chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Elbow operation, Fatigue
Clinical narrative: TAKES A WHILE TO RETURN TO WALKING NORMALLY; FEELS LIKE AN OLD LADY; ACCIDENT THAT ROLLED ANKLE FEELS LIKE PAIN MORE NERVE RELATED THAN MUSCULAR; WHOLE BODY HURTS; MAJOR RECONSTRUCTIVE SURGERY OF RIGHT ELBOW; FLUSHING OF FACE/ FACE TURNS RED; CHILLS; FATIGUE; NUMBNESS OF FEET AND HANDS; TINGLING OF FEET AND HANDS; FEVER (LOW GRADE); This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and neurological issues, and other pre-existing medical conditions included: The patient does not have any no known drug allergies. The patient did not have any history of 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced flushing of face/ face turns red. On 02-APR-2021, the patient experienced chills. On 02-APR-2021, the patient experienced fatigue. On 02-APR-2021, the patient experienced numbness of feet and hands. On 02-APR-2021, the patient experienced tingling of feet and hands. On 02-APR-2021, the patient experienced fever (low grade). Laboratory data included: Body temperature (NR: not provided) 98 F. On 15-APR-2021, the patient experienced major reconstructive surgery of right elbow. On 15-APR-2021, the patient experienced whole body hurts. On AUG-2021, the patient experienced accident that rolled ankle feels like pain more nerve related than muscular. On an unspecified date, the patient experienced takes a while to return to walking normally, and feels like an old lady. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Symptoms did not correlate to pre-menopause. Treatment medications (dates unspecified) included: zolpidem tartrate, oxycodone hydrochloride/paracetamol, hydrocodone bitartrate/paracetamol, and diazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flushing of face/ face turns red, chills, fatigue, numbness of feet and hands, tingling of feet and hands, fever (low grade), major reconstructive surgery of right elbow, feels like an old lady, takes a while to return to walking normally, accident that rolled ankle feels like pain more nerve related than muscular, and whole body hurts. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Gait disturbance, Hypoaesthesia, Neuralgia
Clinical narrative: TAKES A WHILE TO RETURN TO WALKING NORMALLY; FEELS LIKE AN OLD LADY; ACCIDENT THAT ROLLED ANKLE FEELS LIKE PAIN MORE NERVE RELATED THAN MUSCULAR; WHOLE BODY HURTS; MAJOR RECONSTRUCTIVE SURGERY OF RIGHT ELBOW; FLUSHING OF FACE/ FACE TURNS RED; CHILLS; FATIGUE; NUMBNESS OF FEET AND HANDS; TINGLING OF FEET AND HANDS; FEVER (LOW GRADE); This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and neurological issues, and other pre-existing medical conditions included: The patient does not have any no known drug allergies. The patient did not have any history of 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced flushing of face/ face turns red. On 02-APR-2021, the patient experienced chills. On 02-APR-2021, the patient experienced fatigue. On 02-APR-2021, the patient experienced numbness of feet and hands. On 02-APR-2021, the patient experienced tingling of feet and hands. On 02-APR-2021, the patient experienced fever (low grade). Laboratory data included: Body temperature (NR: not provided) 98 F. On 15-APR-2021, the patient experienced major reconstructive surgery of right elbow. On 15-APR-2021, the patient experienced whole body hurts. On AUG-2021, the patient experienced accident that rolled ankle feels like pain more nerve related than muscular. On an unspecified date, the patient experienced takes a while to return to walking normally, and feels like an old lady. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Symptoms did not correlate to pre-menopause. Treatment medications (dates unspecified) included: zolpidem tartrate, oxycodone hydrochloride/paracetamol, hydrocodone bitartrate/paracetamol, and diazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flushing of face/ face turns red, chills, fatigue, numbness of feet and hands, tingling of feet and hands, fever (low grade), major reconstructive surgery of right elbow, feels like an old lady, takes a while to return to walking normally, accident that rolled ankle feels like pain more nerve related than muscular, and whole body hurts. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: TAKES A WHILE TO RETURN TO WALKING NORMALLY; FEELS LIKE AN OLD LADY; ACCIDENT THAT ROLLED ANKLE FEELS LIKE PAIN MORE NERVE RELATED THAN MUSCULAR; WHOLE BODY HURTS; MAJOR RECONSTRUCTIVE SURGERY OF RIGHT ELBOW; FLUSHING OF FACE/ FACE TURNS RED; CHILLS; FATIGUE; NUMBNESS OF FEET AND HANDS; TINGLING OF FEET AND HANDS; FEVER (LOW GRADE); This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and neurological issues, and other pre-existing medical conditions included: The patient does not have any no known drug allergies. The patient did not have any history of 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced flushing of face/ face turns red. On 02-APR-2021, the patient experienced chills. On 02-APR-2021, the patient experienced fatigue. On 02-APR-2021, the patient experienced numbness of feet and hands. On 02-APR-2021, the patient experienced tingling of feet and hands. On 02-APR-2021, the patient experienced fever (low grade). Laboratory data included: Body temperature (NR: not provided) 98 F. On 15-APR-2021, the patient experienced major reconstructive surgery of right elbow. On 15-APR-2021, the patient experienced whole body hurts. On AUG-2021, the patient experienced accident that rolled ankle feels like pain more nerve related than muscular. On an unspecified date, the patient experienced takes a while to return to walking normally, and feels like an old lady. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Symptoms did not correlate to pre-menopause. Treatment medications (dates unspecified) included: zolpidem tartrate, oxycodone hydrochloride/paracetamol, hydrocodone bitartrate/paracetamol, and diazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flushing of face/ face turns red, chills, fatigue, numbness of feet and hands, tingling of feet and hands, fever (low grade), major reconstructive surgery of right elbow, feels like an old lady, takes a while to return to walking normally, accident that rolled ankle feels like pain more nerve related than muscular, and whole body hurts. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: GROGGINESS; FELT SOME SHIVERS; SLIGHT ARM PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced grogginess, felt some shivers, slight arm pain, fever, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt some shivers, fever, fatigue, grogginess and slight arm pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FEVER; This spontaneous report received from a patient 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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, intramuscular, batch number: 1808978 expiry: 11-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Vaccination error
Clinical narrative: PATIENT RECEIVED SECOND DOSE OF JANSSEN VACCINE AFTER 21 DAYS OF PFIZER VACCINE FIRST DOSE (ADMINISTRATION ERROR); OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 62 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: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 15-SEP-2021, the patient experienced patient received second dose of janssen vaccine after 21 days of pfizer vaccine first dose (administration error). On 15-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received second dose of janssen vaccine after 21 days of pfizer vaccine first dose (administration error) and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional 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, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-SEP-2021 (at the time of reporting), the patient underwent finger prick test (Immunoglobulin G (IgG) and Immunoglobulin M (IgM)) and the results showed no antibodies (coded as confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193493.; Sender's Comments: 20210929248-Covid-19 vaccine ad26.cov2.s -Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Dysphagia, Oral herpes
Clinical narrative: METALLIC TASTE ALL AROUND MOUTH MORE ON ONE SIDE THAN THE OTHER; MASSIVE COLD SORE OUTBREAK AROUND WHOLE MOUTH; HARD TIME SWALLOWING FOR A DAY AND A HALF OR TWO; SEVERE JOINT PAIN THAT SEEMS TO BE SPREADING THROUGH BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included: cold sore outbreak. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On SEP-2021, the patient experienced massive cold sore outbreak around whole mouth. On SEP-2021, the patient experienced hard time swallowing for a day and a half or two. On SEP-2021, the patient experienced severe joint pain that seems to be spreading through body. On 01-SEP-2021, the patient experienced metallic taste all around mouth more on one side than the other. The action taken with covid-19 vaccine was not applicable. The patient recovered from hard time swallowing for a day and a half or two on SEP-2021, had not recovered from massive cold sore outbreak around whole mouth, and severe joint pain that seems to be spreading through body, and the outcome of metallic taste all around mouth more on one side than the other was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pain, Pain in extremity, Sensory disturbance
Clinical narrative: ACHING ALL OVER STARTING THE MORNING; STRANGE FEELING IN BOTH THE RIGHT AND LEFT LEGS (DESCRIBED AS LITTLE POPPING THROUGHOUT WHOLE LEGS LIKE BLOOD FLOW IS POPPING AND ALSO DESCRIBED THE FEELING AS GURGLING BLOOD FLOW. THE SENSATION IS OCCURRING IN BOTH LEGS BUT MOSTLY THE RIGHT LEG); FELT LIKE SHE WAS RUN OVER BY A BUS; LEG PAIN/ LEG IS SORE ON THE BACK OF CALF; SWELLING; SMALL AMOUNT OF PAIN BEHIND THE KNEE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ex-smoker, and concurrent conditions included: crooked spine, osteoarthritis, medical tape allergy, alcohol user, and platelets are large, and other pre-existing medical conditions included: patient had no drug abuse or illicit drug usage and has normal number of blood platelets. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced swelling. On SEP-2021, the patient experienced small amount of pain behind the knee. On 15-SEP-2021, the patient experienced aching all over starting the morning. On 15-SEP-2021, the patient experienced strange feeling in both the right and left legs (described as little popping throughout whole legs like blood flow is popping and also described the feeling as gurgling blood flow. the sensation is occurring in both legs but mostly the right leg). On 15-SEP-2021, the patient experienced felt like she was run over by a bus. On 15-SEP-2021, the patient experienced leg pain/ leg is sore on the back of calf. Treatment medications (dates unspecified) included: curcumin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aching all over starting the morning, strange feeling in both the right and left legs (described as little popping throughout whole legs like blood flow is popping and also described the feeling as gurgling blood flow. the sensation is occurring in both legs but mostly the right leg), leg pain/ leg is sore on the back of calf, and felt like she was run over by a bus, and the outcome of small amount of pain behind the knee and swelling was not reported. This report was non-serious. This case, from the same reporter is linked to 20210928799, 20210928678 and 20210929077.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: ACHING ALL OVER STARTING THE MORNING; STRANGE FEELING IN BOTH THE RIGHT AND LEFT LEGS (DESCRIBED AS LITTLE POPPING THROUGHOUT WHOLE LEGS LIKE BLOOD FLOW IS POPPING AND ALSO DESCRIBED THE FEELING AS GURGLING BLOOD FLOW. THE SENSATION IS OCCURRING IN BOTH LEGS BUT MOSTLY THE RIGHT LEG); FELT LIKE SHE WAS RUN OVER BY A BUS; LEG PAIN/ LEG IS SORE ON THE BACK OF CALF; SWELLING; SMALL AMOUNT OF PAIN BEHIND THE KNEE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ex-smoker, and concurrent conditions included: crooked spine, osteoarthritis, medical tape allergy, alcohol user, and platelets are large, and other pre-existing medical conditions included: patient had no drug abuse or illicit drug usage and has normal number of blood platelets. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced swelling. On SEP-2021, the patient experienced small amount of pain behind the knee. On 15-SEP-2021, the patient experienced aching all over starting the morning. On 15-SEP-2021, the patient experienced strange feeling in both the right and left legs (described as little popping throughout whole legs like blood flow is popping and also described the feeling as gurgling blood flow. the sensation is occurring in both legs but mostly the right leg). On 15-SEP-2021, the patient experienced felt like she was run over by a bus. On 15-SEP-2021, the patient experienced leg pain/ leg is sore on the back of calf. Treatment medications (dates unspecified) included: curcumin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aching all over starting the morning, strange feeling in both the right and left legs (described as little popping throughout whole legs like blood flow is popping and also described the feeling as gurgling blood flow. the sensation is occurring in both legs but mostly the right leg), leg pain/ leg is sore on the back of calf, and felt like she was run over by a bus, and the outcome of small amount of pain behind the knee and swelling was not reported. This report was non-serious. This case, from the same reporter is linked to 20210928799, 20210928678 and 20210929077.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative 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, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Oropharyngeal plaque
Clinical narrative: WHITE PLAQUES ON TONGUE AND THROAT; NO ENERGY OR LACK OF ENERGY; HEADACHE; This spontaneous report received from a patient concerned a 60 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: Unknown) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-SEP-2021, the patient experienced no energy or lack of energy. On 13-SEP-2021, the patient experienced headache. On 14-SEP-2021, the patient experienced white plaques on tongue and throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy or lack of energy, white plaques on tongue and throat, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: SWELL ON BOTH EYES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced swell on both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swell on both eyes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED DOSE OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced administration of expired dose of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired dose of the janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Nausea
Clinical narrative: stomach is upset; just don't feel good; Little nauseous; headache; 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 ABDOMINAL DISCOMFORT (stomach is upset), FEELING ABNORMAL (just don't feel good), NAUSEA (Little nauseous) and HEADACHE (headache) 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 ABDOMINAL DISCOMFORT (stomach is upset), FEELING ABNORMAL (just don't feel good), NAUSEA (Little nauseous) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach is upset), FEELING ABNORMAL (just don't feel good), NAUSEA (Little nauseous) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  No treatment  medication were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine given after the vial has been open for 6 hours and refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine given after the vial has been open for 6 hours and refrigerated) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given after the vial has been open for 6 hours and refrigerated). At the time of the report, PRODUCT STORAGE ERROR (vaccine given after the vial has been open for 6 hours and refrigerated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No treatment medications were reported
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Swelling
Clinical narrative: Redness; Swelling; Itching; Pain in the arm; Heat in the arm; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Pain in the arm ) and FEELING HOT (Heat in the arm) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Pain in the arm ) and FEELING HOT (Heat in the arm). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Pain in the arm ) and FEELING HOT (Heat in the arm) 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.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-003300 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003300:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: severe muscle pain; joint pain; low grade fever of 99.4-99.6F; chills; nausea; bad headache; dry heaves; arm hurting; This spontaneous case was reported by an other health professional and describes the occurrence of   in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (previously diagnosed with COVID).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dose every 4 hours.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Body temperature: 99.4-99.6 (High) low grade fever of 99.4-99.6F.     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 medication was provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Retching
Clinical narrative: severe muscle pain; joint pain; low grade fever of 99.4-99.6F; chills; nausea; bad headache; dry heaves; arm hurting; This spontaneous case was reported by an other health professional and describes the occurrence of   in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (previously diagnosed with COVID).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dose every 4 hours.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Body temperature: 99.4-99.6 (High) low grade fever of 99.4-99.6F.     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 medication was provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after vaccination) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K2JA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Coronary disease.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm pain after vaccination). In January 2021, PAIN IN EXTREMITY (Arm pain after vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia eye, Hypoaesthesia oral, Injection site pain
Clinical narrative: Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth; Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth; Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth; Mild soreness and sensitvity at the site of injection; 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 HYPOAESTHESIA EYE (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth), HYPOAESTHESIA ORAL (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth), FATIGUE (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth) and INJECTION SITE PAIN (Mild soreness and sensitvity at the site of injection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA EYE (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth), HYPOAESTHESIA ORAL (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth), FATIGUE (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth) and INJECTION SITE PAIN (Mild soreness and sensitvity at the site of injection). At the time of the report, HYPOAESTHESIA EYE (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth), HYPOAESTHESIA ORAL (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth), FATIGUE (Mild fatigue and a little numbness on the left side of my left eye and left corner of my mouth) and INJECTION SITE PAIN (Mild soreness and sensitvity at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: reaction on her arm 48 hours after the injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (reaction on her arm 48 hours after the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In January 2021, the patient experienced SKIN REACTION (reaction on her arm 48 hours after the injection). At the time of the report, SKIN REACTION (reaction on her arm 48 hours after the injection) 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.   No concomitant and treatment medication provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Non-Significant follow-up received on 20-JAN-2021.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Injection site warm; Injection site itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 16-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy). At the time of the report, INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) outcome was unknown. Crosslinked with case number MOD21-06047, MOD21-06146 and MOD21-06161 Warm transferred from Costumer Care, case number 000 21316 Caller states she, her husband, daughter and granddaughter got their first shot of the Moderna COVID-19.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-008434 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: having a cough before Moderna Vaccine and after 1 dose still experiencing cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (having a cough before Moderna Vaccine and after 1 dose still experiencing cough) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cough.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (having a cough before Moderna Vaccine and after 1 dose still experiencing cough). At the time of the report, COUGH (having a cough before Moderna Vaccine and after 1 dose still experiencing cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: negative (Negative) tested negative for COVID-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness
Clinical narrative: anaphylaxis; dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of   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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  Company comment: Very limited information regarding this event has been provided at this time. Basic details including the patient demographics, date of vaccine administration, event terms, and date or onset for the events are required for further assessment.   This case was linked to US-MODERNATX, INC.-MOD-2021-005623 (Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Basic details including the patient demographics, date of vaccine administration, event terms, and date or onset for the events are required for further assessment. US-MODERNATX, INC.-MOD-2021-005623:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: after threw up she administered the moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (after threw up she administered the moderna vaccine) 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 INCORRECT DOSE ADMINISTERED (after threw up she administered the moderna vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (after threw up she administered the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore/a little tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore/a little tender) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore/a little tender). At the time of the report, PAIN IN EXTREMITY (Arm sore/a little tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: localize reaction at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (localize reaction at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (localize reaction at the injection site). At the time of the report, INJECTION SITE REACTION (localize reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: all of a sudden gets a stabbing pain in the middle of the night; not able to move shoulder or arm because of the pain; could not move the shoulder/arm; limited range of motion in the area; sore; extreme pain in the site area; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm), JOINT RANGE OF MOTION DECREASED (limited range of motion in the area), PAIN (all of a sudden gets a stabbing pain in the middle of the night) and ARTHRALGIA (sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced ARTHRALGIA (sore) and INJECTION SITE PAIN (extreme pain in the site area). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm) and JOINT RANGE OF MOTION DECREASED (limited range of motion in the area). On an unknown date, the patient experienced PAIN (all of a sudden gets a stabbing pain in the middle of the night). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm), JOINT RANGE OF MOTION DECREASED (limited range of motion in the area), PAIN (all of a sudden gets a stabbing pain in the middle of the night), ARTHRALGIA (sore) and INJECTION SITE PAIN (extreme pain in the site area) 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.   No concomitant medications were reported.   This case was linked to MOD-2021-010401 (E2B Linked Report).; Sender's Comments:  MOD-2021-010401:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint movement impairment
Clinical narrative: all of a sudden gets a stabbing pain in the middle of the night; not able to move shoulder or arm because of the pain; could not move the shoulder/arm; limited range of motion in the area; sore; extreme pain in the site area; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm), JOINT RANGE OF MOTION DECREASED (limited range of motion in the area), PAIN (all of a sudden gets a stabbing pain in the middle of the night) and ARTHRALGIA (sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced ARTHRALGIA (sore) and INJECTION SITE PAIN (extreme pain in the site area). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm) and JOINT RANGE OF MOTION DECREASED (limited range of motion in the area). On an unknown date, the patient experienced PAIN (all of a sudden gets a stabbing pain in the middle of the night). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm), JOINT RANGE OF MOTION DECREASED (limited range of motion in the area), PAIN (all of a sudden gets a stabbing pain in the middle of the night), ARTHRALGIA (sore) and INJECTION SITE PAIN (extreme pain in the site area) 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.   No concomitant medications were reported.   This case was linked to MOD-2021-010401 (E2B Linked Report).; Sender's Comments:  MOD-2021-010401:
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness; 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 MYALGIA (Muscle soreness) 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 MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact