chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood glucose, Blood pressure fluctuation, Blood test, Chest X-ray
Clinical narrative: FEELING DIZZY/LIGHT HEADED/FEELING GOING TO PASS OUT; SWEATY HANDS; SHORTNESS OF BREATH; NAUSEA THAT COMES AND GOES IN WAVES; HEADACHE THAT COMES AND GOES IN WAVES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lyme disease, and concurrent conditions included: thyroid, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced nausea that comes and goes in waves. On 03-SEP-2021, the patient experienced headache that comes and goes in waves. On 11-SEP-2021, the patient experienced feeling dizzy/light headed/feeling going to pass out. On 11-SEP-2021, the patient experienced sweaty hands. On 11-SEP-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache that comes and goes in waves, nausea that comes and goes in waves, feeling dizzy/light headed/feeling going to pass out, sweaty hands and shortness of breath was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Discomfort, Electrocardiogram, Fatigue, Flank pain
Clinical narrative: FEELING DIZZY/LIGHT HEADED/FEELING GOING TO PASS OUT; SWEATY HANDS; SHORTNESS OF BREATH; NAUSEA THAT COMES AND GOES IN WAVES; HEADACHE THAT COMES AND GOES IN WAVES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lyme disease, and concurrent conditions included: thyroid, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced nausea that comes and goes in waves. On 03-SEP-2021, the patient experienced headache that comes and goes in waves. On 11-SEP-2021, the patient experienced feeling dizzy/light headed/feeling going to pass out. On 11-SEP-2021, the patient experienced sweaty hands. On 11-SEP-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache that comes and goes in waves, nausea that comes and goes in waves, feeling dizzy/light headed/feeling going to pass out, sweaty hands and shortness of breath was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Syncope, Urine analysis
Clinical narrative: FEELING DIZZY/LIGHT HEADED/FEELING GOING TO PASS OUT; SWEATY HANDS; SHORTNESS OF BREATH; NAUSEA THAT COMES AND GOES IN WAVES; HEADACHE THAT COMES AND GOES IN WAVES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lyme disease, and concurrent conditions included: thyroid, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced nausea that comes and goes in waves. On 03-SEP-2021, the patient experienced headache that comes and goes in waves. On 11-SEP-2021, the patient experienced feeling dizzy/light headed/feeling going to pass out. On 11-SEP-2021, the patient experienced sweaty hands. On 11-SEP-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache that comes and goes in waves, nausea that comes and goes in waves, feeling dizzy/light headed/feeling going to pass out, sweaty hands and shortness of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210921477 and 20210921423.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Injection site reaction
Clinical narrative: BODY ACHE; INJECTION SITE LITTLE HARD (ON RIGHT ARM); CHILLS; NAUSEA; 101 F FEVER; FATIGUE; NO ENERGY; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: hernia, and concurrent conditions included: irritable bowel syndrome, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A20A, expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for irritable bowel syndrome. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced injection site little hard (on right arm). On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced 101 f fever. On 10-SEP-2021, the patient experienced fatigue. On 10-SEP-2021, the patient experienced no energy. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, nausea, 101 f fever, chills, fatigue, no energy, and injection site little hard (on right arm). This report was non-serious.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; INJECTION SITE LITTLE HARD (ON RIGHT ARM); CHILLS; NAUSEA; 101 F FEVER; FATIGUE; NO ENERGY; This spontaneous report received from a patient concerned a 36 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: hernia, and concurrent conditions included: irritable bowel syndrome, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A20A, expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included omeprazole for irritable bowel syndrome. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced injection site little hard (on right arm). On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced 101 f fever. On 10-SEP-2021, the patient experienced fatigue. On 10-SEP-2021, the patient experienced no energy. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, nausea, 101 f fever, chills, fatigue, no energy, and injection site little hard (on right arm). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Chest pain, Heart rate, Oxygen saturation
Clinical narrative: CHEST PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, Laboratory data included: Blood pressure systolic (NR: not provided) 107 mmHg, Oxygen saturation (NR: not provided) 99-100, and Pulse rate (NR: not provided) 60. On 07-SEP-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Fatigue, Myalgia, Pain in extremity
Clinical narrative: ANXIETY OVERWHELMING; ARM SORENESS; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced anxiety overwhelming. On SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle pain, arm soreness, and anxiety overwhelming. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: ANXIETY OVERWHELMING; ARM SORENESS; FATIGUE; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced anxiety overwhelming. On SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle pain, arm soreness, and anxiety overwhelming. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Nervousness, Pain in extremity, Peripheral swelling
Clinical narrative: problems with her thyroid / her thyroid is all messed up right now; gets nervous usually; Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.; Arm sore; Arm swollen; Arm red; arm itchy; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease, COPD, Anemia and Drug allergy (contrast dye). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), VITAMIN D3, FOLIC ACID and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch). On an unknown date, the patient experienced THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now), NERVOUSNESS (gets nervous usually) and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.). At the time of the report, PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy), FEELING HOT (Warm to touch), THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now) and NERVOUSNESS (gets nervous usually) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant medication includes injections for anemia, inhaler (trelogy) for copd, medication for acid reflux added. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up appended-. Reporter contact details and new events -problems with her thyroid / her thyroid is all messed up right now(thyroid disorder),get nervous usually(nervousness) and the event (missed dose) added. On 16-Aug-2021: Significant follow up
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Thyroid disorder
Clinical narrative: problems with her thyroid / her thyroid is all messed up right now; gets nervous usually; Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.; Arm sore; Arm swollen; Arm red; arm itchy; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease, COPD, Anemia and Drug allergy (contrast dye). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), VITAMIN D3, FOLIC ACID and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy) and FEELING HOT (Warm to touch). On an unknown date, the patient experienced THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now), NERVOUSNESS (gets nervous usually) and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.). At the time of the report, PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PRURITUS (arm itchy), FEELING HOT (Warm to touch), THYROID DISORDER (problems with her thyroid / her thyroid is all messed up right now) and NERVOUSNESS (gets nervous usually) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Consumer did not receive the second dose of the vaccine, and it has been past 36 days since her first dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant medication includes injections for anemia, inhaler (trelogy) for copd, medication for acid reflux added. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up appended-. Reporter contact details and new events -problems with her thyroid / her thyroid is all messed up right now(thyroid disorder),get nervous usually(nervousness) and the event (missed dose) added. On 16-Aug-2021: Significant follow up
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea
Clinical narrative: feeling sick; nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 15-Apr-2021, MALAISE (feeling sick), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment also includes fluids like water and juice
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jul-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 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacy received vaccine on 28 May 2021 On 27 Jun 2021 the vaccine was used and was refrigerated. Then the product used by twenty patients and most were of second dose and few were first dose. No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received in which reporter details were added. Event start date is added. On 26-Aug-2021: The TCR form received in which fax details were provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Headache; Achiness; Tired Feeling; 2nd dose prior to 21 days; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Headache), PAIN (Achiness), FATIGUE (Tired Feeling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose prior to 21 days) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021 at 4:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021 at 4:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PAIN (Achiness), FATIGUE (Tired Feeling) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose prior to 21 days). At the time of the report, HEADACHE (Headache), PAIN (Achiness) and FATIGUE (Tired Feeling) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose prior to 21 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant history was not reported. The treatment history was not provided. Pharmacist talked to patient after 4 days if second dose and reported events.   This case was linked to MOD-2021-303495 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up information received on 31-AUG-2021 contains significant information. Reporter information, Patient race, ethnic group, facility information and new events were mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Joint swelling
Clinical narrative: Have been sick; Wrist has swelling in it/left knee has swollen up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up). At the time of the report, ILLNESS (Have been sick) and JOINT SWELLING (Wrist has swelling in it/left knee has swollen up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up received on 06 SEP 2021 contains NNI.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Gait inability, Joint swelling, Limb discomfort
Clinical narrative: he couldn't walk for several days.; It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods; feet (bilateral), hands (lateral) pain; Swelling in joints; Had to shuffle to get to the shower; pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral)); This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints) and LIMB DISCOMFORT (Had to shuffle to get to the shower) in a 60-year-old male 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 MS, Sulfonamide allergy and Drug allergy (Allergy to Clindamycin.). Concomitant products included METOPROLOL for Atrial fibrillation, EZETIMIBE (ZETIA) and SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, OCRELIZUMAB from 15-Aug-2021 to an unknown date for Multiple sclerosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints), LIMB DISCOMFORT (Had to shuffle to get to the shower) and ARTHRALGIA (pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral))). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints), LIMB DISCOMFORT (Had to shuffle to get to the shower) and ARTHRALGIA (pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral))) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed with steroids.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021 included historical condition, concomitant drugs and  events added. On 01-Sep-2021: Follow-up contains new event limb discomfort
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he couldn't walk for several days.; It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods; feet (bilateral), hands (lateral) pain; Swelling in joints; Had to shuffle to get to the shower; pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral)); This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints) and LIMB DISCOMFORT (Had to shuffle to get to the shower) in a 60-year-old male 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 MS, Sulfonamide allergy and Drug allergy (Allergy to Clindamycin.). Concomitant products included METOPROLOL for Atrial fibrillation, EZETIMIBE (ZETIA) and SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, OCRELIZUMAB from 15-Aug-2021 to an unknown date for Multiple sclerosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints), LIMB DISCOMFORT (Had to shuffle to get to the shower) and ARTHRALGIA (pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral))). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (he couldn't walk for several days.), GAIT DISTURBANCE (It took 20 minutes to  get to his shower which is 15 feet away, Difficulty walking and standing for prolonged periods), PAIN IN EXTREMITY (feet (bilateral), hands (lateral) pain), JOINT SWELLING (Swelling in joints), LIMB DISCOMFORT (Had to shuffle to get to the shower) and ARTHRALGIA (pain in joints(knees (bilateral), ankles (bilateral), hips (bilateral))) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed with steroids.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021 included historical condition, concomitant drugs and  events added. On 01-Sep-2021: Follow-up contains new event limb discomfort
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Soreness; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history is provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROBIOTICS NOS;VITAMINS NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was 10-Aug-2021. On 20-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred  on 10-Aug-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 20-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products include additional vitamin C probiotics  This is a case of product exposure during pregnancy with the associated AE of vaccination site pain. And 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.   Patient will be contacted to confirm the the pregnancy outcome.  Treatment information was not provided.   This case was linked to MOD-2021-278102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up information received includes updated patient initial; Sender's Comments: This is a case of product exposure during pregnancy with the associated AE of vaccination site pain. And 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.   Patient will be contacted to confirm the the pregnancy outcome.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: vaccinated a pregnant woman; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccinated a pregnant woman) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3003604) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccinated a pregnant woman). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccinated a pregnant woman) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? Second dose of vaccine scheduled for 06-Sep-2021.  Very limited information regarding these events has been provided at this time. There is no content in the source document to properly do a medical review. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Translated document received on 7-sep-2021_Translated in language weaver, updated event start date and stop date, outcome.; Sender's Comments: Very limited information regarding these events has been provided at this time. There is no content in the source document to properly do a medical review. Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Influenza, Pain
Clinical narrative: had no energy and laid around; felt like he had the flu; ached; started coughing; fever up to 101.3 degrees F; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), COUGH (started coughing) and VACCINATION SITE PAIN (vaccination site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.     On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 20-Aug-2021, the patient experienced INFLUENZA (felt like he had the flu), PAIN (ached) and COUGH (started coughing). 20-Aug-2021, the patient experienced PYREXIA (fever up to 101.3 degrees F). On 21-Aug-2021, the patient experienced ASTHENIA (had no energy and laid around). The patient was treated with PARACETAMOL (TYLENOL) on 20-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, COUGH (started coughing) had resolved. On 22-Aug-2021, ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever up to 101.3 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: up to 101.3 (High) 101.3 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: had no energy and laid around; felt like he had the flu; ached; started coughing; fever up to 101.3 degrees F; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), COUGH (started coughing) and VACCINATION SITE PAIN (vaccination site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.     On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 20-Aug-2021, the patient experienced INFLUENZA (felt like he had the flu), PAIN (ached) and COUGH (started coughing). 20-Aug-2021, the patient experienced PYREXIA (fever up to 101.3 degrees F). On 21-Aug-2021, the patient experienced ASTHENIA (had no energy and laid around). The patient was treated with PARACETAMOL (TYLENOL) on 20-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, COUGH (started coughing) had resolved. On 22-Aug-2021, ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever up to 101.3 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: up to 101.3 (High) 101.3 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of. The vial was accidently used for vaccines given on 20-Aug-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A, 002C21A and 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Dec-2020 and Kidney transplant on 01-Feb-2013.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine vial was opened on 11-Aug-2021. The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered expired covid vaccine. The vaccine vial was opened on 11-Aug-2021 and one dose was given to a patient.  The vial was never removed from the refrigerator after that day and wasted/disposed of.  The vial was accidently used for vaccines given on 20-Aug-2021. This was the patient's booster of covid vaccine.  No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow-up information included patient details, medical history, lab data and vaccine administration details.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bursitis, Urticaria
Clinical narrative: bursitis; hives; inflammation with the joints; This spontaneous case was reported by an other health care professional and describes the occurrence of BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included torn rotator cuff. Concurrent medical conditions included Hives (Hives cleared before recurring again).    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 BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints). At the time of the report, BURSITIS (bursitis), URTICARIA (hives) and ARTHRITIS (inflammation with the joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a torn rotator cuff years ago.   Patient was on steroid treatment for hives and inflammation of joints.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Tremendous pain in both arms for 36-48 hours after second shot; Fever for 36-48 hours after second shot; Chills for 36-48 hours after second shot; Headache for 36-48 hours after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pneumonia and Cancer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot). In April 2021, PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot) outcome was unknown.            No concomitant medications reported.  No treatment information was reported by reporter.    This case was linked to MOD-2021-297516, MOD-2021-297591 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting; a 101 F fever; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a 101 F fever), CHILLS (Cold chills) and VOMITING (Vomiting) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PYREXIA (a 101 F fever) and CHILLS (Cold chills). On 26-Aug-2021, the patient experienced VOMITING (Vomiting). At the time of the report, PYREXIA (a 101 F fever), CHILLS (Cold chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) The patient had COVID..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product packaging quantity issue
Clinical narrative: A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients). On 26-Aug-2021, PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they were not sure of what exactly occurred as the facility was sent a sealed vial and only 4 doses were contained within it. There were no doses withdrawn from the vial at their pharmacy and therefore she do not believe that the patients received expired product.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: New event-product packaging issue added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 24-Jan-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking Diabetes medication.   This case was linked to MOD-2021-297898 (Patient Link).