chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Left common femoral venous thrombosis; This literature-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) in an 84-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to DEEP VEIN THROMBOSIS. The patient was treated with HEPARIN for Anticoagulant therapy, at an unspecified dose and frequency and APIXABAN for Anticoagulant therapy, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: thrombus in left common femoral vein (abnormal) thrombus in left common femoral vein. On an unknown date, Haematology test: hypercoagulable panel, negati (Negative) performed a hypercoagulable panel in patients which was negative for a genetic predisposition to VTE (hospital days 2-4). On an unknown date, Haemoglobin: 12.7 gm/dl (Low) 12.7  gm/dl. On an unknown date, International normalised ratio: 1.1 (Low) 1.1. On an unknown date, Platelet count: 144 per mm3 (Low) 144 per mm3. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Ultrasound Doppler: femoral, popliteal, and peroneal dvt (Inconclusive) left common femoral, popliteal, and peroneal DVT. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) to be possibly related. Concomitant medications were not provided by the reporter. Patient presented with 8 days left leg pain and swelling symptoms. Her symptoms occurred 3 day after second dose vaccination. Pulmonary embolism was not detected. Her symptom improved on a heparin drip and was ultimately discharged from hospital with 3 days on apixaban. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-282440, MOD-2021-282332; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: trouble breathing,can't take a full breathe of air; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing,can't take a full breathe of air) 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 DYSPNOEA (trouble breathing,can't take a full breathe of air). At the time of the report, DYSPNOEA (trouble breathing,can't take a full breathe of air) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  No Concomitant medication was reported.  No lab data was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient had 3 doses of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient had 3 doses of Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 016C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (patient had 3 doses of Moderna vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (patient had 3 doses of Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.       Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthritis
Clinical narrative: arthritis worsened; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis worsened) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (suffering with arthritis for 5 or 6 years.). Concomitant products included ABATACEPT (ORENCIA) and GOLIMUMAB (SIMPONI) for Arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-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 ARTHRITIS (arthritis worsened). The patient was treated with METHOTREXATE for Arthritis aggravated, at a dose of UNK (4 pills once a week). At the time of the report, ARTHRITIS (arthritis worsened) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Low.         She stated that on 12-May-2021, her doctor told her that her antibodies were very low, stated it may be because of the medications. She also stated that methotrexate is a cancer drug but also was found that it's useful for people with arthritis. She has been taking a biological infusion for her arthritis once a month for the last 4 years in which Orencia was the first one she used and Simponi was the second one.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Bone pain, Fatigue, Illness
Clinical narrative: couldn't feed her son as he turned his head and didn't drink her milk for 7 days; sick so badly; pain in her bones; so weak; bedridden for 4 days/couldn't leave her bed; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SUPPRESSED LACTATION (couldn't feed her son as he turned his head and didn't drink her milk for 7 days), ILLNESS (sick so badly), BONE PAIN (pain in her bones), ASTHENIA (so weak) and BEDRIDDEN (bedridden for 4 days/couldn't leave her bed) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q3AA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and IRON for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUPPRESSED LACTATION (couldn't feed her son as he turned his head and didn't drink her milk for 7 days), ILLNESS (sick so badly), BONE PAIN (pain in her bones), ASTHENIA (so weak), BEDRIDDEN (bedridden for 4 days/couldn't leave her bed), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, SUPPRESSED LACTATION (couldn't feed her son as he turned his head and didn't drink her milk for 7 days) and BEDRIDDEN (bedridden for 4 days/couldn't leave her bed) had resolved and ILLNESS (sick so badly), BONE PAIN (pain in her bones), ASTHENIA (so weak), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no medical history was reported no treatment drugs were reported   This case was linked to MOD-2021-285010 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suppressed lactation
Clinical narrative: couldn't feed her son as he turned his head and didn't drink her milk for 7 days; sick so badly; pain in her bones; so weak; bedridden for 4 days/couldn't leave her bed; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SUPPRESSED LACTATION (couldn't feed her son as he turned his head and didn't drink her milk for 7 days), ILLNESS (sick so badly), BONE PAIN (pain in her bones), ASTHENIA (so weak) and BEDRIDDEN (bedridden for 4 days/couldn't leave her bed) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q3AA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and IRON for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUPPRESSED LACTATION (couldn't feed her son as he turned his head and didn't drink her milk for 7 days), ILLNESS (sick so badly), BONE PAIN (pain in her bones), ASTHENIA (so weak), BEDRIDDEN (bedridden for 4 days/couldn't leave her bed), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, SUPPRESSED LACTATION (couldn't feed her son as he turned his head and didn't drink her milk for 7 days) and BEDRIDDEN (bedridden for 4 days/couldn't leave her bed) had resolved and ILLNESS (sick so badly), BONE PAIN (pain in her bones), ASTHENIA (so weak), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no medical history was reported no treatment drugs were reported   This case was linked to MOD-2021-285010 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: pretty bad flu symptoms, but no fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (pretty bad flu symptoms, but no fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (pretty bad flu symptoms, but no fever). At the time of the report, INFLUENZA LIKE ILLNESS (pretty bad flu symptoms, but no fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Reporter stated patient had 1st shot 10 days ago. That night patient woke up in the middle of the night with pretty bad flu symptoms, but no fever. Lasted 2 days. Then symptom free for 2 days. Then it hit the patient again 2 days later and lasted 4 days. Had to go to bed. It dissappred again   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: anti-inflammatory response to the vaccine; feel weird; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19), FEELING ABNORMAL (feel weird) and VACCINATION COMPLICATION (anti-inflammatory response to the vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). On 31-Jul-2021, the patient experienced FEELING ABNORMAL (feel weird). On 02-Aug-2021, the patient experienced VACCINATION COMPLICATION (anti-inflammatory response to the vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 06-Aug-2021, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) had resolved. At the time of the report, FEELING ABNORMAL (feel weird) and VACCINATION COMPLICATION (anti-inflammatory response to the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 31-Jul-2021, Heart rate: 118 (High) Elevated at 118.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. On 06Aug2021 patient finished the quarantine, and was negative for covid-19.They went to the pharmacy to get their second dose of the Moderna vaccine and were advice not to take it and to wait for 30 days.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; full body itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (full body itching) 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 URTICARIA (hives) and PRURITUS (full body itching). At the time of the report, URTICARIA (hives) and PRURITUS (full body itching) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasopharyngitis, Paraesthesia, Rash
Clinical narrative: Colds; Tingling; Numbness; Spots all over the body; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Colds), PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness) and RASH (Spots all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced NASOPHARYNGITIS (Colds), PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness) and RASH (Spots all over the body). At the time of the report, NASOPHARYNGITIS (Colds), PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness) and RASH (Spots all over the body) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the occurrence of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Lip pruritus, Throat irritation, Tongue pruritus
Clinical narrative: After I received shot that my lips, tongue and throat started itching; After I received shot that my lips, tongue and throat started itching; After I received shot that my lips, tongue and throat started itching; This spontaneous case was reported by a consumer and describes the occurrence of LIP PRURITUS (After I received shot that my lips, tongue and throat started itching), TONGUE PRURITUS (After I received shot that my lips, tongue and throat started itching) and THROAT IRRITATION (After I received shot that my lips, tongue and throat started itching) 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.    In March 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 LIP PRURITUS (After I received shot that my lips, tongue and throat started itching), TONGUE PRURITUS (After I received shot that my lips, tongue and throat started itching) and THROAT IRRITATION (After I received shot that my lips, tongue and throat started itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, LIP PRURITUS (After I received shot that my lips, tongue and throat started itching), TONGUE PRURITUS (After I received shot that my lips, tongue and throat started itching) and THROAT IRRITATION (After I received shot that my lips, tongue and throat started itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Joint swelling
Clinical narrative: pain in her back; dizziness; her left ankle which is twice the size of her right ankle; nausea; fatigue; lots of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her back), DIZZINESS (dizziness), JOINT SWELLING (her left ankle which is twice the size of her right ankle), NAUSEA (nausea) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (pain in her back), DIZZINESS (dizziness), JOINT SWELLING (her left ankle which is twice the size of her right ankle), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (lots of joint pain). At the time of the report, BACK PAIN (pain in her back), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (lots of joint pain) had resolved and JOINT SWELLING (her left ankle which is twice the size of her right ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided.  No treatment  was provided.  Reporter does have some aches and she is not able to do the exact things she could when she was younger but that was normal for her age.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: pain in her back; dizziness; her left ankle which is twice the size of her right ankle; nausea; fatigue; lots of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her back), DIZZINESS (dizziness), JOINT SWELLING (her left ankle which is twice the size of her right ankle), NAUSEA (nausea) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (pain in her back), DIZZINESS (dizziness), JOINT SWELLING (her left ankle which is twice the size of her right ankle), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (lots of joint pain). At the time of the report, BACK PAIN (pain in her back), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (lots of joint pain) had resolved and JOINT SWELLING (her left ankle which is twice the size of her right ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided.  No treatment  was provided.  Reporter does have some aches and she is not able to do the exact things she could when she was younger but that was normal for her age.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Palpitations, Product dose omission issue
Clinical narrative: very sick; heart palpitation side effects; first vaccine at the end of March 2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), PALPITATIONS (heart palpitation side effects) and PRODUCT DOSE OMISSION ISSUE (first vaccine at the end of March 2021) 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.    In March 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 ILLNESS (very sick), PALPITATIONS (heart palpitation side effects) and PRODUCT DOSE OMISSION ISSUE (first vaccine at the end of March 2021). At the time of the report, ILLNESS (very sick) and PALPITATIONS (heart palpitation side effects) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first vaccine at the end of March 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 screening, Drug ineffective
Clinical narrative: Lack of drug effect; Positive Covid after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid after vaccine) and DRUG INEFFECTIVE (Lack of drug effect) 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 COVID-19 (Positive Covid after vaccine) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Positive Covid after vaccine) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19 screening: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No Treatment medications were provided   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain
Clinical narrative: After 1st dose, she had body aches started within 24 hours; She slept a lot for about 4 days.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept a lot for about 4 days.) and PAIN (After 1st dose, she had body aches started within 24 hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, METOPROLOL, LOSARTAN, FLUOXETINE and ATORVASTATIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERSOMNIA (She slept a lot for about 4 days.). On 01-Apr-2021, the patient experienced PAIN (After 1st dose, she had body aches started within 24 hours). On 03-Apr-2021, HYPERSOMNIA (She slept a lot for about 4 days.) outcome was unknown. At the time of the report, PAIN (After 1st dose, she had body aches started within 24 hours) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications were not reported.   This case was linked to MOD-2021-286585 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: When I had my shots I was sick 3days both times.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (When I had my shots I was sick 3days both times.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (When I had my shots I was sick 3days both times.). At the time of the report, ILLNESS (When I had my shots I was sick 3days both times.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication information was provided. No concomitant medication information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). At the time of the report, VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: flu like symptoms; swollen lymph nodes in her neck; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and LYMPHADENOPATHY (swollen lymph nodes in her neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0114214) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.   On 24-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and LYMPHADENOPATHY (swollen lymph nodes in her neck). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes in her neck) had not resolved.            no treatment drugs were reported no concomitants were reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up information received on 13 Aug 2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Chills, Dyspnoea, Vaccination site reaction
Clinical narrative: Covid arm which is huge and bubbly; chest pain; Feels like she  needs air which is similar to air hunger.; nerves are  firing; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm which is huge and bubbly), CHEST PAIN (chest pain), DYSPNOEA (Feels like she  needs air which is similar to air hunger.), BURNING SENSATION (nerves are  firing) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included MS (MS patient (an autoimmune disease).) and Immunocompromised.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION SITE REACTION (Covid arm which is huge and bubbly), CHEST PAIN (chest pain), DYSPNOEA (Feels like she  needs air which is similar to air hunger.), BURNING SENSATION (nerves are  firing) and CHILLS (chills). At the time of the report, VACCINATION SITE REACTION (Covid arm which is huge and bubbly), CHEST PAIN (chest pain), DYSPNOEA (Feels like she  needs air which is similar to air hunger.), BURNING SENSATION (nerves are  firing) and CHILLS (chills) outcome was unknown.            Patient concomitant product included 20mg of steroids No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included CIDP. Concomitant products included LEVOTHYROXINE, ALPRAZOLAM and OMEPRAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medications include Supplements.  Patient got a steroid shot for the tendinitis in her elbow 2 hours prior to second dose of Moderna COVID-19 vaccine.   This case was linked to MOD-2021-286530 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Ear pain, Lymphadenopathy, Oropharyngeal pain, Peripheral swelling
Clinical narrative: made it hard to talk.; all around the ears hurt; all around the the throat hurt; swollen under the arm too but those didn't hurt; swelling on the lymph nodes around the jaw and the neck, and the side of the throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (made it hard to talk.), EAR PAIN (all around the ears hurt), OROPHARYNGEAL PAIN (all around the the throat hurt), PERIPHERAL SWELLING (swollen under the arm too but those didn't hurt) and LYMPHADENOPATHY (swelling on the lymph nodes around the jaw and the neck, and the side of the throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced DYSARTHRIA (made it hard to talk.), EAR PAIN (all around the ears hurt), OROPHARYNGEAL PAIN (all around the the throat hurt), PERIPHERAL SWELLING (swollen under the arm too but those didn't hurt) and LYMPHADENOPATHY (swelling on the lymph nodes around the jaw and the neck, and the side of the throat). At the time of the report, DYSARTHRIA (made it hard to talk.), EAR PAIN (all around the ears hurt), OROPHARYNGEAL PAIN (all around the the throat hurt), PERIPHERAL SWELLING (swollen under the arm too but those didn't hurt) and LYMPHADENOPATHY (swelling on the lymph nodes around the jaw and the neck, and the side of the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.  Patient received 1st dose on 10Aug2021, and has had a headache, he was asking whether to take aspirin or Advil.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A16-year-old received her first dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine). On 16-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine) to be not applicable.    No concomitant medications were reported.   No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine); Little itchy upper body (After second vaccine); Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Little itchy upper body (After second vaccine)), LYMPHADENOPATHY (Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine)) and RASH (Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included Disseminated histoplasmosis, Pneumonia and Intervertebral disc disorder (Disc problems). Concurrent medical conditions included Blood pressure high (Controlled) and High cholesterol (Controlled). Concomitant products included METOPROLOL, EVOLOCUMAB (REPATHA), ESCITALOPRAM and FLUCONAZOLE (DIFLUCAN) for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced PRURITUS (Little itchy upper body (After second vaccine)) and LYMPHADENOPATHY (Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine)). On 26-Jun-2021, the patient experienced RASH (Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine)). At the time of the report, PRURITUS (Little itchy upper body (After second vaccine)), LYMPHADENOPATHY (Swollen lymph nodes near the clavicle and left arm-pit (After second vaccine)) and RASH (Rash (bigger than a silver dollar about 1.5 inch circular) on the left breast (After second vaccine)) outcome was unknown.            On 09-Aug-2021, the patient visited the Emergency Room (third Contact) and was prescribed with Triamcinolone cream and Diflucan pills by mouth.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Neuralgia, Pain
Clinical narrative: Aches; Radiating nerve pain down arm and leg; Shoulder pain; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches), NEURALGIA (Radiating nerve pain down arm and leg), ARTHRALGIA (Shoulder pain) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 PAIN (Aches), NEURALGIA (Radiating nerve pain down arm and leg), ARTHRALGIA (Shoulder pain) and CHILLS (Chills). At the time of the report, PAIN (Aches), NEURALGIA (Radiating nerve pain down arm and leg), ARTHRALGIA (Shoulder pain) and CHILLS (Chills) 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 provided.  No treatment information was provided.   This case was linked to MOD-2021-294679 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic pain, Nausea, Pyrexia, Renal pain, Vomiting
Clinical narrative: pain on one side of kidney, spread to both sides of kidney; pain around liver; high fever since vaccine; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (pain on one side of kidney, spread to both sides of kidney), HEPATIC PAIN (pain around liver), PYREXIA (high fever since vaccine), VOMITING (vomiting) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (pain on one side of kidney, spread to both sides of kidney), HEPATIC PAIN (pain around liver), PYREXIA (high fever since vaccine), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, RENAL PAIN (pain on one side of kidney, spread to both sides of kidney), HEPATIC PAIN (pain around liver), PYREXIA (high fever since vaccine), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant and treatment drugs were not provided
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: missed her  second dose; got Covid-19 infection after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her  second dose) and COVID-19 (got Covid-19 infection after the first dose) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknwon) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her  second dose) and COVID-19 (got Covid-19 infection after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her  second dose) and COVID-19 (got Covid-19 infection after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Medical History information was reported. No treatment and   concomitant drugs are not provided.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Only received one dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only received one dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Only received one dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hot flush, Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: 1st dose June 16 2021/ 2nd dose 13August 2021; Hot flushes; felt like his arm was gonna fall out; Headache; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (Hot flushes), LIMB DISCOMFORT (felt like his arm was gonna fall out), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose June 16 2021/ 2nd dose 13August 2021) and HEADACHE (Headache) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 039C21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE and LORAZEPAM (ATIVAN) for an unknown indication.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced HOT FLUSH (Hot flushes), LIMB DISCOMFORT (felt like his arm was gonna fall out) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose June 16 2021/ 2nd dose 13August 2021). At the time of the report, HOT FLUSH (Hot flushes), LIMB DISCOMFORT (felt like his arm was gonna fall out) and HEADACHE (Headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose June 16 2021/ 2nd dose 13August 2021) had resolved.            No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients who received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) 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 15-Jul-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 EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: First shot was fine no itching Or redness very mild side affects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First shot was fine no itching Or redness very mild side affects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Encephalitis (Brain infection), Bilateral pneumonia (was hospitalized for 6 days and was pumped with so many steroids, antibiotics and Heparin injections) and Neurosurgery (3 brain surgeries). Concurrent medical conditions included Epilepsy (Epilepsy due to brain infection) and Drug allergy (Multiple allergic reactions to drugs).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (First shot was fine no itching Or redness very mild side affects). At the time of the report, VACCINATION COMPLICATION (First shot was fine no itching Or redness very mild side affects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-286573 (Patient Link).