chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Fatigue
Clinical narrative: Little more fatigued after second dose; 5-7 days after second dose atopic dermatitis was starting to go away/ after 10- 14 days the atopic dermatitis cleared up/ Now there is only a little tiny little bit left; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little more fatigued after second dose) and DERMATITIS ATOPIC (5-7 days after second dose atopic dermatitis was starting to go away/ after 10- 14 days the atopic dermatitis cleared up/ Now there is only a little tiny little bit left) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis, Eczema and Psoriasis (mainly on the palms of their hands, on the inside of their elbows, on the back of knee,  in the lower back and in the inguinal area, and inner thigh.).    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced DERMATITIS ATOPIC (5-7 days after second dose atopic dermatitis was starting to go away/ after 10- 14 days the atopic dermatitis cleared up/ Now there is only a little tiny little bit left). On an unknown date, the patient experienced FATIGUE (Little more fatigued after second dose). At the time of the report, FATIGUE (Little more fatigued after second dose) and DERMATITIS ATOPIC (5-7 days after second dose atopic dermatitis was starting to go away/ after 10- 14 days the atopic dermatitis cleared up/ Now there is only a little tiny little bit left) outcome was unknown.            The treatment history was not reported. The concomitant medication was not reported.  The patient stated that after 5 to 7 days of receiving the second dose, there was an evidence that  atopic dermatitis started to go away, and after about 10 to 14 days, his atopic dermatitis cleared up.   Patient also stated that have not been cured of the atopic dermatitis.   This case was linked to MOD-2021-297399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received on 30-AUG-2021, report contains patient demographics , facility information where vaccine given and outcom of event information were added.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Head injury, Illness, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: 2nd dose in April 3rd dose on 19AUG2021; 2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something; Tremendous pain in both arms after 3rd shot; Sick after 3rd shot; Tired after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous pain in both arms after 3rd shot), HEAD INJURY (2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose in April 3rd dose on 19AUG2021), ILLNESS (Sick after 3rd shot) and FATIGUE (Tired after 3rd shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia and Cancer.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Tremendous pain in both arms after 3rd shot), ILLNESS (Sick after 3rd shot) and FATIGUE (Tired after 3rd shot). On 20-Aug-2021, the patient experienced HEAD INJURY (2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose in April 3rd dose on 19AUG2021). At the time of the report, PAIN IN EXTREMITY (Tremendous pain in both arms after 3rd shot), HEAD INJURY (2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something), ILLNESS (Sick after 3rd shot) and FATIGUE (Tired after 3rd shot) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose in April 3rd dose on 19AUG2021) had resolved.      No concomitant medications reported.  No treatment information was reported by reporter   This case was linked to MOD-2021-297590, MOD-2021-297516 (Patient Link).
Age: 101.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination complication
Clinical narrative: two weeks after first dose, right hand developed rheumatoid arthritis; very, very severe reaction; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) (seriousness criterion medically significant) and VACCINATION COMPLICATION (very, very severe reaction). At the time of the report, RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) and VACCINATION COMPLICATION (very, very severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  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.   This case was linked to MOD-2021-297622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Upon internal review on 07-Sep-2021: E2B Company Number was updated from US-irms-MOD21-135841 to US-MODERNATX, INC.-MOD-2021-297603; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: hard red spot on the deltoid near the injection site about the size of a half dollar; hard red spot on the deltoid near the injection site about the size of a half dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard red spot on the deltoid near the injection site about the size of a half dollar) and VACCINATION SITE ERYTHEMA (hard red spot on the deltoid near the injection site about the size of a half dollar) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Aug-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 VACCINATION SITE INDURATION (hard red spot on the deltoid near the injection site about the size of a half dollar) and VACCINATION SITE ERYTHEMA (hard red spot on the deltoid near the injection site about the size of a half dollar). At the time of the report, VACCINATION SITE INDURATION (hard red spot on the deltoid near the injection site about the size of a half dollar) and VACCINATION SITE ERYTHEMA (hard red spot on the deltoid near the injection site about the size of a half dollar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Patient had hard red spot and it was barely raised.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vial that has been opened for 9 days was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided Treatment information was not provided  CASE CROSSLINKED TO MOD21-135951, MOD21-135963
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site bruising, Vaccination site pain
Clinical narrative: left armpit had fluid/left armpit felt like there was fluid there with lymph nodes; there is some pain; She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot; bruise at the inoculation site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the inoculation site), LYMPHADENOPATHY (left armpit had fluid/left armpit felt like there was fluid there with lymph nodes), LYMPH NODE PAIN (there is some pain) and VACCINATION SITE PAIN (She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION SITE BRUISING (bruise at the inoculation site). On 25-Aug-2021, the patient experienced LYMPHADENOPATHY (left armpit had fluid/left armpit felt like there was fluid there with lymph nodes), LYMPH NODE PAIN (there is some pain) and VACCINATION SITE PAIN (She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot). At the time of the report, VACCINATION SITE BRUISING (bruise at the inoculation site) had not resolved and LYMPHADENOPATHY (left armpit had fluid/left armpit felt like there was fluid there with lymph nodes), LYMPH NODE PAIN (there is some pain) and VACCINATION SITE PAIN (She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  The day after receiving the vaccine she noticed that she had a bruise at the inoculation site. This has continued to today.   Patient took an epsom salt bath yesterday and it helped with the pain. She can still feel it when she presses on that spot. She had some pain with the initial injection but that got better with moving it around.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary, Dyspnoea
Clinical narrative: severe shortness of breath when exercising / Difficulty breathing; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (severe shortness of breath when exercising / Difficulty breathing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Hiatal hernia in 2018. Concurrent medical conditions included Anaphylaxis, Hypertension (BP was increasing for a few months before, in 2020) since 2000, Clotting disorder since 1999 and Heartburn. Concomitant products included OMEPRAZOLE from 2091 to an unknown date for Heartburn, HYDROCHLOROTHIAZIDE from 2001 to an unknown date and AMLODIPINE from 2017 to an unknown date for Hypertension.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021 at 9:30 AM, the patient experienced DYSPNOEA (severe shortness of breath when exercising / Difficulty breathing). At the time of the report, DYSPNOEA (severe shortness of breath when exercising / Difficulty breathing) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Angiogram pulmonary: abnormal (abnormal) PE, COVID and perocardiis ruled out by pulmonay angiogram.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab tests include: ECG and Blood troponins. Patient stated that: Respirations >20 per min.  Patient was sent to a cardiologist for increased BP management. Full workup to exclude infarct, studies included stress echo. Meds increased and BP was lowered, over a few weeks, but the dyspnoea did not improve. Treatment information was not provided. Event Recovered with residual effects - Reduced effort tolerance. Patient also asked about the booster dose.   This case was linked to MOD-2021-297778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Reporter name,Patient demographics( height, weight, race, ethnic group), Patient's medical history, concomitant medications, date of start of event and  outcome of the event were added.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Nausea, Vomiting
Clinical narrative: Inappropriate schedule of vaccine administered; Fatigue; Muscle ache; Nausea; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea), VOMITING (Vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Vaccine facility information also included , .   This case was linked to MOD-2021-297814 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Swelling, Vaccination complication
Clinical narrative: itching; swelling; big reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SWELLING (swelling) and VACCINATION COMPLICATION (big reaction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PRURITUS (itching), SWELLING (swelling) and VACCINATION COMPLICATION (big reaction). At the time of the report, PRURITUS (itching) and SWELLING (swelling) had resolved and VACCINATION COMPLICATION (big reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.         No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-229580 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Fatigue, Injection site warmth, Peripheral swelling
Clinical narrative: Bruised left arm; Swollen left arm; Burning feeling down left arm; Hot left arm; Very tired/ Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruised left arm), PERIPHERAL SWELLING (Swollen left arm), BURNING SENSATION (Burning feeling down left arm), INJECTION SITE WARMTH (Hot left arm) and FATIGUE (Very tired/ Fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 088021A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced CONTUSION (Bruised left arm), PERIPHERAL SWELLING (Swollen left arm), BURNING SENSATION (Burning feeling down left arm), INJECTION SITE WARMTH (Hot left arm) and FATIGUE (Very tired/ Fatigued). At the time of the report, CONTUSION (Bruised left arm), PERIPHERAL SWELLING (Swollen left arm), BURNING SENSATION (Burning feeling down left arm), INJECTION SITE WARMTH (Hot left arm) and FATIGUE (Very tired/ Fatigued) outcome was unknown.            Relevant concomitant medications includes antibiotics for UTI and severe sinus infections with double ear infections and take calcium  and vitamin D for my bones.  Treatment product information was not provided.   This case was linked to MOD-2021-297880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow up received on 30-AUG-2021 and date of second dose of vaccine, concomitant medications and events has been updated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lipoma, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: Low grade pain; Sore above it and below it; little bump underneath left armpit area; Lipoma (fatty cyst); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Low grade pain), PAIN IN EXTREMITY (Sore above it and below it), AXILLARY PAIN (little bump underneath left armpit area) and LIPOMA (Lipoma (fatty cyst)) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-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 PAIN (Low grade pain), PAIN IN EXTREMITY (Sore above it and below it), AXILLARY PAIN (little bump underneath left armpit area) and LIPOMA (Lipoma (fatty cyst)). At the time of the report, PAIN (Low grade pain), PAIN IN EXTREMITY (Sore above it and below it), AXILLARY PAIN (little bump underneath left armpit area) and LIPOMA (Lipoma (fatty cyst)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (Negative) Patient authorized an ultrasound which came back negative for anything cancerous/tumor..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced aggravated low grade pain and sore above it and below it when he works out.  Patient tried physical therapy, massages, ice and heat to treat the pain.  Treatment product information was not provided. Concomitant product use was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness in left arm; Very tired, fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm) and FATIGUE (Very tired, fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Soreness in left arm) and FATIGUE (Very tired, fatigued). On 28-Jul-2021, VACCINATION SITE PAIN (Soreness in left arm) had resolved. At the time of the report, FATIGUE (Very tired, fatigued) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported by reporter.  Treatment information were not reported by reporter.   This case was linked to MOD-2021-297855 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received contains Non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Vaccination complication
Clinical narrative: started to experience a lot of side effects; Feeling under the weather.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (started to experience a lot of side effects) and MALAISE (Feeling under the weather.) 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 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION COMPLICATION (started to experience a lot of side effects) and MALAISE (Feeling under the weather.). At the time of the report, VACCINATION COMPLICATION (started to experience a lot of side effects) and MALAISE (Feeling under the weather.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation time shortened
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of shortened coagulation time (blood hasn't clotted this quickly before) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 053E21A) for COVID-19 immunization. No medical history reported. On Aug 26, 2021 at 10:25 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 26, 2021, patient experienced shortened coagulation time (blood hasn't clotted this quickly before). At the time of the report, shortened coagulation time (blood hasn't clotted this quickly before) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not reported. Patient reported she never experienced a blood clot so quickly before.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Dizziness, Feeling hot, Illness
Clinical narrative: Feeling hot; Sleep disturbance; Sickness; Bone pain; Felt faint; Decreased appetite; Weight loss; Myalgia; all the food made me sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain) and DIZZINESS (Felt faint) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN for an unknown indication.   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain), DIZZINESS (Felt faint), DECREASED APPETITE (Decreased appetite), WEIGHT DECREASED (Weight loss), MYALGIA (Myalgia) and ILLNESS (all the food made me sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain), DIZZINESS (Felt faint), DECREASED APPETITE (Decreased appetite), WEIGHT DECREASED (Weight loss) and MYALGIA (Myalgia) outcome was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sleep disorder, Weight decreased
Clinical narrative: Feeling hot; Sleep disturbance; Sickness; Bone pain; Felt faint; Decreased appetite; Weight loss; Myalgia; all the food made me sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain) and DIZZINESS (Felt faint) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN for an unknown indication.   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain), DIZZINESS (Felt faint), DECREASED APPETITE (Decreased appetite), WEIGHT DECREASED (Weight loss), MYALGIA (Myalgia) and ILLNESS (all the food made me sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING HOT (Feeling hot), SLEEP DISORDER (Sleep disturbance), ILLNESS (Sickness), BONE PAIN (Bone pain), DIZZINESS (Felt faint), DECREASED APPETITE (Decreased appetite), WEIGHT DECREASED (Weight loss) and MYALGIA (Myalgia) outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Pfizer as booster dose instead of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pt received Pfizer as booster dose instead of Moderna) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 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 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pt received Pfizer as booster dose instead of Moderna). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Pt received Pfizer as booster dose instead of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: rash feels warm to the touch; big bullseye rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash feels warm to the touch) and VACCINATION SITE RASH (big bullseye rash at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-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 VACCINATION SITE WARMTH (rash feels warm to the touch) and VACCINATION SITE RASH (big bullseye rash at injection site). At the time of the report, VACCINATION SITE WARMTH (rash feels warm to the touch) and VACCINATION SITE RASH (big bullseye rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported. The treatment history was not provided. Patient also reported events like  "does not hurt", "is in her left arm".   This case was linked to MOD-2021-298374 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: never got the second dose since than; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never got the second dose since than) 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 22-Jan-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 PRODUCT DOSE OMISSION ISSUE (never got the second dose since than). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never got the second dose since than) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, SARS-CoV-2 antibody test
Clinical narrative: Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Asthma, Hypertension, Hypercholesterolemia and Obesity (BMI 30.5).   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a Moderna coronavirus vaccine "1st dose" today exactly 4 months after completing a Pfizer coronavirus vaccine regimen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) tested negative for coronavirus antibodies immediately prior to the first Pfizer dose.         No concomitant medications provided. No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up contains no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: very mild symptoms; mild soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very mild symptoms) and MYALGIA (mild soreness in the arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included FISH OIL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very mild symptoms) and MYALGIA (mild soreness in the arm). At the time of the report, VACCINATION COMPLICATION (very mild symptoms) and MYALGIA (mild soreness in the arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment medications was provided.   This case was linked to MOD-2021-298226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and contains no new information regarding 1st Dose.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (slight fever 5 days after vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (slight fever 5 days after vaccination). At the time of the report, pyrexia (slight fever 5 days after vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Exposure to SARS-CoV-2, Fatigue, Intentional dose omission, Product dose omission issue
Clinical narrative: the patient was exposed to her grandson who tested positive for; the patient's primary care doctor suggested that she did not need to continue the vaccination series/ She has not received the second dose at the time of the call; loss of appetite; loss of 10lbs; too tired to do anything/dog tired; second dose not received in allowed time; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (loss of 10lbs), FATIGUE (too tired to do anything/dog tired), EXPOSURE TO SARS-COV-2 (the patient was exposed to her grandson who tested positive for  ) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported by reporter.  Concomitant products included ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (loss of 10lbs) and FATIGUE (too tired to do anything/dog tired). In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (the patient was exposed to her grandson who tested positive for  ) and INTENTIONAL DOSE OMISSION (the patient's primary care doctor suggested that she did not need to continue the vaccination series/ She has not received the second dose at the time of the call). At the time of the report, DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (loss of 10lbs), FATIGUE (too tired to do anything/dog tired) and EXPOSURE TO SARS-COV-2 (the patient was exposed to her grandson who tested positive for  ) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time) and INTENTIONAL DOSE OMISSION (the patient's primary care doctor suggested that she did not need to continue the vaccination series/ She has not received the second dose at the time of the call) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: 10 (Low) his wife lost 10lbs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was exposed to her grandson who tested positive for COVID-19. After the exposure patient experienced adverse events due to which her primary care doctor suggested that she had enough protection from the virus and did not needed to continue the vaccination series. So patient did not receive the second dose of Moderna vaccine.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: the patient was exposed to her grandson who tested positive for; the patient's primary care doctor suggested that she did not need to continue the vaccination series/ She has not received the second dose at the time of the call; loss of appetite; loss of 10lbs; too tired to do anything/dog tired; second dose not received in allowed time; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (loss of 10lbs), FATIGUE (too tired to do anything/dog tired), EXPOSURE TO SARS-COV-2 (the patient was exposed to her grandson who tested positive for  ) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported by reporter.  Concomitant products included ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (loss of 10lbs) and FATIGUE (too tired to do anything/dog tired). In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (the patient was exposed to her grandson who tested positive for  ) and INTENTIONAL DOSE OMISSION (the patient's primary care doctor suggested that she did not need to continue the vaccination series/ She has not received the second dose at the time of the call). At the time of the report, DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (loss of 10lbs), FATIGUE (too tired to do anything/dog tired) and EXPOSURE TO SARS-COV-2 (the patient was exposed to her grandson who tested positive for  ) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time) and INTENTIONAL DOSE OMISSION (the patient's primary care doctor suggested that she did not need to continue the vaccination series/ She has not received the second dose at the time of the call) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: 10 (Low) his wife lost 10lbs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was exposed to her grandson who tested positive for COVID-19. After the exposure patient experienced adverse events due to which her primary care doctor suggested that she had enough protection from the virus and did not needed to continue the vaccination series. So patient did not receive the second dose of Moderna vaccine.  Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection in his mouth) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Immunocompromised. Concomitant products included INSULIN for Diabetes.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (infection in his mouth). At the time of the report, INFECTION (infection in his mouth) outcome was unknown.        Concomitant medication was not provided Treatment information was not reported  Patient is going for his booster shot on 01SEP2021. Patient reported that he may have to take an antibiotic for an infection in his mouth, he is going to the dentist tomorrow.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itches terribly; red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itches terribly) and VACCINATION SITE ERYTHEMA (red) 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 22-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itches terribly) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE PRURITUS (itches terribly) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.            No concurrent and treatment medication was reported by patient.  Patient experienced the same reaction after two shots.   This case was linked to MOD-2021-298578, MOD-2021-298578 (Patient Link).   Reporter did not allow further contact
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: droopy; drugged; nausea; possible fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (droopy), FEELING ABNORMAL (drugged), NAUSEA (nausea) and PYREXIA (possible fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (droopy), FEELING ABNORMAL (drugged), NAUSEA (nausea) and PYREXIA (possible fever). At the time of the report, ASTHENIA (droopy), FEELING ABNORMAL (drugged), NAUSEA (nausea) and PYREXIA (possible fever) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-296450, MOD-2021-298769 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: droopy; drugged; left pain in shoulder and neck; nausea; possible fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (droopy), FEELING ABNORMAL (drugged), ARTHRALGIA (left pain in shoulder and neck), NAUSEA (nausea) and PYREXIA (possible fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (droopy), FEELING ABNORMAL (drugged), ARTHRALGIA (left pain in shoulder and neck), NAUSEA (nausea) and PYREXIA (possible fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (droopy), FEELING ABNORMAL (drugged), ARTHRALGIA (left pain in shoulder and neck), NAUSEA (nausea) and PYREXIA (possible fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant medication included Thyroid Medication(Unspecified).   This case was linked to MOD-2021-298768, MOD-2021-296450 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. There are no onset dates for the events hence cannot establish any temporal association. Further information has been requested.