chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Dizziness, Electrocardiogram
Clinical narrative: panic attack; hot flushes; a little lightheaded; dizzy spell; crazy rapid heartbeat/heart rate was 105/heart was tachy; blood pressure in the 150s; tongue and legs began to tingle; tongue and legs began to tingle; sore arm; upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell) and HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attacks (positive for panic attacks). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: inconclusive (Inconclusive) Blood pressure was in 150's.. In February 2021, Electrocardiogram: inconclusive (Inconclusive) EKG showed "heart was tachy" but still in sinus rhythm.. In February 2021, Heart rate: 105 (High) heart rate was 105..         This case was linked to MOD-2021-013265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR with details of second dose AE
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hot flush, Pain in extremity
Clinical narrative: panic attack; hot flushes; a little lightheaded; dizzy spell; crazy rapid heartbeat/heart rate was 105/heart was tachy; blood pressure in the 150s; tongue and legs began to tingle; tongue and legs began to tingle; sore arm; upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell) and HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attacks (positive for panic attacks). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: inconclusive (Inconclusive) Blood pressure was in 150's.. In February 2021, Electrocardiogram: inconclusive (Inconclusive) EKG showed "heart was tachy" but still in sinus rhythm.. In February 2021, Heart rate: 105 (High) heart rate was 105..         This case was linked to MOD-2021-013265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR with details of second dose AE
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Paraesthesia, Paraesthesia oral
Clinical narrative: panic attack; hot flushes; a little lightheaded; dizzy spell; crazy rapid heartbeat/heart rate was 105/heart was tachy; blood pressure in the 150s; tongue and legs began to tingle; tongue and legs began to tingle; sore arm; upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell) and HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attacks (positive for panic attacks). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (panic attack), HOT FLUSH (hot flushes), DIZZINESS (a little lightheaded), DIZZINESS (dizzy spell), HEART RATE INCREASED (crazy rapid heartbeat/heart rate was 105/heart was tachy), BLOOD PRESSURE INCREASED (blood pressure in the 150s), PARAESTHESIA ORAL (tongue and legs began to tingle), PARAESTHESIA (tongue and legs began to tingle), PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: inconclusive (Inconclusive) Blood pressure was in 150's.. In February 2021, Electrocardiogram: inconclusive (Inconclusive) EKG showed "heart was tachy" but still in sinus rhythm.. In February 2021, Heart rate: 105 (High) heart rate was 105..         This case was linked to MOD-2021-013265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR with details of second dose AE
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: lost my sense of taste about three days ago; This spontaneous case was reported by an other and describes the occurrence of AGEUSIA (lost my sense of taste about three days ago) 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 AGEUSIA (lost my sense of taste about three days ago). At the time of the report, AGEUSIA (lost my sense of taste about three days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Infectious mononucleosis, Influenza, Malaise
Clinical narrative: was really sick; No appetite; Chills; really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104; Body Aches/Severe body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was really sick), DECREASED APPETITE (No appetite), PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104), MYALGIA (Body Aches/Severe body aches) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 05-Jan-2013 to an unknown date for Anxiety, DROSPIRENONE, ETHINYLESTRADIOL (SYEDA) from 05-Jan-2012 to an unknown date for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Jan-2020 to an unknown date for Seasonal allergy.   On 24-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104) and MYALGIA (Body Aches/Severe body aches). On an unknown date, the patient experienced MALAISE (was really sick), DECREASED APPETITE (No appetite) and CHILLS (Chills). On 26-Mar-2021, PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104) had resolved. On 28-Mar-2021, MYALGIA (Body Aches/Severe body aches) had resolved. At the time of the report, MALAISE (was really sick), DECREASED APPETITE (No appetite) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: other (Positive) tested positive for COVID-19. On an unknown date, Infectious mononucleosis: other (Negative) Negative. On an unknown date, Influenza: other (Negative) Negative.         Platelets and kidney numbers were low. No treatment medication reported by the reporter.   This case was linked to MOD-2021-255845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received as new events myalgia, chills, appetite absent were added. Concomitant medications were added. Start date of suspect drug for first dose was added. Patient demographic information was added. Event outcome for feeling sick, fever was updated from unknwon to recovered. Laboratory data was added. Causality of fever and myalgia updated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: was really sick; No appetite; Chills; really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104; Body Aches/Severe body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was really sick), DECREASED APPETITE (No appetite), PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104), MYALGIA (Body Aches/Severe body aches) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 05-Jan-2013 to an unknown date for Anxiety, DROSPIRENONE, ETHINYLESTRADIOL (SYEDA) from 05-Jan-2012 to an unknown date for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Jan-2020 to an unknown date for Seasonal allergy.   On 24-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104) and MYALGIA (Body Aches/Severe body aches). On an unknown date, the patient experienced MALAISE (was really sick), DECREASED APPETITE (No appetite) and CHILLS (Chills). On 26-Mar-2021, PYREXIA (really high fevers/High Fever (104 deg. F)/lowest fever of 100.5 and highest of 104.6/ lowest fever 99.9 and highest of 104) had resolved. On 28-Mar-2021, MYALGIA (Body Aches/Severe body aches) had resolved. At the time of the report, MALAISE (was really sick), DECREASED APPETITE (No appetite) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: other (Positive) tested positive for COVID-19. On an unknown date, Infectious mononucleosis: other (Negative) Negative. On an unknown date, Influenza: other (Negative) Negative.         Platelets and kidney numbers were low. No treatment medication reported by the reporter.   This case was linked to MOD-2021-255845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received as new events myalgia, chills, appetite absent were added. Concomitant medications were added. Start date of suspect drug for first dose was added. Patient demographic information was added. Event outcome for feeling sick, fever was updated from unknwon to recovered. Laboratory data was added. Causality of fever and myalgia updated.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Aggresive hives; No swollen lip or very small swollen but "aggresive hives"; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Aggresive hives) and LIP SWELLING (No swollen lip or very small swollen but "aggresive hives") in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 044AZ21A) 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 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced URTICARIA (Aggresive hives) and LIP SWELLING (No swollen lip or very small swollen but "aggresive hives"). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date for Hives, at a dose of UNK, bid and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Lip swelling, at a dose of UNK, bid. At the time of the report, URTICARIA (Aggresive hives) had not resolved and LIP SWELLING (No swollen lip or very small swollen but "aggresive hives") was resolving.            Patient had taken a muscle relaxer on 5/17/2021 and woke up full of hives.   This case was linked to MOD-2021-073809 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site reaction
Clinical narrative: Covid Arm; vaccination site was red and became hard; vaccination site was red and became hard; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE INDURATION (vaccination site was red and became hard) and VACCINATION SITE ERYTHEMA (vaccination site was red and became hard) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE INDURATION (vaccination site was red and became hard) and VACCINATION SITE ERYTHEMA (vaccination site was red and became hard). At the time of the report, VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE INDURATION (vaccination site was red and became hard) and VACCINATION SITE ERYTHEMA (vaccination site was red and became hard) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; rash on arm/ long rash- not uncomfortable for many days/ not at site of shot; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (itching) and RASH (rash on arm/ long rash- not uncomfortable for many days/ not at site of shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM (ATIVAN) for Anxiety.    On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 10:00 AM, the patient experienced RASH (rash on arm/ long rash- not uncomfortable for many days/ not at site of shot). On 18-Mar-2021, the patient experienced PRURITUS (itching). On 20-Mar-2021, PRURITUS (itching) and RASH (rash on arm/ long rash- not uncomfortable for many days/ not at site of shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-146376 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Feeling abnormal, Pruritus, Rash
Clinical narrative: very uncomfortable; dermatitis; Redness; Itchy; Body rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS (dermatitis), FEELING ABNORMAL (very uncomfortable), ERYTHEMA (Redness), PRURITUS (Itchy) and RASH (Body rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Allergy to chemicals (sulphur). Concomitant products included LORAZEPAM (ATIVAN) for Anxiety.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021 at 9:00 AM, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itchy). 08-Apr-2021 at 9:00 AM, the patient experienced RASH (Body rash). On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DERMATITIS (dermatitis). On an unknown date, the patient experienced FEELING ABNORMAL (very uncomfortable). The patient was treated with CLOBETASOL PROPIONATE from 10-Apr-2021 to 20-Apr-2021 for Rash, at a dose of .05 percent twice a day. On 15-Apr-2021, ERYTHEMA (Redness), PRURITUS (Itchy) and RASH (Body rash) had resolved. On 20-Apr-2021, DERMATITIS (dermatitis) had resolved. At the time of the report, FEELING ABNORMAL (very uncomfortable) outcome was unknown.            Patient reported  body rash was described as new spots appearing each day. Treatment was also provided with the use of ice packs.   This case was linked to MOD-2021-146319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Updated patient demographics[DOB]. Added allergy[Sulphur] .Updated treatment medicine dose. Added new Event [Dermatitis].
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 66-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, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved.        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 16-Jul-2021: Follow up information received, included updates related to outcome of reported events.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: Diarrhea; Injection site pain; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain). At the time of the report, DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (Injection site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nodule, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: swollen hand/forearm; pain in right elbow and now left elbow; nodules in right elbow and now left elbow; pain and nodules in right elbow and left elbow; This spontaneous case was reported by an other and describes the occurrence of PERIPHERAL SWELLING (swollen hand/forearm), PAIN IN EXTREMITY (pain in right elbow and now left elbow), NODULE (nodules in right elbow and now left elbow) and VACCINATION SITE PAIN (pain and nodules in right elbow and left elbow) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK duration, citrate free. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen hand/forearm), PAIN IN EXTREMITY (pain in right elbow and now left elbow), NODULE (nodules in right elbow and now left elbow) and VACCINATION SITE PAIN (pain and nodules in right elbow and left elbow). At the time of the report, PERIPHERAL SWELLING (swollen hand/forearm), PAIN IN EXTREMITY (pain in right elbow and now left elbow) and NODULE (nodules in right elbow and now left elbow) was resolving and VACCINATION SITE PAIN (pain and nodules in right elbow and left elbow) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products reported  No treatment products reported
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES VIRUS ON BACK; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (SHINGLES VIRUS ON BACK) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) from 12-Apr-2021 to an unknown date for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced HERPES ZOSTER (SHINGLES VIRUS ON BACK). At the time of the report, HERPES ZOSTER (SHINGLES VIRUS ON BACK) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information as not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Influenza like illness, Nasopharyngitis, Pain
Clinical narrative: Joint pain; FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE; Achy; Cold; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Joint pain), INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE), PAIN (Achy) and NASOPHARYNGITIS (Cold) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Joint pain), INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE), PAIN (Achy) and NASOPHARYNGITIS (Cold). At the time of the report, ARTHRALGIA (Joint pain) had resolved and INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE), PAIN (Achy) and NASOPHARYNGITIS (Cold) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications was not given.  Patient was off of Rinvoq for two weeks due to COVID vaccine and had joint pain that she did not had before stopping.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chromaturia, Condition aggravated, Headache, Hyperhidrosis
Clinical narrative: Sweating; Pain  legs really bad, pain in his feet; Back pain; He had allergies before but after he took the shot are worse; sleeping more/woke up later than 5:00 or 7.00 AM; running nose; chest congestion; peeing yellow; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse) and HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse), HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM), RHINORRHOEA (running nose), RESPIRATORY TRACT CONGESTION (chest congestion), CHROMATURIA (peeing yellow) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse), HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM), RHINORRHOEA (running nose), RESPIRATORY TRACT CONGESTION (chest congestion), CHROMATURIA (peeing yellow) and HEADACHE (headache) outcome was unknown.            Patient mentioned something about a sleeping machine. No concomitant medication was provided by the reporter. Patient took all kind of medicines - pain killer for treatment.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Patient refused to give anymore information.
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Pain in extremity, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Sweating; Pain  legs really bad, pain in his feet; Back pain; He had allergies before but after he took the shot are worse; sleeping more/woke up later than 5:00 or 7.00 AM; running nose; chest congestion; peeing yellow; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse) and HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse), HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM), RHINORRHOEA (running nose), RESPIRATORY TRACT CONGESTION (chest congestion), CHROMATURIA (peeing yellow) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse), HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM), RHINORRHOEA (running nose), RESPIRATORY TRACT CONGESTION (chest congestion), CHROMATURIA (peeing yellow) and HEADACHE (headache) outcome was unknown.            Patient mentioned something about a sleeping machine. No concomitant medication was provided by the reporter. Patient took all kind of medicines - pain killer for treatment.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Patient refused to give anymore information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Severe Reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE REACTION (Severe Reaction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     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. In January 2021, the patient experienced ADVERSE REACTION (Severe Reaction). At the time of the report, ADVERSE REACTION (Severe Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were received by the reporter. Treatment medication for these events were not reported by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Tinnitus, Vision blurred
Clinical narrative: Blurring of vision; Ringing of ears; Headache; Chills; Fever; This spontaneous case was reported by an other caregiver and describes the occurrence of VISION BLURRED (Blurring of vision), TINNITUS (Ringing of ears), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Environmental allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VISION BLURRED (Blurring of vision), TINNITUS (Ringing of ears), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 12-May-2021, TINNITUS (Ringing of ears), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, VISION BLURRED (Blurring of vision) and HEADACHE (Headache) had not resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose fluctuation, Chest discomfort, Musculoskeletal discomfort, Rhinalgia
Clinical narrative: Tightness in chest; Tightness in shoulder; Nose sore; Nose draining into throat; Knot on right side of stomach; Tight on right side of stomach; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), MUSCULOSKELETAL DISCOMFORT (Tightness in shoulder), RHINALGIA (Nose sore), RHINORRHOEA (Nose draining into throat) and STOMACH MASS (Knot on right side of stomach) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 11-May-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 CHEST DISCOMFORT (Tightness in chest), MUSCULOSKELETAL DISCOMFORT (Tightness in shoulder), RHINALGIA (Nose sore), RHINORRHOEA (Nose draining into throat), STOMACH MASS (Knot on right side of stomach) and ABDOMINAL DISCOMFORT (Tight on right side of stomach). At the time of the report, CHEST DISCOMFORT (Tightness in chest), MUSCULOSKELETAL DISCOMFORT (Tightness in shoulder), RHINALGIA (Nose sore), RHINORRHOEA (Nose draining into throat), STOMACH MASS (Knot on right side of stomach) and ABDOMINAL DISCOMFORT (Tight on right side of stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood glucose fluctuation: 215 mg/dl (High) blood sugar was 215. On 19-May-2021, Blood glucose fluctuation: 178 mg/dl (High) then 168, then 215.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was reported. No treatment was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Stomach mass
Clinical narrative: Tightness in chest; Tightness in shoulder; Nose sore; Nose draining into throat; Knot on right side of stomach; Tight on right side of stomach; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), MUSCULOSKELETAL DISCOMFORT (Tightness in shoulder), RHINALGIA (Nose sore), RHINORRHOEA (Nose draining into throat) and STOMACH MASS (Knot on right side of stomach) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 11-May-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 CHEST DISCOMFORT (Tightness in chest), MUSCULOSKELETAL DISCOMFORT (Tightness in shoulder), RHINALGIA (Nose sore), RHINORRHOEA (Nose draining into throat), STOMACH MASS (Knot on right side of stomach) and ABDOMINAL DISCOMFORT (Tight on right side of stomach). At the time of the report, CHEST DISCOMFORT (Tightness in chest), MUSCULOSKELETAL DISCOMFORT (Tightness in shoulder), RHINALGIA (Nose sore), RHINORRHOEA (Nose draining into throat), STOMACH MASS (Knot on right side of stomach) and ABDOMINAL DISCOMFORT (Tight on right side of stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Blood glucose fluctuation: 215 mg/dl (High) blood sugar was 215. On 19-May-2021, Blood glucose fluctuation: 178 mg/dl (High) then 168, then 215.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Poor quality sleep
Clinical narrative: slept poorly; Headache; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (slept poorly) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (slept poorly) and HEADACHE (Headache). At the time of the report, POOR QUALITY SLEEP (slept poorly) and HEADACHE (Headache) had resolved.            No concomitant medications were reported.  It was reported that the patient experienced headache and slept poorly after receiving the second vaccination dose. The events resolved the following day and the patient did not face any further issues.  No treatment medications were reported.   This case was linked to MOD-2021-067578, US-MODERNATX, INC.-MOD-2021-067578 (E2B Linked Report).; Sender's Comments:  MOD-2021-067578:Dose 1 US-MODERNATX, INC.-MOD-2021-067578:Dose 1
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Endoscopy, Gastritis, Weight decreased
Clinical narrative: My appetite went away; A lot of inflammation in my stomach; Lost weight, around 10 pounds; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTRITIS (A lot of inflammation in my stomach), WEIGHT DECREASED (Lost weight, around 10 pounds) and DECREASED APPETITE (My appetite went away) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-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 WEIGHT DECREASED (Lost weight, around 10 pounds). On 23-Apr-2021, the patient experienced GASTRITIS (A lot of inflammation in my stomach). In May 2021, the patient experienced DECREASED APPETITE (My appetite went away). At the time of the report, GASTRITIS (A lot of inflammation in my stomach), WEIGHT DECREASED (Lost weight, around 10 pounds) and DECREASED APPETITE (My appetite went away) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Endoscopy: normal (normal) normal.         No relevant concomitant medications were reported.  Treatment medications included unspecified medication for stomach and serum.  DIAGNOSTIC RESULTS  On an unknown date, ultrasound and unspecified tests for bacterial infection: Normal  On an unknown date, Endoscopy: normal   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcome and lab data were provided.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Myalgia, Nausea
Clinical narrative: dizziness; being unable to balance; nausea; chills; neck pain; arm pain; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (neck pain), BALANCE DISORDER (being unable to balance), DIZZINESS (dizziness), MYALGIA (arm pain) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product zyrtec for an unknown indication.    Concomitant products included ISOSORBIDE MONONITRATE, ATENOLOL, DULOXETINE HYDROCHLORIDE (CYMBALTA), LEVOTHYROXINE, lisinopril-hctz, BUPROPION and aspirin.   On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient started zyrtec (unknown route) at an unspecified dose. On 17-May-2021, the patient experienced NECK PAIN (neck pain) and MYALGIA (arm pain). On 18-May-2021, the patient experienced BALANCE DISORDER (being unable to balance), NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (dizziness). On 18-May-2021, NECK PAIN (neck pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: dizziness; being unable to balance; nausea; chills; neck pain; arm pain; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (neck pain), BALANCE DISORDER (being unable to balance), DIZZINESS (dizziness), MYALGIA (arm pain) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product zyrtec for an unknown indication.    Concomitant products included ISOSORBIDE MONONITRATE, ATENOLOL, DULOXETINE HYDROCHLORIDE (CYMBALTA), LEVOTHYROXINE, lisinopril-hctz, BUPROPION and aspirin.   On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient started zyrtec (unknown route) at an unspecified dose. On 17-May-2021, the patient experienced NECK PAIN (neck pain) and MYALGIA (arm pain). On 18-May-2021, the patient experienced BALANCE DISORDER (being unable to balance), NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced DIZZINESS (dizziness). On 18-May-2021, NECK PAIN (neck pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nail discolouration, Skin discolouration, Sweat discolouration
Clinical narrative: Sweating purple pigment; purplish tinge to her hands; Purple pigment under nails; Body Aches; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NAIL DISCOLOURATION (Purple pigment under nails), SWEAT DISCOLOURATION (Sweating purple pigment), INFLUENZA LIKE ILLNESS (Flu-like symptoms), SKIN DISCOLOURATION (purplish tinge to her hands) and MYALGIA (Body Aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 032B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MYALGIA (Body Aches). On 18-May-2021, the patient experienced NAIL DISCOLOURATION (Purple pigment under nails) and SKIN DISCOLOURATION (purplish tinge to her hands). On 19-May-2021, the patient experienced SWEAT DISCOLOURATION (Sweating purple pigment). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MYALGIA (Body Aches) had resolved. At the time of the report, NAIL DISCOLOURATION (Purple pigment under nails) had not resolved and SWEAT DISCOLOURATION (Sweating purple pigment) and SKIN DISCOLOURATION (purplish tinge to her hands) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable