chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Pain, Pain of skin
Clinical narrative: FEELING SLEEPY; BODY ACHES; HEADACHE; TEMPERATURE OF 101.8 F; SKIN HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 166 pounds, and height was not reported. The patient's past medical history included covid-19 and concurrent conditions included penicillin allergy, non alcoholic, and non smoker and other pre-existing medical conditions included patient had no drug abuse or no illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin hurting. On MAR-2021, the subject experienced temperature of 101.8 f. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 25-MAR-2021, the subject experienced feeling sleepy. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin hurting, and had not recovered from feeling sleepy, headache, body aches, and temperature of 101.8 f. This report was non-serious.  Version created to amend previously reported information on 25-Mar-2021. Upon review, the following information was amended: Narrative inconsistency corrected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: FEELING SLEEPY; BODY ACHES; HEADACHE; TEMPERATURE OF 101.8 F; SKIN HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 166 pounds, and height was not reported. The patient's past medical history included covid-19 and concurrent conditions included penicillin allergy, non alcoholic, and non smoker and other pre-existing medical conditions included patient had no drug abuse or no illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin hurting. On MAR-2021, the subject experienced temperature of 101.8 f. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 25-MAR-2021, the subject experienced feeling sleepy. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin hurting, and had not recovered from feeling sleepy, headache, body aches, and temperature of 101.8 f. This report was non-serious.  Version created to amend previously reported information on 25-Mar-2021. Upon review, the following information was amended: Narrative inconsistency corrected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Fatigue, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: RESTLESS LEGS; FEELING WEIRD; SUPER EMOTIONAL AND CRIED VERY  EASILY; ACHING PAIN IN LEGS; FEELING TIRED; THROBBING; TINGLING OF BODY AND TINGLING IN LEGS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, 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: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced throbbing. On 23-MAR-2021, the subject experienced tingling of body and tingling in legs. On 23-MAR-2021, the subject experienced aching pain in legs. On 23-MAR-2021, the subject experienced feeling tired. On 24-MAR-2021, the subject experienced restless legs. On 24-MAR-2021, the subject experienced feeling weird. On 24-MAR-2021, the subject experienced super emotional and cried very easily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing, tingling of body and tingling in legs, restless legs, feeling weird, super emotional and cried very easily, aching pain in legs, and feeling tired on 30-MAR-2021. This report was non-serious.  Additional information received from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Outcome of the events updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Restless legs syndrome
Clinical narrative: RESTLESS LEGS; FEELING WEIRD; SUPER EMOTIONAL AND CRIED VERY  EASILY; ACHING PAIN IN LEGS; FEELING TIRED; THROBBING; TINGLING OF BODY AND TINGLING IN LEGS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, 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: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced throbbing. On 23-MAR-2021, the subject experienced tingling of body and tingling in legs. On 23-MAR-2021, the subject experienced aching pain in legs. On 23-MAR-2021, the subject experienced feeling tired. On 24-MAR-2021, the subject experienced restless legs. On 24-MAR-2021, the subject experienced feeling weird. On 24-MAR-2021, the subject experienced super emotional and cried very easily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing, tingling of body and tingling in legs, restless legs, feeling weird, super emotional and cried very easily, aching pain in legs, and feeling tired on 30-MAR-2021. This report was non-serious.  Additional information received from patient on 30-MAR-2021 The following information was updated and incorporated into the case narrative: Outcome of the events updated.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: SORE ARM; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from nausea, and had not recovered from sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included on 06/mar/2021, patient got exposed to another person with covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) COVID-19 Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Influenza like illness, Injection site pain, Muscle spasms
Clinical narrative: FLUTTER LIKE PRESSURE; MUSCLE SPASM AND FLUTTER SPASM; PAIN IN THE CENTER OF CHEST; FLU-LIKE SYMPTOMS (CHILLS, FEVER); PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hole in heart, hypertensive, chronic migraine, and murmurs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included paracetamol. On 23-MAR-2021, the subject experienced pain in left arm. On 24-MAR-2021, the subject experienced flu-like symptoms (chills, fever). On 25-MAR-2021, the subject experienced flutter like pressure. On 25-MAR-2021, the subject experienced muscle spasm and flutter spasm. On 25-MAR-2021, the subject experienced pain in the center of chest. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Negative negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasm and flutter spasm, flu-like symptoms (chills, fever), pain in the center of chest, and pain in left arm, and the outcome of flutter like pressure was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: FLUTTER LIKE PRESSURE; MUSCLE SPASM AND FLUTTER SPASM; PAIN IN THE CENTER OF CHEST; FLU-LIKE SYMPTOMS (CHILLS, FEVER); PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hole in heart, hypertensive, chronic migraine, and murmurs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included paracetamol. On 23-MAR-2021, the subject experienced pain in left arm. On 24-MAR-2021, the subject experienced flu-like symptoms (chills, fever). On 25-MAR-2021, the subject experienced flutter like pressure. On 25-MAR-2021, the subject experienced muscle spasm and flutter spasm. On 25-MAR-2021, the subject experienced pain in the center of chest. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Negative negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasm and flutter spasm, flu-like symptoms (chills, fever), pain in the center of chest, and pain in left arm, and the outcome of flutter like pressure was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-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 24-MAR-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: : MAC not required as per standard procedure as case was assessed as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Limb discomfort
Clinical narrative: JOINT PAIN; SHIVER; FEVER; HEADACHE; BODY ACHE; INJECTION SEEMED TO BE ADMINISTERED TOO HIGH UP ON THE SHOULDER; RUNNY NOSE; FELT PRESSURE ON LEFT ARM; DEEP ARM ACHE/ARM SORENESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was not reported and height was 160 centimeters. The patient's past medical history included fever, and body ache, and concurrent conditions included codeine allergy, high blood pressure, vitilago, obesity, seasonal allergy, non smoker, non alcohol, and allergic reaction to flu vaccine, and other pre-existing medical conditions included the patient had no illness at the time of vaccination, acute illness 30 days prior to vaccination or history of hospitalization in last 30 days. the patient had family history of any disease (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included garcinia mangostana for daily superfruit taken to control allergies, and valsartan for high blood pressure. On 23-MAR-2021, the subject experienced body ache. On 23-MAR-2021, the subject experienced injection seemed to be administered too high up on the shoulder. On 23-MAR-2021, the subject experienced runny nose. On 23-MAR-2021, the subject experienced felt pressure on left arm. On 23-MAR-2021, the subject experienced deep arm ache/arm soreness. On 23-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 97.8 F, 101.8 F. On 23-MAR-2021 04:00, the subject experienced fever. On 23-MAR-2021 04:30, the subject experienced shiver. On 24-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6. On an unspecified date, the subject experienced joint pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.5-99.3. The patient recovered from body ache, joint pain, fever, and headache, had not recovered from felt pressure on left arm, deep arm ache/arm soreness, shiver, and runny nose, and the outcome of injection seemed to be administered too high up on the shoulder was not reported. This report was non-serious..  Version created to amend previously reported information on 23/Mar/2021. Upon review the following information was amended: Labeling of event (felt pressure on left arm) updated to unlabeled from labeled. Version created to amend previously reported information on 31-Mar-2021: Reporter name and outcome of the event updated, concurrent condition, patient details, concomitant medication, past vaccine and new event added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site, Pyrexia, Rhinorrhoea
Clinical narrative: JOINT PAIN; SHIVER; FEVER; HEADACHE; BODY ACHE; INJECTION SEEMED TO BE ADMINISTERED TOO HIGH UP ON THE SHOULDER; RUNNY NOSE; FELT PRESSURE ON LEFT ARM; DEEP ARM ACHE/ARM SORENESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was not reported and height was 160 centimeters. The patient's past medical history included fever, and body ache, and concurrent conditions included codeine allergy, high blood pressure, vitilago, obesity, seasonal allergy, non smoker, non alcohol, and allergic reaction to flu vaccine, and other pre-existing medical conditions included the patient had no illness at the time of vaccination, acute illness 30 days prior to vaccination or history of hospitalization in last 30 days. the patient had family history of any disease (relevant to vaccination) or allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included garcinia mangostana for daily superfruit taken to control allergies, and valsartan for high blood pressure. On 23-MAR-2021, the subject experienced body ache. On 23-MAR-2021, the subject experienced injection seemed to be administered too high up on the shoulder. On 23-MAR-2021, the subject experienced runny nose. On 23-MAR-2021, the subject experienced felt pressure on left arm. On 23-MAR-2021, the subject experienced deep arm ache/arm soreness. On 23-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 97.8 F, 101.8 F. On 23-MAR-2021 04:00, the subject experienced fever. On 23-MAR-2021 04:30, the subject experienced shiver. On 24-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6. On an unspecified date, the subject experienced joint pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.5-99.3. The patient recovered from body ache, joint pain, fever, and headache, had not recovered from felt pressure on left arm, deep arm ache/arm soreness, shiver, and runny nose, and the outcome of injection seemed to be administered too high up on the shoulder was not reported. This report was non-serious..  Version created to amend previously reported information on 23/Mar/2021. Upon review the following information was amended: Labeling of event (felt pressure on left arm) updated to unlabeled from labeled. Version created to amend previously reported information on 31-Mar-2021: Reporter name and outcome of the event updated, concurrent condition, patient details, concomitant medication, past vaccine and new event added.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer via a company representative concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 23-MAR-2021, the subject tested positive for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Somnolence, Vaccination site pain
Clinical narrative: Fell down the stairs; Drowsy; very painful sore arm and hurting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell down the stairs) and SOMNOLENCE (Drowsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    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 FALL (Fell down the stairs) (seriousness criterion hospitalization), SOMNOLENCE (Drowsy) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (very painful sore arm and hurting). At the time of the report, FALL (Fell down the stairs), SOMNOLENCE (Drowsy) and VACCINATION SITE PAIN (very painful sore arm and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow-up received on 30 Mar 2021 included added serious events of fell down the stairs and drowsy.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-032445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant Follow up appended; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry mouth, Mental impairment, Myalgia, Throat irritation
Clinical narrative: Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) 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.   No concomitant medications provided.  No treatment was provided.  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. Further information has been requested.; 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. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) 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.   No concomitant medications provided.  No treatment was provided.  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. Further information has been requested.; 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. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Swelling face, Throat tightness
Clinical narrative: all of a sudden my face felt really tight/Looked into the mirror and it was swollen; face very flushed; throat started to close; feel tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen), FLUSHING (face very flushed), THROAT TIGHTNESS (throat started to close) and FATIGUE (feel tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included LEVOTHYROXINE and VALSARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen) (seriousness criterion medically significant), FLUSHING (face very flushed) (seriousness criterion medically significant), THROAT TIGHTNESS (throat started to close) (seriousness criterion medically significant) and FATIGUE (feel tired) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (all of a sudden my face felt really tight/Looked into the mirror and it was swollen), FLUSHING (face very flushed), THROAT TIGHTNESS (throat started to close) and FATIGUE (feel tired) 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.; Sender's Comments: This case concerns a 74 Y/O F with a serious unexpected event of facial swelling along with throat tightness, flushing and fatigue.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on 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.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Barotitis media, Body temperature increased, Headache, Lethargy
Clinical narrative: Arrhythmia; Supraventricular Tachycardia; Severe cramping; Trouble equalising pressure in ears; sinking spells; Sore arm; Headache; Lethargy; Elevated Temperature; This spontaneous case was reported by a non-health professional and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia. Concomitant products included METOPROLOL, SIMVASTATIN, OLMESARTAN and WARFARIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced LETHARGY (Lethargy), BODY TEMPERATURE INCREASED (Elevated Temperature), PRESYNCOPE (sinking spells), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia), MUSCLE SPASMS (Severe cramping) and BAROTITIS MEDIA (Trouble equalising pressure in ears). On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). On 22-Feb-2021, LETHARGY (Lethargy), BODY TEMPERATURE INCREASED (Elevated Temperature), SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia), MUSCLE SPASMS (Severe cramping), BAROTITIS MEDIA (Trouble equalising pressure in ears), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, ARRHYTHMIA (Arrhythmia) outcome was unknown and PRESYNCOPE (sinking spells) had resolved.            Treatment information was not provided.  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. However, the patient's past medical history of Arrhythmia may remain as a risk factor for this event, Further information is requested.; 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. However, the patient's past medical history of Arrhythmia may remain as a risk factor for this event, Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Presyncope, Supraventricular tachycardia, Vaccination site pain
Clinical narrative: Arrhythmia; Supraventricular Tachycardia; Severe cramping; Trouble equalising pressure in ears; sinking spells; Sore arm; Headache; Lethargy; Elevated Temperature; This spontaneous case was reported by a non-health professional and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia. Concomitant products included METOPROLOL, SIMVASTATIN, OLMESARTAN and WARFARIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced LETHARGY (Lethargy), BODY TEMPERATURE INCREASED (Elevated Temperature), PRESYNCOPE (sinking spells), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia), MUSCLE SPASMS (Severe cramping) and BAROTITIS MEDIA (Trouble equalising pressure in ears). On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). On 22-Feb-2021, LETHARGY (Lethargy), BODY TEMPERATURE INCREASED (Elevated Temperature), SUPRAVENTRICULAR TACHYCARDIA (Supraventricular Tachycardia), MUSCLE SPASMS (Severe cramping), BAROTITIS MEDIA (Trouble equalising pressure in ears), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, ARRHYTHMIA (Arrhythmia) outcome was unknown and PRESYNCOPE (sinking spells) had resolved.            Treatment information was not provided.  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. However, the patient's past medical history of Arrhythmia may remain as a risk factor for this event, Further information is requested.; 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. However, the patient's past medical history of Arrhythmia may remain as a risk factor for this event, Further information is requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: Cough; Nasal congestion; cold symptoms; Chest congestion; Postnasal drip; Sore throat; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Chest congestion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Inflammation. Concomitant products included MESALAZINE (LIALDA) for Inflammation NOS.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm was sore). On 07-Mar-2021, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms). On 06-Mar-2021, PAIN IN EXTREMITY (Arm was sore) was resolving. At the time of the report, PULMONARY CONGESTION (Chest congestion), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided. Treatment included pseudoephedrine, guaifenesin daily, nyquil and oxymetazoline at night.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper-airway cough syndrome, Vaccination site pain
Clinical narrative: Cough; Nasal congestion; cold symptoms; Chest congestion; Postnasal drip; Sore throat; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Chest congestion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Inflammation. Concomitant products included MESALAZINE (LIALDA) for Inflammation NOS.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Arm was sore). On 07-Mar-2021, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms). On 06-Mar-2021, PAIN IN EXTREMITY (Arm was sore) was resolving. At the time of the report, PULMONARY CONGESTION (Chest congestion), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASAL CONGESTION (Nasal congestion) and NASOPHARYNGITIS (cold symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided. Treatment included pseudoephedrine, guaifenesin daily, nyquil and oxymetazoline at night.; 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: F
Vaccine: COVID19
Symptoms: Pain in extremity, Transient ischaemic attack
Clinical narrative: Mild stroke; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/ transient ischaemic attack and sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Batch Number: unknown) via unspecified route for prophylaxis of COVID-19 infection.  On an unspecified date, after the vaccination, the patient experienced sore arm and mild stroke. Treatment information for the events was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, mild stroke and sore arm, was unknown at the time of this report.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Pain in extremity
Clinical narrative: Developed kindey infection following Moderna COVID 19 vaccine; Pain in legs; A spontaneous report was received from a pharmacist concerning a 51-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  kidney infection(kidney infection)  following Moderna COVID 19 vaccine, and pain in legs/ pain in extremity.  The patient's medical history, was not provided by the reporter. No  concomitant product use was not provided by the reporter.  On 27 Feb 2021, approximately same day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Feb 2021, prior to receiving mRNA-1273, the patient developed kidney infection following Moderna COVID 19 vaccine with seriousness criteria as medically significant and  pain in legs.   Treatment for the events included antibiotic medication.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed kidney infection following Moderna COVID 19 vaccine, pain in legs were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) 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 adverse event reported.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route).   On 20-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant).   At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Pneumonia, Sinus disorder
Clinical narrative: Pneumonia; Feeling weird; Stomach problems; Sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcers aphthous oral and Hernia.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling weird), ABDOMINAL DISCOMFORT (Stomach problems) and SINUS DISORDER (Sinus problems). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), FEELING ABNORMAL (Feeling weird) and SINUS DISORDER (Sinus problems) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach problems) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.; 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis
Clinical narrative: Left side of body weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (Left side of body weakness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Learning disability and Seizure.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEMIPARESIS (Left side of body weakness) (seriousness criterion medically significant). At the time of the report, HEMIPARESIS (Left side of body weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Fatigue, Pneumonia, SARS-CoV-2 test negative
Clinical narrative: Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax; got really run down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) (seriousness criterion medically significant) and FATIGUE (got really run down). At the time of the report, PNEUMONIA (Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax) had not resolved and FATIGUE (got really run down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: abnormal (abnormal) Community Acquired Pneumonia in left lower lobe with no evidence of plural effusion, negative for pneumothorax. On 26-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based in the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based in the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 21-Mar-2021 to 24-Mar-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information included was blood thinner.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell Palsy; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell Palsy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell Palsy) was resolving.        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 drugs included, valacyclovir and Prednisone. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.