chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: 10-12 days after the first shot, noticed a rash in the vaccination site; 1/14 and 3/4 inch red circles/The whole area is red.; Sluggish and tired the day after injection; Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish and tired the day after injection), VACCINATION SITE PAIN (Soreness in the left arm), VACCINATION SITE ERYTHEMA (1/14 and 3/4 inch red circles/The whole area is red.) and VACCINATION SITE RASH (10-12 days after the first shot, noticed a rash in the vaccination site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the left arm). On 17-Jan-2021, the patient experienced SLUGGISHNESS (Sluggish and tired the day after injection). On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (1/14 and 3/4 inch red circles/The whole area is red.). On an unknown date, the patient experienced VACCINATION SITE RASH (10-12 days after the first shot, noticed a rash in the vaccination site). At the time of the report, SLUGGISHNESS (Sluggish and tired the day after injection), VACCINATION SITE PAIN (Soreness in the left arm) and VACCINATION SITE ERYTHEMA (1/14 and 3/4 inch red circles/The whole area is red.) outcome was unknown and VACCINATION SITE RASH (10-12 days after the first shot, noticed a rash in the vaccination site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-187608.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Added new event; updated narrative. On 12-Jul-2021: Non-significant Follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Polyuria, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzines), DYSPNOEA (short of breath), POLYURIA (Polyuria) and VERTIGO (whole bathroom was spinning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (Dizzines) and DYSPNOEA (short of breath). On an unknown date, the patient experienced POLYURIA (Polyuria) and VERTIGO (whole bathroom was spinning). At the time of the report, DIZZINESS (Dizzines), DYSPNOEA (short of breath) and POLYURIA (Polyuria) had not resolved and VERTIGO (whole bathroom was spinning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment information were not provided. Patient reports feeling extremely dizzy the day after her vaccination, 7Feb2021 and noticed shortness of breath. Side effects are ongoing. Patient reports feeling better as of 8Feb2021, with less dizziness, but she still has frequent urination and shortness of breath. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Skin swelling
Clinical narrative: very large red circle; warm; puffy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very large red circle), FEELING HOT (warm) and SKIN SWELLING (puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (very large red circle), FEELING HOT (warm) and SKIN SWELLING (puffy). At the time of the report, ERYTHEMA (very large red circle), FEELING HOT (warm) and SKIN SWELLING (puffy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Vaccination site warmth; vaccination site rash; Itching at injection site; hardness at injection site; redness at injection site; tenderness at injection site; bad pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bad pain), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PAIN (bad pain), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (vaccination site rash). The patient was treated with AMIKACIN SULFATE (AMICA) at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, PAIN (bad pain), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (tenderness at injection site) 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: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Vaccination site warmth; vaccination site rash; Itching at injection site; hardness at injection site; redness at injection site; tenderness at injection site; bad pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bad pain), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PAIN (bad pain), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (vaccination site rash). The patient was treated with AMIKACIN SULFATE (AMICA) at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, PAIN (bad pain), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (tenderness at injection site) 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Dyspnoea, Insomnia, Nasopharyngitis
Clinical narrative: low energy; very cold; difficulty breathing; hard to sleep; no taste; itching ALL over body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep) and AGEUSIA (no taste) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep), AGEUSIA (no taste) and PRURITUS (itching ALL over body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep), AGEUSIA (no taste) and PRURITUS (itching ALL over body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: low energy; very cold; difficulty breathing; hard to sleep; no taste; itching ALL over body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep) and AGEUSIA (no taste) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep), AGEUSIA (no taste) and PRURITUS (itching ALL over body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (low energy), NASOPHARYNGITIS (very cold), DYSPNOEA (difficulty breathing), INSOMNIA (hard to sleep), AGEUSIA (no taste) and PRURITUS (itching ALL over body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin tightness, Vaccination site pain
Clinical narrative: right side of face tight; pain in injection site (right arm); head tingling off and on like needles; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (head tingling off and on like needles), SKIN TIGHTNESS (right side of face tight) and VACCINATION SITE PAIN (pain in injection site (right arm)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), PARACETAMOL (TYLENOL REGULAR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PARAESTHESIA (head tingling off and on like needles) and VACCINATION SITE PAIN (pain in injection site (right arm)). On 26-Jan-2021, the patient experienced SKIN TIGHTNESS (right side of face tight). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (head tingling off and on like needles), SKIN TIGHTNESS (right side of face tight) and VACCINATION SITE PAIN (pain in injection site (right arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up TCR received on 18-MAY-2021 included possible NNI and denied further follow up.; Reporter'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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Joint space narrowing, Muscle atrophy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE ATROPHY (Muscles are shrinking), JOINT SPACE NARROWING (Joints are shrinking) and DRY THROAT (Throat is dry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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 MUSCLE ATROPHY (Muscles are shrinking), JOINT SPACE NARROWING (Joints are shrinking) and DRY THROAT (Throat is dry). At the time of the report, MUSCLE ATROPHY (Muscles are shrinking), JOINT SPACE NARROWING (Joints are shrinking) and DRY THROAT (Throat is dry) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.; 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: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Body Ache; Bad Headache; fatigue; Injection site arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Ache), HEADACHE (Bad Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site arm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETAMINOPHEN and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body Ache), HEADACHE (Bad Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site arm pain). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Myalgia, Fatigue and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body Ache), HEADACHE (Bad Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (Injection site arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm a little sore; injection site also felt warm; red and puffed up at injection site; red and puffed up at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm a little sore), VACCINATION SITE WARMTH (injection site also felt warm), VACCINATION SITE ERYTHEMA (red and puffed up at injection site) and VACCINATION SITE SWELLING (red and puffed up at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm a little sore), VACCINATION SITE WARMTH (injection site also felt warm), VACCINATION SITE ERYTHEMA (red and puffed up at injection site) and VACCINATION SITE SWELLING (red and puffed up at injection site). At the time of the report, PAIN IN EXTREMITY (Left arm a little sore), VACCINATION SITE WARMTH (injection site also felt warm), VACCINATION SITE ERYTHEMA (red and puffed up at injection site) and VACCINATION SITE SWELLING (red and puffed up at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information included outcome of events pain in extremity, vaccination site warmth, vaccination site erythema and vaccination site swelling  was updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm" where the area had a large, hot, red rash), VACCINATION SITE MASS (Red, hard lump at the site of injection), VACCINATION SITE INDURATION (Red, hard lump at the site of injection) and VACCINATION SITE ERYTHEMA (Red, hard lump at the site of injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE MASS (Red, hard lump at the site of injection), VACCINATION SITE INDURATION (Red, hard lump at the site of injection) and VACCINATION SITE ERYTHEMA (Red, hard lump at the site of injection). On 04-Feb-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm" where the area had a large, hot, red rash). The patient was treated with CORTISONE at a dose of 1 %. At the time of the report, VACCINATION SITE REACTION ("COVID arm" where the area had a large, hot, red rash), VACCINATION SITE MASS (Red, hard lump at the site of injection), VACCINATION SITE INDURATION (Red, hard lump at the site of injection) and VACCINATION SITE ERYTHEMA (Red, hard lump at the site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up document received on 12 Jul 2021, contains non significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Pruritus, Rash macular
Clinical narrative: big red spot on arm; hot; like inflammation; itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big red spot on arm), FEELING HOT (hot), INFLAMMATION (like inflammation) and PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic granulomatous disease. Concomitant products included LISINOPRIL, CHOLECALCIFEROL and ZINC for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced RASH MACULAR (big red spot on arm), FEELING HOT (hot), INFLAMMATION (like inflammation) and PRURITUS (itchy). The patient was treated with FLUOCINONIDE (TOPSYN) at a dose of unknown. At the time of the report, RASH MACULAR (big red spot on arm), FEELING HOT (hot), INFLAMMATION (like inflammation) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Rash
Clinical narrative: Lower back pain; Rash on arm for 2-3 days and it went away; A spontaneous report was received from a consumer concerning a 29-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on arm for 2-3 days and it went away, rash is back and getting bigger, and lower back pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced the events rash on arm for 2-3 days and it went away. rash is back and getting bigger, and lower back pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of event, rash on arm for 2-3 days and it went away was recovered. The outcome of the events rash is back and getting bigger and lower back pain were unknown.; Reporter's Comments: Based on the current available information which shows a  temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: sores on mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (sores on mouth) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025j20a and 029K20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CARVEDILOL (COREG), ACETYLSALICYLIC ACID, ATORVASTATIN, CLOPIDOGREL (CLAVIX GOLD), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and multivitmamins for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MOUTH ULCERATION (sores on mouth). At the time of the report, MOUTH ULCERATION (sores on mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: lump in arm; 3-inch red spot; Itch; A little redness; A spontaneous report was received from a 61 year old, female patient, concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  little redness, itch and 3-inch red spot and lump in her am.  The patient's medical history was not reported. Concomitant medications was not reported.   On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: M013L20A) via unknown route and unknown anatomical Location  for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient experienced a little redness. It went away, and on Saturday 23 Jan 2021, she started getting an itch on the site where the vaccine was. Now 25 Jan 2021 she had a 3-inch a red spot and lump in her arm. The patient went to urgent care on 25 Jan 2021. The patient was advised to take Benadryl and gave her steroids (Methylprednisolone) as a 5-day pack that started with 6 pills.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, the outcome of the events, erythema was resolved, pruritus and rash macular were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Severe body ache; limb stiffness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe body ache) and MUSCULOSKELETAL STIFFNESS (limb stiffness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Severe body ache) and MUSCULOSKELETAL STIFFNESS (limb stiffness). On 17-Jan-2021, PAIN (Severe body ache) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (limb stiffness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.; Reporter'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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Vaccination site erythema
Clinical narrative: earache; red rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR PAIN (earache) and VACCINATION SITE ERYTHEMA (red rash at injection site) in an 80-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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced EAR PAIN (earache) and VACCINATION SITE ERYTHEMA (red rash at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EAR PAIN (earache) and VACCINATION SITE ERYTHEMA (red rash at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Tylenol ( paracetamol )
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in the Urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the Urine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history reported.  The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO), LOSARTAN, CHLORTHALIDONE, CARVEDILOL (COREG), MEMANTINE and ATORVASTATIN for an unknown indication.   On 27-Jan-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 BLOOD URINE PRESENT (Blood in the Urine). At the time of the report, BLOOD URINE PRESENT (Blood in the Urine) outcome was unknown.              The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: IMMUNOGLOBULIN I.V (The patient has Cancer and get monthly infusions of IV IG.) since an unknown date. Concurrent medical conditions included Cancer (The patient has Cancer and get monthly infusions of IV IG.).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient gets monthly infusions of IV IG  Treatment medications were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: Left arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Left arm is still sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-219) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Past medical history includes high blood pressure) and Seasonal allergy. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ATORVASTATIN, CITALOPRAM, CHLORTHALIDONE and POTASSIUM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Left arm is still sore). At the time of the report, JOINT RANGE OF MOTION DECREASED (Left arm is still sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: warmness around the injection site; redness 2 to 4 inches in diameter around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmness around the injection site) and VACCINATION SITE ERYTHEMA (redness 2 to 4 inches in diameter around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus (It is reported as the patient takes pain medications for Lupus.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmness around the injection site) and VACCINATION SITE ERYTHEMA (redness 2 to 4 inches in diameter around the injection site). At the time of the report, VACCINATION SITE WARMTH (warmness around the injection site) and VACCINATION SITE ERYTHEMA (redness 2 to 4 inches in diameter around the injection site) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PYREXIA (SLIGHT FEVER) and CHILLS (CHILLS) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 DIZZINESS (Light headedness), PYREXIA (SLIGHT FEVER) and CHILLS (CHILLS). At the time of the report, DIZZINESS (Light headedness), PYREXIA (SLIGHT FEVER) and CHILLS (CHILLS) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included blood pressure medication. Treatment details included were reported as none.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain
Clinical narrative: inflamed area on arm 7 days after injection; Patient have little tenderness in arm 7 days after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflamed area on arm 7 days after injection) and VACCINATION SITE PAIN (Patient have little tenderness in arm 7 days after injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE INFLAMMATION (inflamed area on arm 7 days after injection) and VACCINATION SITE PAIN (Patient have little tenderness in arm 7 days after injection). At the time of the report, VACCINATION SITE INFLAMMATION (inflamed area on arm 7 days after injection) and VACCINATION SITE PAIN (Patient have little tenderness in arm 7 days after injection) 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Influenza like illness, Influenza virus test
Clinical narrative: pain in arm; Terrible headache; chills; nausea; Feeling flu-ish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling flu-ish), PAIN IN EXTREMITY (pain in arm), HEADACHE (Terrible headache), CHILLS (chills) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Asthma.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling flu-ish), HEADACHE (Terrible headache), CHILLS (chills) and NAUSEA (nausea). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, INFLUENZA LIKE ILLNESS (Feeling flu-ish), PAIN IN EXTREMITY (pain in arm), HEADACHE (Terrible headache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) negative. On an unknown date, Influenza virus test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: pain in arm; Terrible headache; chills; nausea; Feeling flu-ish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling flu-ish), PAIN IN EXTREMITY (pain in arm), HEADACHE (Terrible headache), CHILLS (chills) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Asthma.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling flu-ish), HEADACHE (Terrible headache), CHILLS (chills) and NAUSEA (nausea). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, INFLUENZA LIKE ILLNESS (Feeling flu-ish), PAIN IN EXTREMITY (pain in arm), HEADACHE (Terrible headache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) negative. On an unknown date, Influenza virus test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not available.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive for Covid-19) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for an unknown indication.    On 15-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 SARS-COV-2 TEST POSITIVE (positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site reaction
Clinical narrative: Covid arm; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and VACCINATION SITE REACTION (Covid arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (Itchiness). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). On 25-Jan-2021, PRURITUS (Itchiness) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dry throat, Duodenogastric reflux, Eructation, Pallor
Clinical narrative: Asking a lot of water to clear throat; Dry heaving; little bit of bile came up; Burping; Got pale; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping) and PALLOR (Got pale) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Atrial fibrillation and Dementia. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, DONEPEZIL for Dementia, METOPROLOL, SUCCINATE D'ESTRIOL, POTASSIUM (POTASIUM M), LEVOTHYROXINE SODIUM (LEVOTIROXIN), DOCUSATE SODIUM (COLACE CLEAR) and NYSTATIN (NISTATIN) for an unknown indication.    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 THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping), PALLOR (Got pale) and VOMITING (Vomiting). On 27-Jan-2021, PALLOR (Got pale) had resolved. At the time of the report, THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.2°f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported. During follow up reporter states that the patient is treated and discharged, denied hospital admission. Medical history includes atrial fibrillation and dementia.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: This significant follow-up was received on 16-APR-2021 which updated event outcome as recovered/resolved and reporter's mail address.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Vomiting
Clinical narrative: Asking a lot of water to clear throat; Dry heaving; little bit of bile came up; Burping; Got pale; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping) and PALLOR (Got pale) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Atrial fibrillation and Dementia. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, DONEPEZIL for Dementia, METOPROLOL, SUCCINATE D'ESTRIOL, POTASSIUM (POTASIUM M), LEVOTHYROXINE SODIUM (LEVOTIROXIN), DOCUSATE SODIUM (COLACE CLEAR) and NYSTATIN (NISTATIN) for an unknown indication.    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 THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping), PALLOR (Got pale) and VOMITING (Vomiting). On 27-Jan-2021, PALLOR (Got pale) had resolved. At the time of the report, THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.2°f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported. During follow up reporter states that the patient is treated and discharged, denied hospital admission. Medical history includes atrial fibrillation and dementia.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: This significant follow-up was received on 16-APR-2021 which updated event outcome as recovered/resolved and reporter's mail address.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (She was hurting) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (She was hurting). At the time of the report, MYALGIA (She was hurting) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient want to know whether Tylenol can be taken.