chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Mouth ulceration, Pyrexia, Rash
Clinical narrative: mouth ulcers; stomach ache; rash all over the body; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOUTH ULCERATION (mouth ulcers), ABDOMINAL PAIN UPPER (stomach ache), RASH (rash all over the body) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-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 01-Feb-2021, the patient experienced MOUTH ULCERATION (mouth ulcers), ABDOMINAL PAIN UPPER (stomach ache), RASH (rash all over the body) and PYREXIA (fever). At the time of the report, MOUTH ULCERATION (mouth ulcers), ABDOMINAL PAIN UPPER (stomach ache), RASH (rash all over the body) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medication was reported.  Treatment details include, steroids and pain medications.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: very very tired with no energy; like flu; headache; severe muscle aches; chills; Fever; L arm sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like flu), PAIN IN EXTREMITY (L arm sore for a couple of days), HEADACHE (headache), MYALGIA (severe muscle aches) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (L arm sore for a couple of days). On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (like flu), HEADACHE (headache), MYALGIA (severe muscle aches), CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced FATIGUE (very very tired with no energy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like flu), PAIN IN EXTREMITY (L arm sore for a couple of days), HEADACHE (headache), MYALGIA (severe muscle aches), CHILLS (chills), PYREXIA (Fever) and FATIGUE (very very tired with no energy) outcome was unknown.            Treatment medication include Zincodin  to sleep.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-078266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078266:cross linked to Dose 1
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: very very tired with no energy; like flu; headache; severe muscle aches; chills; Fever; L arm sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like flu), PAIN IN EXTREMITY (L arm sore for a couple of days), HEADACHE (headache), MYALGIA (severe muscle aches) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (L arm sore for a couple of days). On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (like flu), HEADACHE (headache), MYALGIA (severe muscle aches), CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced FATIGUE (very very tired with no energy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like flu), PAIN IN EXTREMITY (L arm sore for a couple of days), HEADACHE (headache), MYALGIA (severe muscle aches), CHILLS (chills), PYREXIA (Fever) and FATIGUE (very very tired with no energy) outcome was unknown.            Treatment medication include Zincodin  to sleep.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-078266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078266:cross linked to Dose 1
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Allergic hives; Elevation on the site of injection; Redness on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Allergic hives), VACCINATION SITE SWELLING (Elevation on the site of injection) and VACCINATION SITE ERYTHEMA (Redness on the site of injection) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-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 URTICARIA (Allergic hives), VACCINATION SITE SWELLING (Elevation on the site of injection) and VACCINATION SITE ERYTHEMA (Redness on the site of injection). At the time of the report, URTICARIA (Allergic hives), VACCINATION SITE SWELLING (Elevation on the site of injection) and VACCINATION SITE ERYTHEMA (Redness on the site of injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant product use was reported.  Treatment details included diphenhydramine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Small Amount of Vaccine went in during adminstration; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Small Amount of Vaccine went in during adminstration) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 UNDERDOSE (Small Amount of Vaccine went in during adminstration). At the time of the report, UNDERDOSE (Small Amount of Vaccine went in during adminstration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product details was not provided by the reporter. Treatment information was not provided. Post vaccination patient did not experience any Adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received on 23-JUL-2021, indicated patient experienced no adverse events after the vaccine was administered, no new information was received.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the neck; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on the neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on the neck). At the time of the report, RASH (Rash on the neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported. No treatment details were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Nasopharyngitis, Pyrexia, Vaccination site nodule
Clinical narrative: Where I received the injection there is a big knot; Itchy (at injection site); Red (at injection site); Cold all day and thought she might have had a fever; Cold all day and thought she might have had a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Where I received the injection there is a big knot), INJECTION SITE PRURITUS (Itchy (at injection site)), INJECTION SITE ERYTHEMA (Red (at injection site)), NASOPHARYNGITIS (Cold all day and thought she might have had a fever) and PYREXIA (Cold all day and thought she might have had a fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE NODULE (Where I received the injection there is a big knot), INJECTION SITE PRURITUS (Itchy (at injection site)), INJECTION SITE ERYTHEMA (Red (at injection site)), NASOPHARYNGITIS (Cold all day and thought she might have had a fever) and PYREXIA (Cold all day and thought she might have had a fever). At the time of the report, VACCINATION SITE NODULE (Where I received the injection there is a big knot), INJECTION SITE PRURITUS (Itchy (at injection site)), INJECTION SITE ERYTHEMA (Red (at injection site)), NASOPHARYNGITIS (Cold all day and thought she might have had a fever) and PYREXIA (Cold all day and thought she might have had a fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MODERNATX, INC.-MOD-2021-078257 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078257:first dose case
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy
Clinical narrative: the lymph nodes of the whole body became swollen, especially those in the armpit of the right arm and; It was difficult to bring the arm  close to the body; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (the lymph nodes of the whole body became swollen, especially those in the armpit of the right arm and) and LIMB DISCOMFORT (It was difficult to bring the arm  close to the body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced LYMPHADENOPATHY (the lymph nodes of the whole body became swollen, especially those in the armpit of the right arm and) and LIMB DISCOMFORT (It was difficult to bring the arm  close to the body). At the time of the report, LYMPHADENOPATHY (the lymph nodes of the whole body became swollen, especially those in the armpit of the right arm and) and LIMB DISCOMFORT (It was difficult to bring the arm  close to the body) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history and concomitant medications were provided.  No treatment information provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Soreness in her arm; Warm to touch; Injection site was hard; Injection site was red; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 045A214) for COVID-19 vaccination.     No Medical History information was reported.   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 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown. Not Provided          Concomitant medicine and Medical history were not reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 04-Aug-2021 included no new information
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sinusitis
Clinical narrative: SInus; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (SInus) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMIN 15 for an unknown indication.    On 17-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 SINUSITIS (SInus) and HEADACHE (Headache). At the time of the report, SINUSITIS (SInus) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.    This case was linked to MODERNATX, INC.-MOD-2021-078456 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078456:DOSE 2
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Carotid artery dissection in 2000. Concurrent medical conditions included Cholesterol (controlled high cholesterol), Blood pressure high and Supraventricular tachycardia. Concomitant products included CARVEDILOL, DILTIAZEM, SPIRONOLACTONE and FISH OIL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medication was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-078336 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078336:cross linked to Dose 2
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MC0A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included GABAPENTIN, LISINOPRIL, TAMSULOSIN, CYCLOBENZAPRINE, PRAVASTATIN, ISOSORBIDE MONONITRATE, DILTIAZEM and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    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 PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078366 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078366:Crossed linked (Second Dose)
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-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 ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-MAY-2021 contains non-significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: pain in hips; pain in hands; pain in neck; pain in back; Her right hand has not healed, it feels swollen and tight; She felt weak; lethargic; She had diarrhea as well; felt like she got hit by truck; She felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back) and PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-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 21-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), FEELING ABNORMAL (felt like she got hit by truck) and FATIGUE (She felt very tired). At the time of the report, MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), FEELING ABNORMAL (felt like she got hit by truck) and FATIGUE (She felt very tired) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-May-2021, Contains No New Information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Musculoskeletal discomfort, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: pain in hips; pain in hands; pain in neck; pain in back; Her right hand has not healed, it feels swollen and tight; She felt weak; lethargic; She had diarrhea as well; felt like she got hit by truck; She felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back) and PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-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 21-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), FEELING ABNORMAL (felt like she got hit by truck) and FATIGUE (She felt very tired). At the time of the report, MUSCULOSKELETAL DISCOMFORT (pain in hips), PAIN IN EXTREMITY (pain in hands), NECK PAIN (pain in neck), BACK PAIN (pain in back), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), FEELING ABNORMAL (felt like she got hit by truck) and FATIGUE (She felt very tired) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-May-2021, Contains No New Information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 14-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information contained updated outcome.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Nausea, Pyrexia, Vomiting
Clinical narrative: didn't want to eat; joints were hurting; fever of 102.4F; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.4F), NAUSEA (nausea), VOMITING (vomiting), DECREASED APPETITE (didn't want to eat) and ARTHRALGIA (joints were hurting) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever of 102.4F), NAUSEA (nausea), VOMITING (vomiting) and ARTHRALGIA (joints were hurting). On 15-Apr-2021, the patient experienced DECREASED APPETITE (didn't want to eat). At the time of the report, PYREXIA (fever of 102.4F), NAUSEA (nausea), VOMITING (vomiting), DECREASED APPETITE (didn't want to eat) and ARTHRALGIA (joints were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Chills, Cold sweat, Dizziness
Clinical narrative: very light headed; slight pain in my neck.; cold sweat; nauseous; extremely tired; shivering so uncontrolably; started throwing up\thought entire insides were about to come out; headache; trembling; pain in stomach on right side; body felt like it was on fire inside and outside; unreal pain all over the entire body,; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,) and DIZZINESS (very light headed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteo arthritis knees on 01-Jan-2005. Concurrent medical conditions included Allergy and Allergy. Concomitant products included ACETAMINOPHEN from 10-Oct-2005 to an unknown date for Arthritis, LOSARTAN from 10-Oct-2015 to an unknown date for Blood pressure, SIMVASTATIN from 10-Oct-2015 to an unknown date for Cholesterol, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3) from 10-Oct-2015 to an unknown date for Vitamin A.    On 14-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 TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), VOMITING (started throwing up\thought entire insides were about to come out) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably). At the time of the report, TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), VOMITING (started throwing up\thought entire insides were about to come out), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional info received
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Neck pain, Pain
Clinical narrative: very light headed; slight pain in my neck.; cold sweat; nauseous; extremely tired; shivering so uncontrolably; started throwing up\thought entire insides were about to come out; headache; trembling; pain in stomach on right side; body felt like it was on fire inside and outside; unreal pain all over the entire body,; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,) and DIZZINESS (very light headed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteo arthritis knees on 01-Jan-2005. Concurrent medical conditions included Allergy and Allergy. Concomitant products included ACETAMINOPHEN from 10-Oct-2005 to an unknown date for Arthritis, LOSARTAN from 10-Oct-2015 to an unknown date for Blood pressure, SIMVASTATIN from 10-Oct-2015 to an unknown date for Cholesterol, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3) from 10-Oct-2015 to an unknown date for Vitamin A.    On 14-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 TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), VOMITING (started throwing up\thought entire insides were about to come out) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably). At the time of the report, TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), VOMITING (started throwing up\thought entire insides were about to come out), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional info received
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: very light headed; slight pain in my neck.; cold sweat; nauseous; extremely tired; shivering so uncontrolably; started throwing up\thought entire insides were about to come out; headache; trembling; pain in stomach on right side; body felt like it was on fire inside and outside; unreal pain all over the entire body,; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,) and DIZZINESS (very light headed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteo arthritis knees on 01-Jan-2005. Concurrent medical conditions included Allergy and Allergy. Concomitant products included ACETAMINOPHEN from 10-Oct-2005 to an unknown date for Arthritis, LOSARTAN from 10-Oct-2015 to an unknown date for Blood pressure, SIMVASTATIN from 10-Oct-2015 to an unknown date for Cholesterol, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3) from 10-Oct-2015 to an unknown date for Vitamin A.    On 14-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 TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), VOMITING (started throwing up\thought entire insides were about to come out) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably). At the time of the report, TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), VOMITING (started throwing up\thought entire insides were about to come out), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional info received
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Nausea
Clinical narrative: sickness; body aches; chills; bad headache; nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), PAIN (body aches), CHILLS (chills), HEADACHE (bad headache) and NAUSEA (nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included albuterol Inhaler and ALPRAZOLAM for an unknown indication.    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 HEADACHE (bad headache), NAUSEA (nausea) and FATIGUE (Fatigue). On 12-Mar-2021, the patient experienced ILLNESS (sickness), PAIN (body aches) and CHILLS (chills). On 14-Mar-2021, PAIN (body aches) and CHILLS (chills) had resolved. At the time of the report, ILLNESS (sickness) outcome was unknown and HEADACHE (bad headache), NAUSEA (nausea) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Ibuprofen, aspirin, zofran, ginger ale beverage   This case was linked to US-MODERNATX, INC.-MOD-2021-079168 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079168:2nd dose
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sickness; body aches; chills; bad headache; nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), PAIN (body aches), CHILLS (chills), HEADACHE (bad headache) and NAUSEA (nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included albuterol Inhaler and ALPRAZOLAM for an unknown indication.    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 HEADACHE (bad headache), NAUSEA (nausea) and FATIGUE (Fatigue). On 12-Mar-2021, the patient experienced ILLNESS (sickness), PAIN (body aches) and CHILLS (chills). On 14-Mar-2021, PAIN (body aches) and CHILLS (chills) had resolved. At the time of the report, ILLNESS (sickness) outcome was unknown and HEADACHE (bad headache), NAUSEA (nausea) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Ibuprofen, aspirin, zofran, ginger ale beverage   This case was linked to US-MODERNATX, INC.-MOD-2021-079168 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079168:2nd dose
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: similar but not as intense reaction; This spontaneous case was reported by a consumer and describes the occurrence of SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG (similar but not as intense reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG (similar but not as intense reaction). At the time of the report, SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG (similar but not as intense reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable    This case was linked to MOD-2021-078312 (E2B Linked Report).; Sender's Comments:  MOD-2021-078312:1st dose
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Myalgia, Pain
Clinical narrative: feel like on a block of ice; couldn't get warm; achy; shaking; muscle aches; chills; muscle sore; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm) and PAIN (achy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MC0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, LISINOPRIL, TAMSULOSIN, CYCLOBENZAPRINE, PRAVASTATIN, ISOSORBIDE MONONITRATE, DILTIAZEM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm), PAIN (achy), TREMOR (shaking) and MYALGIA (muscle sore). At the time of the report, CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm), PAIN (achy), TREMOR (shaking) and MYALGIA (muscle sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078324:Crossed linked (First dose)
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: feel like on a block of ice; couldn't get warm; achy; shaking; muscle aches; chills; muscle sore; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm) and PAIN (achy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MC0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, LISINOPRIL, TAMSULOSIN, CYCLOBENZAPRINE, PRAVASTATIN, ISOSORBIDE MONONITRATE, DILTIAZEM and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm), PAIN (achy), TREMOR (shaking) and MYALGIA (muscle sore). At the time of the report, CHILLS (chills), MYALGIA (muscle aches), FEELING ABNORMAL (feel like on a block of ice), FEELING COLD (couldn't get warm), PAIN (achy), TREMOR (shaking) and MYALGIA (muscle sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078324:Crossed linked (First dose)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: itchy; RED; bump around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), ERYTHEMA (RED) and INJECTION SITE SWELLING (bump around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-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 PRURITUS (itchy), ERYTHEMA (RED) and INJECTION SITE SWELLING (bump around the injection site). At the time of the report, PRURITUS (itchy), ERYTHEMA (RED) and INJECTION SITE SWELLING (bump around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.   This case was linked to MOD21-076769 (E2B Linked Report).; Sender's Comments:  MOD21-076769:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Hypersensitivity, Pain in extremity
Clinical narrative: red eye hematoma; severe pain in the arm and leg, stabbing/sling pain/sore arm; Severe allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (red eye hematoma), PAIN IN EXTREMITY (severe pain in the arm and leg, stabbing/sling pain/sore arm) and HYPERSENSITIVITY (Severe allergic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (red eye hematoma), PAIN IN EXTREMITY (severe pain in the arm and leg, stabbing/sling pain/sore arm) and HYPERSENSITIVITY (Severe allergic reaction). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (red eye hematoma), PAIN IN EXTREMITY (severe pain in the arm and leg, stabbing/sling pain/sore arm) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was included. Treatment included acetaminophen and prednisone (not sure with the dose) and put cream on it to lessen the pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided   This case was linked to MODERNATX, INC.-MOD-2021-078437 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-078437:second dose case
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash, Rash papular
Clinical narrative: rash, raised, hot, red; rash; raised, hot, red; rash; raised, hot, red; rash; raised, hot, red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (rash; raised, hot, red), ERYTHEMA (rash; raised, hot, red), RASH PAPULAR (rash, raised, hot, red) and RASH (rash; raised, hot, 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 14-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 FEELING HOT (rash; raised, hot, red), ERYTHEMA (rash; raised, hot, red) and RASH (rash; raised, hot, red). On an unknown date, the patient experienced RASH PAPULAR (rash, raised, hot, red). At the time of the report, FEELING HOT (rash; raised, hot, red), ERYTHEMA (rash; raised, hot, red), RASH PAPULAR (rash, raised, hot, red) and RASH (rash; raised, hot, red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.