chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Faeces discoloured, Gingival bleeding, Headache
Clinical narrative: DARK FECES; LIGHT HEADACHE; BLOOD WHEN BRUSHING TEETH; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 73 kilograms, and height was 173 centimeters. The patient's past medical history included: broke his knee, residual bruising in left leg, and high cholesterol levels, and concurrent conditions included: developed veins in left leg that appear and disappear, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient noted that he has been eating a lot of yogurt, so his stool is usually more white in color. The patient experienced side effects when treated with rosuvastatin calcium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 7-MAR-2022) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced blood when brushing teeth. On 26-SEP-2021, the patient experienced light headache. On 27-SEP-2021, the patient experienced dark feces. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood when brushing teeth on 27-SEP-2021, and had not recovered from light headache, and dark feces. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: SHOOTING PAIN FROM KNEE TO INSIDE OF THIGH; SLIGHT FEVER ON 1ST 2 DAYS, HIGH FEVER SPIKES ON 9TH AND 10TH DAY; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis in left knee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced shooting pain from knee to inside of thigh. On 17-SEP-2021, the patient experienced slight fever on 1st 2 days, high fever spikes on 9th and 10th day. On 25-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever on 1st 2 days, high fever spikes on 9th and 10th day, and the outcome of shooting pain from knee to inside of thigh was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN THE LEGS; This spontaneous report received from a consumer 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 25-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced pain in the legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the legs. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: COLD SYMPTOMS (SORE THROAT, NASAL CONGESTION AND SNEEZING); This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 150 pounds, and height was 57 inches. The patient's concurrent conditions included: high blood pressure, and post partum preeclampsia, and other pre-existing medical conditions included: The patient and her son had not done covid-19 test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for post partum preeclampsia. On 24-SEP-2021, the patient experienced cold symptoms (sore throat, nasal congestion and sneezing). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms (sore throat, nasal congestion and sneezing) was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000194835.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO A MINOR; This spontaneous report received from a pharmacist concerned a 12 year old male. The patient's weight was 280 pounds, and height was 74 inches. 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: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-SEP-2021, the patient experienced off label use. On 17-SEP-2021, the patient experienced vaccine administered to a minor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to a minor was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: WORST POSSIBLE CHILLS; FEVER OF 101; 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, and batch number were not reported) dose was not reported, administered on 24-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 24-SEP-2021, the patient experienced worst possible chills. On 24-SEP-2021, the patient experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101 and worst possible chills was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: POTENTIAL ADMINISTRATION ERROR - EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced potential administration error - expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration error - expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953327, 20210953012, 20210952662.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 74 year old of unspecified 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: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952718.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; HEADACHE; COMPLICATIONS; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced complications. On 23-SEP-2021, the patient experienced body aches. On 23-SEP-2021, the patient experienced fever. On 23-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 26-SEP-2021, and the outcome of complications was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953241.
Sex: U
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: PEA SIZED NODULE AT INJECTION SITE; TENDER WHEN TOUCHED; This spontaneous report received from a patient concerned a 53 year old of unspecified 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, and batch number were not reported) 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 SEP-2021, the patient experienced pea sized nodule at injection site. On SEP-2021, the patient experienced tender when touched. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pea sized nodule at injection site and tender when touched was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952662.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Fatigue, Feeling abnormal, Somnolence
Clinical narrative: FELT LIKE BEING FORCED TO MOVE; FELT SEVERE FATIGUE; SLEPT FOR THE DAY/ SLEEPS FOR 13-15 HOURS.; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 265 pounds, and height was 69 inches. The patient's past medical history included: shingles, and concurrent conditions included: sleep apnea, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid; and experienced drug allergy when treated with phenobarbital. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced slept for the day/ sleeps for 13-15 hours. On JUN-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On an unspecified date, the patient experienced felt like being forced to move, and felt severe fatigue. Treatment medications (dates unspecified) included: solriamfetol hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt severe fatigue, and slept for the day/ sleeps for 13-15 hours., and the outcome of felt like being forced to move was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy
Clinical narrative: CHILLS; HEADACHE; SWOLLEN LYMPH NODE UNDER ARMPIT; 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 07-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced headache. On SEP-2021, the patient experienced swollen lymph node under armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and swollen lymph node under armpit was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: ADMINISTRATION OF JANSSEN COVID 19 VACCINE AFTER RECEIVING AND HAVING AN ALLERGIC REACTION TO THE PFIZER COVID VACCINE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic reaction to the pfizer covid vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 14-MAY-2021, the patient experienced administration of janssen covid 19 vaccine after receiving and having an allergic reaction to the pfizer covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of janssen covid 19 vaccine after receiving and having an allergic reaction to the pfizer covid vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Fatigue, Migraine, Pyrexia
Clinical narrative: VACCINE HIT LIKE A SACK OF BRICKS; MIGRAINE; JOINTS DID NOT SUPPORT HAD TO WAIT 30 MINUTES BEFORE STAND AFTER WOKE UP BECAUSE OF KNEES AND FEET; JOINT PAIN FELT LIKE 40 YEARS OLDER FOR A DAY; EXTREMELY TIRED; FEVER; 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. 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 vaccine hit like a sack of bricks, migraine, joints did not support had to wait 30 minutes before stand after woke up because of knees and feet, joint pain felt like 40 years older for a day, extremely tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine hit like a sack of bricks, fever, migraine, extremely tired, joint pain felt like 40 years older for a day and joints did not support had to wait 30 minutes before stand after woke up because of knees and feet was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: VACCINE HIT LIKE A SACK OF BRICKS; MIGRAINE; JOINTS DID NOT SUPPORT HAD TO WAIT 30 MINUTES BEFORE STAND AFTER WOKE UP BECAUSE OF KNEES AND FEET; JOINT PAIN FELT LIKE 40 YEARS OLDER FOR A DAY; EXTREMELY TIRED; FEVER; 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. 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 vaccine hit like a sack of bricks, migraine, joints did not support had to wait 30 minutes before stand after woke up because of knees and feet, joint pain felt like 40 years older for a day, extremely tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine hit like a sack of bricks, fever, migraine, extremely tired, joint pain felt like 40 years older for a day and joints did not support had to wait 30 minutes before stand after woke up because of knees and feet was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; 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 not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administered expired vaccine. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952956.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952662, 20210953012 and 20210952909.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: PAINFUL BIG LUMP STICKING OUT AT THE INJECTION SITE IN LEFT ARM; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, sulfa allergy, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced painful big lump sticking out at the injection site in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful big lump sticking out at the injection site in left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Pain in extremity, Sensory disturbance
Clinical narrative: FEELING/SENSATION IN ARM GOING DOWN INTO HER HAND; PAIN GOING DOWN TO HAND WHEN VACCINE WAS ADMINISTERED; FEELS TIRED; BLOOD PRESSURE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced blood pressure increased. On SEP-2021, the patient experienced pain going down to hand when vaccine was administered. On SEP-2021, the patient experienced feels tired. Laboratory data included: Blood pressure (NR: not provided) 120/80 or 128/81 (units unspecified). On 22-SEP-2021, the patient experienced feeling/sensation in arm going down into her hand. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/70 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling/sensation in arm going down into her hand, and the outcome of feels tired, pain going down to hand when vaccine was administered and blood pressure increased was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) had resolved.            No Concomitant medication was provided.  No treatment medication was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: sore arm; stomach ache; itchy rash on body; Dizzy all day; muscle aches; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dizziness and Rash. Concurrent medical conditions included Drug allergy (Cipro allergy and Vicodin) and Contrast media allergy (Iodine based contrast dye). Concomitant products included BUDESONIDE (PULMICORT FLEXHALER) for Asthma, LIFITEGRAST (XIIDRA) for Dry eye, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, OXYGEN supplementation (OXYGEN), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM CITRATE, VITAMIN D3, VITAMIN B2 [RIBOFLAVIN], PROBIOTICS NOS, FISH OIL, DOCOSAHEXAENOIC ACID (DHA) and CURCUMIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue). an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to MOD-2021-021976 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: sore arm; stomach ache; itchy rash on body; Dizzy all day; muscle aches; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dizziness and Rash. Concurrent medical conditions included Drug allergy (Cipro allergy and Vicodin) and Contrast media allergy (Iodine based contrast dye). Concomitant products included BUDESONIDE (PULMICORT FLEXHALER) for Asthma, LIFITEGRAST (XIIDRA) for Dry eye, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, OXYGEN supplementation (OXYGEN), MULTIVITAMIN [VITAMINS NOS], MAGNESIUM CITRATE, VITAMIN D3, VITAMIN B2 [RIBOFLAVIN], PROBIOTICS NOS, FISH OIL, DOCOSAHEXAENOIC ACID (DHA) and CURCUMIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue). an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach ache), RASH PRURITIC (itchy rash on body), DIZZINESS (Dizzy all day), MYALGIA (muscle aches), HEADACHE (headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to MOD-2021-021976 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. 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.  Company Comment: 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.    conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-245527, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for clinic so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new 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 event, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Musculoskeletal discomfort, Perineal cyst, Pyrexia
Clinical narrative: adverse reaction; area in the groin; a cyst that kept getting bigger in the perineal area; fever/I had all of it, everything; chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction), MUSCULOSKELETAL DISCOMFORT (area in the groin), PERINEAL CYST (a cyst that kept getting bigger in the perineal area), PYREXIA (fever/I had all of it, everything) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included DOXYCYCLINE for Hidradenitis suppurativa.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction), MUSCULOSKELETAL DISCOMFORT (area in the groin), PERINEAL CYST (a cyst that kept getting bigger in the perineal area), PYREXIA (fever/I had all of it, everything) and CHILLS (chills). The patient was treated with CORTISONE at a dose of 1 dosage form and Surgery for Perineal cyst. At the time of the report, ADVERSE REACTION (adverse reaction), MUSCULOSKELETAL DISCOMFORT (area in the groin), PERINEAL CYST (a cyst that kept getting bigger in the perineal area), PYREXIA (fever/I had all of it, everything) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-320951 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Disability, Fall, Transient ischaemic attack
Clinical narrative: TIA after her first shot; Incapacitated for over an hour,lost the whole right side of the body; Fell to the ground, this lasted for 2 or 3 hours; This spontaneous case was reported by a nurse and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) and FALL (Fell to the ground, this lasted for 2 or 3 hours) in an elderly 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot) (seriousness criteria disability, medically significant and life threatening), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) (seriousness criteria disability, medically significant and life threatening) and FALL (Fell to the ground, this lasted for 2 or 3 hours) (seriousness criteria disability and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) and FALL (Fell to the ground, this lasted for 2 or 3 hours) 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 provided.  No treatment information was provided.  Patient was over the age of 60, female who had a TIA after her first shot.TIA was right sided, she was in capitated for over an hour. When she was driving and got to the house, she lost the whole right side of the body. she was tried to get out of the car and fell to the ground, this lasted for 2 or 3 hours. It finally resolved after that.   Company Comment: This case concerns an elderly female subject, who experienced the unexpected events of transient ischaemic attack, Disability and Fall. The event occurred after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns an elderly female subject, who experienced the unexpected events of transient ischaemic attack, Disability and Fall. The event occurred after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Fatigue, Feeling abnormal, Injection site pain, Lymph node pain
Clinical narrative: 3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart"; Heart felt real restless; Fatigue; Injection site tenderness; Tender lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart"), CARDIAC DISCOMFORT (Heart felt real restless), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site tenderness) and LYMPH NODE PAIN (Tender lymph nodes) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatic fever (when patient was 16 years old), Angina attack, Blood pressure raised (Patient blood pressure raised due to fear of side effects before receiving first dose) and Fear (Patient blood pressure raised due to fear of side effects before receiving first dose).    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced FEELING ABNORMAL (3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart") and CARDIAC DISCOMFORT (Heart felt real restless). In September 2021, the patient experienced FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site tenderness) and LYMPH NODE PAIN (Tender lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ALPRAZOLAM (XANAX) for Adverse event, at a dose of UNK dosage form. In September 2021, FEELING ABNORMAL (3rd and 4th day after receiving 1st dose "felt like small elephant sitting over heart"), CARDIAC DISCOMFORT (Heart felt real restless), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site tenderness) and LYMPH NODE PAIN (Tender lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was not reported  Patient was anxious and her blood pressure raised due to fear of side effects before receiving first dose.  Patient worried about myocarditis and pericarditis risk and was unsure if she would get 2nd dose or not.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted Covid-19 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 3 weeks ago) in a 59-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 COVID-19 (contracted Covid-19 3 weeks ago). At the time of the report, COVID-19 (contracted Covid-19 3 weeks ago) outcome was unknown.            No Concomitant medications were reported No treatment medications were reported Patient got quarantined for 10 days.; Sender's Comments: This case concerns a 59-year-old female patient who experienced the non-serious  unexpected event COVID-19, after receiving mRNA-1273 Moderna vaccine. No information was provided regarding the event and date doses of the product. Further information has been requested.  No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive after vaccination) in a male 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 COVID-19 (COVID positive after vaccination). At the time of the report, COVID-19 (COVID positive after vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  The patient had received the Moderna COVID-19 vaccine and was currently experiencing COVID-19. The reporter asked if the patient can be treated with the "defensa antibody treatment, 2 injections in the arm and 2 in the stomach area".; Sender's Comments: This report concerns a male patient with no relevant medical history who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Extra dose administered, Faeces discoloured
Clinical narrative: nose bleeds; darkening in the stools; extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (nose bleeds), FAECES DISCOLOURED (darkening in the stools) and EXTRA DOSE ADMINISTERED (extra dose administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (extra dose administered). On 18-Sep-2021, the patient experienced EPISTAXIS (nose bleeds) and FAECES DISCOLOURED (darkening in the stools). On 17-Sep-2021, EXTRA DOSE ADMINISTERED (extra dose administered) had resolved. At the time of the report, EPISTAXIS (nose bleeds) and FAECES DISCOLOURED (darkening in the stools) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug was reported No concomitant product reported  It was reported that patient received the 1st dose in 20 Mar 2021 with lot 044a21a, 2nd dose 23 Apr 2021 with lot 037b21a. The symptoms were ongoing but they were getting better.  Company Comment : This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of epistaxis and Faeces discoloured. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Events seriousness were downgrade due there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender's Comments: This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of epistaxis and Faeces discoloured. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Events seriousness were downgrade due there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.