chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unknown) dose was not reported, administered on 20-MAR-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 20-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 21-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210501553.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: ITCHY EYES; EYE SWELLING; This spontaneous report received from a health care professional concerned a 56 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, batch number: 043A21A expiry: unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced eye swelling. On 29-APR-2021, the subject experienced itchy eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye swelling, and itchy eyes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Ear pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: HEART SENSATION OF TURNING INSIDE OUT; WEIRD FEELING; SORE ARM; FATIGUE; painful injection site; HEADACHE; NUMBNESS AND TINGLING  IN RIGHT SIDE OF FACE; NUMBNESS AND TINGLING IN RIGHT SIDE OF CHEST AND RIBCAGE; DISORIENTED; TROUBLE GRASPING REFLEX; PAIN IN EARS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, hypothyroid, pollen allergy, alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 14:45 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, levothyroxine sodium for hypothyroid, and liothyronine sodium for hypothyroid. On 28-APR-2021, the subject experienced numbness and tingling in right side of face. On 28-APR-2021, the subject experienced numbness and tingling in right side of chest and ribcage. On 28-APR-2021, the subject experienced disoriented. On 28-APR-2021, the subject experienced trouble grasping reflex. On 28-APR-2021, the subject experienced pain in ears. On 28-APR-2021, the subject experienced weird feeling. On 28-APR-2021, the subject experienced sore arm. On 28-APR-2021, the subject experienced fatigue. On 28-APR-2021, the subject experienced painful injection site. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced heart sensation of turning inside out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness and tingling in right side of face, numbness and tingling in right side of chest and ribcage, disoriented, trouble grasping reflex, pain in ears, weird feeling, sore arm, and painful injection site on 28-APR-2021, and heart sensation of turning inside out, and headache on 29-APR-2021, and was recovering from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hyporeflexia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: HEART SENSATION OF TURNING INSIDE OUT; WEIRD FEELING; SORE ARM; FATIGUE; painful injection site; HEADACHE; NUMBNESS AND TINGLING  IN RIGHT SIDE OF FACE; NUMBNESS AND TINGLING IN RIGHT SIDE OF CHEST AND RIBCAGE; DISORIENTED; TROUBLE GRASPING REFLEX; PAIN IN EARS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, hypothyroid, pollen allergy, alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 14:45 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, levothyroxine sodium for hypothyroid, and liothyronine sodium for hypothyroid. On 28-APR-2021, the subject experienced numbness and tingling in right side of face. On 28-APR-2021, the subject experienced numbness and tingling in right side of chest and ribcage. On 28-APR-2021, the subject experienced disoriented. On 28-APR-2021, the subject experienced trouble grasping reflex. On 28-APR-2021, the subject experienced pain in ears. On 28-APR-2021, the subject experienced weird feeling. On 28-APR-2021, the subject experienced sore arm. On 28-APR-2021, the subject experienced fatigue. On 28-APR-2021, the subject experienced painful injection site. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced heart sensation of turning inside out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness and tingling in right side of face, numbness and tingling in right side of chest and ribcage, disoriented, trouble grasping reflex, pain in ears, weird feeling, sore arm, and painful injection site on 28-APR-2021, and heart sensation of turning inside out, and headache on 29-APR-2021, and was recovering from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: HEART SENSATION OF TURNING INSIDE OUT; WEIRD FEELING; SORE ARM; FATIGUE; painful injection site; HEADACHE; NUMBNESS AND TINGLING  IN RIGHT SIDE OF FACE; NUMBNESS AND TINGLING IN RIGHT SIDE OF CHEST AND RIBCAGE; DISORIENTED; TROUBLE GRASPING REFLEX; PAIN IN EARS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, hypothyroid, pollen allergy, alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 14:45 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, levothyroxine sodium for hypothyroid, and liothyronine sodium for hypothyroid. On 28-APR-2021, the subject experienced numbness and tingling in right side of face. On 28-APR-2021, the subject experienced numbness and tingling in right side of chest and ribcage. On 28-APR-2021, the subject experienced disoriented. On 28-APR-2021, the subject experienced trouble grasping reflex. On 28-APR-2021, the subject experienced pain in ears. On 28-APR-2021, the subject experienced weird feeling. On 28-APR-2021, the subject experienced sore arm. On 28-APR-2021, the subject experienced fatigue. On 28-APR-2021, the subject experienced painful injection site. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced heart sensation of turning inside out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness and tingling in right side of face, numbness and tingling in right side of chest and ribcage, disoriented, trouble grasping reflex, pain in ears, weird feeling, sore arm, and painful injection site on 28-APR-2021, and heart sensation of turning inside out, and headache on 29-APR-2021, and was recovering from fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES ON  THE UNDER SIDE OF BOTH ARMS AND LOWER LEGS; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 25-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced hives on the under side of both arms and lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on the under side of both arms and lower legs. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 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. Non-company suspect drugs included: adalimumab (subcutaneous, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of soreness in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: DROWSINESS; FEELING PAIN IN ARM; TIREDNESS; FEVER; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug allergies and no drug abuse or drug illicit use.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 18-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced feeling pain in arm. On 18-APR-2021, the subject experienced tiredness. On 18-APR-2021, the subject experienced fever. On 01-MAY-2021, the subject experienced drowsiness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling pain in arm, and tiredness, and had not recovered from fever, and drowsiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a patient concerned a female of unspecified age. 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, 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 subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Deafness unilateral, Fatigue, Feeling abnormal, Peripheral swelling
Clinical narrative: Left ear hearing loss; unilateral vision loss; Brain fog; Hot; Swelling in her arm that is the size of a baseball; COVID Arm; Itchy; Red circle around injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear hearing loss) and BLINDNESS UNILATERAL (unilateral vision loss) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dairy intolerance. Concomitant products included DOXYCYCLINE from 01-Jan-2020 to an unknown date for Rosacea, DEXLANSOPRAZOLE (DEXILANT) and FAMOTIDINE for Stomach discomfort, ROSUVASTATIN for Stroke, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CALCIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MAGNESIUM OXIDE for an unknown indication.   On 29-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Left ear hearing loss) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (unilateral vision loss) (seriousness criterion medically significant). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, DEAFNESS UNILATERAL (Left ear hearing loss), FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired) outcome was unknown.            Treatment information not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Case upgraded to serious based on event update. Con meds added. Prior event outcome updated. Medical history updated based on information; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Left ear hearing loss; unilateral vision loss; Brain fog; Hot; Swelling in her arm that is the size of a baseball; COVID Arm; Itchy; Red circle around injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear hearing loss) and BLINDNESS UNILATERAL (unilateral vision loss) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dairy intolerance. Concomitant products included DOXYCYCLINE from 01-Jan-2020 to an unknown date for Rosacea, DEXLANSOPRAZOLE (DEXILANT) and FAMOTIDINE for Stomach discomfort, ROSUVASTATIN for Stroke, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CALCIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MAGNESIUM OXIDE for an unknown indication.   On 29-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Left ear hearing loss) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (unilateral vision loss) (seriousness criterion medically significant). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, DEAFNESS UNILATERAL (Left ear hearing loss), FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired) outcome was unknown.            Treatment information not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Case upgraded to serious based on event update. Con meds added. Prior event outcome updated. Medical history updated based on information; 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Rash pruritic
Clinical narrative: Bronchitis; Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy) in a 78-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy). At the time of the report, RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy) outcome was unknown.            Information about concomitant medication was not reported. Follow up information was received on 29-APR-2021, regarding the patients second vaccine. The patient was hospitalized for 5 days after receiving the second vaccine. Her primary care doctor does not have any information regarding her symptoms yet. The patient was admitted with shortness of breath and was diagnosed with bronchitis. The patient also developed a rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area. The rash was very itchy. No treatment information 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant Follow up, Case upgraded to serious; 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Superficial blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Superficial blood clot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Superficial blood clot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Ultrasound scan: abnormal (abnormal) Ultrasound of left arm was done and determined a blood clot in that arm..         Patient went to the emergency room on 24 Apr 2021, approximately 7 pm. The patient was a healthy individual and used to do bike ride 11 miles per day with average speed 16mph. He did bike ride the evening of his second covid shot. No relevant concomitant medications were reported. Treatment information included anti-inflammatory medicine. Action taken with mRNA-1273 in response to the events was not applicable.  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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information was received on 26 Apr 2021. Added lab data and treatment; 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: he couldn't pee; low appetite; he thought he may pass out; Chills; severe headache every time he got up; feel sick to his stomach but never vomited; low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (he couldn't pee) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A2L1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced URINARY RETENTION (he couldn't pee) (seriousness criterion medically significant), DECREASED APPETITE (low appetite), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired). On 23-Apr-2021, DECREASED APPETITE (low appetite) had resolved. On 25-Apr-2021, URINARY RETENTION (he couldn't pee), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired) had resolved.            The reporter stated, the patient had similar side effect from what he had from the 1st dose.  Additional concomitant medications included Blood pressure pills, Cholesterol pills and maybe back pain pill. Treatment medication included Tylenol.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.      Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: An additional document received on 26 Apr 2021 has information Upgraded case to serious, updated suspect product details, concomitant medication, treatment medication and event details.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, Urinary retention
Clinical narrative: he couldn't pee; low appetite; he thought he may pass out; Chills; severe headache every time he got up; feel sick to his stomach but never vomited; low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (he couldn't pee) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A2L1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced URINARY RETENTION (he couldn't pee) (seriousness criterion medically significant), DECREASED APPETITE (low appetite), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired). On 23-Apr-2021, DECREASED APPETITE (low appetite) had resolved. On 25-Apr-2021, URINARY RETENTION (he couldn't pee), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired) had resolved.            The reporter stated, the patient had similar side effect from what he had from the 1st dose.  Additional concomitant medications included Blood pressure pills, Cholesterol pills and maybe back pain pill. Treatment medication included Tylenol.  Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.      Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: An additional document received on 26 Apr 2021 has information Upgraded case to serious, updated suspect product details, concomitant medication, treatment medication and event details.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Feeling hot, Hyperhidrosis, Lethargy
Clinical narrative: passing out; blood pressure of 70/40; Feeling hot; Sweaty; Dizziness; Lethargy; Sore arm; Achy all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over). On 21-Apr-2021, LOSS OF CONSCIOUSNESS (passing out) had resolved. At the time of the report, BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient reports that paramedics had to come after he passed out.   Treatment of the events included acetaminophen.  Company comment: This case concerns a 56-year-old male with a serious unexpected event of loss of consciousness, and nonserious unexpected blood pressure decreased, feeling hot, hyperhidrosis, dizziness, lethargy and expected pain in extremity. Event onset the same day as first dose mRNA-1273. Events resolved. 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Myalgia, Pain in extremity
Clinical narrative: passing out; blood pressure of 70/40; Feeling hot; Sweaty; Dizziness; Lethargy; Sore arm; Achy all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over). On 21-Apr-2021, LOSS OF CONSCIOUSNESS (passing out) had resolved. At the time of the report, BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient reports that paramedics had to come after he passed out.   Treatment of the events included acetaminophen.  Company comment: This case concerns a 56-year-old male with a serious unexpected event of loss of consciousness, and nonserious unexpected blood pressure decreased, feeling hot, hyperhidrosis, dizziness, lethargy and expected pain in extremity. Event onset the same day as first dose mRNA-1273. Events resolved. 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Diagnosed Two Pulmonary Embolism; DVT on left leg; Coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (DVT on left leg) (seriousness criterion medically significant) and COUGH (Coughing) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) outcome was unknown.  After his 2nd dose of Moderna vaccine on 01-Apr-2021, the patient's coughing become worst again. His pulmonologist prescribed prednisone and his family physician prescribed him Azithromycin.  No concomitant medications were not provided.  Treatment included as Eliquis, Azithromycin, cough medicine, prednisone.  Company comment: 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.   This case was linked to  (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: bleeding from rectum; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from rectum) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (bleeding from rectum) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. No treatment information was provided.  The colonoscopy was scheduled for May.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (Bood clot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and THROMBOSIS (Bood clot) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Heart attack and Clot blood. It is unknown if an autopsy was performed. Not Provided          No concomitant medication were reported. No treatment information was provided.; Reported Cause(s) of Death: Heart attack; Clot blood
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Herpes zoster
Clinical narrative: shingles; Eyes swells a lot; headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concurrent medical conditions included Drug allergy. Concomitant products included HYDRALAZINE, LOSARTAN, ATENOLOL, AMLODIPINE, OXYCODONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and Ibuprofen 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (headache). On 05-Apr-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion medically significant) and EYE SWELLING (Eyes swells a lot). At the time of the report, HERPES ZOSTER (shingles) had not resolved and EYE SWELLING (Eyes swells a lot) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient could not see good due to swelling of eyes. Her face was itching, had rash and bumps on her face due to shingles.  Treatment details include acyclovir tablet 800mg 5 times a day, acyclovir ointment.  Company Comment:Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles/.  Headache is consistent with the product known safety profile.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Transient ischaemic attack
Clinical narrative: TIA Stroke (transient ischemic attack); loss of memory for 15 minues could not spell the word "side" nor "effect"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) (seriousness criterion medically significant) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect"). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included vitamin-c and fish oil  Company comment: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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: This is a 68-year-old, male patient who received mRNA-1273 vaccine (batch no. unknown) who died, on an unknown date after receiving first dose of vaccine.  No medical history or conmeds were provided. Existing comorbidities probably could have been the causative factor in his death. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Product dose omission issue
Clinical narrative: Died due to his many medical conditions; could not administer second vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Died due to his many medical conditions) in a male 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 Rehabilitation therapy (Patient was in rehabilitation center) and General physical health deterioration (It is reported that patient had history of many medical conditions, unspecified.).    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 GENERAL PHYSICAL HEALTH DETERIORATION (Died due to his many medical conditions) (seriousness criterion death) and PRODUCT DOSE OMISSION ISSUE (could not administer second vaccine). The patient died on an unknown date. The reported cause of death was medical conditions. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (could not administer second vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This is a male patient of unknown age who received mRNA-1273 vaccine (batch no. unknown) who died on an unknown date after receiving first dose of vaccine. Patient had history of many medical conditions. No conmeds were given. Reporter could not administer second vaccine. Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: medical conditions
Sex: F
Vaccine: HPV4
Symptoms: Product storage error
Clinical narrative: incorrect product storage; incorrect product storage; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with improperly stored quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (formulation, strength, dose, frequency, route of administration, lot#, expiry date were not provided) for prophylaxis.  Other improperly stored suspect therapies included etonogestrel (+) ethinyl estradiol(NUVARING), insulin glargine(TOUJEO MAX SOLOSTAR), insulin lispro(ADMELOG), dulaglutide(TRULICITY), semaglutide(OZEMPIC), galcanezumab-gnlm(EMGALITY), calcium undecylenate (CRUEX), gabapentin, acyclovir(ZOSTER), insulin aspart(NOVOLOG), insulin human(HUMULIN R), insulin glargine(BASAGLAR) and insulin lispro(HUMALOG)  (for all: formulation, strength, dose, frequency, indication, route of administration, lot number and expiry date were not provided). The pharmacist reported a temperature excursion due to moving above mentioned products to other refrigerators. Excursion limits were reported as: 50.3 degrees Fahrenheit for 3 hours.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Prostate cancer, Vaccination site pain
Clinical narrative: prostate cancer; Had some pain 1st and 2nd at injection site; some joint pain next 3 to 9 days; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Vaccination facility type was hospital. Patient received the first dose of the vaccine and is due to receive the second dose on 04Feb2021. On 03Feb2021, he is due to receive a steroid injection in his back and was wondering if the two are compatible. He will have his injection shot at his lower back the day before his 2nd dose vaccine. It was further reported that on 14Jan2021, the patient received his first covid vaccine and had some pain 1st and 2nd (day) at injection site (14Jan2021) and some joint pain next 3 to 9 days (Jan2021), went into hospital for prostate cancer on 02Feb2021. The patient experienced prostate cancer on an unspecified date. The patient was hospitalized for prostate cancer from 02Feb2021 to an unknown date. They would not give him 2nd vaccine at hospital. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.