chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Condition aggravated, Incorrect route of product administration, Pruritus, Vaccination site erythema
Clinical narrative: Patient believes the injection went under the skin not muscularly; Formed a knot; Feels hot, got heat in it; Got blister on skin; Increasingly worse; itching of skin; Injection site  kind of burn; Spread bigger and red; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient believes the injection went under the skin not muscularly), VACCINATION SITE MASS (Formed a knot), VACCINATION SITE WARMTH (Feels hot, got heat in it), BLISTER (Got blister on skin) and CONDITION AGGRAVATED (Increasingly worse) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included DIAZEPAM, DULOXETINE, TRAZODONE and METFORMIN for an unknown indication.    On 06-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient believes the injection went under the skin not muscularly), VACCINATION SITE MASS (Formed a knot), VACCINATION SITE WARMTH (Feels hot, got heat in it), BLISTER (Got blister on skin), CONDITION AGGRAVATED (Increasingly worse), PRURITUS (itching of skin), VACCINATION SITE PAIN (Injection site  kind of burn) and VACCINATION SITE ERYTHEMA (Spread bigger and red). On 06-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient believes the injection went under the skin not muscularly) had resolved. At the time of the report, VACCINATION SITE MASS (Formed a knot), VACCINATION SITE WARMTH (Feels hot, got heat in it), BLISTER (Got blister on skin), CONDITION AGGRAVATED (Increasingly worse), PRURITUS (itching of skin), VACCINATION SITE PAIN (Injection site  kind of burn) and VACCINATION SITE ERYTHEMA (Spread bigger and red) 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.   Concomitant medication include vitamins. No treatment medication details was reported.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021. No new information was updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient believes the injection went under the skin not muscularly; Formed a knot; Feels hot, got heat in it; Got blister on skin; Increasingly worse; itching of skin; Injection site  kind of burn; Spread bigger and red; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient believes the injection went under the skin not muscularly), VACCINATION SITE MASS (Formed a knot), VACCINATION SITE WARMTH (Feels hot, got heat in it), BLISTER (Got blister on skin) and CONDITION AGGRAVATED (Increasingly worse) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included DIAZEPAM, DULOXETINE, TRAZODONE and METFORMIN for an unknown indication.    On 06-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient believes the injection went under the skin not muscularly), VACCINATION SITE MASS (Formed a knot), VACCINATION SITE WARMTH (Feels hot, got heat in it), BLISTER (Got blister on skin), CONDITION AGGRAVATED (Increasingly worse), PRURITUS (itching of skin), VACCINATION SITE PAIN (Injection site  kind of burn) and VACCINATION SITE ERYTHEMA (Spread bigger and red). On 06-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient believes the injection went under the skin not muscularly) had resolved. At the time of the report, VACCINATION SITE MASS (Formed a knot), VACCINATION SITE WARMTH (Feels hot, got heat in it), BLISTER (Got blister on skin), CONDITION AGGRAVATED (Increasingly worse), PRURITUS (itching of skin), VACCINATION SITE PAIN (Injection site  kind of burn) and VACCINATION SITE ERYTHEMA (Spread bigger and red) 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.   Concomitant medication include vitamins. No treatment medication details was reported.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021. No new information was updated
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Tremor
Clinical narrative: shakes; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMIN & MINERAL, NALTREXONE and PREDNISONE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified cholesterol medication and eye drops.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No new information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Hypoaesthesia, Rash
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Right side of his face was numb), DIZZINESS (Dizziness), ASTHENIA (Weak all over), RASH (Rash) and HEADACHE (Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Heart valve replacement. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (Right side of his face was numb), DIZZINESS (Dizziness), ASTHENIA (Weak all over), RASH (Rash) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Right side of his face was numb), DIZZINESS (Dizziness), ASTHENIA (Weak all over), RASH (Rash) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use included blood pressure medications. No treatment details were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: face swelling up; rash all over her body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swelling up) and RASH (rash all over her body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome and Autoimmune disorder.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING FACE (face swelling up) and RASH (rash all over her body). At the time of the report, SWELLING FACE (face swelling up) and RASH (rash all over her body) was resolving.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  Treatment details included antihistamines (names not specified).  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Other relevant history in patient tab added, outcome of event changed from unknown to recovering.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Aches; Diarrhea; Headache; Fatigue; Muscle pain; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 13-Mar-2021 for Adverse event, at a dose of 500 milligram, every 5 hours. At the time of the report, PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.            No concomitant medications reported by investigator
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches; Diarrhea; Headache; Fatigue; Muscle pain; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 13-Mar-2021 for Adverse event, at a dose of 500 milligram, every 5 hours. At the time of the report, PAIN (Aches), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.            No concomitant medications reported by investigator
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Product dose omission issue, Vaccination site mass
Clinical narrative: Passed 37 days mark for second dose/didn't get the second dose yet; Really big knot at the side of the injection; Nausea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed 37 days mark for second dose/didn't get the second dose yet), VACCINATION SITE MASS (Really big knot at the side of the injection), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE MASS (Really big knot at the side of the injection), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed 37 days mark for second dose/didn't get the second dose yet). On 08-Jan-2021, NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had resolved. On 15-Jan-2021, VACCINATION SITE MASS (Really big knot at the side of the injection) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed 37 days mark for second dose/didn't get the second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Vaccination site mass, nausea, chills, headache, a causal relationship cannot be excluded.  This report also refers to a case of product dose omission issue for mRNA-1273, lot # unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: left side of face numb, and left eye; left side of face numb, and left eye; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left side of face numb, and left eye) and HYPOAESTHESIA EYE (left side of face numb, and left eye) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (left side of face numb, and left eye) and HYPOAESTHESIA EYE (left side of face numb, and left eye). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA (left side of face numb, and left eye) and HYPOAESTHESIA EYE (left side of face numb, and left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received first dose of Vaccine on January 24th (About 50 days ago) and has not received; A Spontaneous report was received from a health care professional, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and has not received the second dose.  The patients medical history was not provided. Concomitant product was not provided by reporter.  On 24-JAN-2021, the patient received their first dose of two planned doses of mRNA-1273(lot number unknown) via unknown route for COVID-19 infection prophylaxis and is yet to receive second dose. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was Unknown.  The outcome of the event, Inappropriate schedule of drug was resolved at the time of the report.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #  unknown  with no associated Adverse Events.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: stuff neck; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stuff neck), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stuff neck), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (stuff neck), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not apllicable  No concomitant or treatment information was reported.   This case was linked to MOD-2021-046335, MOD-2021-110283.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Little dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little dizziness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (Little dizziness). At the time of the report, DIZZINESS (Little dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment information not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm Pain; Headache; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 14-Mar-2021, PAIN IN EXTREMITY (Arm Pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Pruritus
Clinical narrative: itching in back; few hives/hives between knuckles; swamped in sweat during night; whole body was in pain; could not get out of bed; headache between neck and head; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in back), URTICARIA (few hives/hives between knuckles), HYPERHIDROSIS (swamped in sweat during night), MYALGIA (whole body was in pain) and FATIGUE (could not get out of bed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010421A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN D3, CYANOCOBALAMIN (B-12) and VITAMIN E [VITAMIN E NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching in back), URTICARIA (few hives/hives between knuckles), HYPERHIDROSIS (swamped in sweat during night), MYALGIA (whole body was in pain), FATIGUE (could not get out of bed) and HEADACHE (headache between neck and head). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching in back), URTICARIA (few hives/hives between knuckles), HYPERHIDROSIS (swamped in sweat during night), MYALGIA (whole body was in pain) and FATIGUE (could not get out of bed) had resolved and HEADACHE (headache between neck and head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itching in back; few hives/hives between knuckles; swamped in sweat during night; whole body was in pain; could not get out of bed; headache between neck and head; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in back), URTICARIA (few hives/hives between knuckles), HYPERHIDROSIS (swamped in sweat during night), MYALGIA (whole body was in pain) and FATIGUE (could not get out of bed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010421A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN D3, CYANOCOBALAMIN (B-12) and VITAMIN E [VITAMIN E NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching in back), URTICARIA (few hives/hives between knuckles), HYPERHIDROSIS (swamped in sweat during night), MYALGIA (whole body was in pain), FATIGUE (could not get out of bed) and HEADACHE (headache between neck and head). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching in back), URTICARIA (few hives/hives between knuckles), HYPERHIDROSIS (swamped in sweat during night), MYALGIA (whole body was in pain) and FATIGUE (could not get out of bed) had resolved and HEADACHE (headache between neck and head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 03-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 105 f (High) 105 F.     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 and treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rotator cuff syndrome, Vaccination site rash
Clinical narrative: dropped her coffee cup, so she thought she had torn her rotator cuff; rash on the vaccination arm with the size of an apple; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ROTATOR CUFF SYNDROME (dropped her coffee cup, so she thought she had torn her rotator cuff), VACCINATION SITE RASH (rash on the vaccination arm with the size of an apple) and FATIGUE (tired) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included CHLOPHEDIANOL HCL, ATORVASTATIN, PROBIOTICS NOS, LISINOPRIL and METOPROLOL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (tired). On 08-Mar-2021, the patient experienced ROTATOR CUFF SYNDROME (dropped her coffee cup, so she thought she had torn her rotator cuff) and VACCINATION SITE RASH (rash on the vaccination arm with the size of an apple). On 07-Mar-2021, FATIGUE (tired) had resolved. At the time of the report, ROTATOR CUFF SYNDROME (dropped her coffee cup, so she thought she had torn her rotator cuff) and VACCINATION SITE RASH (rash on the vaccination arm with the size of an apple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Patient got the first dose of the vaccine on 4Mar2021. She was tired over the weekend. On 8Mar2021 she noticed a rash on the vaccination arm with the size of an apple. Also, she dropped her coffee cup, so she thought she had torn her rotator cuff. She went to the doctor and the PA send her to get an MRI.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow Up received on 06-MAY-2021 Contains Non Significant Information
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-) 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 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-). At the time of the report, COVID-19 (Received 2 doses of the Moderna Vaccine and more than 2 weeks later tested positive with Covid-) outcome was unknown. Not Provided          No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-046434, US-MODERNATX, INC.-MOD-2021-046649 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: document updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046434:cosslinked US-MODERNATX, INC.-MOD-2021-046649:cosslinked
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Pruritus, Skin irritation, Urticaria
Clinical narrative: itchiness on scalp; itchiness on back; appearance of hives on the back; back appeared red; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (itchiness on scalp), PRURITUS (itchiness on back), URTICARIA (appearance of hives on the back), ERYTHEMA (back appeared red) and NAUSEA (nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SKIN IRRITATION (itchiness on scalp), PRURITUS (itchiness on back), URTICARIA (appearance of hives on the back), ERYTHEMA (back appeared red) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (itchiness on scalp), PRURITUS (itchiness on back), URTICARIA (appearance of hives on the back), ERYTHEMA (back appeared red) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044M21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 27-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: positive (Positive) Positive. On 18-Feb-2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had 3 previous pregnancies which included one live full time birth and two miscarriages. Patient reported that this pregnancy resulted from fertility treatment.  No concomitant or treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site mass, Vaccination site pain
Clinical narrative: Arm pain during injection/ arm pain is now a few inches from injection site shooting to hand; Unable to move arm without severe pain; Knot is forming a few inches away from injection site; Arm pain is now a few inches from injection site shooting to hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain during injection/ arm pain is now a few inches from injection site shooting to hand), PAIN (Unable to move arm without severe pain), VACCINATION SITE MASS (Knot is forming a few inches away from injection site) and VACCINATION SITE PAIN (Arm pain is now a few inches from injection site shooting to hand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-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 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain during injection/ arm pain is now a few inches from injection site shooting to hand), PAIN (Unable to move arm without severe pain), VACCINATION SITE MASS (Knot is forming a few inches away from injection site) and VACCINATION SITE PAIN (Arm pain is now a few inches from injection site shooting to hand). At the time of the report, PAIN IN EXTREMITY (Arm pain during injection/ arm pain is now a few inches from injection site shooting to hand), PAIN (Unable to move arm without severe pain), VACCINATION SITE MASS (Knot is forming a few inches away from injection site) and VACCINATION SITE PAIN (Arm pain is now a few inches from injection site shooting to hand) outcome was unknown. Unknown          No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Invalid dose (less than 0.5mL); This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Invalid dose (less than 0.5mL)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Invalid dose (less than 0.5mL)). On 15-Mar-2021, INCORRECT DOSE ADMINISTERED (Invalid dose (less than 0.5mL)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Upon in internal review on 24 May 2021, the age was corrected to unknown age.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included NAPROXEN SODIUM (ALEVE) and One A Day multivitamins for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was reported.   This case was linked to MOD-2021-046329 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received on 07-May-2021 included no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: Diarrhea; Nausea; felt very tired and achy whole day; Body Ache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), DIARRHOEA (Diarrhea), MYALGIA (Body Ache), NAUSEA (Nausea) and FATIGUE (felt very tired and achy whole day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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 12-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body Ache) and FATIGUE (felt very tired and achy whole day). On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore Arm), DIARRHOEA (Diarrhea), MYALGIA (Body Ache), NAUSEA (Nausea) and FATIGUE (felt very tired and achy whole day) outcome was unknown.            She was taking concomitant medication. She did not take any medicine for treatment.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Little soreness after vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Little soreness after vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Little soreness after vaccine). At the time of the report, PAIN (Little soreness after vaccine) outcome was unknown.        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 were reported.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Reporter refused to give contact info and no need to follow up anymore.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site movement impairment, Injection site nodule, Injection site swelling
Clinical narrative: knot at injection site; arm was hard to lift; hard as a rock at injection site; goose egg at injection site; red at injection site; fever of 100; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (knot at injection site), INJECTION SITE MOVEMENT IMPAIRMENT (arm was hard to lift), INJECTION SITE MASS (hard as a rock at injection site), INJECTION SITE SWELLING (goose egg at injection site) and INJECTION SITE ERYTHEMA (red at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE NODULE (knot at injection site), INJECTION SITE MOVEMENT IMPAIRMENT (arm was hard to lift), INJECTION SITE MASS (hard as a rock at injection site), INJECTION SITE SWELLING (goose egg at injection site), INJECTION SITE ERYTHEMA (red at injection site) and PYREXIA (fever of 100). On 10-Mar-2021, INJECTION SITE NODULE (knot at injection site), INJECTION SITE MOVEMENT IMPAIRMENT (arm was hard to lift), INJECTION SITE MASS (hard as a rock at injection site), INJECTION SITE SWELLING (goose egg at injection site), INJECTION SITE ERYTHEMA (red at injection site) and PYREXIA (fever of 100) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: knot at injection site; arm was hard to lift; hard as a rock at injection site; goose egg at injection site; red at injection site; fever of 100; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (knot at injection site), INJECTION SITE MOVEMENT IMPAIRMENT (arm was hard to lift), INJECTION SITE MASS (hard as a rock at injection site), INJECTION SITE SWELLING (goose egg at injection site) and INJECTION SITE ERYTHEMA (red at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE NODULE (knot at injection site), INJECTION SITE MOVEMENT IMPAIRMENT (arm was hard to lift), INJECTION SITE MASS (hard as a rock at injection site), INJECTION SITE SWELLING (goose egg at injection site), INJECTION SITE ERYTHEMA (red at injection site) and PYREXIA (fever of 100). On 10-Mar-2021, INJECTION SITE NODULE (knot at injection site), INJECTION SITE MOVEMENT IMPAIRMENT (arm was hard to lift), INJECTION SITE MASS (hard as a rock at injection site), INJECTION SITE SWELLING (goose egg at injection site), INJECTION SITE ERYTHEMA (red at injection site) and PYREXIA (fever of 100) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Tiredness; Achy; Had chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), MYALGIA (Achy) and CHILLS (Had chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 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 FATIGUE (Tiredness), MYALGIA (Achy) and CHILLS (Had chills). At the time of the report, FATIGUE (Tiredness), MYALGIA (Achy) and CHILLS (Had chills) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Tachycardia, Vision blurred
Clinical narrative: Blurry vision; Light sensitivity; Fast heartrate; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), PHOTOPHOBIA (Light sensitivity) and TACHYCARDIA (Fast heartrate) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE) and MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision), PHOTOPHOBIA (Light sensitivity) and TACHYCARDIA (Fast heartrate). At the time of the report, VISION BLURRED (Blurry vision), PHOTOPHOBIA (Light sensitivity) and TACHYCARDIA (Fast heartrate) outcome was unknown.            After the second dose the patient experienced these events. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-046322 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Skin burning sensation, Urticaria
Clinical narrative: Skin look burnt and inch of size; Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers; Skin feels like leather to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Skin look burnt and inch of size), URTICARIA (Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers) and INDURATION (Skin feels like leather to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 025J202A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified (Was taking heart medication) and Seizure. Concomitant products included TOPIRAMATE (TOPAMAX) for Seizure, RANOLAZINE, VITAMIN B6, ACETYLSALICYLIC ACID (ASPIRIN LOW) and THYROID for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced SKIN BURNING SENSATION (Skin look burnt and inch of size), URTICARIA (Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers) and INDURATION (Skin feels like leather to touch). At the time of the report, SKIN BURNING SENSATION (Skin look burnt and inch of size), URTICARIA (Hives started on left side of chest/hives spread to stomach, bend of elbow inside of arms, palms of hands and in between fingers) and INDURATION (Skin feels like leather to touch) outcome was unknown.            Treatment medication were not provided. concomitant medication includes blood pressure medications.   This case was linked to MOD-2021-046304, MOD-2021-110283.