chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Headache, Hyperaesthesia, Myalgia, Pain
Clinical narrative: pain legs/burning pain in my lower legs/painful to stand; On Saturday 30th the spots were barely there and then on Sunday 31st they where worst; Rash legs; linger on head ache; when walking they get more red and more sensitive to the touch; standing is worst; the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch; initially experienced fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain legs/burning pain in my lower legs/painful to stand), DYSKINESIA (standing is worst), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), HYPERAESTHESIA (when walking they get more red and more sensitive to the touch) and RASH (Rash legs) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (initially experienced fever). On 30-Jan-2021, the patient experienced MYALGIA (the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch). On 31-Jan-2021, the patient experienced DYSKINESIA (standing is worst) and HYPERAESTHESIA (when walking they get more red and more sensitive to the touch). On an unknown date, the patient experienced PAIN (pain legs/burning pain in my lower legs/painful to stand), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), RASH (Rash legs) and HEADACHE (linger on head ache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (pain legs/burning pain in my lower legs/painful to stand), DYSKINESIA (standing is worst), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), HYPERAESTHESIA (when walking they get more red and more sensitive to the touch), RASH (Rash legs), PYREXIA (initially experienced fever), HEADACHE (linger on head ache) and MYALGIA (the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch) 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 concomitant medications were provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Significant follow-up appended as event added
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin disorder
Clinical narrative: pain legs/burning pain in my lower legs/painful to stand; On Saturday 30th the spots were barely there and then on Sunday 31st they where worst; Rash legs; linger on head ache; when walking they get more red and more sensitive to the touch; standing is worst; the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch; initially experienced fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (pain legs/burning pain in my lower legs/painful to stand), DYSKINESIA (standing is worst), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), HYPERAESTHESIA (when walking they get more red and more sensitive to the touch) and RASH (Rash legs) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (initially experienced fever). On 30-Jan-2021, the patient experienced MYALGIA (the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch). On 31-Jan-2021, the patient experienced DYSKINESIA (standing is worst) and HYPERAESTHESIA (when walking they get more red and more sensitive to the touch). On an unknown date, the patient experienced PAIN (pain legs/burning pain in my lower legs/painful to stand), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), RASH (Rash legs) and HEADACHE (linger on head ache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN (pain legs/burning pain in my lower legs/painful to stand), DYSKINESIA (standing is worst), SKIN DISORDER (On Saturday 30th the spots were barely there and then on Sunday 31st they where worst), HYPERAESTHESIA (when walking they get more red and more sensitive to the touch), RASH (Rash legs), PYREXIA (initially experienced fever), HEADACHE (linger on head ache) and MYALGIA (the next morning woke up with sore muscles and specific spots on the legs that is tender to the touch) 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 concomitant medications were provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Significant follow-up appended as event added
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm that day; body did not hurt as badly as it hurt when had COVID; They had the shot 21 days ago exactly today, the first shot,; run a fever that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm that day), PAIN (body did not hurt as badly as it hurt when had COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They had the shot 21 days ago exactly today, the first shot,) and PYREXIA (run a fever that night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had COVID diagnosis, testing and symptoms on 01Dec2020) on 01-Dec-2020.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm that day), PAIN (body did not hurt as badly as it hurt when had COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They had the shot 21 days ago exactly today, the first shot,) and PYREXIA (run a fever that night). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They had the shot 21 days ago exactly today, the first shot,) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm that day), PAIN (body did not hurt as badly as it hurt when had COVID) and PYREXIA (run a fever that night) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-026193, MOD-2021-016551, MOD-2021-017943 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: low grade fever; aches and pain; is a little fatigue; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), PAIN (aches and pain), FATIGUE (is a little fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (low grade fever), PAIN (aches and pain), FATIGUE (is a little fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: (left) arm 3x3" area progressing to 3 x 12"; Pain injection site (Left) arm; A spontaneous report was received from a consumer concerning a 56 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain injection site (left) arm /vaccination site pain, rash (left) arm 3x3 area progressing to 3 x 12 /rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021,approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) pain injection site (left) arm. On 18 Feb 2021, the patient experienced the event(s) rash (left) arm 3x3 area progressing to 3 x 12.  Treatment details included antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain injection site (left) arm was resolved on 13 Feb 2021 . The outcome of event(s), rash (left) arm 3x3 area progressing to 3 x 12 was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Left lymph nodes are swollen; Sore arm; A spontaneous report was received from a consumer concerning a 71-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymphadenopathy (left lymph nodes are swollen) and pain in extremity (sore arm).  The patient's medical history was not provided. concomitant medications as reported included that patient was taking thyroid medications.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient stated that his left lymph nodes were swollen. On 16 Feb 2021, he experienced sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 21 Feb 2021 the outcome of event, sore arm was resolved. The outcome of event, left lymph nodes are swollen was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypertension, Pulmonary pain
Clinical narrative: High blood pressure; Pain in lungs; Dizziness; Headache; Tiredness; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: High blood pressure; Pain in lungs; Dizziness; Headache; Tiredness; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Insomnia, Nausea
Clinical narrative: could not sleep; headache; Nausea; felt sick to stomach for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (felt sick to stomach for 36 hours), INSOMNIA (could not sleep), HEADACHE (headache) and NAUSEA (Nausea) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 01-Jan-2013, Penicillin allergy, Glaucoma since 01-Jan-2013 and Thyroid activity decreased since 01-Jan-2021. Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) for Migraine headache, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid activity decreased.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (felt sick to stomach for 36 hours), HEADACHE (headache) and NAUSEA (Nausea). On 06-Feb-2021, the patient experienced INSOMNIA (could not sleep). The patient was treated with LATANOPROST, TIMOLOL MALEATE (LATANAPROST/TIMOLOL) on 01-Jan-2013 for Glaucoma, at a dose of .005 % once a day; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPRIN) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; KETOROLAC TROMETHAMINE (TORADOL) at a dose of 1 dosage form and METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]) at a dose of 1 dosage form. On 07-Feb-2021, ABDOMINAL PAIN UPPER (felt sick to stomach for 36 hours), INSOMNIA (could not sleep), HEADACHE (headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: The follow up information received contain significant information: outcome of events changed from unknown to recovered and resolved, other relevant history added , treatment medications and concomitant medications added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysgeusia, Paraesthesia oral
Clinical narrative: back ache; metallic taste in mouth; tip of tounge felt tingly; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (tip of tounge felt tingly) and BACK PAIN (back ache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included eloquis and LORAZEPAM (ATIVAN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSGEUSIA (metallic taste in mouth) and PARAESTHESIA ORAL (tip of tounge felt tingly). On 14-Feb-2021, the patient experienced BACK PAIN (back ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, DYSGEUSIA (metallic taste in mouth) had resolved. On 06-Feb-2021, PARAESTHESIA ORAL (tip of tounge felt tingly) had resolved. At the time of the report, BACK PAIN (back ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-Significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event Sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sore arm was unknown.; 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.
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: they've been really tired; A spontaneous report was received from a consumer concerning a 102-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event really tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) they've been really tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), they've been really tired was unknown.; 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.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid rash, Ocular hyperaemia, Rash
Clinical narrative: Rash on right eye; Reddish eye; Rash on the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID RASH (Rash on right eye), OCULAR HYPERAEMIA (Reddish eye) and RASH (Rash on the neck) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced EYELID RASH (Rash on right eye), OCULAR HYPERAEMIA (Reddish eye) and RASH (Rash on the neck). The patient was treated with METHYLPREDNISOLONE for Eyelid rash, Ocular hyperemia and Neck rash, at an unspecified dose and frequency. At the time of the report, EYELID RASH (Rash on right eye), OCULAR HYPERAEMIA (Reddish eye) and RASH (Rash on the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received: NNI.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Feeling abnormal, Influenza like illness, Rhinorrhoea, Sensory disturbance
Clinical narrative: Voice is changing due to runny nose; Feels lousy; Runny nose; Legs are rubbery; Has flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice is changing due to runny nose), FEELING ABNORMAL (Feels lousy), RHINORRHOEA (Runny nose), SENSORY DISTURBANCE (Legs are rubbery) and INFLUENZA LIKE ILLNESS (Has flu like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No relevant concomitant medications reported.  Concurrent medical conditions included HIV disease (HIV patient with a weakened immune system).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPHONIA (Voice is changing due to runny nose), FEELING ABNORMAL (Feels lousy), RHINORRHOEA (Runny nose), SENSORY DISTURBANCE (Legs are rubbery) and INFLUENZA LIKE ILLNESS (Has flu like symptoms). On 01-Mar-2021, DYSPHONIA (Voice is changing due to runny nose), FEELING ABNORMAL (Feels lousy), RHINORRHOEA (Runny nose), SENSORY DISTURBANCE (Legs are rubbery) and INFLUENZA LIKE ILLNESS (Has flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (six to eight red bumps appeared on her thumbs whose center was tender to the touch on both) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (Cholesterol levels now fine), Penicillin allergy and Allergy to antibiotic (Bactrim). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Aneurysm, EZETIMIBE (ZETIA) for High cholesterol, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for Macular degeneration.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced SKIN REACTION (six to eight red bumps appeared on her thumbs whose center was tender to the touch on both). At the time of the report, SKIN REACTION (six to eight red bumps appeared on her thumbs whose center was tender to the touch on both) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient states that some bumps were swollen, tender, sore for both the hands. concomitant medication include supplemental iron 65 mg 3times a week for low stores of iron AREDS 2 with multivitamins 2 daily for macular issues. treatment medication include steroid cream,listerine No lab test were done. second dose was administered on 25-feb-2021 right arm   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added treatment medication.Updated patient demographics, relevant history, Concomitant medication and outcome of the events.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hot flush, Pain in extremity
Clinical narrative: Sore arm; Hot flashes; Body weakness; Chills; Severe fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HOT FLUSH (Hot flashes), ASTHENIA (Body weakness), CHILLS (Chills) and FATIGUE (Severe fatigue) 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 antibody test positive (was tested with positive antibodies 5 days before I received my first dose.).    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FATIGUE (Severe fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HOT FLUSH (Hot flashes), ASTHENIA (Body weakness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), HOT FLUSH (Hot flashes), ASTHENIA (Body weakness), CHILLS (Chills) and FATIGUE (Severe fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient on day 3 had severe fatigue set in to the point that I had to medicate myself to push through work . The patient slept the entire following weekend again and after 10 days the fatigue finally subsided, although it spurs up every 2-3 days so far again lasting about 6 hours.   This case was linked to MOD-2021-026499 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 5, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Disease Crohns since 2009, Alcohol use (Prior use), Nicotine dependence (Prior use) and Marijuana use (Prior use). Concurrent medical conditions included Allergy (Erythromycin-when she was a kid). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pregnancy, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    On 24-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 07-Jul-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) to be not related.    on 02-DEC-2020 and 16-FEB-2021 Lab tests included Ultrasounds  Patient has underlying condition: Chron's disease. She has been for a long time on prenatal vitamins because of that. After pregnancy, doctor recommended she takes baby aspirin. Positive pregnancy test: 30/10/2020. Pregnancy dates: 2013(Spontaneous Abortion),2014(live, full term birth), 5/-/2015(Spontaneous Abortion),7/8/2020(Spontaneous Abortion).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: huge lump on her injection site that was red and swollen; 100°F body temperature; huge lump on her injection site that was red and swollen; huge lump on her injection site that was red and swollen; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (huge lump on her injection site that was red and swollen), PYREXIA (100°F body temperature), INJECTION SITE ERYTHEMA (huge lump on her injection site that was red and swollen), INJECTION SITE SWELLING (huge lump on her injection site that was red and swollen) and FATIGUE (exhaustion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE MASS (huge lump on her injection site that was red and swollen), PYREXIA (100°F body temperature), INJECTION SITE ERYTHEMA (huge lump on her injection site that was red and swollen), INJECTION SITE SWELLING (huge lump on her injection site that was red and swollen) and FATIGUE (exhaustion). On 28-Jan-2021, PYREXIA (100°F body temperature) outcome was unknown. On 31-Jan-2021, FATIGUE (exhaustion) outcome was unknown. At the time of the report, INJECTION SITE MASS (huge lump on her injection site that was red and swollen), INJECTION SITE ERYTHEMA (huge lump on her injection site that was red and swollen) and INJECTION SITE SWELLING (huge lump on her injection site that was red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: redness on his right eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (redness on his right eye) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MD0A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 26-Feb-2021, the patient experienced OCULAR HYPERAEMIA (redness on his right eye). At the time of the report, OCULAR HYPERAEMIA (redness on his right eye) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Limb discomfort, Pyrexia, Vaccination site movement impairment
Clinical narrative: could barely pick it up; couldn't get warm in bed; left arm is still really sore; got a fever; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could barely pick it up), FEELING OF BODY TEMPERATURE CHANGE (couldn't get warm in bed), LIMB DISCOMFORT (left arm is still really sore) and PYREXIA (got a fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol (The patient is taking concomitant for cholesterol.).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could barely pick it up), FEELING OF BODY TEMPERATURE CHANGE (couldn't get warm in bed), LIMB DISCOMFORT (left arm is still really sore) and PYREXIA (got a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (could barely pick it up), FEELING OF BODY TEMPERATURE CHANGE (couldn't get warm in bed) and PYREXIA (got a fever) had resolved. At the time of the report, LIMB DISCOMFORT (left arm is still really sore) 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.   Concomitant product include cholesterol medication
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Skin reaction, Vaccination site erythema
Clinical narrative: Aches; Diarrhea; Injection site Hot; Delayed injection site reaction; Injection site redness; Injection site swollen; Injection site tender; Headaches; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN (Aches), DIARRHOEA (Diarrhea), VACCINATION SITE WARMTH (Injection site Hot), SKIN REACTION (Delayed injection site reaction) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     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 PAIN (Aches), DIARRHOEA (Diarrhea), VACCINATION SITE WARMTH (Injection site Hot), SKIN REACTION (Delayed injection site reaction), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site tender) and HEADACHE (Headaches). At the time of the report, PAIN (Aches), DIARRHOEA (Diarrhea), VACCINATION SITE WARMTH (Injection site Hot), SKIN REACTION (Delayed injection site reaction), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site tender) and HEADACHE (Headaches) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Aches; Diarrhea; Injection site Hot; Delayed injection site reaction; Injection site redness; Injection site swollen; Injection site tender; Headaches; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN (Aches), DIARRHOEA (Diarrhea), VACCINATION SITE WARMTH (Injection site Hot), SKIN REACTION (Delayed injection site reaction) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     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 PAIN (Aches), DIARRHOEA (Diarrhea), VACCINATION SITE WARMTH (Injection site Hot), SKIN REACTION (Delayed injection site reaction), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site tender) and HEADACHE (Headaches). At the time of the report, PAIN (Aches), DIARRHOEA (Diarrhea), VACCINATION SITE WARMTH (Injection site Hot), SKIN REACTION (Delayed injection site reaction), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE PAIN (Injection site tender) and HEADACHE (Headaches) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Herpes zoster, Rash
Clinical narrative: Shingles; Back Pain; Back rash; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), BACK PAIN (Back Pain), RASH (Back rash) and FATIGUE (Fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer, Hypertension, Shingles and Fracture (Fractures in back). Concomitant products included LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID, LOSARTAN, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), BACLOFEN, MELOXICAM (MOBIC), VALACICLOVIR HYDROCHLORIDE (VALTREX), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), IBANDRONATE SODIUM (BONIVA), FLUORESCEIN SODIUM, LIDOCAINE HYDROCHLORIDE (LIDOCAINE & FLUORESCEIN MINIMS), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and PREDNISONE for an unknown indication.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 20-Feb-2021, the patient experienced FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced BACK PAIN (Back Pain) and RASH (Back rash). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles), BACK PAIN (Back Pain), RASH (Back rash) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site movement impairment, Vaccination site rash
Clinical narrative: 9 days after vaccine round rash at injection site; arm was red; arm felt hard to move; hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (arm felt hard to move), VACCINATION SITE INDURATION (hard to touch), VACCINATION SITE RASH (9 days after vaccine round rash at injection site) and VACCINATION SITE ERYTHEMA (arm was red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (arm felt hard to move), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE ERYTHEMA (arm was red). On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (9 days after vaccine round rash at injection site). On 16-Jan-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (arm felt hard to move), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE ERYTHEMA (arm was red) had resolved. On 25-Jan-2021, VACCINATION SITE RASH (9 days after vaccine round rash at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received and reporter contact details were updated.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smelling smoky smells; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smelling smoky smells) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition reported).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAROSMIA (Smelling smoky smells). At the time of the report, PAROSMIA (Smelling smoky smells) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Sinus headache, Vaccination site pain
Clinical narrative: Flu like symptoms; Sinus headache; Nausea; Injection site arm aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), SINUS HEADACHE (Sinus headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site arm aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included GABAPENTIN, BACLOFEN, PANTOPRAZOLE, ESCITALOPRAM, RIVAROXABAN, VITAMIN D3, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 24-Feb-2021, the patient received second 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), SINUS HEADACHE (Sinus headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site arm aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), SINUS HEADACHE (Sinus headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site arm aches) outcome was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Peripheral swelling, Pruritus, Skin mass, Skin warm
Clinical narrative: Hard; swollen arm; Extremely itchy arm; A big red spot on arm; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hard), PERIPHERAL SWELLING (swollen arm), PRURITUS (Extremely itchy arm), SKIN MASS (A big red spot on arm) and SKIN WARM (Warm to touch) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Allergic to sulfa drugs) and Drug allergy (Allergic to Amoxicillin). Concomitant products included CETIRIZINE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INDURATION (Hard), PERIPHERAL SWELLING (swollen arm), PRURITUS (Extremely itchy arm), SKIN MASS (A big red spot on arm) and SKIN WARM (Warm to touch). At the time of the report, INDURATION (Hard), PERIPHERAL SWELLING (swollen arm), PRURITUS (Extremely itchy arm), SKIN MASS (A big red spot on arm) and SKIN WARM (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: No new information. On 20-Jul-2021: TCR Received-Non Significant FU-Denied Further Followup
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vomiting
Clinical narrative: Sore arm; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting) and HEADACHE (Headache) 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 COVID-19.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD21-038723 (E2B Linked Report).; Sender's Comments:  MOD21-038723:Crosslinked to MOD21-038723, Same Reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash erythematous, Vaccination site pain, Vaccination site pruritus
Clinical narrative: On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red spots on her chest), VACCINATION SITE PRURITUS (Itching on arm), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   At the time of the report, RASH ERYTHEMATOUS (Red spots on her chest), VACCINATION SITE PRURITUS (Itching on arm), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.