chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Eye swelling, Pruritus
Clinical narrative: dry skin around eyes two weeks after receiving the vaccine; swollen eyes two weeks after receiving vaccine; neck itches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (dry skin around eyes two weeks after receiving the vaccine), EYE SWELLING (swollen eyes two weeks after receiving vaccine) and PRURITUS (neck itches) 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 11-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 DRY SKIN (dry skin around eyes two weeks after receiving the vaccine), EYE SWELLING (swollen eyes two weeks after receiving vaccine) and PRURITUS (neck itches). At the time of the report, DRY SKIN (dry skin around eyes two weeks after receiving the vaccine), EYE SWELLING (swollen eyes two weeks after receiving vaccine) and PRURITUS (neck itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: "achy feeling'; "felling very tired"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PAIN ("achy feeling') and FATIGUE ("felling very tired") in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Blood pressure.   On 15-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. On 14-Feb-2021, the patient experienced PAIN ("achy feeling') and FATIGUE ("felling very tired"). On 15-Feb-2021, PAIN ("achy feeling') and FATIGUE ("felling very tired") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pulmonary pain
Clinical narrative: Pain over right lung, on and off in nature; Pain moved to my heart; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain over right lung, on and off in nature) and CHEST PAIN (Pain moved to my heart) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1176) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PULMONARY PAIN (Pain over right lung, on and off in nature) and CHEST PAIN (Pain moved to my heart). On 19-Mar-2021, PULMONARY PAIN (Pain over right lung, on and off in nature) and CHEST PAIN (Pain moved to my heart) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: considerably sore arm - left arm; pain in arm; a red rash - left arm; swelling at the injection site - left arm; itchy - at the injection site - left arm; I started to feel very sick; felt like I've been hit by a truck; diarrhea; lightheaded for several hours; achy body - aches all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I started to feel very sick), FEELING ABNORMAL (felt like I've been hit by a truck), DIARRHOEA (diarrhea), HEADACHE (lightheaded for several hours) and MYALGIA (achy body - aches all over) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021821A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-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) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (I started to feel very sick), FEELING ABNORMAL (felt like I've been hit by a truck), DIARRHOEA (diarrhea), HEADACHE (lightheaded for several hours) and MYALGIA (achy body - aches all over). On an unknown date, the patient experienced VACCINATION SITE PAIN (considerably sore arm - left arm), VACCINATION SITE PAIN (pain in arm), RASH (a red rash - left arm), VACCINATION SITE SWELLING (swelling at the injection site - left arm) and VACCINATION SITE PRURITUS (itchy - at the injection site - left arm). The patient was treated with PARACETAMOL (TYLENOL) on 27-Mar-2021 for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, MALAISE (I started to feel very sick), FEELING ABNORMAL (felt like I've been hit by a truck), DIARRHOEA (diarrhea), HEADACHE (lightheaded for several hours) and MYALGIA (achy body - aches all over) had resolved. At the time of the report, VACCINATION SITE PAIN (considerably sore arm - left arm), VACCINATION SITE PAIN (pain in arm), RASH (a red rash - left arm), VACCINATION SITE SWELLING (swelling at the injection site - left arm) and VACCINATION SITE PRURITUS (itchy - at the injection site - left arm) outcome was unknown.            No concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: considerably sore arm - left arm; pain in arm; a red rash - left arm; swelling at the injection site - left arm; itchy - at the injection site - left arm; I started to feel very sick; felt like I've been hit by a truck; diarrhea; lightheaded for several hours; achy body - aches all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I started to feel very sick), FEELING ABNORMAL (felt like I've been hit by a truck), DIARRHOEA (diarrhea), HEADACHE (lightheaded for several hours) and MYALGIA (achy body - aches all over) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021821A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-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) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MALAISE (I started to feel very sick), FEELING ABNORMAL (felt like I've been hit by a truck), DIARRHOEA (diarrhea), HEADACHE (lightheaded for several hours) and MYALGIA (achy body - aches all over). On an unknown date, the patient experienced VACCINATION SITE PAIN (considerably sore arm - left arm), VACCINATION SITE PAIN (pain in arm), RASH (a red rash - left arm), VACCINATION SITE SWELLING (swelling at the injection site - left arm) and VACCINATION SITE PRURITUS (itchy - at the injection site - left arm). The patient was treated with PARACETAMOL (TYLENOL) on 27-Mar-2021 for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, MALAISE (I started to feel very sick), FEELING ABNORMAL (felt like I've been hit by a truck), DIARRHOEA (diarrhea), HEADACHE (lightheaded for several hours) and MYALGIA (achy body - aches all over) had resolved. At the time of the report, VACCINATION SITE PAIN (considerably sore arm - left arm), VACCINATION SITE PAIN (pain in arm), RASH (a red rash - left arm), VACCINATION SITE SWELLING (swelling at the injection site - left arm) and VACCINATION SITE PRURITUS (itchy - at the injection site - left arm) outcome was unknown.            No concomitant medications were provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN and EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced UNDERDOSE (Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm). On 24-Mar-2021, UNDERDOSE (Forgot to release the muscle when he had the injection and a lot of the vaccine slipped through his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Batch number for Moderna Covid-19 vaccine is unknown; Sender's Comments: This report refers to a case of underdose for mRNA-1273, lot # unknown with no associated AEs.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Illness, Interchange of vaccine products, Myalgia, Pyrexia
Clinical narrative: 1st dose from Pfizer vaccine 2nd dose from Moderna vaccine; became sick for two days; fever; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose from Pfizer vaccine 2nd dose from Moderna vaccine), ILLNESS (became sick for two days), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19.    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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose from Pfizer vaccine 2nd dose from Moderna vaccine), ILLNESS (became sick for two days), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose from Pfizer vaccine 2nd dose from Moderna vaccine) and ILLNESS (became sick for two days) outcome was unknown and PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) had resolved. Not applicable          No relevant concomitant medications were reported. No treatment details were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-060652 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15 Jun 2021 included information on: Additional adverse event details and its outcome; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060652:Same reporter (MOD21-064563)
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) 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, the patient experienced FATIGUE (felt tired). At the time of the report, FATIGUE (felt tired) outcome was unknown. Not Provided          No treatment information was provided.  No concomitant medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vomiting
Clinical narrative: equilibrium problem; Dizziness; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium problem), DIZZINESS (Dizziness) and VOMITING (vomiting) in a 67-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BALANCE DISORDER (equilibrium problem), DIZZINESS (Dizziness) and VOMITING (vomiting). On 29-Mar-2021, BALANCE DISORDER (equilibrium problem), DIZZINESS (Dizziness) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash pruritic, Vaccination site rash
Clinical narrative: Redness/erythema; probably 3 by 3 inches; rashes on the arm; Itchy little bit but not that bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy little bit but not that bad), ERYTHEMA (Redness/erythema), RASH (probably 3 by 3 inches) and VACCINATION SITE RASH (rashes on the arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 031a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (allegic to penicillian drugs, gets body rash.) and Drug hypersensitivity (allergic to sulfa drugs,gets  body rashes.). Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (LILLOW) for Birth control.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RASH PRURITIC (Itchy little bit but not that bad), RASH (probably 3 by 3 inches) and VACCINATION SITE RASH (rashes on the arm). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema). At the time of the report, RASH PRURITIC (Itchy little bit but not that bad), ERYTHEMA (Redness/erythema), RASH (probably 3 by 3 inches) and VACCINATION SITE RASH (rashes on the arm) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant FU contained Medical history includes allergic to penicillin and sulfa drugs. 2nd dose was updated. Concomitant medication LILLOW(birth control pills) added. Adverse event Redness/erythema, rash reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Pharyngeal paraesthesia, Vaccination site pain
Clinical narrative: tested positive for covid; tingling throat; chest pains; arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL PARAESTHESIA (tingling throat), CHEST PAIN (chest pains), COVID-19 (tested positive for covid) and VACCINATION SITE PAIN (arm soreness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 20-Mar-2021, the patient experienced PHARYNGEAL PARAESTHESIA (tingling throat) and CHEST PAIN (chest pains). On 23-Mar-2021, the patient experienced COVID-19 (tested positive for covid). On 20-Mar-2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, PHARYNGEAL PARAESTHESIA (tingling throat) and CHEST PAIN (chest pains) had resolved and COVID-19 (tested positive for covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, COVID-19: positive (Positive) Positive.     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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Lethargy, Pain
Clinical narrative: lethargic; pain which started to settle in lower back; could not bend over; did not feel like eating all day; arm became sore; terrible pain in shoulder; pain worked down the body down her ankles to legs; Temperature of 100.3 degrees Fahrenheit; itching; pain in joints and muscles; overwhelming pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), LETHARGY (lethargic) and BACK PAIN (pain which started to settle in lower back) in an 87-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 LOSARTAN and PRAVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), VACCINATION SITE PAIN (arm became sore), ARTHRALGIA (terrible pain in shoulder), ARTHRALGIA (pain worked down the body down her ankles to legs) and PYREXIA (Temperature of 100.3 degrees Fahrenheit). On 02-Mar-2021, the patient experienced LETHARGY (lethargic), BACK PAIN (pain which started to settle in lower back), BACK PAIN (could not bend over) and DECREASED APPETITE (did not feel like eating all day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), LETHARGY (lethargic), BACK PAIN (pain which started to settle in lower back), BACK PAIN (could not bend over), DECREASED APPETITE (did not feel like eating all day), VACCINATION SITE PAIN (arm became sore), ARTHRALGIA (terrible pain in shoulder), ARTHRALGIA (pain worked down the body down her ankles to legs) and PYREXIA (Temperature of 100.3 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Temperature of 100.3 degrees Fahrenheit was reported on 01-MAR-2021   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up information received on 11-AUG-2021. reporter first name and patient initials updated.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: lethargic; pain which started to settle in lower back; could not bend over; did not feel like eating all day; arm became sore; terrible pain in shoulder; pain worked down the body down her ankles to legs; Temperature of 100.3 degrees Fahrenheit; itching; pain in joints and muscles; overwhelming pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), LETHARGY (lethargic) and BACK PAIN (pain which started to settle in lower back) in an 87-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 LOSARTAN and PRAVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), VACCINATION SITE PAIN (arm became sore), ARTHRALGIA (terrible pain in shoulder), ARTHRALGIA (pain worked down the body down her ankles to legs) and PYREXIA (Temperature of 100.3 degrees Fahrenheit). On 02-Mar-2021, the patient experienced LETHARGY (lethargic), BACK PAIN (pain which started to settle in lower back), BACK PAIN (could not bend over) and DECREASED APPETITE (did not feel like eating all day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), PAIN (pain in joints and muscles), PAIN (overwhelming pain in the body), LETHARGY (lethargic), BACK PAIN (pain which started to settle in lower back), BACK PAIN (could not bend over), DECREASED APPETITE (did not feel like eating all day), VACCINATION SITE PAIN (arm became sore), ARTHRALGIA (terrible pain in shoulder), ARTHRALGIA (pain worked down the body down her ankles to legs) and PYREXIA (Temperature of 100.3 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Temperature of 100.3 degrees Fahrenheit was reported on 01-MAR-2021   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up information received on 11-AUG-2021. reporter first name and patient initials updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: warm to the touch; raised then flattens out; larger, now smaller; sore arm; redness at injection site; swollen at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm to the touch), FEELING HOT (raised then flattens out), VACCINATION SITE REACTION (larger, now smaller), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 27-Mar-2021, the patient experienced FEELING HOT (warm to the touch), FEELING HOT (raised then flattens out), VACCINATION SITE REACTION (larger, now smaller) and VACCINATION SITE PAIN (sore arm). On 21-Mar-2021, VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (swollen at injection site) had resolved. At the time of the report, FEELING HOT (warm to the touch), FEELING HOT (raised then flattens out), VACCINATION SITE REACTION (larger, now smaller) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING; Hives on hands and feet; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on hands and feet) and PRURITUS (ITCHING) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Drug allergy (Allergic to cephalexin), Sulfonamide allergy and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for Cholesterol, INSULIN LISPRO (HUMALOG) and METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN 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 09-Mar-2021, the patient experienced URTICARIA (Hives on hands and feet). On 10-Mar-2021, the patient experienced PRURITUS (ITCHING). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; TRIAMCINOLONE from 15-Mar-2021 to 01-Apr-2021 at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2021 to 01-Apr-2021 at an unspecified dose and frequency. On 29-Mar-2021, URTICARIA (Hives on hands and feet) had resolved. On 01-Apr-2021, PRURITUS (ITCHING) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other medications include Omega 3 acid. Patient reported that the reaction to sulfa or cephalexin lasted for 3 weeks, which will usually last for 5 to 7 days. patient reached out to doctor via patient portal online for advice and sent photos   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Significant FU - reporter Info added, Medical history and event information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhausted; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Exhausted). At the time of the report, FATIGUE (Exhausted) outcome was unknown. Not Provided           No relevant concomitant medications were reported.  No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test positive
Clinical narrative: very very tired; hurting all over the body; bad headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very very tired), MYALGIA (hurting all over the body) and HEADACHE (bad headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included OLMESARTAN, OMEPRAZOLE and HYDROCODONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (very very tired), MYALGIA (hurting all over the body) and HEADACHE (bad headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (very very tired), MYALGIA (hurting all over the body) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (swollen lymph node on neck) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included hypertension. Concomitant products included Bystolic (nebivolol hydrochloride) for hypertension. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 20, 2021, patient experienced  lymphadenopathy (swollen lymph node on neck). The patient treated with Tylenol (paracetamol) for adverse event, at an unspecified dose and frequency. At the time of the report, lymphadenopathy (swollen lymph node on neck) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site is swollen and red; Injection site is swollen and red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Injection site is swollen and red) and VACCINATION SITE ERYTHEMA (Injection site is swollen and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 27-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site is swollen and red) and VACCINATION SITE ERYTHEMA (Injection site is swollen and red). At the time of the report, VACCINATION SITE SWELLING (Injection site is swollen and red) and VACCINATION SITE ERYTHEMA (Injection site is swollen and red) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Treatment information included antibiotic for injection site.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Headache, Pyrexia
Clinical narrative: Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PROPRANOLOL, VITAMIN D3, DULOXETINE HCL, IBUPROFEN (MOTRIN [IBUPROFEN]), CLONAZEPAM (KLONOPIN), CEFIXIME (FLEXERIL [CEFIXIME]), DICLOFENAC SODIUM (PENNSAID), PREGABALIN, ZOLPIDEM TARTRATE (AMBIEN), LIDOCAINE, CALCIUM, MELATONIN, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]), EZETIMIBE (ZETIA), SOLIFENACIN SUCCINATE (VESICARE), ASCORBIC ACID (VITAMIN C ACID) and LORATADINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache). On 26-Mar-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature decreased: (Low) Body temperature is lower than normal.. On 26-Mar-2021, Pyrexia: 99.1 (Low) Lowgrade fever in 99.1Fs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Oropharyngeal pain, Tremor
Clinical narrative: Sore Throat; Pain in the Right Ear; Headache; Shaking After taking Tylenol; Felt like Fainting after taking Tylenol; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), TREMOR (Shaking After taking Tylenol), DIZZINESS (Felt like Fainting after taking Tylenol), EAR PAIN (Pain in the Right Ear) and HEADACHE (Headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 TREMOR (Shaking After taking Tylenol), DIZZINESS (Felt like Fainting after taking Tylenol) and HEADACHE (Headache). On 20-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Pain in the Right Ear). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, TREMOR (Shaking After taking Tylenol) and DIZZINESS (Felt like Fainting after taking Tylenol) had resolved. On 06-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Pain in the Right Ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Palpitations; Lymph nodes swollen; Body Aches; Body temperature 102; Nausea; Muscle cramps; Tingling in hand and feet; Numbness; Weakness; Rapid Heart Rate 126 bpm; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), MUSCLE SPASMS (Muscle cramps), PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness) and ASTHENIA (Weakness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 09-Dec-2020. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Hypertension since 18-Dec-1987, Penicillin allergy and Drug allergy (Sulphur, codeine, niaspan, tofranil (imipramine)). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL and LOSARTAN for Hypertension, CLONAZEPAM, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3 1000) and MAGNESIUM 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 04-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle cramps), PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid Heart Rate 126 bpm), DYSPNOEA (Shortness of breath), MYALGIA (Body Aches), PYREXIA (Body temperature 102) and NAUSEA (Nausea). On 05-Mar-2021, the patient experienced PALPITATIONS (Palpitations) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, PALPITATIONS (Palpitations), MUSCLE SPASMS (Muscle cramps), HEART RATE INCREASED (Rapid Heart Rate 126 bpm) and LYMPHADENOPATHY (Lymph nodes swollen) had not resolved and PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness), ASTHENIA (Weakness), DYSPNOEA (Shortness of breath), MYALGIA (Body Aches), PYREXIA (Body temperature 102) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive. On 04-Mar-2021, Body temperature: 102 (High) 102 and 101.6 (High) 101.6. On 04-Mar-2021, Heart rate: 126 (Inconclusive) 126 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporters email address updated, patient demographics updated, medical history updated, concomitant medication updated, additional events reported (weak, shortness of breath, palpitations) and outcome of the events updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Muscle spasms, Myalgia, Nausea
Clinical narrative: Palpitations; Lymph nodes swollen; Body Aches; Body temperature 102; Nausea; Muscle cramps; Tingling in hand and feet; Numbness; Weakness; Rapid Heart Rate 126 bpm; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), MUSCLE SPASMS (Muscle cramps), PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness) and ASTHENIA (Weakness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 09-Dec-2020. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Hypertension since 18-Dec-1987, Penicillin allergy and Drug allergy (Sulphur, codeine, niaspan, tofranil (imipramine)). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL and LOSARTAN for Hypertension, CLONAZEPAM, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3 1000) and MAGNESIUM 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 04-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle cramps), PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid Heart Rate 126 bpm), DYSPNOEA (Shortness of breath), MYALGIA (Body Aches), PYREXIA (Body temperature 102) and NAUSEA (Nausea). On 05-Mar-2021, the patient experienced PALPITATIONS (Palpitations) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, PALPITATIONS (Palpitations), MUSCLE SPASMS (Muscle cramps), HEART RATE INCREASED (Rapid Heart Rate 126 bpm) and LYMPHADENOPATHY (Lymph nodes swollen) had not resolved and PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness), ASTHENIA (Weakness), DYSPNOEA (Shortness of breath), MYALGIA (Body Aches), PYREXIA (Body temperature 102) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive. On 04-Mar-2021, Body temperature: 102 (High) 102 and 101.6 (High) 101.6. On 04-Mar-2021, Heart rate: 126 (Inconclusive) 126 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporters email address updated, patient demographics updated, medical history updated, concomitant medication updated, additional events reported (weak, shortness of breath, palpitations) and outcome of the events updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Palpitations; Lymph nodes swollen; Body Aches; Body temperature 102; Nausea; Muscle cramps; Tingling in hand and feet; Numbness; Weakness; Rapid Heart Rate 126 bpm; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), MUSCLE SPASMS (Muscle cramps), PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness) and ASTHENIA (Weakness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 09-Dec-2020. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Hypertension since 18-Dec-1987, Penicillin allergy and Drug allergy (Sulphur, codeine, niaspan, tofranil (imipramine)). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL and LOSARTAN for Hypertension, CLONAZEPAM, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D3 1000) and MAGNESIUM 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 04-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle cramps), PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid Heart Rate 126 bpm), DYSPNOEA (Shortness of breath), MYALGIA (Body Aches), PYREXIA (Body temperature 102) and NAUSEA (Nausea). On 05-Mar-2021, the patient experienced PALPITATIONS (Palpitations) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, PALPITATIONS (Palpitations), MUSCLE SPASMS (Muscle cramps), HEART RATE INCREASED (Rapid Heart Rate 126 bpm) and LYMPHADENOPATHY (Lymph nodes swollen) had not resolved and PARAESTHESIA (Tingling in hand and feet), HYPOAESTHESIA (Numbness), ASTHENIA (Weakness), DYSPNOEA (Shortness of breath), MYALGIA (Body Aches), PYREXIA (Body temperature 102) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive. On 04-Mar-2021, Body temperature: 102 (High) 102 and 101.6 (High) 101.6. On 04-Mar-2021, Heart rate: 126 (Inconclusive) 126 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporters email address updated, patient demographics updated, medical history updated, concomitant medication updated, additional events reported (weak, shortness of breath, palpitations) and outcome of the events updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: broke in hives on back and legs; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and URTICARIA (broke in hives on back and legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urticaria (with really severe hives took 2 years to control it.). Concurrent medical conditions included Glaucoma. Concomitant products included BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for Glaucoma, HYDROCHLOROTHIAZIDE, CITALOPRAM, LEVOTHYROXINE and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (itchy). On 06-Mar-2021, the patient experienced URTICARIA (broke in hives on back and legs). At the time of the report, PRURITUS (itchy) and URTICARIA (broke in hives on back and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Took a medicine, OTC chlorodyne (generic) as Treatment drug.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Palpitations, Pruritus, Rash, Rash pruritic
Clinical narrative: Body all broke out and itchy rash; itchy; rash flared up again today; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heart beat), RASH PRURITIC (Body all broke out and itchy rash), PRURITUS (itchy) and RASH (rash flared up again today) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Irritable bowel. Concomitant products included METHOTREXATE and DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel, GOLIMUMAB (SIMPONI ARIA) for Rheumatoid arthritis.    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 PALPITATIONS (fast heart beat). On 29-Mar-2021, the patient experienced RASH PRURITIC (Body all broke out and itchy rash), PRURITUS (itchy) and RASH (rash flared up again today). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (fast heart beat), RASH PRURITIC (Body all broke out and itchy rash), PRURITUS (itchy) and RASH (rash flared up again today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as steroid.