chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dizziness
Clinical narrative: Mild Cough that is worsening; dizziness; lightheadedness; loose stools; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Mild Cough that is worsening), DIZZINESS (dizziness), DIZZINESS (lightheadedness) and DIARRHOEA (loose stools) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Mild Cough that is worsening), DIZZINESS (dizziness), DIZZINESS (lightheadedness) and DIARRHOEA (loose stools). At the time of the report, COUGH (Mild Cough that is worsening), DIZZINESS (dizziness), DIZZINESS (lightheadedness) and DIARRHOEA (loose stools) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Muscle tightness, Tinnitus
Clinical narrative: Dizziness; Tightening around the circumfrence of my face; Tinnitus got worse; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MUSCLE TIGHTNESS (Tightening around the circumfrence of my face), TINNITUS (Tinnitus got worse), FATIGUE (Fatigue) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness), MUSCLE TIGHTNESS (Tightening around the circumfrence of my face), TINNITUS (Tinnitus got worse), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), MUSCLE TIGHTNESS (Tightening around the circumfrence of my face), TINNITUS (Tinnitus got worse), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: is worm to the touch; injection site (L arm) started to burning and is itchy; injection site (L arm) started to burning and is itchy; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache), VACCINATION SITE PAIN (injection site (L arm) started to burning and is itchy), VACCINATION SITE PRURITUS (injection site (L arm) started to burning and is itchy) and VACCINATION SITE WARMTH (is worm to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (slight headache). On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site (L arm) started to burning and is itchy) and VACCINATION SITE PRURITUS (injection site (L arm) started to burning and is itchy). On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (is worm to the touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 20-Feb-2021, HEADACHE (slight headache) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site (L arm) started to burning and is itchy), VACCINATION SITE PRURITUS (injection site (L arm) started to burning and is itchy) and VACCINATION SITE WARMTH (is worm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Cholesterol. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatmment Information was not reported.  Concomitant medications included unspecified cholesterol medication and unspecified hypertension medication.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pain
Clinical narrative: low grade flu; body pain; pain at injection site; fatigue; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 74-year-old male 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.     Concurrent medical conditions included Disability (disability in both feet) and Autoimmune disorder NOS.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: low grade flu; body pain; pain at injection site; fatigue; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 74-year-old male 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.     Concurrent medical conditions included Disability (disability in both feet) and Autoimmune disorder NOS.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (low grade flu), PAIN (body pain), VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: infection - left arm; hot at the site - left arm; hard at the site - left arm; very itchy at the site - left arm; rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches; red marks at site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection - left arm), INJECTION SITE WARMTH (hot at the site - left arm), VACCINATION SITE INDURATION (hard at the site - left arm), INJECTION SITE PRURITUS (very itchy at the site - left arm) and INJECTION SITE RASH (rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection - left arm), INJECTION SITE WARMTH (hot at the site - left arm), VACCINATION SITE INDURATION (hard at the site - left arm), INJECTION SITE PRURITUS (very itchy at the site - left arm), INJECTION SITE RASH (rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches) and INJECTION SITE ERYTHEMA (red marks at site - left arm). At the time of the report, INFECTION (infection - left arm), INJECTION SITE WARMTH (hot at the site - left arm), VACCINATION SITE INDURATION (hard at the site - left arm), INJECTION SITE PRURITUS (very itchy at the site - left arm), INJECTION SITE RASH (rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches) and INJECTION SITE ERYTHEMA (red marks at site - left arm) 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 medications include Bactrim, Benadryl,Fluocinonide ointment twice daily.  Patient provided consent for safety to Follow-up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: infection - left arm; hot at the site - left arm; hard at the site - left arm; very itchy at the site - left arm; rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches; red marks at site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection - left arm), INJECTION SITE WARMTH (hot at the site - left arm), VACCINATION SITE INDURATION (hard at the site - left arm), INJECTION SITE PRURITUS (very itchy at the site - left arm) and INJECTION SITE RASH (rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection - left arm), INJECTION SITE WARMTH (hot at the site - left arm), VACCINATION SITE INDURATION (hard at the site - left arm), INJECTION SITE PRURITUS (very itchy at the site - left arm), INJECTION SITE RASH (rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches) and INJECTION SITE ERYTHEMA (red marks at site - left arm). At the time of the report, INFECTION (infection - left arm), INJECTION SITE WARMTH (hot at the site - left arm), VACCINATION SITE INDURATION (hard at the site - left arm), INJECTION SITE PRURITUS (very itchy at the site - left arm), INJECTION SITE RASH (rash that got bigger - left arm - started of small 1 inch by 1/2 inch got to be about 4 inches by 2 inches) and INJECTION SITE ERYTHEMA (red marks at site - left arm) 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 medications include Bactrim, Benadryl,Fluocinonide ointment twice daily.  Patient provided consent for safety to Follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Heart rate, Pyrexia
Clinical narrative: chills; temperature of 100.4 ºF; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (temperature of 100.4 ºF) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D 3), VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ZINC for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (temperature of 100.4 ºF). At the time of the report, CHILLS (chills) and PYREXIA (temperature of 100.4 ºF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: 141/76 (Inconclusive) unknown. On 04-Mar-2021, Body temperature: 100.4 (Inconclusive) Patient had temperature of 100.4 ºF. On 04-Mar-2021, Heart rate: 111 (Inconclusive) Patient had pulse of 111. On an unknown date, Body temperature: 100.3 (Inconclusive) Patient's temperature  was 100.3 ºF but still not normal.     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.   Patient also took blood pressure medications and aspirin (they stopped taking aspirin to take the vaccine).Patient also took lemon with ginger tea and Tylenol. He was walking and taking water.  Concomitant medication include Omega 3.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: TCR added(Fax number).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nasal congestion, Pyrexia, Rash
Clinical narrative: stuffy; rash on neck; Rash on arms; Rash on side; Rash on groin; Fatigue; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy), RASH (rash on neck), RASH (Rash on arms), RASH (Rash on side) and RASH (Rash on groin) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 Benedryl, PARACETAMOL (TYLENOL), Zonagram, VERAPAMIL, DESVENLAFAXINE SUCCINATE (PRISTIQ), Trazadone, Adavan and Marpax for an unknown indication, levathyroxine.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (fever). On 05-Mar-2021, the patient experienced NASAL CONGESTION (stuffy), RASH (rash on neck), RASH (Rash on arms), RASH (Rash on side) and RASH (Rash on groin). At the time of the report, NASAL CONGESTION (stuffy), RASH (rash on neck), RASH (Rash on arms), RASH (Rash on side), RASH (Rash on groin), FATIGUE (Fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Neck pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: extremely itchy; whole body is covered with rash; slight fever; sore arm; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extremely itchy), PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache), RASH (whole body is covered with rash) and PYREXIA (slight fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache) and PYREXIA (slight fever). On 06-Mar-2021, the patient experienced PRURITUS (extremely itchy) and RASH (whole body is covered with rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (extremely itchy), PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache), RASH (whole body is covered with rash) and PYREXIA (slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f and 98.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: extremely itchy; whole body is covered with rash; slight fever; sore arm; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extremely itchy), PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache), RASH (whole body is covered with rash) and PYREXIA (slight fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache) and PYREXIA (slight fever). On 06-Mar-2021, the patient experienced PRURITUS (extremely itchy) and RASH (whole body is covered with rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (extremely itchy), PAIN IN EXTREMITY (sore arm), NECK PAIN (neck ache), RASH (whole body is covered with rash) and PYREXIA (slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f and 98.5 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Peripheral swelling, Pruritus, Rash
Clinical narrative: itchy; blisters on skin; terrible rash in his shoulder; shoulder was hurting; injection site swelling; injection site redness; discharge; arm became bright pink; arm was getting warm; swelling arm; puffy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), SKIN SWELLING (puffy arm), PRURITUS (itchy), BLISTER (blisters on skin) and VACCINATION SITE WARMTH (arm was getting warm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling arm), SKIN SWELLING (puffy arm) and VACCINATION SITE WARMTH (arm was getting warm). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became bright pink). On 24-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (discharge). On an unknown date, the patient experienced PRURITUS (itchy), BLISTER (blisters on skin), RASH (terrible rash in his shoulder), ARTHRALGIA (shoulder was hurting), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 16-Feb-2021, PERIPHERAL SWELLING (swelling arm) and SKIN SWELLING (puffy arm) had resolved, VACCINATION SITE WARMTH (arm was getting warm) outcome was unknown. On 24-Feb-2021, VACCINATION SITE ERYTHEMA (arm became bright pink) had resolved. At the time of the report, PRURITUS (itchy), BLISTER (blisters on skin), VACCINATION SITE DISCHARGE (discharge), RASH (terrible rash in his shoulder), ARTHRALGIA (shoulder was hurting), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) 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.   Concomitant medication not reported.  Treatment medication not reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Skin swelling, Vaccination site discharge, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itchy; blisters on skin; terrible rash in his shoulder; shoulder was hurting; injection site swelling; injection site redness; discharge; arm became bright pink; arm was getting warm; swelling arm; puffy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), SKIN SWELLING (puffy arm), PRURITUS (itchy), BLISTER (blisters on skin) and VACCINATION SITE WARMTH (arm was getting warm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling arm), SKIN SWELLING (puffy arm) and VACCINATION SITE WARMTH (arm was getting warm). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became bright pink). On 24-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (discharge). On an unknown date, the patient experienced PRURITUS (itchy), BLISTER (blisters on skin), RASH (terrible rash in his shoulder), ARTHRALGIA (shoulder was hurting), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 16-Feb-2021, PERIPHERAL SWELLING (swelling arm) and SKIN SWELLING (puffy arm) had resolved, VACCINATION SITE WARMTH (arm was getting warm) outcome was unknown. On 24-Feb-2021, VACCINATION SITE ERYTHEMA (arm became bright pink) had resolved. At the time of the report, PRURITUS (itchy), BLISTER (blisters on skin), VACCINATION SITE DISCHARGE (discharge), RASH (terrible rash in his shoulder), ARTHRALGIA (shoulder was hurting), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) 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.   Concomitant medication not reported.  Treatment medication not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Illness
Clinical narrative: DIARRHEA; BODY PAIN ALL OVER; CHILLS; MUSCLE PAIN; FATIGUE; HEADACHE; COULDENT SLEEP; VERY SICK; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), SLEEP DISORDER (COULDENT SLEEP), DIARRHOEA (DIARRHEA), PAIN (BODY PAIN ALL OVER) and CHILLS (CHILLS) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pancreatitis (pancreatitis 10 years ago.). Concurrent medical conditions included Arthritis and Difficult digestion. Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (VERY SICK). On an unknown date, the patient experienced SLEEP DISORDER (COULDENT SLEEP), DIARRHOEA (DIARRHEA), PAIN (BODY PAIN ALL OVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), FATIGUE (FATIGUE) and HEADACHE (HEADACHE). At the time of the report, ILLNESS (VERY SICK), SLEEP DISORDER (COULDENT SLEEP), PAIN (BODY PAIN ALL OVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), FATIGUE (FATIGUE) and HEADACHE (HEADACHE) outcome was unknown.            Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Sleep disorder
Clinical narrative: DIARRHEA; BODY PAIN ALL OVER; CHILLS; MUSCLE PAIN; FATIGUE; HEADACHE; COULDENT SLEEP; VERY SICK; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), SLEEP DISORDER (COULDENT SLEEP), DIARRHOEA (DIARRHEA), PAIN (BODY PAIN ALL OVER) and CHILLS (CHILLS) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pancreatitis (pancreatitis 10 years ago.). Concurrent medical conditions included Arthritis and Difficult digestion. Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (VERY SICK). On an unknown date, the patient experienced SLEEP DISORDER (COULDENT SLEEP), DIARRHOEA (DIARRHEA), PAIN (BODY PAIN ALL OVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), FATIGUE (FATIGUE) and HEADACHE (HEADACHE). At the time of the report, ILLNESS (VERY SICK), SLEEP DISORDER (COULDENT SLEEP), PAIN (BODY PAIN ALL OVER), CHILLS (CHILLS), MYALGIA (MUSCLE PAIN), FATIGUE (FATIGUE) and HEADACHE (HEADACHE) outcome was unknown.            Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Lip blister, Stomatitis
Clinical narrative: fever blister in her lower lip; roof of mouth/gum line is sensitive; roof of mouth/gum line is numb; metallic taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (fever blister in her lower lip), STOMATITIS (roof of mouth/gum line is sensitive), HYPOAESTHESIA ORAL (roof of mouth/gum line is numb) and DYSGEUSIA (metallic taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease. Concurrent medical conditions included Drug allergy (Patient have allergy towards sulfa drug and hydrocodone.), Latex allergy and Seasonal allergy. Concomitant products included ALLOPURINOL for Arthritis gouty, METOPROLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CALCIUM, MAGNESIUM and ZINC for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LIP BLISTER (fever blister in her lower lip), STOMATITIS (roof of mouth/gum line is sensitive), HYPOAESTHESIA ORAL (roof of mouth/gum line is numb) and DYSGEUSIA (metallic taste). At the time of the report, LIP BLISTER (fever blister in her lower lip), STOMATITIS (roof of mouth/gum line is sensitive), HYPOAESTHESIA ORAL (roof of mouth/gum line is numb) and DYSGEUSIA (metallic taste) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details was given.  After 15 minutes, patient experienced a fever blister in her lower lip (sometimes caused by HPV1 or stress), roof of mouth/gum line is sensitive and numb (swelling/blistering) and metallic taste. Symptoms are still evident today and patient states that it is not severe.   Treatment Took abreva cream on the fever blister
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: a lot of pain in their hips; he pain has moved down to both their knees; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (a lot of pain in their hips) and ARTHRALGIA (he pain has moved down to both their knees) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, APIXABAN (ELIQUIS) and METHIMAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (a lot of pain in their hips) and ARTHRALGIA (he pain has moved down to both their knees). At the time of the report, ARTHRALGIA (a lot of pain in their hips) and ARTHRALGIA (he pain has moved down to both their knees) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, X-ray: Normal.     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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: Body aches; Diarrhea; Chills/Shaking chills; Headache; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Urinary tract infection (urinary track infection on 03-JAN-2021 in the morning and given an antibiotic at urgent care.) since 03-Jan-2020. Concomitant products included LOVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99 degree Celsius (Inconclusive) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications were taken for blood pressure and other antibiotics. Treatment information in response to events was not provided.  Received Moderna vaccine while on antibiotic
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Body aches; Diarrhea; Chills/Shaking chills; Headache; Muscle pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Urinary tract infection (urinary track infection on 03-JAN-2021 in the morning and given an antibiotic at urgent care.) since 03-Jan-2020. Concomitant products included LOVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea), CHILLS (Chills/Shaking chills), HEADACHE (Headache), MYALGIA (Muscle pain) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99 degree Celsius (Inconclusive) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications were taken for blood pressure and other antibiotics. Treatment information in response to events was not provided.  Received Moderna vaccine while on antibiotic
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Hot feeling at injection site; Feeling Tired; Rash at injection site; Pain and tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot feeling at injection site), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain and tenderness) and FATIGUE (Feeling Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, ALLOPURINOL, TRIMETHOPRIM, FUROSEMIDE, CETIRIZINE HYDROCHLORIDE (ALLER TEC), FISH OIL, CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]), BACILLUS COAGULANS (DIGESTIVE ADVANTAGE [BACILLUS COAGULANS]), VITAMIN D3 and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 24-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 VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain and tenderness). On 05-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot feeling at injection site) and FATIGUE (Feeling Tired). At the time of the report, VACCINATION SITE WARMTH (Hot feeling at injection site), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain and tenderness) and FATIGUE (Feeling Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site warm; injection site itchy; injection site red; injection site slightly raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site slightly raised) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site slightly raised). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) for Itching, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site slightly raised) 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.   Patient kept Cold compresses.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Feel a little achy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PAIN (Feel a little achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol), Drug allergy (aspirin) and Drug allergy. (ibuprofen).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced CHILLS (Chills) and PAIN (Feel a little achy). At the time of the report, CHILLS (Chills) and PAIN (Feel a little achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     The wife of the patient called because her husband was concerned. She inquired about about what her husband  can take after second shot if husband develops a fever or headache or anything similar. She asked if the second shot the same as the first one. If they are the same, they will not worry too much. And she was concerned because she heard the second dose is worse.   Reporter did not allow further phone contact.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: left arm soreness at injection site; left neck swollen lymph nodes; left arm hot at injection site; left arm swollen at injection site; left arm hard at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (left arm soreness at injection site), INJECTION SITE SWELLING (left arm swollen at injection site), INJECTION SITE INDURATION (left arm hard at injection site), SWELLING (left neck swollen lymph nodes) and INJECTION SITE WARMTH (left arm hot at injection site) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ISOSORBIDE MONONITRATE, CLOPIDOGREL, CARVEDILOL, GABAPENTIN, ROSUVASTATIN, RANOLAZINE (RANEXA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and SERTRALINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE SWELLING (left arm swollen at injection site), INJECTION SITE INDURATION (left arm hard at injection site) and INJECTION SITE WARMTH (left arm hot at injection site). On 05-Feb-2021, the patient experienced SWELLING (left neck swollen lymph nodes). On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (left arm soreness at injection site). At the time of the report, INJECTION SITE PAIN (left arm soreness at injection site), INJECTION SITE SWELLING (left arm swollen at injection site), INJECTION SITE INDURATION (left arm hard at injection site), SWELLING (left neck swollen lymph nodes) and INJECTION SITE WARMTH (left arm hot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain after the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    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, the patient experienced PAIN IN EXTREMITY (arm pain after the second dose). At the time of the report, PAIN IN EXTREMITY (arm pain after the second dose) outcome was unknown. Not Provided          No concomitant and treatment medications were provided.   This case was linked to MOD-2021-035864 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly). At the time of the report, DIZZINESS (Light headed whenever she got out of bed, sat down or tried to get up quickly/ Gets dizzy and feels light headed when she moves her head too quickly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Severe reaction to second shot, might be an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Severe reaction to second shot, might be an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ALLERGY TO VACCINE (Severe reaction to second shot, might be an allergic reaction). At the time of the report, ALLERGY TO VACCINE (Severe reaction to second shot, might be an allergic reaction) outcome was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity
Clinical narrative: his arm hurt so bad, he wanted to amputate it; carpal tunnel/arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his arm hurt so bad, he wanted to amputate it) and ARTHRITIS (carpal tunnel/arthritis pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Wrist pain (carpal tunnel/arthritis pain in wrists).    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (his arm hurt so bad, he wanted to amputate it). On an unknown date, the patient experienced ARTHRITIS (carpal tunnel/arthritis pain). On 19-Feb-2021, PAIN IN EXTREMITY (his arm hurt so bad, he wanted to amputate it) had resolved. At the time of the report, ARTHRITIS (carpal tunnel/arthritis pain) had resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Nausea, Pain in extremity
Clinical narrative: sore arm; nausea; feel tired; horrific headache; felt very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt very lethargic), PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (feel tired) and HEADACHE (horrific headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and COVID-19.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LETHARGY (felt very lethargic), NAUSEA (nausea), FATIGUE (feel tired) and HEADACHE (horrific headache). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LETHARGY (felt very lethargic), PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), FATIGUE (feel tired) and HEADACHE (horrific headache) 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.   The patient takes CBD capsules daily.