chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Myalgia
Clinical narrative: flu-like symptoms, I thought I had a touch of the flu.; A week later I started having severe pains in my calves, hips, shoulder, neck and back.; body aches, I never had a fever, but I was so achy, I couldn't believe how intense the pain was.; slight headache that day but it was gone the next day; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms, I thought I had a touch of the flu.), HEADACHE (slight headache that day but it was gone the next day), ARTHRALGIA (A week later I started having severe pains in my calves, hips, shoulder, neck and back.) and MYALGIA (body aches, I never had a fever, but I was so achy, I couldn't believe how intense the pain was.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (slight headache that day but it was gone the next day). On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms, I thought I had a touch of the flu.), ARTHRALGIA (A week later I started having severe pains in my calves, hips, shoulder, neck and back.) and MYALGIA (body aches, I never had a fever, but I was so achy, I couldn't believe how intense the pain was.). On 28-Feb-2021, HEADACHE (slight headache that day but it was gone the next day) had resolved. On 13-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms, I thought I had a touch of the flu.), ARTHRALGIA (A week later I started having severe pains in my calves, hips, shoulder, neck and back.) and MYALGIA (body aches, I never had a fever, but I was so achy, I couldn't believe how intense the pain was.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication details were provided.   This case was linked to MOD-2021-085486 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site induration, Vaccination site pain
Clinical narrative: Hard and had a bruise at the injection site; Hard and had a bruise at the injection site; Arm hurt; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021. The most recent information was received on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Hard and had a bruise at the injection site), VACCINATION SITE INDURATION (Hard and had a bruise at the injection site) and VACCINATION SITE PAIN (Arm hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Hard and had a bruise at the injection site), VACCINATION SITE INDURATION (Hard and had a bruise at the injection site) and VACCINATION SITE PAIN (Arm hurt). At the time of the report, VACCINATION SITE BRUISING (Hard and had a bruise at the injection site), VACCINATION SITE INDURATION (Hard and had a bruise at the injection site) and VACCINATION SITE PAIN (Arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up information received included outcome of the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gingival discomfort, Gingival oedema, Gingival pruritus, Headache
Clinical narrative: gums got really swollen; gums got itchy; gums felt like burning; Fatigue, tired; Headache; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at the injection site). On 21-Apr-2021, GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications was reported. No treatment medications specified.  Treatment information was not provided.   This case was linked to MOD21-080267 (E2B Linked Report).; Sender's Comments:  MOD21-080267:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: gums got really swollen; gums got itchy; gums felt like burning; Fatigue, tired; Headache; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at the injection site). On 21-Apr-2021, GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications was reported. No treatment medications specified.  Treatment information was not provided.   This case was linked to MOD21-080267 (E2B Linked Report).; Sender's Comments:  MOD21-080267:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: Received 2nd dose of Pfizer vaccine; sore arm after first dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose of Moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 2nd dose of Pfizer vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MARIJUANA for Muscle spasms, GLATIRAMER ACETATE (COPAXONE), TROSPIUM CHLORIDE, SERTRALINE, CLONAZEPAM, VITAMIN D NOS and LATANOPROST for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose of Moderna vaccine). On 08-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received 2nd dose of Pfizer vaccine). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose of Moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Received 2nd dose of Pfizer vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She was on a drug for multiple sclerosis.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS. At the time of the report, INFLUENZA LIKE ILLNESS outcome was unknown. Not Provided.          Concomitant medications included blood pressure medicine.  Treatment information included Tylenol.   This case was linked to MOD-2021-085406.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever; nausea; Achiness,so much pain; Whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (nausea), PAIN (Achiness,so much pain) and MYALGIA (Whole body hurts) 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 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever), NAUSEA (nausea), PAIN (Achiness,so much pain) and MYALGIA (Whole body hurts). At the time of the report, PYREXIA (Fever), NAUSEA (nausea), PAIN (Achiness,so much pain) and MYALGIA (Whole body hurts) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Urticaria
Clinical narrative: Hives on the thigh/still having hives every night; Feeling warm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on the thigh/still having hives every night), FEELING HOT (Feeling warm) and PAIN IN EXTREMITY (Sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced URTICARIA (Hives on the thigh/still having hives every night), FEELING HOT (Feeling warm) and PAIN IN EXTREMITY (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on the thigh/still having hives every night), FEELING HOT (Feeling warm) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Initial Additional-1 : Pictures of AE event and updated verbatim for event hives
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site rash
Clinical narrative: Swollen lymph nodes in both arm pits; large rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in both arm pits) and VACCINATION SITE RASH (large rash around the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in both arm pits) and VACCINATION SITE RASH (large rash around the injection site). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in both arm pits) outcome was unknown and VACCINATION SITE RASH (large rash around the injection site) had not 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.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspepsia, Epistaxis, Fatigue
Clinical narrative: Heartburn for 2 days; Nose bleed for 3 days; Dizziness; feet is swollen no matter she does; Neck hurt; Extremely tired; Light headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn for 2 days), EPISTAXIS (Nose bleed for 3 days), DIZZINESS (Dizziness), PERIPHERAL SWELLING (feet is swollen no matter she does) and NECK PAIN (Neck hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Bee sting and Drug allergy.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heartburn for 2 days), EPISTAXIS (Nose bleed for 3 days), DIZZINESS (Dizziness), PERIPHERAL SWELLING (feet is swollen no matter she does), NECK PAIN (Neck hurt), FATIGUE (Extremely tired), HEADACHE (Light headache) and ARTHRALGIA (Joint pain). On 15-Apr-2021, DYSPEPSIA (Heartburn for 2 days), EPISTAXIS (Nose bleed for 3 days), DIZZINESS (Dizziness), PERIPHERAL SWELLING (feet is swollen no matter she does) and ARTHRALGIA (Joint pain) had resolved, NECK PAIN (Neck hurt) had not resolved. At the time of the report, FATIGUE (Extremely tired) had not resolved and HEADACHE (Light headache) was resolving.        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 was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Peripheral swelling
Clinical narrative: Heartburn for 2 days; Nose bleed for 3 days; Dizziness; feet is swollen no matter she does; Neck hurt; Extremely tired; Light headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn for 2 days), EPISTAXIS (Nose bleed for 3 days), DIZZINESS (Dizziness), PERIPHERAL SWELLING (feet is swollen no matter she does) and NECK PAIN (Neck hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Bee sting and Drug allergy.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heartburn for 2 days), EPISTAXIS (Nose bleed for 3 days), DIZZINESS (Dizziness), PERIPHERAL SWELLING (feet is swollen no matter she does), NECK PAIN (Neck hurt), FATIGUE (Extremely tired), HEADACHE (Light headache) and ARTHRALGIA (Joint pain). On 15-Apr-2021, DYSPEPSIA (Heartburn for 2 days), EPISTAXIS (Nose bleed for 3 days), DIZZINESS (Dizziness), PERIPHERAL SWELLING (feet is swollen no matter she does) and ARTHRALGIA (Joint pain) had resolved, NECK PAIN (Neck hurt) had not resolved. At the time of the report, FATIGUE (Extremely tired) had not resolved and HEADACHE (Light headache) was resolving.        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 was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contains no new information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, SARS-CoV-2 test positive
Clinical narrative: More than 36 days have passed since first dose given; tested positive for Covid Infection; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid Infection) and INCORRECT DOSE ADMINISTERED (More than 36 days have passed since first dose given) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid Infection). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (More than 36 days have passed since first dose given). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid Infection) outcome was unknown and INCORRECT DOSE ADMINISTERED (More than 36 days have passed since first dose given) 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.   Relevant concomitant medications were not reported.  Treatment medication was not provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Lethargic for 8 hours; Headache; felt tiredness; Low grade temperature; Muscle and joint pain; Muscle and joint pain; Chills on and off; This spontaneous case was reported by a pharmacist and describes the occurrence of LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature) and MYALGIA (Muscle and joint pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to excipient.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature), MYALGIA (Muscle and joint pain), ARTHRALGIA (Muscle and joint pain) and CHILLS (Chills on and off). At the time of the report, LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature), MYALGIA (Muscle and joint pain), ARTHRALGIA (Muscle and joint pain) and CHILLS (Chills on and off) 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 reported.  No treatment medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Lethargic for 8 hours; Headache; felt tiredness; Low grade temperature; Muscle and joint pain; Muscle and joint pain; Chills on and off; This spontaneous case was reported by a pharmacist and describes the occurrence of LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature) and MYALGIA (Muscle and joint pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to excipient.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature), MYALGIA (Muscle and joint pain), ARTHRALGIA (Muscle and joint pain) and CHILLS (Chills on and off). At the time of the report, LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature), MYALGIA (Muscle and joint pain), ARTHRALGIA (Muscle and joint pain) and CHILLS (Chills on and off) 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 reported.  No treatment medications were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Tenderness, Vaccination site discolouration, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose) and VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-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 TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose), VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose), VACCINATION SITE SWELLING (Injection site swollen after 1st dose) and VACCINATION SITE PAIN (Injection site tender after 1st dose). At the time of the report, TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose), VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose), VACCINATION SITE SWELLING (Injection site swollen after 1st dose) and VACCINATION SITE PAIN (Injection site tender after 1st dose) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information not provided. List of concomitant medication were not given.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose) and VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-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 TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose), VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose), VACCINATION SITE SWELLING (Injection site swollen after 1st dose) and VACCINATION SITE PAIN (Injection site tender after 1st dose). At the time of the report, TENDERNESS (Arm tender to the touch after 1st dose), PAIN (Pain after 1st dose), DYSGEUSIA (Started tasting metal about 20 minutes after 1st dose), VACCINATION SITE INDURATION (Hardening at injection site after 1st dose), VACCINATION SITE DISCOLOURATION (Injection site slightly pink after 1st dose), VACCINATION SITE SWELLING (Injection site swollen after 1st dose) and VACCINATION SITE PAIN (Injection site tender after 1st dose) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information not provided. List of concomitant medication were not given.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: left hand is totally swollen; left hand is in pain; left hand is warm; If she presses her palm she feels it, like it's hard; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (left hand is totally swollen), PAIN IN EXTREMITY (left hand is in pain), FEELING HOT (left hand is warm) and INDURATION (If she presses her palm she feels it, like it's hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), PANTOPRAZOLE and VITAMINS NOS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PERIPHERAL SWELLING (left hand is totally swollen), PAIN IN EXTREMITY (left hand is in pain), FEELING HOT (left hand is warm) and INDURATION (If she presses her palm she feels it, like it's hard). At the time of the report, PERIPHERAL SWELLING (left hand is totally swollen), PAIN IN EXTREMITY (left hand is in pain), FEELING HOT (left hand is warm) and INDURATION (If she presses her palm she feels it, like it's hard) had not resolved.            No treatment medication was provided.   This case was linked to MOD-2021-073900 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some soreness in arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Some soreness in arm). At the time of the report, VACCINATION SITE PAIN (Some soreness in arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-085479 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test positive
Clinical narrative: Allergy symptoms; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy symptoms) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 07-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergy symptoms) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, HYPERSENSITIVITY (Allergy symptoms) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test positive: (Positive) test result was positive ,outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Severe tinnitus) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced TINNITUS (Severe tinnitus). At the time of the report, TINNITUS (Severe tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in the mouth) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in the mouth). At the time of the report, DYSGEUSIA (Metallic taste in the mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: warmth and hotness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmth and hotness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced INJECTION SITE WARMTH (warmth and hotness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE WARMTH (warmth and hotness at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown. 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 are provided. treatment to the events not provided. The patient stated that he will call the vaccination provider in 24 hours if it does not resolve, but does not have a primary care provider since his normal provider retired six months ago.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: fever of 38 degrees Celsius; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever of 38 degrees Celsius) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Apr-2021, the patient experienced PYREXIA (fever of 38 degrees Celsius). On 22-Apr-2021, NAUSEA (nausea) had resolved. At the time of the report, HEADACHE (headache) and PYREXIA (fever of 38 degrees Celsius) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up received on 24-MAY-2021, no new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Oropharyngeal pain, Secretion discharge
Clinical narrative: stuffy sinuses; sore throat; mucous in the throat; dizziness; nausea; fatigue; pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Thyroid disorder, Gastro-intestinal disorder NOS, Hair loss and Bipolar disorder. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), LAMOTRIGINE (LAMICTAL) and ARIPIPRAZOLE (ABILIFY) for Bipolar disorder, DEXLANSOPRAZOLE (DEXILANT) for Gastro-intestinal disorder NOS, FINASTERIDE (PROPECIA) for Hair loss.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection arm). At the time of the report, SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection arm) outcome was unknown. 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.   Concomitant medication also included thyroid medication. No treatment was received by the patient for the symptoms developed.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vaccination site pain
Clinical narrative: stuffy sinuses; sore throat; mucous in the throat; dizziness; nausea; fatigue; pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Thyroid disorder, Gastro-intestinal disorder NOS, Hair loss and Bipolar disorder. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), LAMOTRIGINE (LAMICTAL) and ARIPIPRAZOLE (ABILIFY) for Bipolar disorder, DEXLANSOPRAZOLE (DEXILANT) for Gastro-intestinal disorder NOS, FINASTERIDE (PROPECIA) for Hair loss.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection arm). At the time of the report, SINUSITIS (stuffy sinuses), OROPHARYNGEAL PAIN (sore throat), SECRETION DISCHARGE (mucous in the throat), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection arm) outcome was unknown. 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.   Concomitant medication also included thyroid medication. No treatment was received by the patient for the symptoms developed.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Decreased appetite, Hypersomnia
Clinical narrative: Slept a lot; wasn't able to each much; fever seems to come and go; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), DECREASED APPETITE (wasn't able to each much), PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced HYPERSOMNIA (Slept a lot), DECREASED APPETITE (wasn't able to each much), PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Joint ache, at an unspecified dose and frequency. On 23-Apr-2021, PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, HYPERSOMNIA (Slept a lot) and DECREASED APPETITE (wasn't able to each much) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2020, Body temperature: 100.7 f (High) high. On 20-Mar-2020, COVID-19: positive (Positive) Type of test nasal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: non significant follow up received on 23-MAY-2021 contains NNI On 24-May-2021: Significant follow up received om 24-MAY-2021, patient demographic details updated, dosage information was updated, events was updated, lab data was updated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Slept a lot; wasn't able to each much; fever seems to come and go; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), DECREASED APPETITE (wasn't able to each much), PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced HYPERSOMNIA (Slept a lot), DECREASED APPETITE (wasn't able to each much), PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Joint ache, at an unspecified dose and frequency. On 23-Apr-2021, PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, HYPERSOMNIA (Slept a lot) and DECREASED APPETITE (wasn't able to each much) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2020, Body temperature: 100.7 f (High) high. On 20-Mar-2020, COVID-19: positive (Positive) Type of test nasal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: non significant follow up received on 23-MAY-2021 contains NNI On 24-May-2021: Significant follow up received om 24-MAY-2021, patient demographic details updated, dosage information was updated, events was updated, lab data was updated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ABIRATERONE ACETATE (ZYTIGA) and PREDNISONE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 22-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site irritation, Injection site oedema, Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: COVID arm; 2 inches in diameter hard area; a little bit itchy rash; rash that is 4 to 5 inches in diameter red blotchy area; a little bit painful; felt like a pin was constantly being stick in and out; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (COVID arm), INJECTION SITE OEDEMA (2 inches in diameter hard area), INJECTION SITE RASH (a little bit itchy rash), RASH (rash that is 4 to 5 inches in diameter red blotchy area) and INJECTION SITE PAIN (a little bit painful) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (NASONEX) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (COVID arm), INJECTION SITE OEDEMA (2 inches in diameter hard area), INJECTION SITE RASH (a little bit itchy rash), RASH (rash that is 4 to 5 inches in diameter red blotchy area), INJECTION SITE PAIN (a little bit painful) and INJECTION SITE IRRITATION (felt like a pin was constantly being stick in and out). At the time of the report, PAIN IN EXTREMITY (COVID arm), INJECTION SITE OEDEMA (2 inches in diameter hard area), INJECTION SITE RASH (a little bit itchy rash), RASH (rash that is 4 to 5 inches in diameter red blotchy area), INJECTION SITE PAIN (a little bit painful) and INJECTION SITE IRRITATION (felt like a pin was constantly being stick in and out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: COVID arm; 2 inches in diameter hard area; a little bit itchy rash; rash that is 4 to 5 inches in diameter red blotchy area; a little bit painful; felt like a pin was constantly being stick in and out; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (COVID arm), INJECTION SITE OEDEMA (2 inches in diameter hard area), INJECTION SITE RASH (a little bit itchy rash), RASH (rash that is 4 to 5 inches in diameter red blotchy area) and INJECTION SITE PAIN (a little bit painful) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (NASONEX) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (COVID arm), INJECTION SITE OEDEMA (2 inches in diameter hard area), INJECTION SITE RASH (a little bit itchy rash), RASH (rash that is 4 to 5 inches in diameter red blotchy area), INJECTION SITE PAIN (a little bit painful) and INJECTION SITE IRRITATION (felt like a pin was constantly being stick in and out). At the time of the report, PAIN IN EXTREMITY (COVID arm), INJECTION SITE OEDEMA (2 inches in diameter hard area), INJECTION SITE RASH (a little bit itchy rash), RASH (rash that is 4 to 5 inches in diameter red blotchy area), INJECTION SITE PAIN (a little bit painful) and INJECTION SITE IRRITATION (felt like a pin was constantly being stick in and out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown