chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis
Clinical narrative: SYMPTOMS OF THYROIDITIS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had thyroid problems before and had not history of autoimmune disorders. 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 MAR-2021 for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced symptoms of thyroiditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms of thyroiditis was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: SWOLLEN LIPS; BUMPS AND HIVES ON FROM HEAD TO REST OF HER BODY; ITCHY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, non alcoholic, non smoker, allergy to nuts, and allergy to fruits, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced itchy. On 25-AUG-2021, the patient experienced swollen lips. On 25-AUG-2021, the patient experienced bumps and hives on from head to rest of her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy, and bumps and hives on from head to rest of her body, and had not recovered from swollen lips. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Lip swelling, Pruritus
Clinical narrative: SWOLLEN LIPS; BUMPS AND HIVES ON FROM HEAD TO REST OF HER BODY; ITCHY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, non alcoholic, non smoker, allergy to nuts, and allergy to fruits, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced itchy. On 25-AUG-2021, the patient experienced swollen lips. On 25-AUG-2021, the patient experienced bumps and hives on from head to rest of her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy, and bumps and hives on from head to rest of her body, and had not recovered from swollen lips. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: SWOLLEN LIPS; BUMPS AND HIVES ON FROM HEAD TO REST OF HER BODY; ITCHY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, non alcoholic, non smoker, allergy to nuts, and allergy to fruits, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced itchy. On 25-AUG-2021, the patient experienced swollen lips. On 25-AUG-2021, the patient experienced bumps and hives on from head to rest of her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy, and bumps and hives on from head to rest of her body, and had not recovered from swollen lips. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Petechiae
Clinical narrative: BRUISING; PETECHIAE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no history of known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced bruising. On 06-APR-2021, the patient experienced petechiae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising, and petechiae. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: PRESUMED DIAGNOSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (COUGH/WHEEZE/COULDN'T BREATHE); This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the patient experienced presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn't breathe). On 12-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) low. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn't breathe) was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Bedridden, Headache, Nausea
Clinical narrative: STAYED IN BED ALL DAY; NAUSEOUS; BAD HEADACHE; This spontaneous report received from a parent concerned a 43 year old male. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced stayed in bed all day. On 07-APR-2021, the patient experienced nauseous. On 07-APR-2021, the patient experienced bad headache. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) High Immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stayed in bed all day, nauseous, and bad headache on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210852035.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased immune responsiveness, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: IMMUNITY ALSO HIGH BUT NOT AS HIGH AS WIFE; FEET WERE KILLING HIM; This spontaneous report received from a consumer concerned a 70 year old male. 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced feet were killing him. On an unspecified date, the patient experienced immunity also high but not as high as wife. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feet were killing him on 07-APR-2021, and the outcome of immunity also high but not as high as wife was not reported. This report was non-serious. This case, from the same reporter is linked to 20210852005.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, and batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Disturbance in attention, Dizziness
Clinical narrative: DIZZINESS; DIFFICULTY CONCENTRATING; BLURRED VISION; DIFFICULTY BREATHING; SWEATS; BLOOD PRESSURE INCREASED; HEADACHE; EXTREME WEAKNESS; NAUSEA; LIGHT SENSITIVITY; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously treated with azithromycin for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 10:20 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced light sensitivity. Laboratory data included: Blood test (NR: not provided) Normal. On 27-MAR-2021, the patient experienced dizziness. On 27-MAR-2021, the patient experienced difficulty concentrating. On 27-MAR-2021, the patient experienced blurred vision. On 27-MAR-2021, the patient experienced difficulty breathing. On 27-MAR-2021, the patient experienced sweats. On 27-MAR-2021, the patient experienced blood pressure increased. On 27-MAR-2021, the patient experienced headache. On 27-MAR-2021, the patient experienced extreme weakness. On 27-MAR-2021, the patient experienced nausea. On 01-AUG-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. On 20-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 105/95. Treatment medications (dates unspecified) included: cyanocobalamin, ondansetron, glyceryl trinitrate, acetylsalicylic acid, and meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, was recovering from blood pressure increased, and had not recovered from dizziness, headache, difficulty concentrating, nausea, difficulty breathing, extreme weakness, sweats, and light sensitivity. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Headache, Hyperhidrosis, Nausea
Clinical narrative: DIZZINESS; DIFFICULTY CONCENTRATING; BLURRED VISION; DIFFICULTY BREATHING; SWEATS; BLOOD PRESSURE INCREASED; HEADACHE; EXTREME WEAKNESS; NAUSEA; LIGHT SENSITIVITY; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously treated with azithromycin for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 10:20 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced light sensitivity. Laboratory data included: Blood test (NR: not provided) Normal. On 27-MAR-2021, the patient experienced dizziness. On 27-MAR-2021, the patient experienced difficulty concentrating. On 27-MAR-2021, the patient experienced blurred vision. On 27-MAR-2021, the patient experienced difficulty breathing. On 27-MAR-2021, the patient experienced sweats. On 27-MAR-2021, the patient experienced blood pressure increased. On 27-MAR-2021, the patient experienced headache. On 27-MAR-2021, the patient experienced extreme weakness. On 27-MAR-2021, the patient experienced nausea. On 01-AUG-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. On 20-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 105/95. Treatment medications (dates unspecified) included: cyanocobalamin, ondansetron, glyceryl trinitrate, acetylsalicylic acid, and meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, was recovering from blood pressure increased, and had not recovered from dizziness, headache, difficulty concentrating, nausea, difficulty breathing, extreme weakness, sweats, and light sensitivity. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vision blurred
Clinical narrative: DIZZINESS; DIFFICULTY CONCENTRATING; BLURRED VISION; DIFFICULTY BREATHING; SWEATS; BLOOD PRESSURE INCREASED; HEADACHE; EXTREME WEAKNESS; NAUSEA; LIGHT SENSITIVITY; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously treated with azithromycin for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 10:20 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced light sensitivity. Laboratory data included: Blood test (NR: not provided) Normal. On 27-MAR-2021, the patient experienced dizziness. On 27-MAR-2021, the patient experienced difficulty concentrating. On 27-MAR-2021, the patient experienced blurred vision. On 27-MAR-2021, the patient experienced difficulty breathing. On 27-MAR-2021, the patient experienced sweats. On 27-MAR-2021, the patient experienced blood pressure increased. On 27-MAR-2021, the patient experienced headache. On 27-MAR-2021, the patient experienced extreme weakness. On 27-MAR-2021, the patient experienced nausea. On 01-AUG-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. On 20-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 105/95. Treatment medications (dates unspecified) included: cyanocobalamin, ondansetron, glyceryl trinitrate, acetylsalicylic acid, and meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, was recovering from blood pressure increased, and had not recovered from dizziness, headache, difficulty concentrating, nausea, difficulty breathing, extreme weakness, sweats, and light sensitivity. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain in extremity, Pruritus
Clinical narrative: ITCHINESS; DIFFICULTY BREATHING; PAIN IN ARM AND LEG; HEADACHE; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, diabetes, and swelling, and other pre-existing medical conditions included: Patient had problem with salt and swelling for which she uses diuretic. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Concomitant medications included insulin for diabetes.  On AUG-2021, the patient experienced itchiness. On AUG-2021, the patient experienced difficulty breathing. On AUG-2021, the patient experienced pain in arm and leg. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and leg, headache, itchiness and difficulty breathing was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED/ DOSE WAS DRAWN ON 24-AUG-2021 11:00 AND ADMINISTERED ON 25-AUG-2021 13:00; This spontaneous report received from a health care professional concerned a 29 year old female. 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 25-AUG-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced expired vaccine administered/ dose was drawn on 24-aug-2021 11:00 and administered on 25-aug-2021 13:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered/ dose was drawn on 24-aug-2021 11:00 and administered on 25-aug-2021 13:00 was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache
Clinical narrative: Really bad abdominal pain; Nagging headche; A spontaneous report was received from a healthcare professional, who was also a 60-year-old female patient, who received Moderna's COVID-19 Vaccine and experienced nagging headache and really bad abdominal pain.  The patient's medical history was not provided. No concomitant medications were provided.  On 23 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Batch number 039k20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient experienced nagging headache. On 25 Dec 2020, she woke up with really bad abdominal pain. Treatment included bismuth subsalicylate.  Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events nagging headache and really bad abdominal pain was not provided.; Reporter's Comments: This case concerns a 60 year old female patient who experienced events of Abdominal pain and Headache. Abdominal pain occurred 3 days after administration of first of two planned doses of mRNA-1273 (Batch number 039k20A) and Headache occurred 2 days after first of two planned doses of mRNA-1273 (Batch number 039k20A). Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Limping a bit today only going up the stairs; Trouble going up the stairs with joint pain in her right hip; Pain and soreness in her hip; A spontaneous report was received from a pharmacist, who was a  51 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced trouble going up the stairs with joint pain in her right hip, limping a bit today only going up the stairs, and pain and soreness in her hip.   The patient's medical history included exercising. No relevant concomitant medications were reported.   On 24 Dec 2020 at 11:30 or 12:00, about three hours prior to the events, the patient received her first of two planned doses of mRNA-1273 (batch 039k20a) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, around 15:00, the patient noticed she had trouble going up the stairs with joint pain and soreness in her right hip. She did not have any pain or soreness at the injection site, only in her hip. She was limping a bit today only going up the stairs. She had not treated the pain.    Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the evets trouble going up the stairs with joint pain in her right hip, limping a bit today only going up the stairs, and pain and soreness in her hip were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient. The patient's medical history is not provided. The patient experienced trouble going up the stairs with joint pain in her right hip, limping a bit only going up the stairs, and pain and soreness in her hip. The event occurred on 24 Dec 2020, about 3 hours after the administration of the first dose mRNA-1273. The reporter causality assessment for the event was not provided. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Pain of the joint is listed on the company's fact sheet for the healthcare providers. Additional information regarding the patient's medical history and concomitant medications will help to further assess the event of limping.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; 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 VACCINATION COMPLICATION (Vaccination adverse reaction) 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported  Amendment version created on 25-Aug-2021, to correct Initial Receipt Date from 16-Jul-2020 to 16-Jul-2021.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia oral, Swelling
Clinical narrative: Numbness in left hand; sensation like her hand was getting bit or swollen; Face numbness; tingling sensation in her tongue; Headache; A spontaneous report was received from a consumer concerning a 24-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, numbness in the left hand, sensation of swelling, facial numbness, and tongue tingling.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the evening of 06 Jan 2021, the patient began to experience a headache, numbness in the left hand and face. She also reported having a sensation like her hand was getting big or swelling and tongue tingling. Treatment for the event included diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The events, headache, numbness in the left hand, sensation of swelling, and tongue tingling, were considered resolved on 06 Jan 2021.  The event, facial numbness, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy
Clinical narrative: Swollen lymph nodes on my clavicle; A spontaneous report was received from a nurse concerning a 44-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had swollen lymph nodes on clavicle.  The patient's medical history was not reported by the reporter. Concomitant medications were not provided.  On 31 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right deltoid for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient noticed that she had a swollen bump on her clavicle, on the same side as her injection. She had a CT scan on 08 Jan 2021 to determine that her lymph nodes were swollen. She has had no treatment at that time.  Treatment for event was reported as none.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event, swollen lymph nodes on clavicle was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Diarrhea; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (No energy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (No reported medical history) and Blood pressure.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ASTHENIA (No energy). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (No energy) 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 spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (No energy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (No reported medical history) and Blood pressure.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ASTHENIA (No energy). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Oropharyngeal pain, Oxygen saturation
Clinical narrative: Felt tightness in his throat; Felt soreness in his throat; Very slight associated difficulty breathing; tongue was little swollen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen). At the time of the report, THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood pressure measurement: 164/108 mmHg ten minutes after vaccination and 128/98 mmHg ninety minutes after vaccination. On 06-Jan-2021, Heart rate: 110 heart beats per minute ten minutes after vaccination and 65 heart beats per minute ninety minutes after vaccination. On 06-Jan-2021, Oxygen saturation: 94 percent thirty minutes after vaccination and 96-98 percent ninety minutes after vaccination.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Felt tightness in his throat; Felt soreness in his throat; Very slight associated difficulty breathing; tongue was little swollen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen). At the time of the report, THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood pressure measurement: 164/108 mmHg ten minutes after vaccination and 128/98 mmHg ninety minutes after vaccination. On 06-Jan-2021, Heart rate: 110 heart beats per minute ten minutes after vaccination and 65 heart beats per minute ninety minutes after vaccination. On 06-Jan-2021, Oxygen saturation: 94 percent thirty minutes after vaccination and 96-98 percent ninety minutes after vaccination.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Diarrhoea, Dizziness, Presyncope
Clinical narrative: Diarrhea; Dizziness; Sluggish; Cold sweat; Going to passout things were turning black; going back to bed and couldn't make it (too weak)/had to sit on floor; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat) and PRESYNCOPE (Going to passout things were turning black) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor) outcome was unknown.  No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Diarrhea; Dizziness; Sluggish; Cold sweat; Going to passout things were turning black; going back to bed and couldn't make it (too weak)/had to sit on floor; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat) and PRESYNCOPE (Going to passout things were turning black) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor) outcome was unknown.  No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Neck mass, Pain in extremity, Paraesthesia oral, Swelling face
Clinical narrative: lip swelling; lip tingling; lump in her neck; facial swelling; arm pain; A spontaneous report was received from a physician concerning a 40 year old female patient who experienced arm pain, lip swelling, facial swelling, lip tingling, and lump in her neck with the use of mRNA-1273.    The patient's medical history included Ankylosing Spondylitis and on immunosuppression due to her condition.  Concomitant medications included hydrocortisone, buprenorphine, diltiazem and duloxetine. Two other drugs were doubtful(Agent not heard properly).  On 05 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On the night of 05 Jan 2021, the patient experienced the non-serious event of arm pain, which went away. On 08 Jan 2021, the patient experienced lip swelling and tingling, and a lump in her neck. It was noted the patient is on a lot of medication because her condition is immunosuppressive. The physician inquired if the patient can receive prednisone for reported events and how would it affect the second dose. It was not confirmed whether the patient received treatment with prednisone. Treatment included diphenhydramine hydrochloride and famotidine.  Action taken with mRNA-1273 in response to the event was not provided.  The event of arm pain recovered on an unspecified date. The events of facial swelling, lip swelling and tingling, and a lump in her neck were not recovered/not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching like a bug bite around the injection site; mild red ring about 2cm x 3cm around injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: joint pain in left arm; pain initially in the right arm which seemed to the at the joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain in left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced ARTHRALGIA (joint pain in left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jan-2021, ARTHRALGIA (joint pain in left arm) had resolved.            Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Confusional state, Dizziness, Headache, Influenza like illness
Clinical narrative: Dark urine; Confusion/dizziness; Headache; Tingling of the ear; Flu Like Symptoms; Body Aches; Locked Jaw; Confusion/Dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of CONFUSIONAL STATE (Confusion/dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Neurological disorder NOS, Tingling and Panic attacks.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion/dizziness). At the time of the report, CONFUSIONAL STATE (Confusion/dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Trismus
Clinical narrative: Dark urine; Confusion/dizziness; Headache; Tingling of the ear; Flu Like Symptoms; Body Aches; Locked Jaw; Confusion/Dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of CONFUSIONAL STATE (Confusion/dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Neurological disorder NOS, Tingling and Panic attacks.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion/dizziness). At the time of the report, CONFUSIONAL STATE (Confusion/dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: Little Malaise; Mild symptoms; Tested positive for COVID one week after first dose; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose), MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose). On an unknown date, the patient experienced MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose) outcome was unknown and MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID 19.     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.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Local and systemic pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Local and systemic pain at injection site) in a 37-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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Local and systemic pain at injection site). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Local and systemic pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The reporter asked if the patient could self administer Tylenol (paracetamol) to treat symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.