chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Scar, Vaccination site pain, Vaccination site vesicles
Clinical narrative: Itching; Skin scarred; redness; Prickling/Tingling; Burnt looking; 2 blisters with clear liquid right under injection site; sore arm; great big rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site), PARAESTHESIA (Prickling/Tingling), PAIN IN EXTREMITY (sore arm), PRURITUS (Itching) and SCAR (Skin scarred) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 0D1A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sarcoidosis since 2000, Rheumatoid arthritis since 2010, Kidney enlargement (worse-discomfort) since 2000, Diabetic since 2010 and Drug allergy (Allergy to Levaquin for Swelling and , Sulphur drugs for itching). Concomitant products included PREDNISONE and LEFLUNOMIDE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (great big rash). On 26-Feb-2021, the patient experienced VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site). On an unknown date, the patient experienced PARAESTHESIA (Prickling/Tingling), PRURITUS (Itching), SCAR (Skin scarred), ERYTHEMA (redness) and VACCINATION SITE PAIN (Burnt looking). The patient was treated with CORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 03-Mar-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site) had not resolved and PARAESTHESIA (Prickling/Tingling), PRURITUS (Itching), SCAR (Skin scarred), ERYTHEMA (redness), RASH (great big rash) and VACCINATION SITE PAIN (Burnt looking) outcome was unknown.            Concomitant products included Prednisone 6mg, Vitamin c 100mg, , Leflunomide 20mg, , Vitamin D3 100mg, CoQ10 50mg, Zinc  Treatment drug include Cortisone OTC  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Significant FU - Pictures of events attached. On 10-May-2021: Non-Significant FU-Contact info updated. On 01-Jun-2021: Significant FU - Extra events updated. On 04-Jun-2021: Non-Significant FU- NNI
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: exhausted; headache; didn't feel good at all; pain in the back; sore arm/pain in arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (didn't feel good at all), BACK PAIN (pain in the back), PAIN IN EXTREMITY (sore arm/pain in arm), HEADACHE (headache) and FATIGUE (exhausted) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/pain in arm). On 17-Mar-2021, the patient experienced MALAISE (didn't feel good at all), BACK PAIN (pain in the back) and HEADACHE (headache). On 18-Mar-2021, the patient experienced FATIGUE (exhausted). On 19-Mar-2021, MALAISE (didn't feel good at all), BACK PAIN (pain in the back), PAIN IN EXTREMITY (sore arm/pain in arm), HEADACHE (headache) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.6 (High) increased, 99.6F.         Treatment medications included 1 dose of aspirin earlier in the day and 2 doses of aspirin at night before bed on 17 Mar 2021. and muscle relaxer on 18 Mar 2021. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-054932 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: exhausted; headache; didn't feel good at all; pain in the back; sore arm/pain in arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (didn't feel good at all), BACK PAIN (pain in the back), PAIN IN EXTREMITY (sore arm/pain in arm), HEADACHE (headache) and FATIGUE (exhausted) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/pain in arm). On 17-Mar-2021, the patient experienced MALAISE (didn't feel good at all), BACK PAIN (pain in the back) and HEADACHE (headache). On 18-Mar-2021, the patient experienced FATIGUE (exhausted). On 19-Mar-2021, MALAISE (didn't feel good at all), BACK PAIN (pain in the back), PAIN IN EXTREMITY (sore arm/pain in arm), HEADACHE (headache) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.6 (High) increased, 99.6F.         Treatment medications included 1 dose of aspirin earlier in the day and 2 doses of aspirin at night before bed on 17 Mar 2021. and muscle relaxer on 18 Mar 2021. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-054932 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Injection site swelling, Paraesthesia, Rash erythematous
Clinical narrative: Sensation kept spreading; bruise on right leg; Back of right arm has red rash; Swelling at site of injection; Pain in arm of injection; Tingling in right and left arm 30 minutes after injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in right and left arm 30 minutes after injection), CONDITION AGGRAVATED (Sensation kept spreading), CONTUSION (bruise on right leg), RASH ERYTHEMATOUS (Back of right arm has red rash) and INJECTION SITE SWELLING (Swelling at site of injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Motrin).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (Tingling in right and left arm 30 minutes after injection), CONTUSION (bruise on right leg), RASH ERYTHEMATOUS (Back of right arm has red rash), INJECTION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PAIN (Pain in arm of injection). On 18-Mar-2021, the patient experienced CONDITION AGGRAVATED (Sensation kept spreading). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in right and left arm 30 minutes after injection), CONDITION AGGRAVATED (Sensation kept spreading), CONTUSION (bruise on right leg), RASH ERYTHEMATOUS (Back of right arm has red rash), INJECTION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PAIN (Pain in arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sensation kept spreading; bruise on right leg; Back of right arm has red rash; Swelling at site of injection; Pain in arm of injection; Tingling in right and left arm 30 minutes after injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in right and left arm 30 minutes after injection), CONDITION AGGRAVATED (Sensation kept spreading), CONTUSION (bruise on right leg), RASH ERYTHEMATOUS (Back of right arm has red rash) and INJECTION SITE SWELLING (Swelling at site of injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Motrin).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PARAESTHESIA (Tingling in right and left arm 30 minutes after injection), CONTUSION (bruise on right leg), RASH ERYTHEMATOUS (Back of right arm has red rash), INJECTION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PAIN (Pain in arm of injection). On 18-Mar-2021, the patient experienced CONDITION AGGRAVATED (Sensation kept spreading). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in right and left arm 30 minutes after injection), CONDITION AGGRAVATED (Sensation kept spreading), CONTUSION (bruise on right leg), RASH ERYTHEMATOUS (Back of right arm has red rash), INJECTION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PAIN (Pain in arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Rash, Rash erythematous, Vaccination site pain
Clinical narrative: She got chills; Rash on back; Red Arm; headache; very painful at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Arm), HEADACHE (headache), VACCINATION SITE PAIN (very painful at the shot site), CHILLS (She got chills) and RASH (Rash on back) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ESTRADIOL (MINIVELLE) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Arm), HEADACHE (headache), VACCINATION SITE PAIN (very painful at the shot site) and RASH (Rash on back). On 06-Mar-2021, the patient experienced CHILLS (She got chills). At the time of the report, RASH ERYTHEMATOUS (Red Arm), HEADACHE (headache), VACCINATION SITE PAIN (very painful at the shot site), CHILLS (She got chills) and RASH (Rash on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: dizziness; chills; severe fatigue; temperature was 102 degree Fahrenheit; feeling spacey and wonky; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (feeling spacey and wonky), DIZZINESS (dizziness), PYREXIA (temperature was 102 degree Fahrenheit), CHILLS (chills) and FATIGUE (severe fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to levofloxacin), Drug allergy (lisinopril), Drug allergy (septra), Drug allergy (Victoza), Type 2 diabetes mellitus since 2010 and Hypertension since 1978. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for Clotting disorder, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, METOPROLOL and LOSARTAN for Hypertension, DULAGLUTIDE for Type 2 diabetes mellitus.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (feeling spacey and wonky) and PYREXIA (temperature was 102 degree Fahrenheit). On an unknown date, the patient experienced DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (severe fatigue). At the time of the report, FEELING ABNORMAL (feeling spacey and wonky), DIZZINESS (dizziness), PYREXIA (temperature was 102 degree Fahrenheit), CHILLS (chills) and FATIGUE (severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature increased: 102 (High) temperature was 102 degree Fahrenheit. On 04-Mar-2021, Body temperature increased: 99.5 (High) normal for the rest of the day.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Outcome of the event given as recovered and resolved on 05-mar-2021 but didn't specify the event took 3 grams on Tylenol at 5pm on 3Mar2021, the day after being vaccinated her temperature was 102 degree Fahrenheit.  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-055186 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added patient details, medical history, concomitant medications and events. Updated event outcome.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dizziness; chills; severe fatigue; temperature was 102 degree Fahrenheit; feeling spacey and wonky; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (feeling spacey and wonky), DIZZINESS (dizziness), PYREXIA (temperature was 102 degree Fahrenheit), CHILLS (chills) and FATIGUE (severe fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to levofloxacin), Drug allergy (lisinopril), Drug allergy (septra), Drug allergy (Victoza), Type 2 diabetes mellitus since 2010 and Hypertension since 1978. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for Clotting disorder, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, METOPROLOL and LOSARTAN for Hypertension, DULAGLUTIDE for Type 2 diabetes mellitus.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (feeling spacey and wonky) and PYREXIA (temperature was 102 degree Fahrenheit). On an unknown date, the patient experienced DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (severe fatigue). At the time of the report, FEELING ABNORMAL (feeling spacey and wonky), DIZZINESS (dizziness), PYREXIA (temperature was 102 degree Fahrenheit), CHILLS (chills) and FATIGUE (severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature increased: 102 (High) temperature was 102 degree Fahrenheit. On 04-Mar-2021, Body temperature increased: 99.5 (High) normal for the rest of the day.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Outcome of the event given as recovered and resolved on 05-mar-2021 but didn't specify the event took 3 grams on Tylenol at 5pm on 3Mar2021, the day after being vaccinated her temperature was 102 degree Fahrenheit.  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-055186 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added patient details, medical history, concomitant medications and events. Updated event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Diarrhoea, Erythema, Headache
Clinical narrative: Diarrhoea; Mini version of Covid; Stomach ache; Rash at the injection site; red bumps on stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site) and ERYTHEMA (red bumps on stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site), ERYTHEMA (red bumps on stomach) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site), ERYTHEMA (red bumps on stomach) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Diarrhoea; Mini version of Covid; Stomach ache; Rash at the injection site; red bumps on stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site) and ERYTHEMA (red bumps on stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site), ERYTHEMA (red bumps on stomach) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site), ERYTHEMA (red bumps on stomach) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: pretty good hardness at injection site; pretty good swelling at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (pretty good hardness at injection site) and VACCINATION SITE SWELLING (pretty good swelling at injection site) 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 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (pretty good hardness at injection site) and VACCINATION SITE SWELLING (pretty good swelling at injection site). At the time of the report, VACCINATION SITE INDURATION (pretty good hardness at injection site) and VACCINATION SITE SWELLING (pretty good swelling at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is in her 60's.  No relevant concomitant medication was reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate, Sinus headache, Vaccination site pain
Clinical narrative: joint pains/ all joints hurt but it hurts more on legs and left side of body; sinus headache; a little arm pain/sore; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (a little arm pain/sore) and ARTHRALGIA (joint pains/ all joints hurt but it hurts more on legs and left side of body) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (a little arm pain/sore). On 18-Mar-2021, the patient experienced SINUS HEADACHE (sinus headache). On 23-Mar-2021, the patient experienced ARTHRALGIA (joint pains/ all joints hurt but it hurts more on legs and left side of body). At the time of the report, SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (a little arm pain/sore) outcome was unknown and ARTHRALGIA (joint pains/ all joints hurt but it hurts more on legs and left side of body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: unknown (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Patient stated that he is taking medication for heart rate.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received included lab data was added and outcome of event updated from unknown to recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Heart rate, Heart rate increased
Clinical narrative: systolic blood pressure has risen went to 110-115 over 65 to 70; pulse is elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure has risen went to 110-115 over 65 to 70) and HEART RATE INCREASED (pulse is elevated) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Low blood pressure.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure has risen went to 110-115 over 65 to 70) and HEART RATE INCREASED (pulse is elevated). At the time of the report, BLOOD PRESSURE SYSTOLIC INCREASED (systolic blood pressure has risen went to 110-115 over 65 to 70) and HEART RATE INCREASED (pulse is elevated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure systolic: 110-115 (High) 110-115 over 65 to 70. On 18-Mar-2021, Heart rate: (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take concomitant medication and did not take medication to treat his symptoms.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Feeling hot, Hyperhidrosis, Skin discolouration
Clinical narrative: Mild allergic reaction; Pink skin; Warm; Sweaty; Mild difficulty for breathing that lasted some minutes; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Mild allergic reaction), SKIN DISCOLOURATION (Pink skin), FEELING HOT (Warm), HYPERHIDROSIS (Sweaty) and DYSPNOEA (Mild difficulty for breathing that lasted some minutes) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ALLERGY TO VACCINE (Mild allergic reaction), SKIN DISCOLOURATION (Pink skin), FEELING HOT (Warm), HYPERHIDROSIS (Sweaty) and DYSPNOEA (Mild difficulty for breathing that lasted some minutes). On 22-Mar-2021, DYSPNOEA (Mild difficulty for breathing that lasted some minutes) had resolved. At the time of the report, ALLERGY TO VACCINE (Mild allergic reaction), SKIN DISCOLOURATION (Pink skin), FEELING HOT (Warm) and HYPERHIDROSIS (Sweaty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical conditions were reported.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color). At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site, about the size of a nickel, it has been there for a couple days not brownish in color) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head aches) 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 HEADACHE (Head aches). At the time of the report, HEADACHE (Head aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided by the reporter.Treatment information was not provided.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall
Clinical narrative: I had chills again; Fell after his second dose; This spontaneous case was reported by a physician and describes the occurrence of FALL (Fell after his second dose) and CHILLS (I had chills again) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FALL (Fell after his second dose). On an unknown date, the patient experienced CHILLS (I had chills again). At the time of the report, FALL (Fell after his second dose) and CHILLS (I had chills again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD21-038783 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Company assessed the events to be unlikely related to company product.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes near her clavicle on the same side as the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes near her clavicle on the same side as the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes near her clavicle on the same side as the vaccine). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes near her clavicle on the same side as the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritable bowel syndrome, Pain
Clinical narrative: Chronic pain; Chronic fatigue; Irritable bowel syndrome flare up; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome flare up), PAIN (Chronic pain) and FATIGUE (Chronic fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome flare up). On 04-Mar-2021, the patient experienced FATIGUE (Chronic fatigue). On an unknown date, the patient experienced PAIN (Chronic pain). On 05-Mar-2021, FATIGUE (Chronic fatigue) had resolved. At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome flare up) and PAIN (Chronic pain) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash in her face, legs and knuckles,that was also itchy), FEELING HOT (rash in her face and knuckles,that was hot and itchy) and RASH PRURITIC (rash in her face and knuckles,that was hot and itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH PRURITIC (rash in her face, legs and knuckles,that was also itchy). In March 2021, the patient experienced FEELING HOT (rash in her face and knuckles,that was hot and itchy) and RASH PRURITIC (rash in her face and knuckles,that was hot and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash in her face, legs and knuckles,that was also itchy), FEELING HOT (rash in her face and knuckles,that was hot and itchy) and RASH PRURITIC (rash in her face and knuckles,that was hot and itchy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Headache, Malaise
Clinical narrative: Red ring on arm after 1st dose; Sick feeling after 1st dose; Nauseated; Headache; Fever; Chills after 1st dose; Sore arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red ring on arm after 1st dose), MALAISE (Sick feeling after 1st dose), NAUSEA (Nauseated), HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19) on 15-Jan-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red ring on arm after 1st dose), MALAISE (Sick feeling after 1st dose), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills after 1st dose) and VACCINATION SITE PAIN (Sore arm after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red ring on arm after 1st dose) and VACCINATION SITE PAIN (Sore arm after 1st dose) outcome was unknown and MALAISE (Sick feeling after 1st dose), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills after 1st dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99.8 (High) 99.8 to 101.7. On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. The symptoms didn't last long and the patient had  started feeling better after about one day.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Red ring on arm after 1st dose; Sick feeling after 1st dose; Nauseated; Headache; Fever; Chills after 1st dose; Sore arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red ring on arm after 1st dose), MALAISE (Sick feeling after 1st dose), NAUSEA (Nauseated), HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19) on 15-Jan-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red ring on arm after 1st dose), MALAISE (Sick feeling after 1st dose), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills after 1st dose) and VACCINATION SITE PAIN (Sore arm after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red ring on arm after 1st dose) and VACCINATION SITE PAIN (Sore arm after 1st dose) outcome was unknown and MALAISE (Sick feeling after 1st dose), NAUSEA (Nauseated), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills after 1st dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99.8 (High) 99.8 to 101.7. On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. The symptoms didn't last long and the patient had  started feeling better after about one day.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot), VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm) and PERIPHERAL SWELLING (bump is swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Flu: Flu shot. Past adverse reactions to the above products included Allergic reaction with Flu shot. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot). In February 2021, the patient experienced VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm), PERIPHERAL SWELLING (bump is swollen) and PRURITUS (bump is so itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 10-Feb-2021 to 12-Feb-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot) outcome was unknown and VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm), PERIPHERAL SWELLING (bump is swollen) and PRURITUS (bump is so itchy) had not resolved. Concomitant medication was not reported. The patient also applied ice on her arm. It was reported that the pain on her arm with second dose was not as bad as the first shot. The red bumps were in splotches and not streaks. It was not gone away on Friday. The patient felt really good except the arm. This case was linked to MOD-2021-033333.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot), VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm) and PERIPHERAL SWELLING (bump is swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Flu: Flu shot. Past adverse reactions to the above products included Allergic reaction with Flu shot. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot). In February 2021, the patient experienced VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm), PERIPHERAL SWELLING (bump is swollen) and PRURITUS (bump is so itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 10-Feb-2021 to 12-Feb-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (pain in my arm but not as bad as the first shot) outcome was unknown and VACCINATION SITE MASS (small bump on my arm), ERYTHEMA (bump traveling down my arm bright red), SKIN WARM (bump is warm), PERIPHERAL SWELLING (bump is swollen) and PRURITUS (bump is so itchy) had not resolved. Concomitant medication was not reported. The patient also applied ice on her arm. It was reported that the pain on her arm with second dose was not as bad as the first shot. The red bumps were in splotches and not streaks. It was not gone away on Friday. The patient felt really good except the arm. This case was linked to MOD-2021-033333.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: pulse was high upto 108; Raised BP (little high but not that bad); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse was high upto 108) and BLOOD PRESSURE INCREASED (Raised BP (little high but not that bad)) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEART RATE INCREASED (pulse was high upto 108) and BLOOD PRESSURE INCREASED (Raised BP (little high but not that bad)). On 01-Mar-2021, HEART RATE INCREASED (pulse was high upto 108) and BLOOD PRESSURE INCREASED (Raised BP (little high but not that bad)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Premature birth (The patient had IVF for twin pregnancy in 2018 and delivered at 35 weeks) on 13-Nov-2018, Vanishing twin syndrome (During first trimester) in 2020 and In vitro fertilization (Previous twin pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.  The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypertension, Lymphadenopathy, Pain, Swelling
Clinical narrative: Body ache; Swelling on the left side of the neck; Lymph glands at the neck are swollen; Tiredness; Blood pressure is high since vaccination; Aspontaneous report was received from a consumer concerning, a 56-year-old female patient who received Moderna (mRNA-1273) vaccine and developed a swelling on the left side of the neck more near to shoulder blade/swelling, body ache, tiredness/fatigue, lymph glands at the neck were swollen/ lymphadenopathy and blood pressure was high since vaccination/hypertension.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medications, blood pressure medications and anti-depressants.  On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 10A21A) on the left arm for prophylaxis of COVID-19 infection.  On an unspecified date in 2021, few days post receiving the vaccine, the patient developed a swelling on the left side of the neck more near to shoulder blade. The patient also had body ache, tiredness, lymph glands at the neck were swollen and the blood pressure was high since vaccination.  Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, swelling on the left side of the neck more near to shoulder blade/swelling, body ache, tiredness/fatigue, lymph glands at the neck were swollen/ lymphadenopathy and blood pressure was high since vaccination/hypertension were considered as not resolved.; 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.