chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VOMITING (Vomiting) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dyslexia, Auditory disorder and Eyeglasses wearer.    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 VERTIGO (Vertigo) and VOMITING (Vomiting). At the time of the report, VERTIGO (Vertigo) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. No treatment medication was taken for the events.    This case was linked to MOD-2021-163582 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness around injection site, resolved in 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness around injection site, resolved in 6 hours) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M22A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cephalexin).   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Soreness around injection site, resolved in 6 hours). On 03-Jan-2021, INJECTION SITE PAIN (Soreness around injection site, resolved in 6 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Concomitant medication includes High Blood Pressure Medication       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received contains No new information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle strain, Myalgia, Pain in extremity, Rash
Clinical narrative: muscle spasm; ache in arm, pain on left side; trapezius muscle strain; rash; pain in trapezius area up past skull; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasm), PAIN IN EXTREMITY (ache in arm, pain on left side), MUSCLE STRAIN (trapezius muscle strain), RASH (rash) and MYALGIA (pain in trapezius area up past skull) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Relevant medical history was not reported.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced MUSCLE SPASMS (muscle spasm), PAIN IN EXTREMITY (ache in arm, pain on left side), MUSCLE STRAIN (trapezius muscle strain), RASH (rash) and MYALGIA (pain in trapezius area up past skull). At the time of the report, MUSCLE SPASMS (muscle spasm), PAIN IN EXTREMITY (ache in arm, pain on left side), MUSCLE STRAIN (trapezius muscle strain) and RASH (rash) outcome was unknown and MYALGIA (pain in trapezius area up past skull) had not resolved.            Treatment for the events included a muscle relaxer (not further specified).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Blood blister, Erythema, Skin abrasion, Skin atrophy
Clinical narrative: Hands are now red; Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water; Some blisters filled with blood; Putting hand in pocket causes abrasions/cuts; Skin is thin; Soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts), SKIN ATROPHY (Skin is thin) and ERYTHEMA (Hands are now red) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalexin).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site). On 24-Mar-2021, the patient experienced BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts) and SKIN ATROPHY (Skin is thin). On 08-Jun-2021, the patient experienced ERYTHEMA (Hands are now red). The patient was treated with CLOBETASOL at a dose of 1 UNK. On 03-Feb-2021, VACCINATION SITE PAIN (Soreness around injection site) had resolved. At the time of the report, BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts), SKIN ATROPHY (Skin is thin) and ERYTHEMA (Hands are now red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes high blood pressure medication.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Added patient photographic documentation of AE, updated concomitant medications
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hands are now red; Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water; Some blisters filled with blood; Putting hand in pocket causes abrasions/cuts; Skin is thin; Soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts), SKIN ATROPHY (Skin is thin) and ERYTHEMA (Hands are now red) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Cephalexin).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site). On 24-Mar-2021, the patient experienced BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts) and SKIN ATROPHY (Skin is thin). On 08-Jun-2021, the patient experienced ERYTHEMA (Hands are now red). The patient was treated with CLOBETASOL at a dose of 1 UNK. On 03-Feb-2021, VACCINATION SITE PAIN (Soreness around injection site) had resolved. At the time of the report, BLISTER (Developed 1 inch blister on left hand / Developed blisters all over both hands, including palms/Blisters appear around joint spaces/ Some blisters filled with water), BLOOD BLISTER (Some blisters filled with blood), SKIN ABRASION (Putting hand in pocket causes abrasions/cuts), SKIN ATROPHY (Skin is thin) and ERYTHEMA (Hands are now red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes high blood pressure medication.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Added patient photographic documentation of AE, updated concomitant medications
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Pyrexia
Clinical narrative: stomach was a little upset; chills; fever yesterday was 100.8; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was a little upset), PYREXIA (fever yesterday was 100.8) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever yesterday was 100.8). On 11-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was a little upset). On 13-Feb-2021, PYREXIA (fever yesterday was 100.8) outcome was unknown. At the time of the report, ABDOMINAL DISCOMFORT (stomach was a little upset) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100.8 (High) 100.8.         No concomitant medications and treatment medications was provided.   This case was linked to MOD-2021-042700 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment Medications were not provided by the reporter
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pyrexia
Clinical narrative: Joint pain; Temperature of 100.7F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Temperature of 100.7F) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Temperature of 100.7F) and NAUSEA (Nausea). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Temperature of 100.7F) and NAUSEA (Nausea) outcome was unknown. Not Provided                   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Insomnia). The patient was treated with TRAZODONE for Insomnia, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Insomnia) had not resolved.            No concomitant medication information was provided  Action taken with mRNA-1273 in response to the events was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no new information.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Product dose omission issue, Rash
Clinical narrative: Only 1 vaccine dose; weakness; severe rash on the left arm and underarm, rash spread on right arm and shoulder; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), PRODUCT DOSE OMISSION ISSUE (Only 1 vaccine dose), ASTHENIA (weakness) and RASH (severe rash on the left arm and underarm, rash spread on right arm and shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included AMLODIPINE, SOTALOL, LEVOTHYROXINE SODIUM (SYNTHROID) and APIXABAN (ELIQUIS) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog). On 09-Mar-2021, the patient experienced ASTHENIA (weakness) and RASH (severe rash on the left arm and underarm, rash spread on right arm and shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only 1 vaccine dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and AVENA SATIVA FLUID EXTRACT (AVEENO) at an unspecified dose and frequency. On 13-Apr-2021, FEELING ABNORMAL (brain fog) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Only 1 vaccine dose), ASTHENIA (weakness) and RASH (severe rash on the left arm and underarm, rash spread on right arm and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site swelling
Clinical narrative: tenderness; severe swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness) and VACCINATION SITE SWELLING (severe swelling on the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness) and VACCINATION SITE SWELLING (severe swelling on the injection site). At the time of the report, TENDERNESS (tenderness) and VACCINATION SITE SWELLING (severe swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.    Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Injection site pain, Pollakiuria
Clinical narrative: Loss of appetite; Frequent urination; Chills; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), POLLAKIURIA (Frequent urination), CHILLS (Chills) and INJECTION SITE PAIN (Pain at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), POLLAKIURIA (Frequent urination), CHILLS (Chills) and INJECTION SITE PAIN (Pain at the injection site). At the time of the report, DECREASED APPETITE (Loss of appetite), POLLAKIURIA (Frequent urination), CHILLS (Chills) and INJECTION SITE PAIN (Pain at the injection site) outcome was unknown.            No treatment medications were provided by the reporter. No concomitant products were provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: COVID19 type itchy rash at the injection site; COVID19 type rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (COVID19 type itchy rash at the injection site) and VACCINATION SITE RASH (COVID19 type rash at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATENOLOL, PRAVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (COVID19 type itchy rash at the injection site) and VACCINATION SITE RASH (COVID19 type rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (COVID19 type itchy rash at the injection site) and VACCINATION SITE RASH (COVID19 type rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chest pain, Dehydration, Fatigue
Clinical narrative: Intermittent pain; Elevated C-reactive Protein; Burning sensation on the chest; Knee worse; Tingling of the legs; Breath Soreness; Extreme dehydration; Runny nose; weird pain; Exhaustion; Weird Pain/Excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PAIN (weird pain), PARAESTHESIA (Tingling of the legs), PAIN (Breath Soreness) and DEHYDRATION (Extreme dehydration) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (ZOLAX [ALPRAZOLAM]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), PAIN (weird pain), FATIGUE (Exhaustion) and MYALGIA (Weird Pain/Excruciating pain). On 13-Apr-2021, the patient experienced PARAESTHESIA (Tingling of the legs), PAIN (Breath Soreness), DEHYDRATION (Extreme dehydration), CHEST PAIN (Burning sensation on the chest) and ARTHRALGIA (Knee worse). On 16-Apr-2021, the patient experienced C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein). On an unknown date, the patient experienced PAIN (Intermittent pain). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 22-Mar-2021, RHINORRHOEA (Runny nose), PAIN (weird pain) and FATIGUE (Exhaustion) had resolved. At the time of the report, PARAESTHESIA (Tingling of the legs), PAIN (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), CHEST PAIN (Burning sensation on the chest), PAIN (Intermittent pain), ARTHRALGIA (Knee worse) and MYALGIA (Weird Pain/Excruciating pain) outcome was unknown. Not Provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Paraesthesia, Rhinorrhoea
Clinical narrative: Intermittent pain; Elevated C-reactive Protein; Burning sensation on the chest; Knee worse; Tingling of the legs; Breath Soreness; Extreme dehydration; Runny nose; weird pain; Exhaustion; Weird Pain/Excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PAIN (weird pain), PARAESTHESIA (Tingling of the legs), PAIN (Breath Soreness) and DEHYDRATION (Extreme dehydration) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (ZOLAX [ALPRAZOLAM]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), PAIN (weird pain), FATIGUE (Exhaustion) and MYALGIA (Weird Pain/Excruciating pain). On 13-Apr-2021, the patient experienced PARAESTHESIA (Tingling of the legs), PAIN (Breath Soreness), DEHYDRATION (Extreme dehydration), CHEST PAIN (Burning sensation on the chest) and ARTHRALGIA (Knee worse). On 16-Apr-2021, the patient experienced C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein). On an unknown date, the patient experienced PAIN (Intermittent pain). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 22-Mar-2021, RHINORRHOEA (Runny nose), PAIN (weird pain) and FATIGUE (Exhaustion) had resolved. At the time of the report, PARAESTHESIA (Tingling of the legs), PAIN (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), CHEST PAIN (Burning sensation on the chest), PAIN (Intermittent pain), ARTHRALGIA (Knee worse) and MYALGIA (Weird Pain/Excruciating pain) outcome was unknown. Not Provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, C-reactive protein increased, Dehydration, Dyspnoea
Clinical narrative: Tingling of the legs; Breath Soreness; Extreme dehydration; Elevated C-reactive Protein; Burning sensation; Joints hurt - Knee Worse; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein) and BURNING SENSATION (Burning sensation) in a 58-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Joints hurt - Knee Worse). At the time of the report, PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Joints hurt - Knee Worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-214406 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling of the legs; Breath Soreness; Extreme dehydration; Elevated C-reactive Protein; Burning sensation; Joints hurt - Knee Worse; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein) and BURNING SENSATION (Burning sensation) in a 58-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Joints hurt - Knee Worse). At the time of the report, PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Joints hurt - Knee Worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-214406 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Face oedema, Rash
Clinical narrative: Forehead puffy; Forehead red; Rash on chest, back, face-forehead; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (Forehead puffy), ERYTHEMA (Forehead red) and RASH (Rash on chest, back, face-forehead) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Related to alka-sulphur).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH (Rash on chest, back, face-forehead). On 18-Apr-2021, the patient experienced FACE OEDEMA (Forehead puffy) and ERYTHEMA (Forehead red). At the time of the report, FACE OEDEMA (Forehead puffy), ERYTHEMA (Forehead red) and RASH (Rash on chest, back, face-forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: running a fever; tired; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (running a fever) and FATIGUE (tired) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer (Patient is currently on chemotherapy for lung cancer). Concomitant products included BENZONATATE for Cough, PANTOPRAZOLE, METOPROLOL and SIMVASTATIN for an unknown indication, APIXABAN (ELIQUIS).   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 18-Apr-2021, the patient experienced PYREXIA (running a fever) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (running a fever) and FATIGUE (tired) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea
Clinical narrative: GI Issues; diarrhea; nausea; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL DISORDER (GI Issues), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 025b21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021 at 2:57 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GI Issues), DIARRHOEA (diarrhea) and NAUSEA (nausea). At the time of the report, GASTROINTESTINAL DISORDER (GI Issues), DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown. Not Provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn; experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn; fever; nausea; aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), RASH MACULAR (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Medical history was not provided by the reporter.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aches). On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn) and RASH MACULAR (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), RASH MACULAR (experienced: rash going across the upper belly. It is red and blotchy and looks like a sunburn), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aches) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tenderness
Clinical narrative: right arm got tender, is still tender; does feel weird now/ describing the feeling weird symptom as feeling "just off"; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (right arm got tender, is still tender) and FEELING ABNORMAL (does feel weird now/ describing the feeling weird symptom as feeling "just off") in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (right arm got tender, is still tender) and FEELING ABNORMAL (does feel weird now/ describing the feeling weird symptom as feeling "just off"). At the time of the report, TENDERNESS (right arm got tender, is still tender) and FEELING ABNORMAL (does feel weird now/ describing the feeling weird symptom as feeling "just off") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: from the follow-up document there was no new information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of hyperhidrosis (sweating) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006B21A and 025B21A) for COVID-19 immunization. No medical history reported. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient experienced hyperhidrosis (sweating). At the time of the report, hyperhidrosis (sweating) outcome: unknown/not provided. This case linked to MOD-2021-214472 (patient link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Vaccination site pain, Vaccination site rash
Clinical narrative: eczematous lesions over patient's the butt cheeks, on the back, breast and neck,  eczema reaction as "white topped scabs over red background"; eczematous lesions are itchy; rash at injection site; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczematous lesions over patient's the butt cheeks, on the back, breast and neck,  eczema reaction as "white topped scabs over red background"), PRURITUS (eczematous lesions are itchy), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (injection arm soreness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (injection arm soreness). On 16-Apr-2021, the patient experienced ECZEMA (eczematous lesions over patient's the butt cheeks, on the back, breast and neck,  eczema reaction as "white topped scabs over red background") and PRURITUS (eczematous lesions are itchy). The patient was treated with PARACETAMOL (TYLENOL) for Painful arm, at a dose of 1 dosage form and HYDROCORTISONE (topical) at a dose of 1 dosage form. On 12-Apr-2021, VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (injection arm soreness) had resolved. At the time of the report, ECZEMA (eczematous lesions over patient's the butt cheeks, on the back, breast and neck,  eczema reaction as "white topped scabs over red background") and PRURITUS (eczematous lesions are itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medicines were reported
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Somnolence
Clinical narrative: slept for 5 hours in the middle of the day; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (slept for 5 hours in the middle of the day) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced SOMNOLENCE (slept for 5 hours in the middle of the day). At the time of the report, SOMNOLENCE (slept for 5 hours in the middle of the day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-214496 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: sensitivity of teeth; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (sensitivity of teeth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERAESTHESIA TEETH (sensitivity of teeth). At the time of the report, HYPERAESTHESIA TEETH (sensitivity of teeth) had not resolved. Not Provided          Patient stated that she experienced teeth sensitivity a few days after receiving her second dose of vaccine which was ongoing at the time of call. Patient stated that the symptom was like nerve sensitivity to touch affecting both top and bottom sets of her teeth, and is scheduled to meet her dentist.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Vaccination site erythema
Clinical narrative: thought she was on her death bed; couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.; the shot area is still red; worst headache she ever had in her life; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (thought she was on her death bed), MYALGIA (couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.), VACCINATION SITE ERYTHEMA (the shot area is still red) and HEADACHE (worst headache she ever had in her life) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (thought she was on her death bed), MYALGIA (couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.), VACCINATION SITE ERYTHEMA (the shot area is still red) and HEADACHE (worst headache she ever had in her life). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 18-Apr-2021, MYALGIA (couldn't move any muscle in her whole body as she was in pain/still sore but nothing like last night.), VACCINATION SITE ERYTHEMA (the shot area is still red) and HEADACHE (worst headache she ever had in her life) outcome was unknown. At the time of the report, FEELING ABNORMAL (thought she was on her death bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications not provided.   This case was linked to MOD-2021-214487 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR - NNI
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: swelling that was hard like a golf ball; hard like a golf ball; arm was red; arm was hot; brain fog; out of energy; sore; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot) and FEELING ABNORMAL (brain fog) in a 61-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.     The patient's past medical history included Gastric bypass. Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), ALPRAZOLAM (XANAX), BUPROPION, LISINOPRIL, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) and GABAPENTIN for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot), FEELING ABNORMAL (brain fog), ASTHENIA (out of energy), PAIN (sore), HEADACHE (headache) and FATIGUE (fatigue). On 18-Apr-2021, HEADACHE (headache) outcome was unknown. At the time of the report, SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot), FEELING ABNORMAL (brain fog), ASTHENIA (out of energy), PAIN (sore) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Induration, Pain, Swelling
Clinical narrative: swelling that was hard like a golf ball; hard like a golf ball; arm was red; arm was hot; brain fog; out of energy; sore; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot) and FEELING ABNORMAL (brain fog) in a 61-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.     The patient's past medical history included Gastric bypass. Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), ALPRAZOLAM (XANAX), BUPROPION, LISINOPRIL, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) and GABAPENTIN for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot), FEELING ABNORMAL (brain fog), ASTHENIA (out of energy), PAIN (sore), HEADACHE (headache) and FATIGUE (fatigue). On 18-Apr-2021, HEADACHE (headache) outcome was unknown. At the time of the report, SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot), FEELING ABNORMAL (brain fog), ASTHENIA (out of energy), PAIN (sore) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Inflammation at the injection site; Hot felling at the injection site; Redness at the injection site; Itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Hot felling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Hot felling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site). At the time of the report, VACCINATION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Hot felling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PRURITUS (Itchiness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.