arm was sore) and HEADACHE (headaches on both sides of the head). On 03-Apr-2021, VACCINATION SITE PAIN (left arm was sore) had resolved. At the time of the report, DIZZINESS (3 minutes later he almost fainted after getting the vaccine), DYSPNEA (shortness of breath), HYPERHIDROSIS (sweating profusely), FEELING COLD (cold all over the body), FEELING ABNORMAL (felt like he was about to explode) and HEADACHE (headaches on both sides of the head) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Water was the Treatment Medication.  The patient received the vaccine at 9:30am and stated exactly 3 minutes later he almost fainted after getting the vaccine. He started to experience shortness of breath, cold all over the body like when you are about to faint and sweating profusely; His left arm was sore for next 2-3 days and has also been having headaches on both sides of the head. He stated after he started sweating he asked the nurse for some water and felt better after drinking water.  Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: received the second dose of the vaccine subcutaneously instead of intramuscularly; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine subcutaneously instead of intramuscularly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 02-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine subcutaneously instead of intramuscularly). On 02-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine subcutaneously instead of intramuscularly) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant product use was provided. Treatment information was not available.  This report refers to a case of incorrect route of product administration for mRNA-1273, with no associated AEs.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, with no associated AEs.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: arm got very hard; very painful to touch/ about the size of the palm of her hand; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm got very hard) and PAIN IN EXTREMITY (very painful to touch/ about the size of the palm of her hand) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm got very hard) and PAIN IN EXTREMITY (very painful to touch/ about the size of the palm of her hand). At the time of the report, LIMB DISCOMFORT (arm got very hard) and PAIN IN EXTREMITY (very painful to touch/ about the size of the palm of her hand) outcome was unknown.            No concomitant medication were  not provided. No treatment information were  not provided.  The action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-066168 (E2B Linked Report).; Sender's Comments:  MOD-2021-066168:First dose
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: wrong technique in product usage process; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process). On 02-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No laboratory details was provided. No treatment details was provided
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: she got her second dose of vaccine on 03April2021; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her second dose of vaccine on 03April2021) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her second dose of vaccine on 03April2021). On 03-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her second dose of vaccine on 03April2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: F/U uploaded - Patient denied for further follow up
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Pain, Pyrexia
Clinical narrative: Metallic taste; Aches; Fever of 100.9F to 99.6F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), PAIN (Aches), PYREXIA (Fever of 100.9F to 99.6F), CHILLS (Chills) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 003B21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), ROSUVASTATIN CALCIUM (CRESTOR), BUSPIRONE HYDROCHLORIDE (BUSPAR), MULTIVITAMINS [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste), PAIN (Aches), PYREXIA (Fever of 100.9F to 99.6F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Metallic taste), PAIN (Aches), PYREXIA (Fever of 100.9F to 99.6F), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            The patient received both their first dose and second dose of Moderna Covid-19 vaccine on 03-Mar-2021 and 31-Mar-2021 respectively. The patient post receiving their second dose of vaccine reported of experiencing metallic taste in mouth within 15 minutes of waiting period which resolved in seconds.   Reportedly, the patient experienced fever of 100.9F to 99.6F, chills, aches, and headache.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Night sweats, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: Night sweats; Wheezing; Sick every since the vaccine; Upper respiratory infection; Rash; Redness at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and RASH (Rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), RASH (Rash), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Fever). At the time of the report, NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), RASH (Rash), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Wheezing
Clinical narrative: Night sweats; Wheezing; Sick every since the vaccine; Upper respiratory infection; Rash; Redness at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and RASH (Rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), RASH (Rash), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Fever). At the time of the report, NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), RASH (Rash), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu for a week; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu for a week) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu for a week). At the time of the report, INFLUENZA (flu for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used concomitant products to treat diabetes, high blood pressure, hypothyroidism and high cholesterol. Patient used Tylenol y Tus (cough syrup) for the treatment.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Feeling abnormal
Clinical narrative: Slushy feeling during the day; Stomach pain; Pain in throat; Aches in both arms; All joint pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms) and ARTHRALGIA (All joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0081321a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DEXLANSOPRAZOLE (DEXILANT), PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), CLONAZEPAM (KLONOPIN) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms), ARTHRALGIA (All joint pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms), ARTHRALGIA (All joint pain), CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) Fever of 102.         Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-066274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Events outcome were updated from unknown to recovered/resolved.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Slushy feeling during the day; Stomach pain; Pain in throat; Aches in both arms; All joint pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms) and ARTHRALGIA (All joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0081321a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DEXLANSOPRAZOLE (DEXILANT), PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), CLONAZEPAM (KLONOPIN) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms), ARTHRALGIA (All joint pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms), ARTHRALGIA (All joint pain), CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) Fever of 102.         Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-066274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Events outcome were updated from unknown to recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Fatigue, Pain
Clinical narrative: very uncomfortable; aches and pains; diarrhea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (very uncomfortable), PAIN (aches and pains), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DISCOMFORT (very uncomfortable), PAIN (aches and pains), DIARRHOEA (diarrhea) and FATIGUE (fatigue). On 29-Mar-2021, DISCOMFORT (very uncomfortable), PAIN (aches and pains), DIARRHOEA (diarrhea) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore leg pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Vascular disorder NOS.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore leg pain). At the time of the report, PAIN IN EXTREMITY (sore leg pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.  No concomitant medication provided by Reporter
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain, Wheezing
Clinical narrative: left arm very sore; wheezy; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezy), DIARRHEA (diarrhea) and VACCINATION SITE PAIN (left arm very sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced WHEEZING (wheezy) and DIARRHEA (diarrhea). On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (left arm very sore). On 01-Apr-2021, WHEEZING (wheezy) and DIARRHEA (diarrhea) had resolved. At the time of the report, VACCINATION SITE PAIN (left arm very sore) outcome was unknown.            No treatment details were provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A minor consumer, age 17 received the first Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A minor consumer, age 17 received the first Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A minor consumer, age 17 received the first Moderna vaccine). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A minor consumer, age 17 received the first Moderna vaccine) had resolved.        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 adverse event was reported.  No concomitant medications were reported.  No treatment information was specified.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow up information was received : added information about vaccine facility, anatomical location of vaccine administered, and information about second dose.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 008B21-2A) with no associated AEs.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second vaccine given at day 47; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given at day 47) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given at day 47). On 20-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given at day 47) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Peripheral swelling, Vaccination site reaction
Clinical narrative: I had diarrhea; I had the Moderna arm; arm swelled up all the way to my elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I had the Moderna arm), PERIPHERAL SWELLING (arm swelled up all the way to my elbow) and DIARRHOEA (I had diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LORATADINE, AMLODIPINE, BUSPIRONE, XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE REACTION (I had the Moderna arm) and PERIPHERAL SWELLING (arm swelled up all the way to my elbow). On 26-Mar-2021, the patient experienced DIARRHOEA (I had diarrhea). On 29-Mar-2021, PERIPHERAL SWELLING (arm swelled up all the way to my elbow) had resolved. At the time of the report, VACCINATION SITE REACTION (I had the Moderna arm) was resolving and DIARRHOEA (I had diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used ice, cortisone cream and Benadryl for the treatment.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: on going lightheadedness; on going headache; on going fatigue; ongoing slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (on going lightheadedness), HEADACHE (on going headache), FATIGUE (on going fatigue) and NAUSEA (ongoing slight nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (on going lightheadedness), HEADACHE (on going headache), FATIGUE (on going fatigue) and NAUSEA (ongoing slight nausea). At the time of the report, DIZZINESS (on going lightheadedness), HEADACHE (on going headache), FATIGUE (on going fatigue) and NAUSEA (ongoing slight nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pain, Taste disorder, Teething
Clinical narrative: teeth were hurting; metallic taste came in my mouth; Felt like I had a been sting in my arm; sore arm; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of TEETHING (teeth were hurting), TASTE DISORDER (metallic taste came in my mouth), LIMB DISCOMFORT (Felt like I had a been sting in my arm), PAIN (sore arm) and HEADACHE (severe headache) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D/O31MZ0A and 0/Q25A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TEETHING (teeth were hurting), TASTE DISORDER (metallic taste came in my mouth), LIMB DISCOMFORT (Felt like I had a been sting in my arm), PAIN (sore arm) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TEETHING (teeth were hurting), TASTE DISORDER (metallic taste came in my mouth), LIMB DISCOMFORT (Felt like I had a been sting in my arm), PAIN (sore arm) and HEADACHE (severe headache) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: inflammation and redness at the injection site; redness at the injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation and redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation and redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 25-Mar-2021, VACCINATION SITE INFLAMMATION (inflammation and redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       On 19 -Mar-2021, the inflammation and redness became significant enough that the patient went to the  clinic for medical attention. The patient was prescribed steroids and sent back home. The physician also recommended her not to take the second dose.  No relevant concomitant medications were reported.  Treatment included steroids where prescribed to treat the vaccine site reaction.