chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thyroid disorder
Clinical narrative: Hyperthyroid symptoms; Intense pain in feet; racing heartbeat; Intense pain in abdomen; Intense brain fog; Anxious; felt like she was having a period; lymph nodes are swollen and inflamed; Fever of 101.6 degrees; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THYROID DISORDER (Hyperthyroid symptoms), PAIN IN EXTREMITY (Intense pain in feet), PALPITATIONS (racing heartbeat), ABDOMINAL PAIN (Intense pain in abdomen) and FEELING ABNORMAL (Intense brain fog) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 THYROID DISORDER (Hyperthyroid symptoms), PAIN IN EXTREMITY (Intense pain in feet), PALPITATIONS (racing heartbeat), ABDOMINAL PAIN (Intense pain in abdomen), FEELING ABNORMAL (Intense brain fog), ANXIETY (Anxious), DYSMENORRHOEA (felt like she was having a period), LYMPHADENOPATHY (lymph nodes are swollen and inflamed), PYREXIA (Fever of 101.6 degrees) and NAUSEA (nausea). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at a dose of UNK dosage form. On 01-Mar-2021, PYREXIA (Fever of 101.6 degrees) had resolved. At the time of the report, THYROID DISORDER (Hyperthyroid symptoms), PAIN IN EXTREMITY (Intense pain in feet), PALPITATIONS (racing heartbeat), FEELING ABNORMAL (Intense brain fog) and LYMPHADENOPATHY (lymph nodes are swollen and inflamed) had not resolved and ABDOMINAL PAIN (Intense pain in abdomen), ANXIETY (Anxious), DYSMENORRHOEA (felt like she was having a period) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood thyroid stimulating hormone: elevated (High) Elevated. On 27-Feb-2021, Body temperature: 101.6 (High) 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's additional treatment medication included unspecified anti-inflammatory medication as per her physician's advise, but that did not help with her pain. The patient's second dose was scheduled for 27-Mar-2021.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (a metallic taste in my mouth) 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 (No medical history was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (a metallic taste in my mouth). At the time of the report, DYSGEUSIA (a metallic taste in my mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the event was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nasopharyngitis, Pain
Clinical narrative: cold,; body aches; really sick,; Warmth and hardness at the injection site.; Warmth and hardness at the injection site.; experienced chills; fever,; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.) and VACCINATION SITE INDURATION (Warmth and hardness at the injection site.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.), VACCINATION SITE INDURATION (Warmth and hardness at the injection site.), CHILLS (experienced chills), PYREXIA (fever,) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.), VACCINATION SITE INDURATION (Warmth and hardness at the injection site.), CHILLS (experienced chills), PYREXIA (fever,) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.   This case was linked to NO-MODERNATX, INC.-MOD-2021-060168 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021. No new information added.; Sender's Comments:  NO-MODERNATX, INC.-MOD-2021-060168:cross link
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration, Vaccination site warmth
Clinical narrative: cold,; body aches; really sick,; Warmth and hardness at the injection site.; Warmth and hardness at the injection site.; experienced chills; fever,; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.) and VACCINATION SITE INDURATION (Warmth and hardness at the injection site.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.), VACCINATION SITE INDURATION (Warmth and hardness at the injection site.), CHILLS (experienced chills), PYREXIA (fever,) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.), VACCINATION SITE INDURATION (Warmth and hardness at the injection site.), CHILLS (experienced chills), PYREXIA (fever,) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.   This case was linked to NO-MODERNATX, INC.-MOD-2021-060168 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021. No new information added.; Sender's Comments:  NO-MODERNATX, INC.-MOD-2021-060168:cross link
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; broke out in a rash all over body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy) and RASH (broke out in a rash all over body) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and RASH (broke out in a rash all over body). At the time of the report, PRURITUS (Itchy) and RASH (broke out in a rash all over body) outcome was unknown.            Concomitant medication and treatment information were not reported.  The patient reported that after about a week and half from the second Moderna vaccine the patient had broke out in a rash all of body and was very itchy.  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Oral herpes, Pain in extremity
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (his hand was hurting/ arm pain), ORAL HERPES (woke up with fever blisters on his mouth today), ERYTHEMA (His arm is still sore and red) and HEADACHE (headache. Headache felt like his brain was exploding) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037AA21B) for COVID-19 vaccination.  No medical history was provided by reporter. Concomitant products included CARBAMAZEPINE, LEVETIRACETAM (KEPPRA), PRAVASTATIN, FISH OIL and VITAMIN B [VITAMIN B NOS] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (his hand was hurting/ arm pain) and ERYTHEMA (His arm is still sore and red). On 21-Mar-2021, the patient experienced HEADACHE (headache. Headache felt like his brain was exploding). On 22-Mar-2021, the patient experienced ORAL HERPES (woke up with fever blisters on his mouth today). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (his hand was hurting/ arm pain), ORAL HERPES (woke up with fever blisters on his mouth today), ERYTHEMA (His arm is still sore and red) and HEADACHE (headache. Headache felt like his brain was exploding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Fatigue, Illness
Clinical narrative: Woke up sick; Couldn't sleep; Mouth and lips were very dry; Mouth and lips were very dry; Cold chills; Nausea; Really bad fatigue; Joint hurting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Woke up sick), INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry) and CHILLS (Cold chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METFORMIN, GLIPIZIDE, LIRAGLUTIDE (VICTOZA), LOSARTAN, FELODIPINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) 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. In March 2021, the patient experienced INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry), CHILLS (Cold chills), NAUSEA (Nausea), FATIGUE (Really bad fatigue) and ARTHRALGIA (Joint hurting). On 18-Mar-2021, the patient experienced ILLNESS (Woke up sick). At the time of the report, ILLNESS (Woke up sick), INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry), CHILLS (Cold chills), NAUSEA (Nausea), FATIGUE (Really bad fatigue) and ARTHRALGIA (Joint hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information reported included ibuprofen.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lip dry, Nausea
Clinical narrative: Woke up sick; Couldn't sleep; Mouth and lips were very dry; Mouth and lips were very dry; Cold chills; Nausea; Really bad fatigue; Joint hurting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Woke up sick), INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry) and CHILLS (Cold chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METFORMIN, GLIPIZIDE, LIRAGLUTIDE (VICTOZA), LOSARTAN, FELODIPINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) 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. In March 2021, the patient experienced INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry), CHILLS (Cold chills), NAUSEA (Nausea), FATIGUE (Really bad fatigue) and ARTHRALGIA (Joint hurting). On 18-Mar-2021, the patient experienced ILLNESS (Woke up sick). At the time of the report, ILLNESS (Woke up sick), INSOMNIA (Couldn't sleep), DRY MOUTH (Mouth and lips were very dry), LIP DRY (Mouth and lips were very dry), CHILLS (Cold chills), NAUSEA (Nausea), FATIGUE (Really bad fatigue) and ARTHRALGIA (Joint hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information reported included ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria, Vaccination site pain
Clinical narrative: Hives on her neck and face on the same side as the injection arm.; Sore arm; Injection site pain; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives on her neck and face on the same side as the injection arm.), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Injection site pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on her neck and face on the same side as the injection arm.), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on her neck and face on the same side as the injection arm.), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Injection site pain) 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 concomitant medications were reported. Treatment for the events included benadryl.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Somnolence
Clinical narrative: Slept quite a bit and very good last night; Fatigue comes in waves; Pain in her arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept quite a bit and very good last night), PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Slight headache) and FATIGUE (Fatigue comes in waves) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder and Epilepsy. Concomitant products included VITAMINS NOS, CARBAMAZEPINE and LEVETIRACETAM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Slight headache). On 21-Mar-2021, the patient experienced SOMNOLENCE (Slept quite a bit and very good last night) and FATIGUE (Fatigue comes in waves). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept quite a bit and very good last night), PAIN IN EXTREMITY (Pain in her arm), HEADACHE (Slight headache) and FATIGUE (Fatigue comes in waves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received on 06 Jul 2021 contains Non significant information
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: menstrual period did not come; A spontaneous report was received from a healthcare professional concerning a 46-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events spotting: menstrual period, heaviness: menstrual period, menstrual period did not come.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) spotting: menstrual period, heaviness: menstrual period. On 22 Jan 2021, the patient experienced the event(s) menstrual period did not come.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), spotting: menstrual period, heaviness: menstrual period, menstrual period did not come was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the first shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Emphysema, Artificial cardiac pacemaker user (pacemaker) and Heart attack.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after the first shot). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm after the first shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-054934 (E2B Linked Report).; Sender's Comments:  MOD-2021-054934:2nd dose of Vaccine
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Eyes were burning; Fever; Headaches; Swelling at injection site; Redness on arm; This spontaneous case was reported by a patient and describes the occurrence of EYE IRRITATION (Eyes were burning), PYREXIA (Fever), HEADACHE (Headaches), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness on arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced EYE IRRITATION (Eyes were burning), PYREXIA (Fever), HEADACHE (Headaches), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness on arm). On 18-Mar-2021, EYE IRRITATION (Eyes were burning), PYREXIA (Fever) and HEADACHE (Headaches) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in her upper right arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in her upper right arm at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 037K0A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in her upper right arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (pain in her upper right arm at the injection site) outcome was unknown.            Concomitant medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid after first dose) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid after first dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: arm sore; left non-dominate arm was itchy; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PRURITUS (left non-dominate arm was itchy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Balance disorder (Condition gotten better prior to vaccine.) since October 2020 and Dizziness (Condition gotten better prior to vaccine.) since October 2020. Concomitant products included INSULIN for Diabetes, MECLIZINE HCL, TOPIRAMATE and ONDANSETRON for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PRURITUS (left non-dominate arm was itchy). On 21-Feb-2021, PAIN IN EXTREMITY (arm sore) and VACCINATION SITE PRURITUS (left non-dominate arm was itchy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-054916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054916:patient link 2nd dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Rash, SARS-CoV-2 test, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04EAQ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 13-Mar-2021. Concomitant products included METFORMIN and ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) 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. In March 2021, the patient experienced RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: unknown (Positive) Positive. 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. Other medications include birth control. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021 contains non-significant information.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04EAQ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 13-Mar-2021. Concomitant products included METFORMIN and ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) 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. In March 2021, the patient experienced RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: unknown (Positive) Positive. 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. Other medications include birth control. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021 contains non-significant information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Cold sweat, Dizziness, Dysphagia
Clinical narrative: cold sweats; hot and cold flashes; dizziness worse; Patient has no balance; cannot hold solid foods down; headache; nausea; vomiting; cold flash; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance) and DYSPHAGIA (cannot hold solid foods down) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Balance disorder since October 2020 and Dizziness in October 2020. Concomitant products included INSULIN for Diabetes, MECLIZINE HCL, TOPIRAMATE and ONDANSETRON for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance), DYSPHAGIA (cannot hold solid foods down), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (cold flash). At the time of the report, COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance), DYSPHAGIA (cannot hold solid foods down), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (cold flash) outcome was unknown.            Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-054907 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054907:crosslink
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Vomiting
Clinical narrative: cold sweats; hot and cold flashes; dizziness worse; Patient has no balance; cannot hold solid foods down; headache; nausea; vomiting; cold flash; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance) and DYSPHAGIA (cannot hold solid foods down) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Balance disorder since October 2020 and Dizziness in October 2020. Concomitant products included INSULIN for Diabetes, MECLIZINE HCL, TOPIRAMATE and ONDANSETRON for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance), DYSPHAGIA (cannot hold solid foods down), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (cold flash). At the time of the report, COLD SWEAT (cold sweats), HOT FLUSH (hot and cold flashes), DIZZINESS (dizziness worse), BALANCE DISORDER (Patient has no balance), DYSPHAGIA (cannot hold solid foods down), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (cold flash) outcome was unknown.            Treatment information was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-054907 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054907:crosslink
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 11-Mar-2021, VACCINATION SITE PAIN (Sore arm at injection site) had resolved. Not Provided          No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was Not Applicable.  No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-048160 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048160:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, and CHROMATURIA in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression. Concomitant products included LIPITOR for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, CHROMATURIA, HEADACHE, and FATIGUE. The patient was treated with BENADRYL at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PREDNISONE at a dose of 20 mg. At the time of the report, DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, CHROMATURIA, HEADACHE, and FATIGUE 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 medications also included unspecified depression pills for depression.   This case was linked to US-MODERNATX, INC.-MOD-2021-054781. Sender's Comments:  US-MODERNATX, INC MOD-2021-054781: Same reporter; Primary reporter case.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, and CHROMATURIA in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression. Concomitant products included LIPITOR for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, CHROMATURIA, HEADACHE, and FATIGUE. The patient was treated with BENADRYL at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PREDNISONE at a dose of 20 mg. At the time of the report, DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, CHROMATURIA, HEADACHE, and FATIGUE 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 medications also included unspecified depression pills for depression.   This case was linked to US-MODERNATX, INC.-MOD-2021-054781. Sender's Comments:  US-MODERNATX, INC MOD-2021-054781: Same reporter; Primary reporter case.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore but was very minor; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore but was very minor) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore but was very minor). On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore but was very minor) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-054966 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up received contains No New Information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Myalgia
Clinical narrative: difficulty breathing; felt light headed; muscles ached; fatigue/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS (felt light headed), MYALGIA (muscles ached) and FATIGUE (fatigue/exhaustion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Emphysema, Heart attack and Artificial cardiac pacemaker user (pace maker).   On 16-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) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (felt light headed), MYALGIA (muscles ached) and FATIGUE (fatigue/exhaustion). The patient was treated with OXYGEN for Difficulty breathing, at an unspecified dose and frequency. On 19-Mar-2021, DYSPNOEA (difficulty breathing), DIZZINESS (felt light headed), MYALGIA (muscles ached) and FATIGUE (fatigue/exhaustion) had resolved. Not Provided          No concomitant medications were given  It was reported that the patient was on oxygen all day but typically on 17-Mar-2021 the patient was not on oxygen. The reporter stated that all events were went away Wednesday and patient was back to normal bad breathing  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD21-060147 (E2B Linked Report).; Sender's Comments:  MOD21-060147:MOD-2021-054887- 1st dose of Vaccine
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cold sweat, Nervousness
Clinical narrative: Back ache; Cold sweats; Nervous/feels shaky; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats), NERVOUSNESS (Nervous/feels shaky) and BACK PAIN (Back ache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to Cephalexin.), Drug allergy (allergic to  verapamil.), Drug allergy (allergic to lisinopril.), Drug allergy (allergic to sulpamethurarde.), Diabetes, Sleep apnea, Pacemaker insertion (cardiac) since 29-Jun-2016, Blood pressure high and High cholesterol. Concomitant products included LOSARTAN for Blood pressure high, GLIPIZIDE for Diabetes, SIMVASTATIN for Dyslipidemia, PHENYTOIN SODIUM (PHENYTOIN SODIUM SOUTHWOOD) and PHENYTOIN (DILANTIN [PHENYTOIN]) for Seizure.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced COLD SWEAT (Cold sweats) and NERVOUSNESS (Nervous/feels shaky). On 22-Mar-2021, the patient experienced BACK PAIN (Back ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Back ache, at a dose of 1 dosage form. At the time of the report, COLD SWEAT (Cold sweats), NERVOUSNESS (Nervous/feels shaky) and BACK PAIN (Back ache) outcome was unknown. Not Provided          The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: followup document attached. ADR form attached.medical history,concomitant medication has been provided. Treatment medication added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (circle around injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (circle around injection site). At the time of the report, VACCINATION SITE REACTION (circle around injection site) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-054963 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054963:Cross linked with second dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN (Hurt), HEADACHE (Headache) and FATIGUE (Real tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), PAIN (Hurt), HEADACHE (Headache) and FATIGUE (Real tired). At the time of the report, DIZZINESS (Dizzy), PAIN (Hurt), HEADACHE (Headache) and FATIGUE (Real tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Paraesthesia, Pruritus, Rash
Clinical narrative: Itching; Skin scarred; redness; Prickling/Tingling; Burnt looking; 2 blisters with clear liquid right under injection site; sore arm; great big rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site), PARAESTHESIA (Prickling/Tingling), PAIN IN EXTREMITY (sore arm), PRURITUS (Itching) and SCAR (Skin scarred) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 0D1A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sarcoidosis since 2000, Rheumatoid arthritis since 2010, Kidney enlargement (worse-discomfort) since 2000, Diabetic since 2010 and Drug allergy (Allergy to Levaquin for Swelling and , Sulphur drugs for itching). Concomitant products included PREDNISONE and LEFLUNOMIDE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (great big rash). On 26-Feb-2021, the patient experienced VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site). On an unknown date, the patient experienced PARAESTHESIA (Prickling/Tingling), PRURITUS (Itching), SCAR (Skin scarred), ERYTHEMA (redness) and VACCINATION SITE PAIN (Burnt looking). The patient was treated with CORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 03-Mar-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site) had not resolved and PARAESTHESIA (Prickling/Tingling), PRURITUS (Itching), SCAR (Skin scarred), ERYTHEMA (redness), RASH (great big rash) and VACCINATION SITE PAIN (Burnt looking) outcome was unknown.            Concomitant products included Prednisone 6mg, Vitamin c 100mg, , Leflunomide 20mg, , Vitamin D3 100mg, CoQ10 50mg, Zinc  Treatment drug include Cortisone OTC  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Significant FU - Pictures of events attached. On 10-May-2021: Non-Significant FU-Contact info updated. On 01-Jun-2021: Significant FU - Extra events updated. On 04-Jun-2021: Non-Significant FU- NNI