chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Vaccination site induration
Clinical narrative: knot at injection site; feeling blah like about to get sick; head feels floaty; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling blah like about to get sick), FEELING ABNORMAL (head feels floaty) and VACCINATION SITE INDURATION (knot at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MALAISE (feeling blah like about to get sick) and FEELING ABNORMAL (head feels floaty). On an unknown date, the patient experienced VACCINATION SITE INDURATION (knot at injection site). At the time of the report, MALAISE (feeling blah like about to get sick), FEELING ABNORMAL (head feels floaty) and VACCINATION SITE INDURATION (knot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Headache, Hypoaesthesia, Pain
Clinical narrative: tingling; Pain going up the arm (passing the elbow); swelling in fingers and hand; the arthritis was a lot worse in my hand; my hand was numb; dizziness; Light headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (the arthritis was a lot worse in my hand), PAIN (Pain going up the arm (passing the elbow)), PERIPHERAL SWELLING (swelling in fingers and hand), DIZZINESS (dizziness) and HYPOAESTHESIA (my hand was numb) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (Light headache). On 10-Feb-2021, the patient experienced ARTHRITIS (the arthritis was a lot worse in my hand), PERIPHERAL SWELLING (swelling in fingers and hand) and HYPOAESTHESIA (my hand was numb). On 11-Feb-2021, the patient experienced PAIN (Pain going up the arm (passing the elbow)). On an unknown date, the patient experienced PARAESTHESIA (tingling). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 06-Feb-2021, DIZZINESS (dizziness) and HEADACHE (Light headache) had resolved. At the time of the report, ARTHRITIS (the arthritis was a lot worse in my hand), PAIN (Pain going up the arm (passing the elbow)) and HYPOAESTHESIA (my hand was numb) outcome was unknown and PERIPHERAL SWELLING (swelling in fingers and hand) and PARAESTHESIA (tingling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: tingling; Pain going up the arm (passing the elbow); swelling in fingers and hand; the arthritis was a lot worse in my hand; my hand was numb; dizziness; Light headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (the arthritis was a lot worse in my hand), PAIN (Pain going up the arm (passing the elbow)), PERIPHERAL SWELLING (swelling in fingers and hand), DIZZINESS (dizziness) and HYPOAESTHESIA (my hand was numb) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (Light headache). On 10-Feb-2021, the patient experienced ARTHRITIS (the arthritis was a lot worse in my hand), PERIPHERAL SWELLING (swelling in fingers and hand) and HYPOAESTHESIA (my hand was numb). On 11-Feb-2021, the patient experienced PAIN (Pain going up the arm (passing the elbow)). On an unknown date, the patient experienced PARAESTHESIA (tingling). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 06-Feb-2021, DIZZINESS (dizziness) and HEADACHE (Light headache) had resolved. At the time of the report, ARTHRITIS (the arthritis was a lot worse in my hand), PAIN (Pain going up the arm (passing the elbow)) and HYPOAESTHESIA (my hand was numb) outcome was unknown and PERIPHERAL SWELLING (swelling in fingers and hand) and PARAESTHESIA (tingling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Nausea
Clinical narrative: coughing; Shortness of breath; Chest tightening; Chills; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Chest tightening), CHILLS (Chills) and NAUSEA (Nausea) 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 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). On 10-Feb-2021, the patient experienced COUGH (coughing), DYSPNOEA (Shortness of breath) and CHEST DISCOMFORT (Chest tightening). On 10-Feb-2021, CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) had resolved. At the time of the report, COUGH (coughing), DYSPNOEA (Shortness of breath) and CHEST DISCOMFORT (Chest tightening) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: coughing; Shortness of breath; Chest tightening; Chills; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Chest tightening), CHILLS (Chills) and NAUSEA (Nausea) 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 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). On 10-Feb-2021, the patient experienced COUGH (coughing), DYSPNOEA (Shortness of breath) and CHEST DISCOMFORT (Chest tightening). On 10-Feb-2021, CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) had resolved. At the time of the report, COUGH (coughing), DYSPNOEA (Shortness of breath) and CHEST DISCOMFORT (Chest tightening) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient received both doses of vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysgeusia, Fatigue
Clinical narrative: Back pain; Fatigue; Bitter taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bitter taste in the mouth), BACK PAIN (Back pain) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSGEUSIA (Bitter taste in the mouth) and FATIGUE (Fatigue). On an unknown date, the patient experienced BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Bitter taste in the mouth) and FATIGUE (Fatigue) had not resolved and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she took Tylenol and ibuprofen for back pain. She thought that she was fatigued because of her heart. She spoke to her cardiologist and they have been running tests on her previously.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: vaccine was administered 3 inches below the bottom of the deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered 3 inches below the bottom of the deltoid muscle) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1995. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Hypertension, GLUCOSAMINE and COLECALCIFEROL (D3) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 02-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered 3 inches below the bottom of the deltoid muscle). On 02-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine was administered 3 inches below the bottom of the deltoid muscle) had resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: the follow up were received on 03-MAY-2021. the updated information includes:patient demographic details were updated.action taken was updated.medical history was updated.concomitant medications were updated.second vaccine dosage was updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient had not taken any treatment for the symptoms
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Could not find the second dose of vaccine on time, until 9 weeks later; A spontaneous report  was received from a 43 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and could not find the second dose of vaccine on time, until 9 weeks later.  The patient's medical history and concomitant medications were not provided.  On 06-JAN-2021, the patient received his first of two planned doses of mRNA-1273 (lot number: unknown) into the left arm for the prophylaxis of COVID-19 infection. On 10-MAR-2021, the patient received his second of two planned doses of mRNA-1273 (lot number: unknown) for the prophylaxis of COVID-19 infection.  The patient was expected to receive his second dose on 04-MAR-2021. However, the patient had second dose of vaccine after nine weeks from the first dose as pharmacy did not get shipment and when it did, pharmacy was only authorized to give first vaccine to patient, not the second dose, and was only recently authorize to give the second shot.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome for the event, inappropriate schedule of product administration, was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot# unknown, with no associated adverse events.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Muscle spasms, Spinal pain, Vaccination site pain
Clinical narrative: spinal pain; Hot Flashes; Muscle Spasms; Soreness in arm; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010421A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Report not scheduled for Follow up as initial report is pending for submission On 30-Jun-2021: ADR form-AE details(possible NNI)
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: spinal pain; Hot Flashes; Muscle Spasms; Soreness in arm; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010421A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SPINAL PAIN (spinal pain), HOT FLUSH (Hot Flashes), MUSCLE SPASMS (Muscle Spasms), VACCINATION SITE PAIN (Soreness in arm), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Report not scheduled for Follow up as initial report is pending for submission On 30-Jun-2021: ADR form-AE details(possible NNI)
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (chills) 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 No adverse event (No medical history 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 HEADACHE (Headache) and CHILLS (chills). At the time of the report, HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Flatulence, Headache, Pain in extremity
Clinical narrative: just a gas; stomach pain is not that bad; little headache; sore arm; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (just a gas), ABDOMINAL PAIN UPPER (stomach pain is not that bad), HEADACHE (little headache), PAIN IN EXTREMITY (sore arm) and FATIGUE (little tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLATULENCE (just a gas), ABDOMINAL PAIN UPPER (stomach pain is not that bad), HEADACHE (little headache), PAIN IN EXTREMITY (sore arm) and FATIGUE (little tired). At the time of the report, FLATULENCE (just a gas), ABDOMINAL PAIN UPPER (stomach pain is not that bad), HEADACHE (little headache), PAIN IN EXTREMITY (sore arm) and FATIGUE (little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Pain Medicines for back pain as a Concomitant medication.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dry mouth, Feeling abnormal, Hypoaesthesia, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disoriented), HYPOAESTHESIA (had a numbness on the left side at her temple), TACHYCARDIA (a rapid heartbeat), TREMOR (uncontrollable body tremoring) and DRY MOUTH (dry mouth) in a 46-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.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced DISORIENTATION (disoriented), HYPOAESTHESIA (had a numbness on the left side at her temple), TACHYCARDIA (a rapid heartbeat), TREMOR (uncontrollable body tremoring), DRY MOUTH (dry mouth) and FEELING ABNORMAL (brain fog). On 12-Feb-2021, DISORIENTATION (disoriented), HYPOAESTHESIA (had a numbness on the left side at her temple), TACHYCARDIA (a rapid heartbeat), TREMOR (uncontrollable body tremoring), DRY MOUTH (dry mouth) and FEELING ABNORMAL (brain fog) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disoriented), HYPOAESTHESIA (had a numbness on the left side at her temple), TACHYCARDIA (a rapid heartbeat), TREMOR (uncontrollable body tremoring) and DRY MOUTH (dry mouth) in a 46-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.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced DISORIENTATION (disoriented), HYPOAESTHESIA (had a numbness on the left side at her temple), TACHYCARDIA (a rapid heartbeat), TREMOR (uncontrollable body tremoring), DRY MOUTH (dry mouth) and FEELING ABNORMAL (brain fog). On 12-Feb-2021, DISORIENTATION (disoriented), HYPOAESTHESIA (had a numbness on the left side at her temple), TACHYCARDIA (a rapid heartbeat), TREMOR (uncontrollable body tremoring), DRY MOUTH (dry mouth) and FEELING ABNORMAL (brain fog) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Rash
Clinical narrative: back itches; rash on her neck and stomach; Occasional headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (back itches), RASH (rash on her neck and stomach), CHILLS (chills) and HEADACHE (Occasional headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was reported.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills). On 04-Mar-2021, the patient experienced PRURITUS (back itches), RASH (rash on her neck and stomach) and HEADACHE (Occasional headache). At the time of the report, PRURITUS (back itches), RASH (rash on her neck and stomach), CHILLS (chills) and HEADACHE (Occasional headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information  received 05 May 2021 contains events recovered and a new event was added
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on forearm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on forearm) in a 35-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 (No medical history provided.).    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 RASH (rash on forearm). At the time of the report, RASH (rash on forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-034842 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: All of last night felt body aches; Arms are sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore). At the time of the report, PAIN (All of last night felt body aches) and PAIN IN EXTREMITY (Arms are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on her arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hives on her 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) intramuscularly 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: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the event(s) hives on her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hives on her arm was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Pain, Vaccination site erythema
Clinical narrative: Diarrhea that have gotten progressively worse; Felt crappy, in bed all day; Achy; Headache; Redness in arm of injection; Tenderness in arm of injection; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea that have gotten progressively worse, achy/ pain, headache, felt crappy, in bed all day/ malaise, redness in arm of injection/ vaccination site erythema, tenderness in arm of injection/ vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events diarrhea that have gotten progressively worse, achy, headache, felt crappy, in bed all day, redness in arm of injection, tenderness in arm of injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, diarrhea that have gotten progressively worse, achy, headache, felt crappy, in bed all day, redness in arm of injection, tenderness in arm of injection was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diarrhea that have gotten progressively worse; Felt crappy, in bed all day; Achy; Headache; Redness in arm of injection; Tenderness in arm of injection; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea that have gotten progressively worse, achy/ pain, headache, felt crappy, in bed all day/ malaise, redness in arm of injection/ vaccination site erythema, tenderness in arm of injection/ vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events diarrhea that have gotten progressively worse, achy, headache, felt crappy, in bed all day, redness in arm of injection, tenderness in arm of injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, diarrhea that have gotten progressively worse, achy, headache, felt crappy, in bed all day, redness in arm of injection, tenderness in arm of injection was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Contusion, Flatulence, Headache, Injection site haemorrhage
Clinical narrative: a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.; low grade headache; nausea; low abdominal discomfort and pain below the stomach; gas; bleed at the time of injection; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.), ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE HAEMORRHAGE (bleed at the time of injection). On 03-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas) and NAUSEA (nausea). On an unknown date, the patient experienced CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) and HEADACHE (low grade headache). At the time of the report, CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) had resolved and ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection), NAUSEA (nausea) and HEADACHE (low grade headache) 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.   This case was linked to MOD-2021-034833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant: event outcome updated On 02-May-2021: form with pictures
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.; low grade headache; nausea; low abdominal discomfort and pain below the stomach; gas; bleed at the time of injection; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.), ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE HAEMORRHAGE (bleed at the time of injection). On 03-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas) and NAUSEA (nausea). On an unknown date, the patient experienced CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) and HEADACHE (low grade headache). At the time of the report, CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) had resolved and ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection), NAUSEA (nausea) and HEADACHE (low grade headache) 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.   This case was linked to MOD-2021-034833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant: event outcome updated On 02-May-2021: form with pictures
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Rash on shin and knee; Fever; chills; sore bones; headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue) in a 56-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.     Concurrent medical conditions included Thyroid disorder. Concomitant products included NAPROXEN (NAPROSYN E), ATENOLOL, LEVOTHYROXINE, INDAPAMIDE, PERINDOPRIL ARGININE (COVERSYL PLUS [INDAPAMIDE;PERINDOPRIL ARGININE]) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 02-Feb-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 PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced RASH (Rash on shin and knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache), FATIGUE (Fatigue) and RASH (Rash on shin and knee) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on shin and knee; Fever; chills; sore bones; headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue) in a 56-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.     Concurrent medical conditions included Thyroid disorder. Concomitant products included NAPROXEN (NAPROSYN E), ATENOLOL, LEVOTHYROXINE, INDAPAMIDE, PERINDOPRIL ARGININE (COVERSYL PLUS [INDAPAMIDE;PERINDOPRIL ARGININE]) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 02-Feb-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 PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced RASH (Rash on shin and knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache), FATIGUE (Fatigue) and RASH (Rash on shin and knee) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash over her body; very red (rash); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)) in a 78-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 (no medical history.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)). At the time of the report, RASH (Rash over her body) and RASH ERYTHEMATOUS (very red (rash)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2 doses 2 months apart; A spontaneous report was received from a consumer (Nurse) concerning a 29 -year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) received second dose of Moderna COVID-19 vaccine two months apart.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Mar 2021, the patient received her second of two planned doses of mRNA-1273(Batch Number: Unknown) in left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient received second dose of Moderna COVID-19 vaccine two months apart (Inappropriate schedule of vaccine administered).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event received second dose of Moderna COVID-19 vaccine two months apart was not applicable.  The outcome of the event received second dose of Moderna COVID-19 vaccine two months apart was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got a dose 11 days earlier from today; A spontaneous report was received from a healthcare professional, concerning a 70-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got a dose 11 days earlier from today (inappropriate schedule of product administration).  No medical history was reported. The concomitant medication included unspecified psychiatric medications.  On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly in left arm.  The healthcare professional reported that on 19 Feb 2021, the patient got her first Moderna dose. The patient did not disclose to them and on 03 Mar 2021, got another dose of Moderna vaccine which was second dose to left arm. The healthcare professional reported that the patient got a dose 11 days earlier from today. No treatment information was reported.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome for the event, patient got a dose 11 days earlier from today, was considered as resolved on 03 Mar 2021.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (Lot #: Not Provided) with no associated AEs reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Influenza like illness, Nasopharyngitis, Vaccination site erythema
Clinical narrative: "mild cold, flu type feeling"; Redness is spreading; area of the size of her palm that is hard; feels tired; area of the size of her palm that is very red; arm became very sore; "mild cold, flu type feeling"; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard) and FATIGUE (feels tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus-like syndrome, Osteoarthritis, High cholesterol, Fibromyalgia and Drug allergy (codeine). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), DULOXETINE HYDROCHLORIDE (CYMBALTA), METOPROLOL SUCCINATE (TOPROL) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced NASOPHARYNGITIS ("mild cold, flu type feeling"). On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore). At the time of the report, NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: follow up received and contain no new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: "mild cold, flu type feeling"; Redness is spreading; area of the size of her palm that is hard; feels tired; area of the size of her palm that is very red; arm became very sore; "mild cold, flu type feeling"; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard) and FATIGUE (feels tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus-like syndrome, Osteoarthritis, High cholesterol, Fibromyalgia and Drug allergy (codeine). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), DULOXETINE HYDROCHLORIDE (CYMBALTA), METOPROLOL SUCCINATE (TOPROL) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced NASOPHARYNGITIS ("mild cold, flu type feeling"). On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore). At the time of the report, NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: follow up received and contain no new information