chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide; Moderna arm (Covid arm); 2 days of itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Moderna arm (Covid arm)), PRURITUS (2 days of itching) and VACCINATION SITE RASH (Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Moderna arm (Covid arm)) and PRURITUS (2 days of itching). On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide). At the time of the report, VACCINATION SITE REACTION (Moderna arm (Covid arm)) and PRURITUS (2 days of itching) outcome was unknown and VACCINATION SITE RASH (Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR document appended on 6-MAY-2021:Updated the event description and the action taken with the vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Limb discomfort, Myalgia, Pyrexia
Clinical narrative: Can not move arm; Have so bad fever 100.8 degree Fahrenheit; Body ache; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Can not move arm), PYREXIA (Have so bad fever 100.8 degree Fahrenheit) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DULOXETINE and FLUOXETINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced LIMB DISCOMFORT (Can not move arm), PYREXIA (Have so bad fever 100.8 degree Fahrenheit) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, LIMB DISCOMFORT (Can not move arm), PYREXIA (Have so bad fever 100.8 degree Fahrenheit) and MYALGIA (Body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100.8 °F (High) 100.8 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included,  unspecified cholesterol medications for unknown indication and unspecified high blood pressure medications for blood pressure   This case was linked to MOD-2021-218636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information was received on 14-May-2021 from the initial reporter and contains no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Muscle spasms, Nausea
Clinical narrative: muscle spasms; severe nausea; chills; exhaustion; Sick as dogs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as dogs), MUSCLE SPASMS (muscle spasms), NAUSEA (severe nausea), CHILLS (chills) and FATIGUE (exhaustion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Cholesterol, Drug allergy (sulfa drugs, dilaudid, erythromycin, tobramycin) and Bee sting. Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]), LISINOPRIL, OMEPRAZOLE, LOVASTATIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ILLNESS (Sick as dogs). On 13-Mar-2021, the patient experienced MUSCLE SPASMS (muscle spasms), NAUSEA (severe nausea), CHILLS (chills) and FATIGUE (exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Mar-2021 for Adverse event, at a dose of 1 dosage form. On 13-Mar-2021 at 3:00 PM, NAUSEA (severe nausea) had resolved. On 17-Mar-2021, MUSCLE SPASMS (muscle spasms) and FATIGUE (exhaustion) had resolved. At the time of the report, ILLNESS (Sick as dogs) and CHILLS (chills) had resolved.            Concomitant medications also included blood pressure meds, muscle relaxer and cholesterol meds.   This case was linked to MOD-2021-117025, MOD-2021-117025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Reporter information updated and outcome of the event illness was updated from unknown to recovered. On 08-May-2021: NNI On 10-May-2021: Added concomitant drugs, medical history, allergies and 4 new events. On 08-Jun-2021: NNI On 09-Jun-2021: NNI
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low grade fever (99.2 degrees F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever (99.2 degrees F)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Low grade fever (99.2 degrees F)). At the time of the report, PYREXIA (Low grade fever (99.2 degrees F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 99.2 (Inconclusive) Low grade fever (99.2 degrees F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported.    Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chest pain, Chills
Clinical narrative: Very tired; severe chest/ back muscle pain so intense; rib joint pain so intense; Couldn't take deep breaths; severe chest/ back muscle pain so intense; Joint body aches; Low grade fever 100.5; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), BACK PAIN (severe chest/ back muscle pain so intense) and ARTHRALGIA (Joint body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension in March 2000, Gout in 2014 and Flu. Concurrent medical conditions included Drug allergy (Allergic to Ibuprofen (High doses/long duration only)). Concomitant products included FOSINOPRIL for Blood pressure high, ALLOPURINOL for Gout, ASPIRIN [ACETYLSALICYLIC ACID] for Heart injury NOS, MECOBALAMIN (B12 [MECOBALAMIN]), VITAMIN D3, MENAQUINONE-7 (K2) and FISH OIL from 02-Feb-2020 to an unknown date for an unknown indication.    On 03-Mar-2021 at 12:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 2:00 PM, the patient experienced CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), PYREXIA (Low grade fever 100.5) and CHILLS (Chills). 10-Mar-2021 at 2:00 PM, the patient experienced BACK PAIN (severe chest/ back muscle pain so intense). 10-Mar-2021 at 2:00 PM, the patient experienced ARTHRALGIA (Joint body aches). On an unknown date, the patient experienced FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Mar-2021, CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), BACK PAIN (severe chest/ back muscle pain so intense), ARTHRALGIA (Joint body aches), PYREXIA (Low grade fever 100.5), CHILLS (Chills) and FATIGUE (Very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100.5 (High) 100.5; low grade fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Added medical history and treatment drug. Event description and outcomes were changed to recovered/resolved.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Very tired; severe chest/ back muscle pain so intense; rib joint pain so intense; Couldn't take deep breaths; severe chest/ back muscle pain so intense; Joint body aches; Low grade fever 100.5; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), BACK PAIN (severe chest/ back muscle pain so intense) and ARTHRALGIA (Joint body aches) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension in March 2000, Gout in 2014 and Flu. Concurrent medical conditions included Drug allergy (Allergic to Ibuprofen (High doses/long duration only)). Concomitant products included FOSINOPRIL for Blood pressure high, ALLOPURINOL for Gout, ASPIRIN [ACETYLSALICYLIC ACID] for Heart injury NOS, MECOBALAMIN (B12 [MECOBALAMIN]), VITAMIN D3, MENAQUINONE-7 (K2) and FISH OIL from 02-Feb-2020 to an unknown date for an unknown indication.    On 03-Mar-2021 at 12:28 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 2:00 PM, the patient experienced CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), PYREXIA (Low grade fever 100.5) and CHILLS (Chills). 10-Mar-2021 at 2:00 PM, the patient experienced BACK PAIN (severe chest/ back muscle pain so intense). 10-Mar-2021 at 2:00 PM, the patient experienced ARTHRALGIA (Joint body aches). On an unknown date, the patient experienced FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Mar-2021, CHEST PAIN (severe chest/ back muscle pain so intense), MUSCULOSKELETAL CHEST PAIN (rib joint pain so intense), DYSPNOEA (Couldn't take deep breaths), BACK PAIN (severe chest/ back muscle pain so intense), ARTHRALGIA (Joint body aches), PYREXIA (Low grade fever 100.5), CHILLS (Chills) and FATIGUE (Very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100.5 (High) 100.5; low grade fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Added medical history and treatment drug. Event description and outcomes were changed to recovered/resolved.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: ringing in ears is still there, on and off / when it's cold the ringing comes back/when it's warm the ringing goes away; buzzing in his left ear - sounds like the buzzing you hear standing next to high tension wires; right ear doesn't bother as much; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing in his left ear - sounds like the buzzing you hear standing next to high tension wires), EAR DISCOMFORT (right ear doesn't bother as much) and TINNITUS (ringing in ears is still there, on and off / when it's cold the ringing comes back/when it's warm the ringing goes away) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced TINNITUS (buzzing in his left ear - sounds like the buzzing you hear standing next to high tension wires) and EAR DISCOMFORT (right ear doesn't bother as much). On an unknown date, the patient experienced TINNITUS (ringing in ears is still there, on and off / when it's cold the ringing comes back/when it's warm the ringing goes away). At the time of the report, TINNITUS (buzzing in his left ear - sounds like the buzzing you hear standing next to high tension wires), EAR DISCOMFORT (right ear doesn't bother as much) and TINNITUS (ringing in ears is still there, on and off / when it's cold the ringing comes back/when it's warm the ringing goes away) outcome was unknown. Not Provided          Treatment medications includes: Claritin D, Cough drops   This case was linked to MOD21-054838 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Update about First dose events.; Sender's Comments:  MOD21-054838:cross linked id
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain
Clinical narrative: Severe pain; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain) and GAIT INABILITY (Could not walk) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026421A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol and Vitamin D deficiency. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Severe pain) and GAIT INABILITY (Could not walk). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Severe pain) and GAIT INABILITY (Could not walk) outcome was unknown.            Concomitant products used included blood pressure medications, cholesterol medications and Vitamin D.    Patient stated her pain was extensive and she went to the ER for treatment. She stayed overnight at the ER, not admitted to hospital, and was provided unknown pain medication via "a shot". The pain was in her hip and toes on her right side. The pain subsided after 6 days with pain medication.  She had her second dose of vaccination on 8 APR 2021. She had taken Ibuprofen as a prophylaxis and had no issues at all.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-Jun-2021 elaborate the location of pain, added number of days in which pain subsided, add second dose information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Pyrexia
Clinical narrative: They were very cold; They felt foggy and not themselves at all; They were very very tired, and slept for a day and a half.; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (They were very cold), FEELING ABNORMAL (They felt foggy and not themselves at all), FATIGUE (They were very very tired, and slept for a day and a half.) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING COLD (They were very cold), FEELING ABNORMAL (They felt foggy and not themselves at all), FATIGUE (They were very very tired, and slept for a day and a half.) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. In February 2021, FEELING COLD (They were very cold), FEELING ABNORMAL (They felt foggy and not themselves at all), FATIGUE (They were very very tired, and slept for a day and a half.) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was high blood pressure medication NOS and heart condition medication NOS.   This case was linked to MOD-2021-113925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information from the patient updated the outcome for all events to recovered. The patient reported they are doing fine and recovered from all the events, which only lasted for eight hours.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Eczema, Rash
Clinical narrative: eczema (arms, stomach); rash redness; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema (arms, stomach)) and RASH (rash redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Atopic dermatitis (For 6 years) and Cancer. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLERGIA [FEXOFENADINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR) and HYDROXYZINE for an unknown indication.    On 19-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 ECZEMA (eczema (arms, stomach)) and RASH (rash redness). At the time of the report, ECZEMA (eczema (arms, stomach)) and RASH (rash redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-significant follow-up added to include AE contact info
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Bone pain, Chills, Fatigue
Clinical narrative: looked like she's going to faint; bones are aching; fever of 100.8'F; chills; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PRESYNCOPE (looked like she's going to faint), BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection and Pacemaker insertion (cardiac). Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Bladder infection, OMEPRAZOLE, LEVOTHYROXINE, CARVEDILOL, WARFARIN, ISOSORBIDE, ATORVASTATIN, EZETIMIBE, AMIODARONE and ENALAPRIL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness). On 16-Mar-2021, the patient experienced PRESYNCOPE (looked like she's going to faint). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, PRESYNCOPE (looked like she's going to faint), BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 100.8 (High) 100.8'F. On 16-Mar-2021, Blood pressure measurement: 140/60 mmHg 140/60mmhg. On 16-Mar-2021, Heart rate: 94 per minute 94 beats per minute.     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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Presyncope, Pyrexia
Clinical narrative: looked like she's going to faint; bones are aching; fever of 100.8'F; chills; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PRESYNCOPE (looked like she's going to faint), BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Bladder infection and Pacemaker insertion (cardiac). Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Bladder infection, OMEPRAZOLE, LEVOTHYROXINE, CARVEDILOL, WARFARIN, ISOSORBIDE, ATORVASTATIN, EZETIMIBE, AMIODARONE and ENALAPRIL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness). On 16-Mar-2021, the patient experienced PRESYNCOPE (looked like she's going to faint). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, PRESYNCOPE (looked like she's going to faint), BONE PAIN (bones are aching), PYREXIA (fever of 100.8'F), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 100.8 (High) 100.8'F. On 16-Mar-2021, Blood pressure measurement: 140/60 mmHg 140/60mmhg. On 16-Mar-2021, Heart rate: 94 per minute 94 beats per minute.     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.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: problem in his lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (problem in his lymph node) in a male 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 LYMPHADENOPATHY (problem in his lymph node). At the time of the report, LYMPHADENOPATHY (problem in his lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided     Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR  attached on  06-may-2021, Non-significant follow up , patient declined further follow up
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: Faint; weakness; confused; Numbness in left arm, left side of face and tongue; nausea; fatigue; Headache; A spontaneous report was received from a Nurse, concerning herself, a 45-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness in left arm, left side of face and tongue, faint, weakness, confused, nausea, headache and fatigue.  Patient current condition included unknown allergies. No concomitant product use was mentioned by the reporter.  On 10 Mar 2021, prior to the onset of event, the patient received her first of two planned doses of mRNA-1273 (Lot number: 024M20A) via intramuscular route for prophylaxis of COVID-19 infection.  On 10-mar-2021, patient received mRNA-1273 vaccine and patient waited for about 30 minutes after the injection. However, about 45 minutes later on the drive home she developed numbness in left arm. about two to three minutes later the left side of face felt numb, and finally her tongue became numb too. she took benadryl and symptoms improved. Then a few hours later, she felt faint, nausea and weak. over the next few days she also felt fatigue, confused, headache.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events numbness in left arm was reported as recovered, whereas outcome of events faint, weakness, confused, nausea, headache and fatigue was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: Faint; weakness; confused; Numbness in left arm, left side of face and tongue; nausea; fatigue; Headache; A spontaneous report was received from a Nurse, concerning herself, a 45-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness in left arm, left side of face and tongue, faint, weakness, confused, nausea, headache and fatigue.  Patient current condition included unknown allergies. No concomitant product use was mentioned by the reporter.  On 10 Mar 2021, prior to the onset of event, the patient received her first of two planned doses of mRNA-1273 (Lot number: 024M20A) via intramuscular route for prophylaxis of COVID-19 infection.  On 10-mar-2021, patient received mRNA-1273 vaccine and patient waited for about 30 minutes after the injection. However, about 45 minutes later on the drive home she developed numbness in left arm. about two to three minutes later the left side of face felt numb, and finally her tongue became numb too. she took benadryl and symptoms improved. Then a few hours later, she felt faint, nausea and weak. over the next few days she also felt fatigue, confused, headache.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events numbness in left arm was reported as recovered, whereas outcome of events faint, weakness, confused, nausea, headache and fatigue was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vitreous floaters
Clinical narrative: floaters in her vision,; she feels very weak overall; her legs feel very weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in her vision,), ASTHENIA (she feels very weak overall) and FATIGUE (her legs feel very weak and tired) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation.     Concomitant products included TRETINOIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VITREOUS FLOATERS (floaters in her vision,), ASTHENIA (she feels very weak overall) and FATIGUE (her legs feel very weak and tired). 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, VITREOUS FLOATERS (floaters in her vision,), ASTHENIA (she feels very weak overall) and FATIGUE (her legs feel very weak and tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Glossitis, Glossodynia, Tongue erythema
Clinical narrative: tongue was sore; red dots; sometimes it's burning; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (tongue was sore), TONGUE ERYTHEMA (red dots) and GLOSSITIS (sometimes it's burning) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 GLOSSODYNIA (tongue was sore), TONGUE ERYTHEMA (red dots) and GLOSSITIS (sometimes it's burning). At the time of the report, GLOSSODYNIA (tongue was sore), TONGUE ERYTHEMA (red dots) and GLOSSITIS (sometimes it's burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used mouthwash to treat his symptoms. patient suspects it is Plica Fambriata. Patient has underlying condition which he does not want to mention.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Headache, Hypokinesia, Musculoskeletal stiffness
Clinical narrative: Movements reduced; Stiff neck; ache; chills; fever; headache; Neck pain; Difficulty in standing; Sitting disability; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN (ache), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No specified medical history has been reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN (ache), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced NECK PAIN (Neck pain), DYSSTASIA (Difficulty in standing), SITTING DISABILITY (Sitting disability) and HYPOKINESIA (Movements reduced). On 19-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved. At the time of the report, PAIN (ache), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and NECK PAIN (Neck pain), DYSSTASIA (Difficulty in standing), SITTING DISABILITY (Sitting disability) and HYPOKINESIA (Movements reduced) had resolved.            No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow-up  contain patient detail, suspect dose 1 detail, vaccine facility detail, event detail updated and new events are added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia, Sitting disability
Clinical narrative: Movements reduced; Stiff neck; ache; chills; fever; headache; Neck pain; Difficulty in standing; Sitting disability; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN (ache), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No specified medical history has been reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN (ache), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced NECK PAIN (Neck pain), DYSSTASIA (Difficulty in standing), SITTING DISABILITY (Sitting disability) and HYPOKINESIA (Movements reduced). On 19-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved. At the time of the report, PAIN (ache), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and NECK PAIN (Neck pain), DYSSTASIA (Difficulty in standing), SITTING DISABILITY (Sitting disability) and HYPOKINESIA (Movements reduced) had resolved.            No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow-up  contain patient detail, suspect dose 1 detail, vaccine facility detail, event detail updated and new events are added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: tinged blood urination; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (tinged blood urination) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Diabetes. Concomitant products included VITAMIN D3, MAGNESIUM, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) and ZINC for an unknown indication.   On 15-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (tinged blood urination). At the time of the report, BLOOD URINE PRESENT (tinged blood urination) had resolved.            No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received provides no new information. On 29-Jun-2021: Follow-up received provided patient details, medical history, suspect dosage details and event outcome.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Zero apetite; fatigue; body ache; low grade fever; dull headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Zero apetite), FATIGUE (fatigue), MYALGIA (body ache), PYREXIA (low grade fever) and HEADACHE (dull headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure in 2019. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (percocet), Bladder cancer NOS since 2018, Familial hypocalciuric hypercalcaemia, COPD since 2000, Kidney absent since 1975 and High cholesterol. Concomitant products included METOPROLOL for Blood pressure management, FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DECREASED APPETITE (Zero apetite), FATIGUE (fatigue), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (dull headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, DECREASED APPETITE (Zero apetite), HEADACHE (dull headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue), MYALGIA (body ache) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101 (Inconclusive) fever 101 degree F.         No treatment was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient stated she spent 3 days in bed , symptoms completely gone on day8.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Added patient demographics, medical history and concomitant medications. AE(s) added, outcome of event(s) updated from unknown to recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Zero apetite; fatigue; body ache; low grade fever; dull headache; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Zero apetite), FATIGUE (fatigue), MYALGIA (body ache), PYREXIA (low grade fever) and HEADACHE (dull headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure in 2019. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (percocet), Bladder cancer NOS since 2018, Familial hypocalciuric hypercalcaemia, COPD since 2000, Kidney absent since 1975 and High cholesterol. Concomitant products included METOPROLOL for Blood pressure management, FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DECREASED APPETITE (Zero apetite), FATIGUE (fatigue), MYALGIA (body ache), PYREXIA (low grade fever), HEADACHE (dull headache), NAUSEA (nausea) and CHILLS (Chills). At the time of the report, DECREASED APPETITE (Zero apetite), HEADACHE (dull headache), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue), MYALGIA (body ache) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101 (Inconclusive) fever 101 degree F.         No treatment was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient stated she spent 3 days in bed , symptoms completely gone on day8.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Added patient demographics, medical history and concomitant medications. AE(s) added, outcome of event(s) updated from unknown to recovered.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling
Clinical narrative: Muscle Pain in Deltoid Muscle; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain in Deltoid Muscle) and VACCINATION SITE SWELLING (Swelling at injection site) in a male 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 (No medical history reported).    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Muscle Pain in Deltoid Muscle) and VACCINATION SITE SWELLING (Swelling at injection site). On 15-Mar-2021, MYALGIA (Muscle Pain in Deltoid Muscle) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant drug reported. No treatment reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warm to the touch at the injection site; red at injection site; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (sore at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter .  Concomitant products included ATORVASTATIN, LISINOPRIL, LEVOTHYROXINE SODIUM (L-THYROXINE [LEVOTHYROXINE SODIUM]), CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 06-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (sore at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Arthralgia, Fatigue, Nausea
Clinical narrative: body pain; loss of taste; stomach pains; joint pains; nausea; fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), ARTHRALGIA (joint pains) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (body pain), AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), ARTHRALGIA (joint pains), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, PAIN (body pain), AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), ARTHRALGIA (joint pains), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD21-055337, MOD21-055429, US-MODERNATX, INC.-MOD-2021-046223 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-055337: MOD21-055429: US-MODERNATX, INC.-MOD-2021-046223:patient case (male)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: body pain; loss of taste; stomach pains; joint pains; nausea; fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), ARTHRALGIA (joint pains) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (body pain), AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), ARTHRALGIA (joint pains), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, PAIN (body pain), AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), ARTHRALGIA (joint pains), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD21-055337, MOD21-055429, US-MODERNATX, INC.-MOD-2021-046223 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-055337: MOD21-055429: US-MODERNATX, INC.-MOD-2021-046223:patient case (male)
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission
Clinical narrative: 43 days since first dose and hasn't received second one; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (43 days since first dose and hasn't received second one) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ex-smoker and Blood pressure high.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (43 days since first dose and hasn't received second one). On 01-Mar-2021, INTENTIONAL DOSE OMISSION (43 days since first dose and hasn't received second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past the 6-hour time expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past the 6-hour time expiration) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021 at 4:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past the 6-hour time expiration). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine past the 6-hour time expiration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 014M20A)  with no associated AEs.