chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Nausea, Paraesthesia
Clinical narrative: Difficulty in breathing; Body tingle; Nausea; Fatigue; Swollen at the site of injection; Fever; Chills; Redness at site of injection; Pain at the site of injection; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management. Concomitant products included LEVOTHYROXINE, IOVERSOL (IVERSENSE) and DILTIAZEM HYDROCHLORIDE (DILT-XR) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen at the site of injection), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at the site of injection) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen at the site of injection), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at the site of injection) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included blood pressure medication. The patient underwent Covid-19 test at work and results were not available.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Difficulty in breathing; Body tingle; Nausea; Fatigue; Swollen at the site of injection; Fever; Chills; Redness at site of injection; Pain at the site of injection; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management. Concomitant products included LEVOTHYROXINE, IOVERSOL (IVERSENSE) and DILTIAZEM HYDROCHLORIDE (DILT-XR) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen at the site of injection), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at the site of injection) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty in breathing), PARAESTHESIA (Body tingle), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swollen at the site of injection), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness at site of injection), VACCINATION SITE PAIN (Pain at the site of injection) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included blood pressure medication. The patient underwent Covid-19 test at work and results were not available.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Fatigue, Myalgia, Pyrexia
Clinical narrative: Disorientation; Chills / Teeth chatter; Fever; Body ache; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (Disorientation), CHILLS (Chills / Teeth chatter), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DISORIENTATION (Disorientation), CHILLS (Chills / Teeth chatter), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Disorientation, Chills, Fever, Fatigue and Myalgia, at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disorientation), CHILLS (Chills / Teeth chatter), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-056490 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: left deltoid pain, worse with movement; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (left deltoid pain, worse with movement) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-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 INJECTION SITE PAIN (left deltoid pain, worse with movement). At the time of the report, INJECTION SITE PAIN (left deltoid pain, worse with movement) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue
Clinical narrative: arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front; bit tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front) and FATIGUE (bit tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (bit tired). On 27-Feb-2021, the patient experienced ERYTHEMA (arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Redness, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (arm was pinkish red spreading from shoulder down to almost hiselbow at the bend then goes to the front) and FATIGUE (bit tired) was resolving.            Concomitant medications were not provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 01-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 02-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache
Clinical narrative: every bone in body hurting; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone in body hurting), CHILLS (chills) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LOVASTATIN, LISINOPRIL, MONTELUKAST, CETIRIZINE, FINASTERIDE, MELOXICAM, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FISH OIL and VITAMINS;MINERALS;LYSINE 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 28-Feb-2021, the patient experienced BONE PAIN (every bone in body hurting), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of twice. At the time of the report, BONE PAIN (every bone in body hurting), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include AERDS. Patient consumed lots of water along with Tylenol treatment
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Developed high level fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed high level fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Developed high level fever). At the time of the report, PYREXIA (Developed high level fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Pain in extremity, Somnolence
Clinical narrative: shingles at the same time; very tired; so sleepy; arm is hurting and aching a lot, very very sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (so sleepy), PAIN IN EXTREMITY (arm is hurting and aching a lot, very very sore), HERPES ZOSTER (shingles at the same time) and FATIGUE (very tired) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included irritation (On Head) on 27-Jan-2021.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SOMNOLENCE (so sleepy), PAIN IN EXTREMITY (arm is hurting and aching a lot, very very sore) and FATIGUE (very tired). On an unknown date, the patient experienced HERPES ZOSTER (shingles at the same time). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (so sleepy), PAIN IN EXTREMITY (arm is hurting and aching a lot, very very sore), HERPES ZOSTER (shingles at the same time) and FATIGUE (very tired) outcome was unknown.            No Concomitant medications were provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vomiting
Clinical narrative: General aches and pains all over body; Waves of chills like never before; Headache; Vomiting; vomited on empty stomach; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (General aches and pains all over body), CHILLS (Waves of chills like never before), HEADACHE (Headache) and VOMITING (Vomiting; vomited on empty stomach) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (General aches and pains all over body), CHILLS (Waves of chills like never before), HEADACHE (Headache) and VOMITING (Vomiting; vomited on empty stomach). At the time of the report, MYALGIA (General aches and pains all over body), CHILLS (Waves of chills like never before), HEADACHE (Headache) and VOMITING (Vomiting; vomited on empty stomach) outcome was unknown.            The patient did not receive any treatment medications.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Limited motion of arm.; very severe pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Limited motion of arm.) and VACCINATION SITE PAIN (very severe pain in the arm of injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Limited motion of arm.) and VACCINATION SITE PAIN (very severe pain in the arm of injection). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Limited motion of arm.) and VACCINATION SITE PAIN (very severe pain in the arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pruritus, Rash, Vaccination site pain
Clinical narrative: itching; hot at the injection; rash; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE WARMTH (hot at the injection), RASH (rash) and VACCINATION SITE PAIN (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), INJECTION SITE WARMTH (hot at the injection), RASH (rash) and VACCINATION SITE PAIN (soreness). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), INJECTION SITE WARMTH (hot at the injection), RASH (rash) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site bruising, Injection site mass, Injection site warmth
Clinical narrative: hot arm; red arm; painful arm; warm arm; raised lump; arm swelling; injection site bruise; hard lump; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (painful arm), INJECTION SITE WARMTH (warm arm) and INJECTION SITE MASS (raised lump) in a 71-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.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, Drug allergy (Allergies to anesthesia and statins), Diabetes, Diabetic neuropathy and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), EZETIMIBE (ZETIA), HYDROCHLOROTHIAZIDE, INSULIN ASPART (NOVOLOG), INSULIN GLARGINE (LANTUS), METFORMIN, LISINOPRIL, MONTELUKAST and PROPRANOLOL 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 26-Feb-2021, the patient experienced MYALGIA (Body aches). On 27-Feb-2021, the patient experienced FEELING HOT (hot arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (painful arm), INJECTION SITE WARMTH (warm arm), INJECTION SITE MASS (raised lump), PERIPHERAL SWELLING (arm swelling), INJECTION SITE BRUISING (injection site bruise) and INJECTION SITE MASS (hard lump). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Body aches) had resolved. At the time of the report, FEELING HOT (hot arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (painful arm), INJECTION SITE WARMTH (warm arm), INJECTION SITE MASS (raised lump), PERIPHERAL SWELLING (arm swelling), INJECTION SITE BRUISING (injection site bruise) and INJECTION SITE MASS (hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include ice packs.    Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up :- Follow up received on 13-MAY-2021 and AE contact information updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: hot arm; red arm; painful arm; warm arm; raised lump; arm swelling; injection site bruise; hard lump; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (painful arm), INJECTION SITE WARMTH (warm arm) and INJECTION SITE MASS (raised lump) in a 71-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.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, Drug allergy (Allergies to anesthesia and statins), Diabetes, Diabetic neuropathy and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), EZETIMIBE (ZETIA), HYDROCHLOROTHIAZIDE, INSULIN ASPART (NOVOLOG), INSULIN GLARGINE (LANTUS), METFORMIN, LISINOPRIL, MONTELUKAST and PROPRANOLOL 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 26-Feb-2021, the patient experienced MYALGIA (Body aches). On 27-Feb-2021, the patient experienced FEELING HOT (hot arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (painful arm), INJECTION SITE WARMTH (warm arm), INJECTION SITE MASS (raised lump), PERIPHERAL SWELLING (arm swelling), INJECTION SITE BRUISING (injection site bruise) and INJECTION SITE MASS (hard lump). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Body aches) had resolved. At the time of the report, FEELING HOT (hot arm), ERYTHEMA (red arm), PAIN IN EXTREMITY (painful arm), INJECTION SITE WARMTH (warm arm), INJECTION SITE MASS (raised lump), PERIPHERAL SWELLING (arm swelling), INJECTION SITE BRUISING (injection site bruise) and INJECTION SITE MASS (hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include ice packs.    Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up :- Follow up received on 13-MAY-2021 and AE contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills) and FATIGUE (Tired) 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 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.   Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever (101.3F; chills (violently shaking and lasted about 1.5 hours, hard to talk and walk; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (101.3F) and CHILLS (chills (violently shaking and lasted about 1.5 hours, hard to talk and walk) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever (101.3F) and CHILLS (chills (violently shaking and lasted about 1.5 hours, hard to talk and walk). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever (101.3F) and CHILLS (chills (violently shaking and lasted about 1.5 hours, hard to talk and walk) had resolved.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: slight fever; headache; 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 PYREXIA (slight fever) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, PYREXIA (slight fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-029277 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029277:MOD21-025933
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included NAPROXEN from 02-Feb-2021 to an unknown date for Migraine, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Lip swelling, Pruritus
Clinical narrative: allergic reaction; Itching in the Lips and entire body; Swollen Lips Feeling ( in the mirror they did not appear swollen); This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction), PRURITUS (Itching in the Lips and entire body) and LIP SWELLING (Swollen Lips Feeling ( in the mirror they did not appear swollen)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction), PRURITUS (Itching in the Lips and entire body) and LIP SWELLING (Swollen Lips Feeling ( in the mirror they did not appear swollen)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 13-Feb-2021, ALLERGY TO VACCINE (allergic reaction), PRURITUS (Itching in the Lips and entire body) and LIP SWELLING (Swollen Lips Feeling ( in the mirror they did not appear swollen)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Her Allergist told her that she might be allergic to PEG2000 in Moderna COVID-19 vaccine and recommended to get the Johnson & Johnson Vaccine (does not contain PEG) as the second shot.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Tiredness; Fever; Sore arm for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Tiredness), PYREXIA (Fever) and MYALGIA (Sore arm for 12 hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Tiredness), PYREXIA (Fever) and MYALGIA (Sore arm for 12 hours). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 25-Feb-2021, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Sore arm for 12 hours) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.        Treatment drug reported  NSAIDS after 2nd dose of vaccination   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information  As per follow-up( received on APR 29 2021): updated the lot numbers of vaccines (both 1 and 2), updated the date of ist moderna vaccine, updated the dates of Events, changed the outcome of events from unknown to recovered/ resolved , added the event "sore arm"
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Injection site pain, Myalgia, Visual impairment
Clinical narrative: Lost taste; Delayed visual approach left eye/right eye; Joint pain in all body; Muscle pain; Pain in IS; A spontaneous report (United States), was received from a consumer (patient), an 81 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medication was reported.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 010M20A), intramuscular for the prophylaxis of COVID-19 infection.  On 30 Jan 2021, after the vaccine was administered, the patient experienced pain in injection site, muscle pain and joint pain all body. 0n 02 Feb 2021, the patient noticed vision effect and experienced delayed visual approach in left eye. On 04 Feb 2021, there was no focus in left eye. On 05 Feb 2021, the same problem delayed visual approach started in right eye. The patient still got problems in right eye. The patient also lost taste few days ago on an unknown date. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of the event, delayed visual approach left eye/right eye was not resolved, and that of events lost taste, joint pain in all body, muscle pain, and pain in IS, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurting). At the time of the report, PAIN IN EXTREMITY (arm hurting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: no energy; headache; fatigue; Pain; sluggish; gets a little cold and hot; feels awful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SLUGGISHNESS (sluggish), FEELING OF BODY TEMPERATURE CHANGE (gets a little cold and hot), FEELING ABNORMAL (feels awful) and ASTHENIA (no energy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Pain), SLUGGISHNESS (sluggish), FEELING OF BODY TEMPERATURE CHANGE (gets a little cold and hot), FEELING ABNORMAL (feels awful), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ASTHENIA (no energy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), SLUGGISHNESS (sluggish), FEELING OF BODY TEMPERATURE CHANGE (gets a little cold and hot), FEELING ABNORMAL (feels awful), ASTHENIA (no energy), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sluggishness
Clinical narrative: no energy; headache; fatigue; Pain; sluggish; gets a little cold and hot; feels awful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SLUGGISHNESS (sluggish), FEELING OF BODY TEMPERATURE CHANGE (gets a little cold and hot), FEELING ABNORMAL (feels awful) and ASTHENIA (no energy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Pain), SLUGGISHNESS (sluggish), FEELING OF BODY TEMPERATURE CHANGE (gets a little cold and hot), FEELING ABNORMAL (feels awful), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ASTHENIA (no energy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), SLUGGISHNESS (sluggish), FEELING OF BODY TEMPERATURE CHANGE (gets a little cold and hot), FEELING ABNORMAL (feels awful), ASTHENIA (no energy), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vomiting
Clinical narrative: Body Aches; Vomited; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches), VOMITING (Vomited) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (Body Aches), VOMITING (Vomited) and HEADACHE (Headache). At the time of the report, MYALGIA (Body Aches), VOMITING (Vomited) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Night sweats, Pyrexia
Clinical narrative: night sweats; swelling of lymph nodes; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), LYMPHADENOPATHY (swelling of lymph nodes), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats), LYMPHADENOPATHY (swelling of lymph nodes), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, NIGHT SWEATS (night sweats), LYMPHADENOPATHY (swelling of lymph nodes), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema
Clinical narrative: red rash; redness at the site of the injection after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and VACCINATION SITE ERYTHEMA (redness at the site of the injection after the first shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and VACCINATION SITE ERYTHEMA (redness at the site of the injection after the first shot). At the time of the report, RASH ERYTHEMATOUS (red rash) and VACCINATION SITE ERYTHEMA (redness at the site of the injection after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Vaccination site warmth; Vaccination site mass; Itching; Vaccination site pruritus; Vaccination site rash; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE MASS (Vaccination site mass), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) in a 74-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.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE MASS (Vaccination site mass), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE MASS (Vaccination site mass), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received: Date and outcome of the of the events was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site mass; Itching; Vaccination site pruritus; Vaccination site rash; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE MASS (Vaccination site mass), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) in a 74-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.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE MASS (Vaccination site mass), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE MASS (Vaccination site mass), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received: Date and outcome of the of the events was updated.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Itching at the injection site; shoulder and neck pain (on and off) (5 or 6 on pain scale); redness at the injection site,Size of red area reported to be approximately 2"X2"; Swelling at the injection site; Fatigue; Headaches (off and on); Muscle pain; shoulder and neck pain (on and off) (5 or 6 on pain scale); Chills (on and off); Nausea (on and off); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (Fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation, Arthritis, Acid reflux (esophageal) and Penicillin allergy. Concomitant products included OMEPRAZOLE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), HEADACHE (Headaches (off and on)), MYALGIA (Muscle pain), ARTHRALGIA (shoulder and neck pain (on and off) (5 or 6 on pain scale)), CHILLS (Chills (on and off)) and NAUSEA (Nausea (on and off)). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), HEADACHE (Headaches (off and on)), MYALGIA (Muscle pain), ARTHRALGIA (shoulder and neck pain (on and off) (5 or 6 on pain scale)), CHILLS (Chills (on and off)) and NAUSEA (Nausea (on and off)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unknown medication for mild to moderate blood pressure. Treatment information was not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching at the injection site; shoulder and neck pain (on and off) (5 or 6 on pain scale); redness at the injection site,Size of red area reported to be approximately 2"X2"; Swelling at the injection site; Fatigue; Headaches (off and on); Muscle pain; shoulder and neck pain (on and off) (5 or 6 on pain scale); Chills (on and off); Nausea (on and off); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (Fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation, Arthritis, Acid reflux (esophageal) and Penicillin allergy. Concomitant products included OMEPRAZOLE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), HEADACHE (Headaches (off and on)), MYALGIA (Muscle pain), ARTHRALGIA (shoulder and neck pain (on and off) (5 or 6 on pain scale)), CHILLS (Chills (on and off)) and NAUSEA (Nausea (on and off)). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), HEADACHE (Headaches (off and on)), MYALGIA (Muscle pain), ARTHRALGIA (shoulder and neck pain (on and off) (5 or 6 on pain scale)), CHILLS (Chills (on and off)) and NAUSEA (Nausea (on and off)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unknown medication for mild to moderate blood pressure. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair coming out; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with BIOTIN at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: severe myalgia; severe and arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe myalgia) and ARTHRALGIA (severe and arthralgia) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 07-Jan-2021.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MYALGIA (severe myalgia) and ARTHRALGIA (severe and arthralgia). At the time of the report, MYALGIA (severe myalgia) and ARTHRALGIA (severe and arthralgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.