chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthritis, Dizziness
Clinical narrative: Arthritis; Upset stomach; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), ABDOMINAL DISCOMFORT (Upset stomach) and DIZZINESS (felt dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and DIZZINESS (felt dizzy). On 23-Mar-2021, the patient experienced ARTHRITIS (Arthritis). On 16-Mar-2021, ABDOMINAL DISCOMFORT (Upset stomach) and DIZZINESS (felt dizzy) had resolved. At the time of the report, ARTHRITIS (Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications information were not provided.  Patient called in and received her 1st dose of the Moderna COVID-19 vaccine on 15-Mar-2021. The following day,16-Mar-2021 she developed an upset stomach and felt dizzy. The event start date and stop date of the dizziness subsided, 2 hours later it returned. She decided to lay down and went to slept for about 3 hours. Once she did that she had no other signs of dizziness was on 16-MAR-2021. She was calling to report the symptoms and inquire if she will experience them again. She also inquired about taking Celebrex for her arthritis if it will have any affect with the vaccine.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-JUN-2021 contains Non significant or no new information.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Heavy heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heavy heartbeat) 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. In February 2021, the patient experienced TACHYCARDIA (Heavy heartbeat). At the time of the report, TACHYCARDIA (Heavy heartbeat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: follow up received contains no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Nausea, Somnolence, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (I slept for 12 hrs), ABDOMINAL PAIN (abdominal cramping), FEELING ABNORMAL (my brain fog got worse), NAUSEA (nausea) and VACCINATION SITE PAIN (the injection site was really sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac valve leak.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced SOMNOLENCE (I slept for 12 hrs). On 17-Mar-2021, the patient experienced ABDOMINAL PAIN (abdominal cramping), FEELING ABNORMAL (my brain fog got worse), NAUSEA (nausea) and VACCINATION SITE PAIN (the injection site was really sore). At the time of the report, SOMNOLENCE (I slept for 12 hrs), ABDOMINAL PAIN (abdominal cramping), FEELING ABNORMAL (my brain fog got worse), NAUSEA (nausea) and VACCINATION SITE PAIN (the injection site was really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Fatigue, Maternal exposure during pregnancy, Nausea
Clinical narrative: dizziness; fatigue; nausea; Pregnancy; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE PAIN (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 030A21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Acute lymphoblastic leukemia (In remission since 1996) in 1992, Alcohol use (4 drinks per week) from 2009 to 21-Jan-2021 and Marijuana use (1 gram per month) from 2008 to 21-Jan-2021. Concurrent medical conditions included Sulfonamide allergy and Migraine (Improvement since pregnancy) since 2007. Concomitant products included PRENATAL MULTIVITAMIN + DHA from 25-Jan-2021 to an unknown date for Prenatal care.   On 01-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (sore arm). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. On 03-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved. On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (Positive) positive. On 30-Jan-2021, Ultrasound scan: positive (Positive) positive pregnancy. On 16-Jun-2021, Blood glucose: negative (Negative) negative for gestational diabetes. On 29-Apr-2022, Ultrasound foetal: normal (normal) anatomy scan- normal, no findings.         On 01mar2021, post vaccination, the patient reported that she experienced symptoms of dizziness, fatigue, nausea, vaccination site pain and exposure during pregnancy.   No treatment information was provided  Internal review on 21jul2021 resulted in updates to pregnancy information   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Internal reviewon 21jul2021 resulted in updates to pregnancy information
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, Ultrasound foetal, Ultrasound scan, Vaccination site pain
Clinical narrative: dizziness; fatigue; nausea; Pregnancy; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), VACCINATION SITE PAIN (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 030A21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Acute lymphoblastic leukemia (In remission since 1996) in 1992, Alcohol use (4 drinks per week) from 2009 to 21-Jan-2021 and Marijuana use (1 gram per month) from 2008 to 21-Jan-2021. Concurrent medical conditions included Sulfonamide allergy and Migraine (Improvement since pregnancy) since 2007. Concomitant products included PRENATAL MULTIVITAMIN + DHA from 25-Jan-2021 to an unknown date for Prenatal care.   On 01-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 12-Sep-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (sore arm). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. On 03-Mar-2021, VACCINATION SITE PAIN (sore arm) had resolved. On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (Positive) positive. On 30-Jan-2021, Ultrasound scan: positive (Positive) positive pregnancy. On 16-Jun-2021, Blood glucose: negative (Negative) negative for gestational diabetes. On 29-Apr-2022, Ultrasound foetal: normal (normal) anatomy scan- normal, no findings.         On 01mar2021, post vaccination, the patient reported that she experienced symptoms of dizziness, fatigue, nausea, vaccination site pain and exposure during pregnancy.   No treatment information was provided  Internal review on 21jul2021 resulted in updates to pregnancy information   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Internal reviewon 21jul2021 resulted in updates to pregnancy information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection arm hot to the touch; injection arm itchiness; injection arm redness; injection arm swelling; injection arm soreness; Injection arm heaviness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection arm hot to the touch), VACCINATION SITE INDURATION (Injection arm heaviness), VACCINATION SITE PRURITUS (injection arm itchiness), VACCINATION SITE PAIN (injection arm soreness) and VACCINATION SITE ERYTHEMA (injection arm redness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Injection arm heaviness) and VACCINATION SITE PAIN (injection arm soreness). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection arm hot to the touch), VACCINATION SITE PRURITUS (injection arm itchiness), VACCINATION SITE ERYTHEMA (injection arm redness) and VACCINATION SITE SWELLING (injection arm swelling). At the time of the report, VACCINATION SITE WARMTH (injection arm hot to the touch), VACCINATION SITE INDURATION (Injection arm heaviness), VACCINATION SITE PRURITUS (injection arm itchiness), VACCINATION SITE PAIN (injection arm soreness) and VACCINATION SITE ERYTHEMA (injection arm redness) outcome was unknown and VACCINATION SITE SWELLING (injection arm swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unspecified blood pressure medication. Treatment medication included unspecified seasonal allergy pill.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection arm hot to the touch; injection arm itchiness; injection arm redness; injection arm swelling; injection arm soreness; Injection arm heaviness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection arm hot to the touch), VACCINATION SITE INDURATION (Injection arm heaviness), VACCINATION SITE PRURITUS (injection arm itchiness), VACCINATION SITE PAIN (injection arm soreness) and VACCINATION SITE ERYTHEMA (injection arm redness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Injection arm heaviness) and VACCINATION SITE PAIN (injection arm soreness). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection arm hot to the touch), VACCINATION SITE PRURITUS (injection arm itchiness), VACCINATION SITE ERYTHEMA (injection arm redness) and VACCINATION SITE SWELLING (injection arm swelling). At the time of the report, VACCINATION SITE WARMTH (injection arm hot to the touch), VACCINATION SITE INDURATION (Injection arm heaviness), VACCINATION SITE PRURITUS (injection arm itchiness), VACCINATION SITE PAIN (injection arm soreness) and VACCINATION SITE ERYTHEMA (injection arm redness) outcome was unknown and VACCINATION SITE SWELLING (injection arm swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unspecified blood pressure medication. Treatment medication included unspecified seasonal allergy pill.
Sex: F
Vaccine: COVID19
Symptoms: Knee operation
Clinical narrative: knee surgery scheduled; This spontaneous case was reported by a physician and describes the occurrence of KNEE OPERATION (knee surgery scheduled) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced KNEE OPERATION (knee surgery scheduled). At the time of the report, KNEE OPERATION (knee surgery scheduled) outcome was unknown.        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.   No treatment and concomitant medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: purple area on his arm around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (purple area on his arm around the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included NAPROXEN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (purple area on his arm around the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (purple area on his arm around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: pain in her arm; chills for a little bit; little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), CHILLS (chills for a little bit) and NAUSEA (little nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Fall in January 2021 and Lip injury. Concurrent medical conditions included Diabetes, High cholesterol and Blood pressure abnormal.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm), CHILLS (chills for a little bit) and NAUSEA (little nauseous). At the time of the report, PAIN IN EXTREMITY (pain in her arm), CHILLS (chills for a little bit) and NAUSEA (little nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included unspecified blood pressure medications, high cholesterol medications and diabetes medications.  Treatment information was not provided.   On 23-Mar-2021 the patient went to her plastic surgeon who gave her a Kenalog injection for her lip scar.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling the size of a silver dollar) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling the size of a silver dollar). At the time of the report, SWELLING (swelling the size of a silver dollar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Insomnia, Migraine, Nausea
Clinical narrative: Itchy ears; Ear Fullness; Not sleeping very well; Dizzy spell; Migraine; Nausea; Flare up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy spell), MIGRAINE (Migraine), INSOMNIA (Not sleeping very well), PRURITUS (Itchy ears) and EAR DISCOMFORT (Ear Fullness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizzy spell), MIGRAINE (Migraine), NAUSEA (Nausea) and SKIN IRRITATION (Flare up). On 19-Mar-2021, the patient experienced INSOMNIA (Not sleeping very well). On an unknown date, the patient experienced PRURITUS (Itchy ears) and EAR DISCOMFORT (Ear Fullness). At the time of the report, DIZZINESS (Dizzy spell), MIGRAINE (Migraine), INSOMNIA (Not sleeping very well), PRURITUS (Itchy ears), EAR DISCOMFORT (Ear Fullness), NAUSEA (Nausea) and SKIN IRRITATION (Flare up) outcome was unknown.            Concomitant medications included allergy medication. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation
Clinical narrative: Itchy ears; Ear Fullness; Not sleeping very well; Dizzy spell; Migraine; Nausea; Flare up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy spell), MIGRAINE (Migraine), INSOMNIA (Not sleeping very well), PRURITUS (Itchy ears) and EAR DISCOMFORT (Ear Fullness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizzy spell), MIGRAINE (Migraine), NAUSEA (Nausea) and SKIN IRRITATION (Flare up). On 19-Mar-2021, the patient experienced INSOMNIA (Not sleeping very well). On an unknown date, the patient experienced PRURITUS (Itchy ears) and EAR DISCOMFORT (Ear Fullness). At the time of the report, DIZZINESS (Dizzy spell), MIGRAINE (Migraine), INSOMNIA (Not sleeping very well), PRURITUS (Itchy ears), EAR DISCOMFORT (Ear Fullness), NAUSEA (Nausea) and SKIN IRRITATION (Flare up) outcome was unknown.            Concomitant medications included allergy medication. No treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip swelling, SARS-CoV-2 test
Clinical narrative: Swollen lip; Droppy lip; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP DISORDER (Droppy lip) and LIP SWELLING (Swollen lip) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 016821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Nov-2020 and Lip augmentation (Lip fillers.).   On 19-Mar-2021 at 2:11 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced LIP DISORDER (Droppy lip). On 20-Mar-2021 at 8:00 PM, the patient experienced LIP SWELLING (Swollen lip). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 22-Mar-2021, LIP DISORDER (Droppy lip) and LIP SWELLING (Swollen lip) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive,  rapid test.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. Patient did not experience any adverse effects for the second dose and did not take any medications.    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Reporter address and patient demographics added. Medical history was added. Lab data was added. Updated first dose date, batch number and anatomical location along with second dose details. Updated start date of events, stop date and outcome. Added treatment medication.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: Arm hurts so badly/still having the pain; Injected the dose too high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (Injected the dose too high) and PAIN IN EXTREMITY (Arm hurts so badly/still having the pain) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (Injected the dose too high). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts so badly/still having the pain). On 10-Feb-2021, ACCIDENTAL OVERDOSE (Injected the dose too high) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts so badly/still having the pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were provided    Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever of 102°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever of 102°F) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Nov-2020.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PYREXIA (high fever of 102°F). At the time of the report, PYREXIA (high fever of 102°F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-059974 (E2B Linked Report).; Sender's Comments:  MOD21-059974:Crosslink
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Vaccination site pruritus
Clinical narrative: Patient felt lightheadedness and dizziness; Feeling like' something around my head'; Patient felt itching around the injection site; Patient felt tiredness; Patient felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient felt weak), DIZZINESS (Patient felt lightheadedness and dizziness), FEELING ABNORMAL (Feeling like' something around my head'), VACCINATION SITE PRURITUS (Patient felt itching around the injection site) and FATIGUE (Patient felt tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction (patient do not take FLU vaccine because of some allergic reactions). Concomitant products included MONTELUKAST SODIUM for Allergy, CALTRATE + D PLUS for Osteoporosis, MESALAZINE (APRISO), OLMESARTAN, ATORVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE/SALMETEROL), LATANOPROST and CENTRUM SILVER +50 for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Patient felt weak), VACCINATION SITE PRURITUS (Patient felt itching around the injection site) and FATIGUE (Patient felt tiredness). On 21-Mar-2021, the patient experienced DIZZINESS (Patient felt lightheadedness and dizziness) and FEELING ABNORMAL (Feeling like' something around my head'). At the time of the report, ASTHENIA (Patient felt weak), DIZZINESS (Patient felt lightheadedness and dizziness), FEELING ABNORMAL (Feeling like' something around my head'), VACCINATION SITE PRURITUS (Patient felt itching around the injection site) and FATIGUE (Patient felt tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient one hour after the 1st shot patient felt weak and tiredness and symptoms like itching around the injection site. On 21Mar2021, patient woke up with fatigue, weakness, lightheadedness and dizziness. Because of the symptom's patient tried to remain in the bed for 30 - 45 minutes because of feeling like' something around my head.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: The physician stated that the patient did not report the symptoms to his clinic.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Didn't feel well; Fever; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), VACCINATION COMPLICATION (Didn't feel well) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting) and PYREXIA (Fever). On 22-Mar-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), VACCINATION COMPLICATION (Didn't feel well) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 100.3 High. On 23-Mar-2021, Body temperature: 99.6 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Pills for extra acid in stomach, Anti depressant pill, Pill for blood pressure.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic, Vaccination site rash, Vaccination site warmth
Clinical narrative: Delayed itchy,warm rash; Redness; The area was Warm to touch; Spread from injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Delayed itchy,warm rash), ERYTHEMA (Redness), VACCINATION SITE WARMTH (The area was Warm to touch) and VACCINATION SITE RASH (Spread from injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A2119) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RASH PRURITIC (Delayed itchy,warm rash), ERYTHEMA (Redness), VACCINATION SITE WARMTH (The area was Warm to touch) and VACCINATION SITE RASH (Spread from injection site). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at a dose of 500 mg. At the time of the report, RASH PRURITIC (Delayed itchy,warm rash) had resolved, ERYTHEMA (Redness) had not resolved and VACCINATION SITE WARMTH (The area was Warm to touch) and VACCINATION SITE RASH (Spread from injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Ocular myasthenia.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain). At the time of the report, MYALGIA (pain) had not resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: 102 F fever; chills; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 F fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PYREXIA (102 F fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (102 F fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 °F High.         No relevant concomitant medications were reported.  Additional treatment details included sports drink.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT PRODUCT ADMINISTRATION DURATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not provided.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-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 INCORRECT PRODUCT ADMINISTRATION DURATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart). At the time of the report, INCORRECT PRODUCT ADMINISTRATION DURATION (nurse gave an inmate the two doses of the Moderna Covid-19 vaccine 14 days apart) outcome was unknown.      The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of incorrect product administration duration for mRNA-1273, lot # unknown  with no associated AEs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pain in extremity
Clinical narrative: diarrhea; soreness in arm; aching; headache; fever; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache) and PYREXIA (fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache), PYREXIA (fever) and CHILLS (sever chills). At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache), PYREXIA (fever) and CHILLS (sever chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: diarrhea; soreness in arm; aching; headache; fever; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache) and PYREXIA (fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache), PYREXIA (fever) and CHILLS (sever chills). At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in arm), PAIN (aching), HEADACHE (headache), PYREXIA (fever) and CHILLS (sever chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Hypokinesia, Nausea, Pyrexia
Clinical narrative: redness and welts at the injection site going all the way down to her elbow; redness and welts at the injection site going all the way down to her elbow; nausea; chills; fever; sweats; could not lift my arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), HYPOKINESIA (could not lift my arms), VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow), VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METHOTREXATE, FOLIC ACID, LOSARTAN, ESTRADIOL, PANTOPRAZOLE, SIMVASTATIN, LEVOTHYROXINE, TRAMADOL, HYDROXYCHLOROQUINE and VITAMIN B [VITAMIN B NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), HYPOKINESIA (could not lift my arms), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever). On 22-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow) and VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow). On 22-Mar-2021, HYPOKINESIA (could not lift my arms) had resolved. At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow), VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: redness and welts at the injection site going all the way down to her elbow; redness and welts at the injection site going all the way down to her elbow; nausea; chills; fever; sweats; could not lift my arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), HYPOKINESIA (could not lift my arms), VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow), VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METHOTREXATE, FOLIC ACID, LOSARTAN, ESTRADIOL, PANTOPRAZOLE, SIMVASTATIN, LEVOTHYROXINE, TRAMADOL, HYDROXYCHLOROQUINE and VITAMIN B [VITAMIN B NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), HYPOKINESIA (could not lift my arms), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever). On 22-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow) and VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow). On 22-Mar-2021, HYPOKINESIA (could not lift my arms) had resolved. At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow), VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-116565 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Peripheral coldness, Vaccination site pain
Clinical narrative: wrist to shoulder, up to the neck and back hurting; cold arm; wrist to shoulder, up to the neck and back hurting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (wrist to shoulder, up to the neck and back hurting), PERIPHERAL COLDNESS (cold arm), PAIN (wrist to shoulder, up to the neck and back hurting) and VACCINATION SITE PAIN (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04M2DA) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included TELMISARTAN, CALCIUM, MELOXICAM, GLUCOSAMINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 21-Mar-2021, the patient experienced BACK PAIN (wrist to shoulder, up to the neck and back hurting), PERIPHERAL COLDNESS (cold arm) and PAIN (wrist to shoulder, up to the neck and back hurting). The patient was treated with MIGRAINE RELIEF at a dose of 220 mg and PARACETAMOL (TYLENOL) at a dose of 650 mg. At the time of the report, BACK PAIN (wrist to shoulder, up to the neck and back hurting), PERIPHERAL COLDNESS (cold arm), PAIN (wrist to shoulder, up to the neck and back hurting) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Cough, Headache, Pain
Clinical narrative: Body Pain; Cold Sweats; Cough; Joint Soreness; Head Pounding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding). The patient was treated with MORPHINE at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included Nausea Tablet.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information included primary reporter information and patient demographics.