chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: The injection site was tender & sensitive for about 1 hr; The injection site was tender & sensitive for about 1 hr.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site was tender & sensitive for about 1 hr) and VACCINATION SITE PAIN (The injection site was tender & sensitive for about 1 hr.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 013A21A and 939909) 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 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE REACTION (The injection site was tender & sensitive for about 1 hr) and VACCINATION SITE PAIN (The injection site was tender & sensitive for about 1 hr.). On 05-Apr-2021, VACCINATION SITE REACTION (The injection site was tender & sensitive for about 1 hr) and VACCINATION SITE PAIN (The injection site was tender & sensitive for about 1 hr.) had resolved.            No concomitant medications were reported.  Treatment information was not provided. No side effects were experienced after the third dose.   This case was linked to MOD-2021-396105 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: The injection site was tender; The injection site was sensitive; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site was sensitive) and VACCINATION SITE PAIN (The injection site was tender) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 05-Mar-2021, the patient experienced VACCINATION SITE REACTION (The injection site was sensitive). On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (The injection site was tender). On 05-Mar-2021, VACCINATION SITE REACTION (The injection site was sensitive) had resolved. On 05-Apr-2021, VACCINATION SITE PAIN (The injection site was tender) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-396089 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Tender arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm) and PAIN IN EXTREMITY (Sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient had a mastectomy in the left side in the past.). Concomitant products included LEVOTHYROXINE, LISINOPRIL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tender arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, TENDERNESS (Tender arm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details was not reported by the reporter.   This case was linked to MOD-2021-396038, MOD-2021-396130 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Headache; Body aches; 103, 101.7 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (103, 101.7 degree fever) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE NRVV AD26 in March 2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26. Concurrent medical conditions included Hard of hearing.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (103, 101.7 degree fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (103, 101.7 degree fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 103 (High) 103 Degree and 101.7 (High) 101.7 Degree.         No Concomitant medication was reported.     No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (mastectomy in the left side in the past.). Concomitant products included LEVOTHYROXINE, LISINOPRIL, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and VITAMINS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). On 09-Mar-2021, DYSPNOEA (Shortness of breath) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate increased: increased (High) heart was beating real fast for 15 minutes..   After the second dose, while returning home from the vaccinations site, after waiting the recommended 15 minutes. patient experienced the events.  Treatment medications were not provided.   This case was linked to MOD-2021-396109 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: booster given less than 6 months after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months after 2nd dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 048F21A and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months after 2nd dose). On 24-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster given less than 6 months after 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment product use was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Low back pain since 25-May-2011, Peripheral vascular disease since 25-Aug-2020 and Asthma since 05-Nov-2008. Concomitant products included ALBUTEROL SULFATE from 18-Feb-2021 to an unknown date for Asthma, CAPSAICIN from 04-Mar-2021 to an unknown date for Low back pain, GABAPENTIN (NEURONTIN) from 04-Mar-2021 to an unknown date for Peripheral vascular disease.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  On 20-NOV-2021 an appointment was scheduled for each patient that was administered an expired Moderna Covid-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: HCP details, concurrent conditions, patient demographics and medical history was added.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: 101 fever; joint pain; injection site pain normal with the moderna booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (101 fever), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain normal with the moderna booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (101 fever), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain normal with the moderna booster). At the time of the report, PYREXIA (101 fever), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain normal with the moderna booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) The result was 101 with no units reported..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: I took temp no fever but my arm temp is 100 and up my neck; My arm is so sore I can't do anything and  it's hot; This spontaneous case was reported by a nurse and describes the occurrence of FEELING HOT (I took temp no fever but my arm temp is 100 and up my neck) and PAIN IN EXTREMITY (My arm is so sore I can't do anything and  it's hot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (I took temp no fever but my arm temp is 100 and up my neck) and PAIN IN EXTREMITY (My arm is so sore I can't do anything and  it's hot). At the time of the report, FEELING HOT (I took temp no fever but my arm temp is 100 and up my neck) had resolved and PAIN IN EXTREMITY (My arm is so sore I can't do anything and  it's hot) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Follow-up received. Event outcome updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain of skin, Tinnitus
Clinical narrative: Ringing in Ears; Mouth Sores; Sores in skin; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in Ears), ORAL PAIN (Mouth Sores) and PAIN OF SKIN (Sores in skin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MZOA and 012L2OA) for an unknown indication.     The patient's past medical history included Hemochromatosis in 2021, Cirrhosis liver since 2021 and Phlebotomy. Previously administered products included for Product used for unknown indication: Hepa A vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Hepa A vaccine. Concurrent medical conditions included Allergic reaction to analgesics (Dilaudid allergy), Allergy to antibiotic (Allergy to E mycin), Graves' disease since 05-Oct-2010, Allergy to antibiotic (Ciprofloxacin), Allergy to antibiotic (Rocephin), Vitamin D deficiency and Insomnia. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and THYROID (ARMOUR THYROID) for Graves' disease, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, VITAMIN D3 for Vitamin D deficiency.   On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ORAL PAIN (Mouth Sores) and PAIN OF SKIN (Sores in skin). On an unknown date, the patient experienced TINNITUS (Ringing in Ears). At the time of the report, TINNITUS (Ringing in Ears) had not resolved and ORAL PAIN (Mouth Sores) and PAIN OF SKIN (Sores in skin) outcome was unknown. Not Provided          Patient has taken booster dose on 03/Nov/202, lot number 039F21A intramuscular in left gluteus.  Patient had been taking tirosint concomitant medication 112 mcg orally except on Wednesday 100 mcg since 2013 for indication of graves.  Patient had been taking Vital proteins as concomitant medication 2 scoops orally since 2021 for supplemental drink. Patient stopped taking armour thyroid approximately on  May-2021. Patient was administered with Flu vaccine on unknown date   This case was linked to MOD-2021-396157, MOD-2021-396175, MOD-2021-382243, MOD-2021-396175, MOD-2021-396157 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching in the shot are; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itching in the shot are) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching in the shot are). At the time of the report, VACCINATION SITE PRURITUS (itching in the shot are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision after 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 024M20A) 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) (Intramuscular) 1 dosage form. On 02-Apr-2021, 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 VISION BLURRED (Blurry vision after 2nd dose). At the time of the report, VISION BLURRED (Blurry vision after 2nd dose) had not resolved.      Treatment received: Got new eyeglasses made after checkup.  No concomitant medications reported.   This case was linked to MOD-2021-396201 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Felt like he had the flu; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like he had the flu), PAIN (Achy) and FATIGUE (Tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, 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 experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu), PAIN (Achy) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like he had the flu), PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            It was reported that the patient had no adverse events after the first dose.  No concomitant medications were reported.  No treatment information were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision again after booster dose/vision has changed again; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurry vision again after booster dose/vision has changed again) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 003B21A and 024M20A) 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) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision again after booster dose/vision has changed again). At the time of the report, VISION BLURRED (Blurry vision again after booster dose/vision has changed again) had not resolved.            Patient uses concomitant medication but no relevant concomitant medications were reported.  Treatment information included patient got new eyeglasses made after checkup.   This case was linked to MOD-2021-396185 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left injection site arm was sore, My left arm is still occasionally sore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm was sore, My left arm is still occasionally sore.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (left injection site arm was sore, My left arm is still occasionally sore.). At the time of the report, VACCINATION SITE PAIN (left injection site arm was sore, My left arm is still occasionally sore.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-396318, MOD-2021-396324 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: really bad headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headache) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Neosporin) and Drug allergy (codeine). Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (really bad headache) and FATIGUE (fatigue). At the time of the report, HEADACHE (really bad headache) and FATIGUE (fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  On 01-Apr-2021, patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) Intramuscularly into the left deltoid and reported she did not experience any side effects after the second dose.   This case was linked to MOD-2021-396118 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Pain in extremity
Clinical narrative: Didn't feel much discomfort; Like someone punched in the arm/it hurts to raise the arm/hurts more than the first two; Shoulder is more sore muscularly; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Didn't feel much discomfort), PAIN IN EXTREMITY (Like someone punched in the arm/it hurts to raise the arm/hurts more than the first two) and MYALGIA (Shoulder is more sore muscularly) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE and PRAVASTATIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Didn't feel much discomfort), PAIN IN EXTREMITY (Like someone punched in the arm/it hurts to raise the arm/hurts more than the first two) and MYALGIA (Shoulder is more sore muscularly). At the time of the report, DISCOMFORT (Didn't feel much discomfort), PAIN IN EXTREMITY (Like someone punched in the arm/it hurts to raise the arm/hurts more than the first two) and MYALGIA (Shoulder is more sore muscularly) outcome was unknown.            No treatment medication information provided.  Patient's shoulder was more sore muscularly speaking compared to the first two. This started about an hour ago (now is around 19:50 EST) and the booster shot was given at 1.30 pm. Patient said it felt like someone punched in the arm like a bruise. It hurts when patient wants to raise the arm and it hurts more than with the first two. Patient will put on some ice pack to see if it alleviates the pain. Patient said that for the first two shots didn't feel much discomfort.   This case was linked to MOD-2021-396351, MOD-2021-396352 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Epistaxis, Hypertension, Lymphadenopathy
Clinical narrative: Nose bleeding; Blood pressure high 163/95; Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding), HYPERTENSION (Blood pressure high 163/95) and LYMPHADENOPATHY (Swollen lymph node) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 023M20A and 032LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph node). On 24-Nov-2021, the patient experienced EPISTAXIS (Nose bleeding) and HYPERTENSION (Blood pressure high 163/95). The patient was treated with PARACETAMOL (PANADOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, EPISTAXIS (Nose bleeding), HYPERTENSION (Blood pressure high 163/95) and LYMPHADENOPATHY (Swollen lymph node) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, Blood pressure measurement: 163/95 (High) 163/95.         It was reported that the patient still had the symptoms ongoing. No concomitant medications were reported
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Decreased appetite, Weight decreased
Clinical narrative: lost a lot of weight; No appetite; almost immediately my digestive system shut down; absolutely no bowel movements/no movement/no contractions/like gut was paralyzed/it was dead; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (almost immediately my digestive system shut down), CONSTIPATION (absolutely no bowel movements/no movement/no contractions/like gut was paralyzed/it was dead), WEIGHT DECREASED (lost a lot of weight) and DECREASED APPETITE (No appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (almost immediately my digestive system shut down) and CONSTIPATION (absolutely no bowel movements/no movement/no contractions/like gut was paralyzed/it was dead). On an unknown date, the patient experienced WEIGHT DECREASED (lost a lot of weight) and DECREASED APPETITE (No appetite). At the time of the report, ABDOMINAL DISCOMFORT (almost immediately my digestive system shut down) and CONSTIPATION (absolutely no bowel movements/no movement/no contractions/like gut was paralyzed/it was dead) had not resolved and WEIGHT DECREASED (lost a lot of weight) and DECREASED APPETITE (No appetite) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took laxatives every 4 days.  Patient said that before receiving the 2nd dose, she had a bowel movement every morning. She is normally healthy individual with no underlying conditions. She drinks a lot of water and even does yoga. Her GI doctor said that she is doing everything right. She also says that she has not had any appetite and has lost a lot of weight due to this since receiving the 2nd dose She knows that she needs the nutrition so she forces herself to eat. She has a colonoscopy scheduled in DEC2021 for further examinations.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore right arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm for 24 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm for 24 hours). At the time of the report, PAIN IN EXTREMITY (sore right arm for 24 hours) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-396211, MOD-2021-396324 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore right injection site arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 010M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Sore right injection site arm). At the time of the report, INJECTION SITE PAIN (Sore right injection site arm) outcome was unknown.            No concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-396211, MOD-2021-396318 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: hurts more than with the first two; Shoulder is more sore muscularly speaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hurts more than with the first two) and ARTHRALGIA (Shoulder is more sore muscularly speaking) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE and PRAVASTATIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hurts more than with the first two) and ARTHRALGIA (Shoulder is more sore muscularly speaking). At the time of the report, PAIN IN EXTREMITY (hurts more than with the first two) and ARTHRALGIA (Shoulder is more sore muscularly speaking) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-396244, MOD-2021-396352 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Pain in extremity
Clinical narrative: Did not feel much discomfort; It hurts to raise the arm/its hurts more; Shoulder is more sore muscularly speaking; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Did not feel much discomfort), PAIN IN EXTREMITY (It hurts to raise the arm/its hurts more) and ARTHRALGIA (Shoulder is more sore muscularly speaking) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE and PRAVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Did not feel much discomfort), PAIN IN EXTREMITY (It hurts to raise the arm/its hurts more) and ARTHRALGIA (Shoulder is more sore muscularly speaking). At the time of the report, DISCOMFORT (Did not feel much discomfort), PAIN IN EXTREMITY (It hurts to raise the arm/its hurts more) and ARTHRALGIA (Shoulder is more sore muscularly speaking) outcome was unknown.            No treatment medications were provided.   This case was linked to MOD-2021-396351, MOD-2021-396244 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Joint swelling, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: swelling in knees/it is in ankles; swelling on my back; knuckles on her hand are swollen, and it is in hands; extreme body aches; swollen under the arm/(kind of swollen)/it continued to get worse; swollen into the breast area (on left side)/it continued to get worse; arm was really painful (left) and kind of throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse), BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse), JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back) and PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076F21A, 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included SIMVASTATIN, BACLOFEN, OMEGA-3 [OMEGA-3 NOS], COLECALCIFEROL (VITAMIN D3) and LISINOPRIL for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing). On 12-Oct-2021, the patient experienced PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse) and BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse). On an unknown date, the patient experienced JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back), PERIPHERAL SWELLING (knuckles on her hand are swollen, and it is in hands) and MYALGIA (extreme body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse) and BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse) had not resolved and JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back), PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing), PERIPHERAL SWELLING (knuckles on her hand are swollen, and it is in hands) and MYALGIA (extreme body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs included Sulfodene.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling in knees/it is in ankles; swelling on my back; knuckles on her hand are swollen, and it is in hands; extreme body aches; swollen under the arm/(kind of swollen)/it continued to get worse; swollen into the breast area (on left side)/it continued to get worse; arm was really painful (left) and kind of throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse), BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse), JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back) and PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076F21A, 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included SIMVASTATIN, BACLOFEN, OMEGA-3 [OMEGA-3 NOS], COLECALCIFEROL (VITAMIN D3) and LISINOPRIL for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing). On 12-Oct-2021, the patient experienced PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse) and BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse). On an unknown date, the patient experienced JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back), PERIPHERAL SWELLING (knuckles on her hand are swollen, and it is in hands) and MYALGIA (extreme body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen under the arm/(kind of swollen)/it continued to get worse) and BREAST SWELLING (swollen into the breast area (on left side)/it continued to get worse) had not resolved and JOINT SWELLING (swelling in knees/it is in ankles), SWELLING (swelling on my back), PAIN IN EXTREMITY (arm was really painful (left) and kind of throbbing), PERIPHERAL SWELLING (knuckles on her hand are swollen, and it is in hands) and MYALGIA (extreme body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs included Sulfodene.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is a little sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Arm is a little sore). At the time of the report, PAIN IN EXTREMITY (Arm is a little sore) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-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 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: she also experienced numbness in her hands and fingers and body after the first initial vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (she also experienced numbness in her hands and fingers and body after the first initial vaccination.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-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 HYPOAESTHESIA (she also experienced numbness in her hands and fingers and body after the first initial vaccination.). At the time of the report, HYPOAESTHESIA (she also experienced numbness in her hands and fingers and body after the first initial vaccination.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-396582 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Temperature of 98.6 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Temperature of 98.6 degrees) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A-B, 031B21A and 006B21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included LANSOPRAZOLE for Acid reflux (esophageal), ROSUVASTATIN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Temperature of 98.6 degrees). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Temperature of 98.6 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 98.6 (normal) 98.6 degrees.         No treatment was provided for the adverse events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy, Sleep disorder, Trismus
Clinical narrative: Lock jaw on her left side; Caused her to not breath so well; Terrified of sleeping that night; More left armpit lymph node swelling/ lymph node swelling in the left side of her neck; This spontaneous case was reported by a pharmacist and describes the occurrence of TRISMUS (Lock jaw on her left side), DYSPNOEA (Caused her to not breath so well), SLEEP DISORDER (Terrified of sleeping that night) and LYMPHADENOPATHY (More left armpit lymph node swelling/ lymph node swelling in the left side of her neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TRISMUS (Lock jaw on her left side), DYSPNOEA (Caused her to not breath so well), SLEEP DISORDER (Terrified of sleeping that night) and LYMPHADENOPATHY (More left armpit lymph node swelling/ lymph node swelling in the left side of her neck). At the time of the report, TRISMUS (Lock jaw on her left side), DYSPNOEA (Caused her to not breath so well), SLEEP DISORDER (Terrified of sleeping that night) and LYMPHADENOPATHY (More left armpit lymph node swelling/ lymph node swelling in the left side of her neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-395861 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination complication
Clinical narrative: Severe reaction; Sore arm; Headache that was severe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache that was severe) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe reaction), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache that was severe). At the time of the report, VACCINATION COMPLICATION (Severe reaction), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache that was severe) outcome was unknown.       No treatment medications were reported   This case was linked to MOD-2021-395909, MOD-2021-396561 (Patient Link).