chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination complication
Clinical narrative: arm swelled; deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest; started itching; she feels hazy, a little disoriented; allergic reaction; didn't feel well; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZlA and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter. No concomitant medication 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) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction). 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), HYPERSENSITIVITY (allergic reaction), VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue) outcome was unknown and DISORIENTATION (she feels hazy, a little disoriented) had not resolved. Not Provided          Concomitant medications were not provided by the reporter.  The patient went to an urgent care on 13MAR2021. Details about the visit were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing, Vaccination site pain
Clinical narrative: sneezing; stuffiness; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), NASAL CONGESTION (stuffiness) and VACCINATION SITE PAIN (Soreness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 15-Mar-2021, the patient experienced SNEEZING (sneezing) and NASAL CONGESTION (stuffiness). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing), NASAL CONGESTION (stuffiness) and VACCINATION SITE PAIN (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Limb discomfort, Peripheral swelling
Clinical narrative: arm swelled up; arm swelled up, and was hot and heavy; arm swelled up, and was hot and heavy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy), LIMB DISCOMFORT (arm swelled up, and was hot and heavy) and HEADACHE (Headache) in a 67-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 Dialysis since an unknown date. Concomitant products included HYDROXYZINE, ALLOPURINOL, RENA-VITE, VITAMINS NOS (GERITOL [VITAMINS NOS]) and LABETALOL HCL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache). On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy) and LIMB DISCOMFORT (arm swelled up, and was hot and heavy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 16-Mar-2021, PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy) and LIMB DISCOMFORT (arm swelled up, and was hot and heavy) had resolved. At the time of the report, HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Feeling cold, Hypophagia
Clinical narrative: Teeth hurt; Could not get warm; Could not drink anything because water warm hit bad; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LOSARTAN, OMEPRAZOLE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, VITAMIN B COMPLEX, ARMODAFINIL, VITAMIN C [ASCORBIC ACID], PROBIOTICS NOS and VITAMIN D NOS for an unknown indication.   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 12-Mar-2021, the patient experienced DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad). The patient was treated with IBUPROFEN at a dose of UNK, q4h and PARACETAMOL (TYLENOL) 14-Mar-2021 at an unspecified dose and frequency. On 14-Mar-2021, DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad) had resolved.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Burning sensation; Itching on the left arm; Rash on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), PRURITUS (Itching on the left arm) and RASH (Rash on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning sensation), PRURITUS (Itching on the left arm) and RASH (Rash on the left arm). At the time of the report, BURNING SENSATION (Burning sensation), PRURITUS (Itching on the left arm) and RASH (Rash on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip blister, Lip dry, Lip erythema, Lip haemorrhage
Clinical narrative: Lips started to swell/ lips are swollen; Lips crack; Lips bleed; Lips painful; Lips dry; Dehydrated to a point my skin of lips started to came out; Lips are red; Lips has blister; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful) and LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and VITAMIN D3 for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful), LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out), LIP ERYTHEMA (Lips are red) and LIP BLISTER (Lips has blister). At the time of the report, LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful), LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out), LIP ERYTHEMA (Lips are red) and LIP BLISTER (Lips has blister) had not resolved.            Treatment for the event included Chapstick and an unspecified Steroid cream, which the reporter stated does not help.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Pictures added
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: Lips started to swell/ lips are swollen; Lips crack; Lips bleed; Lips painful; Lips dry; Dehydrated to a point my skin of lips started to came out; Lips are red; Lips has blister; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful) and LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and VITAMIN D3 for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful), LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out), LIP ERYTHEMA (Lips are red) and LIP BLISTER (Lips has blister). At the time of the report, LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful), LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out), LIP ERYTHEMA (Lips are red) and LIP BLISTER (Lips has blister) had not resolved.            Treatment for the event included Chapstick and an unspecified Steroid cream, which the reporter stated does not help.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Pictures added
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: been 47 days on the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose) 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.   Pharmacist called today, patient received 1st dose on 29Jan2021, She said the patient is 59 years old and had multiple health conditions so he was in and out of the hospital which caused a delay to his second shot.   This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # not reported  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up case received but it does not contain new information. Case is possible NNI; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # not reported  with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: Fever; chills; stomach ache; body ache; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA), METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TAMSULOSIN and ROSUVASTATIN.    On 16-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 PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite). At the time of the report, PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant drug included Humira -Injections every 15 days for Psoriasis, Metoprolol-For his heart, Rosuvastatin-For cholesterol Consent for safety follow up allowed.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: fever of 100.6; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), PYREXIA (fever of 100.6) and CHILLS (chills) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MYALGIA (muscle aches). On 16-Mar-2021, the patient experienced PYREXIA (fever of 100.6) and CHILLS (chills). On 15-Mar-2021, MYALGIA (muscle aches) had resolved. At the time of the report, PYREXIA (fever of 100.6) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.6 (High) 100.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not provided.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Mobility decreased, Pleural effusion, Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history information reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting. At the time of the report, pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessment, concomitant medication or treatment information. This case linked to MOD-2021-048046 (patient link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pruritus, Rash
Clinical narrative: red skin; dry skin; itchy skin; rash on legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red skin), DRY SKIN (dry skin), PRURITUS (itchy skin) and RASH (rash on legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypertension.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (red skin), DRY SKIN (dry skin), PRURITUS (itchy skin) and RASH (rash on legs). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red skin), DRY SKIN (dry skin), PRURITUS (itchy skin) and RASH (rash on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose 8 weeks after the first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 16-Jan-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 13-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose). On 13-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose) had resolved.            This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It's got heat to it; Iiches; swelling in her injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2/A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information were provided by the reporter     This case was linked to MOD21-056467, US-MODERNATX, INC.-MOD-2021-048101 (E2B Linked Report).; Sender's Comments:  MOD21-056467: US-MODERNATX, INC.-MOD-2021-048101:Reporter case: wife
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: whole arm was red; whole arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red). At the time of the report, VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red) outcome was unknown.            No concomitant and treatment information was provided by the reporter.   This case was linked to MOD-2021-048102 (E2B Linked Report). This case was linked to MOD-2021-048102, MOD-2021-048808 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document is received on 26-MAY-2021 and it doesn't have any new information; Sender's Comments:  MOD-2021-048102:crosslink
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 Year Old Received Vaccine; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 003A21A) intramuscularly for prophylaxis of COVID-19 infection.  The patient received vaccine at the age of 17 Years.  Laboratory details were not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Myalgia, Nasopharyngitis
Clinical narrative: sore arm; lost sense taste; cold; fever; muscle aches; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ZIPRASIDONE, CLONAZEPAM and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-056649, US-MODERNATX, INC.-MOD-2021-048129 (E2B Linked Report).; Sender's Comments:  MOD21-056649:Crosslink father case US-MODERNATX, INC.-MOD-2021-048129:Crosslinked daughter case
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm; lost sense taste; cold; fever; muscle aches; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ZIPRASIDONE, CLONAZEPAM and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-056649, US-MODERNATX, INC.-MOD-2021-048129 (E2B Linked Report).; Sender's Comments:  MOD21-056649:Crosslink father case US-MODERNATX, INC.-MOD-2021-048129:Crosslinked daughter case
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2/A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitants medications were not reported no treatment medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-048097 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048097:Reporter case: wife
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Pain
Clinical narrative: exacerbated neck/shoulder pain; exacerbated neck/shoulder pain; coughing (more during the day); felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (exacerbated neck/shoulder pain), COUGH (coughing (more during the day)), FATIGUE (felt tired) and ARTHRALGIA (exacerbated neck/shoulder pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Neck pain and Shoulder pain.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (coughing (more during the day)) and FATIGUE (felt tired). On 15-Feb-2021, the patient experienced PAIN (exacerbated neck/shoulder pain) and ARTHRALGIA (exacerbated neck/shoulder pain). On 12-Feb-2021, COUGH (coughing (more during the day)) had resolved. On 13-Feb-2021, FATIGUE (felt tired) had resolved. On 19-Feb-2021, PAIN (exacerbated neck/shoulder pain) and ARTHRALGIA (exacerbated neck/shoulder pain) had resolved.            Concomitant medications were not provided.  Treatment included antihistamines (unspecified).   This case was linked to MOD-2021-048098 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Reporter contact information updated .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Pain, Pruritus, Rash
Clinical narrative: tenderness; pale redness changed to redness; soreness if touched; hot to touch; rash increased from size of quarter to size of baseball; itchiness; firmness; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch) and RASH (rash increased from size of quarter to size of baseball) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch), RASH (rash increased from size of quarter to size of baseball), PRURITUS (itchiness) and INJECTION SITE INDURATION (firmness). At the time of the report, TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch), RASH (rash increased from size of quarter to size of baseball), PRURITUS (itchiness) and INJECTION SITE INDURATION (firmness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site warmth
Clinical narrative: tenderness; pale redness changed to redness; soreness if touched; hot to touch; rash increased from size of quarter to size of baseball; itchiness; firmness; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch) and RASH (rash increased from size of quarter to size of baseball) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch), RASH (rash increased from size of quarter to size of baseball), PRURITUS (itchiness) and INJECTION SITE INDURATION (firmness). At the time of the report, TENDERNESS (tenderness), ERYTHEMA (pale redness changed to redness), PAIN (soreness if touched), VACCINATION SITE WARMTH (hot to touch), RASH (rash increased from size of quarter to size of baseball), PRURITUS (itchiness) and INJECTION SITE INDURATION (firmness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE + D [CALCIUM CARBONATE;COLECALCIFEROL]) and DENOSUMAB (PROLIA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-048113 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Sweating; Soreness of arm; Dizziness; Headache; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sweating; Soreness of arm; Dizziness; Headache; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Soreness of arm), DIZZINESS (Dizziness), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid irritation, Eyelid pain, Swelling of eyelid
Clinical narrative: right eyelid is swollen, painful, and sensitive; right eyelid is swollen, painful, and sensitive; right eyelid is swollen, painful, and sensitive; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (right eyelid is swollen, painful, and sensitive), EYELID PAIN (right eyelid is swollen, painful, and sensitive) and EYELID IRRITATION (right eyelid is swollen, painful, and sensitive) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 13-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 SWELLING OF EYELID (right eyelid is swollen, painful, and sensitive), EYELID PAIN (right eyelid is swollen, painful, and sensitive) and EYELID IRRITATION (right eyelid is swollen, painful, and sensitive). At the time of the report, SWELLING OF EYELID (right eyelid is swollen, painful, and sensitive), EYELID PAIN (right eyelid is swollen, painful, and sensitive) and EYELID IRRITATION (right eyelid is swollen, painful, and sensitive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used to take a blood thinner, but he stopped using it two days before taking his first dose No treatment medications were reported
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: I would like to register my pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I would like to register my pregnancy) in a 26-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 031C20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Depression. Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) for Anxiety, QUETIAPINE FUMARATE (SEROQUEL) for Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Aug-2020 and the estimated date of delivery was 10-Jun-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (I would like to register my pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 13-Feb-2021, EXPOSURE DURING PREGNANCY (I would like to register my pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: (Inconclusive) Result not reported. On an unknown date, Prenatal screening test: (Inconclusive) Result not reported. On an unknown date, Ultrasound scan: (Inconclusive) 4 ultrasounds- Result not reported.         No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Rash
Clinical narrative: body aches; Stomach aches; 7 to 10 reddish brown pea sized spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH (7 to 10 reddish brown pea sized spots), PAIN (body aches) and ABDOMINAL PAIN UPPER (Stomach aches) 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 12-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 RASH (7 to 10 reddish brown pea sized spots). On an unknown date, the patient experienced PAIN (body aches) and ABDOMINAL PAIN UPPER (Stomach aches). At the time of the report, RASH (7 to 10 reddish brown pea sized spots) outcome was unknown and PAIN (body aches) and ABDOMINAL PAIN UPPER (Stomach aches) had resolved.            No concomitant medication was not reported. No treatment medication was not reported
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Vaccination complication, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Her arm feels heavy; COVID arm; red; There were hives, and they got bigger and bigger; arm started feeling hot; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching), LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm) and VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching) and VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger). On an unknown date, the patient experienced LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching), LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm), VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger) and VACCINATION SITE ERYTHEMA (red) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Consumer informed that the Adverse Events are now resolved and declined further Follow Up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Her arm feels heavy; COVID arm; red; There were hives, and they got bigger and bigger; arm started feeling hot; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching), LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm) and VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching) and VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger). On an unknown date, the patient experienced LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching), LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm), VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger) and VACCINATION SITE ERYTHEMA (red) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Consumer informed that the Adverse Events are now resolved and declined further Follow Up.