chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; 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 (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210624187.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Heart rate, Oxygen saturation
Clinical narrative: LIGHT BUT DISTINCT, METALLIC-LIKE TASTE IN MY MOUTH, PERSISTENT AND LARGELY UNVARYING FOR WEEKS.; This spontaneous report received from a patient concerned a 72 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included mild glaucoma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos.  On APR-2021, the subject experienced light but distinct, metallic-like taste in my mouth, persistent and largely unvarying for weeks. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/60 mmHg, Oxygen saturation (NR: not provided) 99 %, and Pulse rate (NR: not provided) Under 60. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from light but distinct, metallic-like taste in my mouth, persistent and largely unvarying for weeks. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: JAW PAIN; This spontaneous report received from concerned a 56 year old male. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced jaw pain. The action taken with covid-19 vaccine was not applicable. The patient recovered from jaw pain. This report was non-serious. This case, from the same reporter is linked to 20210627868.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: MUSCLE SPASM; BURNING SENSATION STARTS LIKE BEING ON FIRE; TINGLING; TENDERNESS MOVED DOWN TO ELBOW AND BELOW IT; LITTLE WARM TO TOUCH; FEELS LIKE SOMETHING IS IN IT LIKE A BB-GUN; INJECTED ARM TENDER TO TOUCH /INJECTION SITE SORENESS; BUMPS; NAUSEA; HEADACHE; FATIGUE; ARM SORENESS; BODY ACHE /HURTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included seizure, and migraine, and concurrent conditions included allergic to bees, non-alcohol user, non-smoker, allergic to wasps, penicillin allergy, and allergic to sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient is allergic to seizure and pain medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced body ache /hurts. On 11-MAY-2021, the subject experienced arm soreness. On 11-MAY-2021, the subject experienced nausea. On 11-MAY-2021, the subject experienced headache. On 11-MAY-2021, the subject experienced fatigue. On 16-MAY-2021, the subject experienced little warm to touch. On 16-MAY-2021, the subject experienced feels like something is in it like a bb-gun. On 16-MAY-2021, the subject experienced bumps. On 16-MAY-2021, the subject experienced injected arm tender to touch /injection site soreness. On 17-MAY-2021, the subject experienced tenderness moved down to elbow and below it. On 17-MAY-2021, the subject experienced muscle spasm. On 17-MAY-2021, the subject experienced burning sensation starts like being on fire. On 17-MAY-2021, the subject experienced tingling. Treatment medications (dates unspecified) included: ibuprofen, menthol, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache /hurts, nausea, headache, and fatigue on 15-MAY-2021, and had not recovered from injected arm tender to touch /injection site soreness, little warm to touch, feels like something is in it like a bb-gun, muscle spasm, burning sensation starts like being on fire, bumps, arm soreness, tingling, and tenderness moved down to elbow and below it. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: MUSCLE SPASM; BURNING SENSATION STARTS LIKE BEING ON FIRE; TINGLING; TENDERNESS MOVED DOWN TO ELBOW AND BELOW IT; LITTLE WARM TO TOUCH; FEELS LIKE SOMETHING IS IN IT LIKE A BB-GUN; INJECTED ARM TENDER TO TOUCH /INJECTION SITE SORENESS; BUMPS; NAUSEA; HEADACHE; FATIGUE; ARM SORENESS; BODY ACHE /HURTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included seizure, and migraine, and concurrent conditions included allergic to bees, non-alcohol user, non-smoker, allergic to wasps, penicillin allergy, and allergic to sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient is allergic to seizure and pain medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced body ache /hurts. On 11-MAY-2021, the subject experienced arm soreness. On 11-MAY-2021, the subject experienced nausea. On 11-MAY-2021, the subject experienced headache. On 11-MAY-2021, the subject experienced fatigue. On 16-MAY-2021, the subject experienced little warm to touch. On 16-MAY-2021, the subject experienced feels like something is in it like a bb-gun. On 16-MAY-2021, the subject experienced bumps. On 16-MAY-2021, the subject experienced injected arm tender to touch /injection site soreness. On 17-MAY-2021, the subject experienced tenderness moved down to elbow and below it. On 17-MAY-2021, the subject experienced muscle spasm. On 17-MAY-2021, the subject experienced burning sensation starts like being on fire. On 17-MAY-2021, the subject experienced tingling. Treatment medications (dates unspecified) included: ibuprofen, menthol, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache /hurts, nausea, headache, and fatigue on 15-MAY-2021, and had not recovered from injected arm tender to touch /injection site soreness, little warm to touch, feels like something is in it like a bb-gun, muscle spasm, burning sensation starts like being on fire, bumps, arm soreness, tingling, and tenderness moved down to elbow and below it. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: MUSCLE SPASM; BURNING SENSATION STARTS LIKE BEING ON FIRE; TINGLING; TENDERNESS MOVED DOWN TO ELBOW AND BELOW IT; LITTLE WARM TO TOUCH; FEELS LIKE SOMETHING IS IN IT LIKE A BB-GUN; INJECTED ARM TENDER TO TOUCH /INJECTION SITE SORENESS; BUMPS; NAUSEA; HEADACHE; FATIGUE; ARM SORENESS; BODY ACHE /HURTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included seizure, and migraine, and concurrent conditions included allergic to bees, non-alcohol user, non-smoker, allergic to wasps, penicillin allergy, and allergic to sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug usage. patient is allergic to seizure and pain medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced body ache /hurts. On 11-MAY-2021, the subject experienced arm soreness. On 11-MAY-2021, the subject experienced nausea. On 11-MAY-2021, the subject experienced headache. On 11-MAY-2021, the subject experienced fatigue. On 16-MAY-2021, the subject experienced little warm to touch. On 16-MAY-2021, the subject experienced feels like something is in it like a bb-gun. On 16-MAY-2021, the subject experienced bumps. On 16-MAY-2021, the subject experienced injected arm tender to touch /injection site soreness. On 17-MAY-2021, the subject experienced tenderness moved down to elbow and below it. On 17-MAY-2021, the subject experienced muscle spasm. On 17-MAY-2021, the subject experienced burning sensation starts like being on fire. On 17-MAY-2021, the subject experienced tingling. Treatment medications (dates unspecified) included: ibuprofen, menthol, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache /hurts, nausea, headache, and fatigue on 15-MAY-2021, and had not recovered from injected arm tender to touch /injection site soreness, little warm to touch, feels like something is in it like a bb-gun, muscle spasm, burning sensation starts like being on fire, bumps, arm soreness, tingling, and tenderness moved down to elbow and below it. This report was non-serious.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG USED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE POPULATION; This spontaneous report received from a health care professional concerned a 17 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: Unk) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUN-2021, the subject experienced drug used to subject of inappropriate age. On 10-JUN-2021, the subject experienced off label use population. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug used to patient of inappropriate age and off label use population was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; SORE LEFT ARM; HIGH FEVER 103.9 F; HEADACHE; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 07-AUG-2021) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol/ dextromethorphan hbr /guaifenesin / pseudoephedrine hcl for fever. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced sore left arm. On 12-JUN-2021, the subject experienced high fever 103.9 f. On 12-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever 103.9 f, headache, chills, and sore left arm. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Rash pruritic
Clinical narrative: ITCHY WRIST; ITCHY RASH ON LEFT LOWER BACK AND LEFT SHOULDER; HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies, no known medical conditions and no known current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 07- AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced body ache. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced itchy wrist. On 11-JUN-2021, the subject experienced itchy rash on left lower back and left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy rash on left lower back and left shoulder, headache, body ache and itchy wrist was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate decreased
Clinical narrative: SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-JUN-2021, health care professional (HCP) reported that patient received Janssen Covid-19 vaccine. About 2.5-3 minutes after receiving the injection, the patient began having seizure like activity. HCP described that as full postured seizure like in the upper extremities and chest, and the eyes had been nystagmus. This activity lasted approximately 45 seconds. Emergency medical services (EMS) staff was on the scene and when they came to, the patient self-reported that he was not feeling well and the HCP described him as diaphoretic and was appearing shaky. EMS took his vitals initially (Blood Pressure, BP 87/64 mmHg, Pulse rate 50 unit unspecified and oxygen saturation 100 percentage). Vitals at 5 Min (Blood Pressure, BP 124/80 mmHg, Pulse rate 76 unit unspecified, oxygen saturation 100 percentage and blood glucose level 125 unit unspecified). An ambulance was called to transport the patient to the ER, and upon arrival vitals were taken again at about 10 Min. Post-ictal (Blood Pressure, BP 115/76 mmHg and pulse rate 76 unit unspecified). Patient was taken to the ER for further evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure like activity, not feeling well, BP 87/64, pulse rate 50 and diaphoretic was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210627629-covid-19 vaccine ad26.cov2.s-seizure like activity, BP 87/64 This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Oxygen saturation, Seizure
Clinical narrative: SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-JUN-2021, health care professional (HCP) reported that patient received Janssen Covid-19 vaccine. About 2.5-3 minutes after receiving the injection, the patient began having seizure like activity. HCP described that as full postured seizure like in the upper extremities and chest, and the eyes had been nystagmus. This activity lasted approximately 45 seconds. Emergency medical services (EMS) staff was on the scene and when they came to, the patient self-reported that he was not feeling well and the HCP described him as diaphoretic and was appearing shaky. EMS took his vitals initially (Blood Pressure, BP 87/64 mmHg, Pulse rate 50 unit unspecified and oxygen saturation 100 percentage). Vitals at 5 Min (Blood Pressure, BP 124/80 mmHg, Pulse rate 76 unit unspecified, oxygen saturation 100 percentage and blood glucose level 125 unit unspecified). An ambulance was called to transport the patient to the ER, and upon arrival vitals were taken again at about 10 Min. Post-ictal (Blood Pressure, BP 115/76 mmHg and pulse rate 76 unit unspecified). Patient was taken to the ER for further evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure like activity, not feeling well, BP 87/64, pulse rate 50 and diaphoretic was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210627629-covid-19 vaccine ad26.cov2.s-seizure like activity, BP 87/64 This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; FEVER; 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. The patient's past medical history included covid-19. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced aches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210626803.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immune-mediated myositis, Lymph node pain, Pain in extremity, Pruritus
Clinical narrative: slightly swollen in bicep area; sore arms; lymphnode in her armpit started to hurt; arm was itchy; felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNE-MEDIATED MYOSITIS (slightly swollen in bicep area) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNE-MEDIATED MYOSITIS (slightly swollen in bicep area) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arms), LYMPH NODE PAIN (lymphnode in her armpit started to hurt), PRURITUS (arm was itchy) and FATIGUE (felt tired). At the time of the report, IMMUNE-MEDIATED MYOSITIS (slightly swollen in bicep area), PAIN IN EXTREMITY (sore arms), LYMPH NODE PAIN (lymphnode in her armpit started to hurt), PRURITUS (arm was itchy) and FATIGUE (felt tired) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hospitalisation
Clinical narrative: Had to take them to the hospital; Feeling really bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Had to take them to the hospital) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HOSPITALISATION (Had to take them to the hospital) (seriousness criterion hospitalization) and FEELING ABNORMAL (Feeling really bad). At the time of the report, HOSPITALISATION (Had to take them to the hospital) and FEELING ABNORMAL (Feeling really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller contacted to cancel an appointment for the second dose for a friend (patient), because the patient was feeling really bad and they had to take them to the hospital. Caller did not want to stay on the line because they had to go.  Company Comment - Very limited information regarding this event/s has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Critical details is lacking in this case report to include, the specific event or signs and symptoms, mRNA-1273 vaccination, onset dates of the event, patient's underlying medical history and concomitant medication. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Pain in small joints, feet, toes, both hands, and her neck; Pain in small joints, feet, toes, both hands, and her neck; Pain in small joints, feet, toes, both hands, and her neck; RA worsened; After receiving the 1st dose of the Moderna vaccine, her pains have came back; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA worsened) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis (Significant worsening of illness once received vaccine) since 09-Dec-2020. Concomitant products included HYDROXYCHLOROQUINE from 22-Jan-2021 to an unknown date for Rheumatoid arthritis, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (After receiving the 1st dose of the Moderna vaccine, her pains have came back). On 09-Apr-2021, the patient experienced RHEUMATOID ARTHRITIS (RA worsened) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in small joints, feet, toes, both hands, and her neck), NECK PAIN (Pain in small joints, feet, toes, both hands, and her neck) and ARTHRALGIA (Pain in small joints, feet, toes, both hands, and her neck). At the time of the report, RHEUMATOID ARTHRITIS (RA worsened), PAIN (After receiving the 1st dose of the Moderna vaccine, her pains have came back), PAIN IN EXTREMITY (Pain in small joints, feet, toes, both hands, and her neck), NECK PAIN (Pain in small joints, feet, toes, both hands, and her neck) and ARTHRALGIA (Pain in small joints, feet, toes, both hands, and her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional concomitant medication included unspecified vagina suppository with hormones.  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 06-Jun-2021: Significant Follow up information was received on 06-JUN-2021  and provided patient and event details.; 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: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Feeling abnormal, Oxygen consumption increased, Unevaluable event
Clinical narrative: very weak; need oxygen constantly; everything went downhill; feeling bad; This spontaneous case was reported by an other and describes the occurrence of ASTHENIA (very weak), OXYGEN CONSUMPTION INCREASED (need oxygen constantly), UNEVALUABLE EVENT (everything went downhill) and FEELING ABNORMAL (feeling bad) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INSULIN GLARGINE (INSULIN GLARGINE BIOMEP) injection for Type 2 diabetes mellitus.    Family history included Diabetes mellitus (type I and type II diabetes mellitus). Concurrent medical conditions included Corrective lens wearer, Type II diabetes mellitus, Congenital heart disease NOS and Non-smoker. Concomitant products included INSULIN LISPRO (HUMALOG), APIXABAN (ELIQUIS) and CORTISONE for an unknown indication.   In 1991, the patient started INSULIN GLARGINE (INSULIN GLARGINE BIOMEP) (Subcutaneous) IU at bedtime. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, INSULIN GLARGINE (INSULIN GLARGINE BIOMEP) (Subcutaneous) dosage was changed to 40 IU once a day. In April 2021, the patient experienced ASTHENIA (very weak) (seriousness criterion hospitalization), OXYGEN CONSUMPTION INCREASED (need oxygen constantly) (seriousness criterion hospitalization), UNEVALUABLE EVENT (everything went downhill) (seriousness criterion hospitalization) and FEELING ABNORMAL (feeling bad) (seriousness criterion hospitalization). The patient was hospitalized from 20-Apr-2021 to 26-Apr-2021 due to ASTHENIA, FEELING ABNORMAL, OXYGEN CONSUMPTION INCREASED and UNEVALUABLE EVENT. The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), OXYGEN CONSUMPTION INCREASED (need oxygen constantly), UNEVALUABLE EVENT (everything went downhill) and FEELING ABNORMAL (feeling bad) outcome was unknown.            Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. Company 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.; 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: Arthralgia, Back pain, Gait inability, Incomplete course of vaccination, Intervertebral disc protrusion
Clinical narrative: herniated disc at the back; couldn't walk or get out of bed; Missed 2nd dose; hip started hurting very bad; pain was in her back; pain was going down to leg; This spontaneous case was reported by a patient and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (herniated disc at the back) and GAIT INABILITY (couldn't walk or get out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hip arthritis (for last 15 years).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (herniated disc at the back) (seriousness criterion hospitalization), GAIT INABILITY (couldn't walk or get out of bed) (seriousness criterion hospitalization), BACK PAIN (pain was in her back), PAIN IN EXTREMITY (pain was going down to leg) and ARTHRALGIA (hip started hurting very bad). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Missed 2nd dose). The patient was hospitalized on sometime in April 2021 due to INTERVERTEBRAL DISC PROTRUSION. The patient was treated with Surgery (surgery of herniated disc) for Intervertebral disc protrusion; Surgery for Back pain and Surgery for Pain in extremity. At the time of the report, INTERVERTEBRAL DISC PROTRUSION (herniated disc at the back), GAIT INABILITY (couldn't walk or get out of bed), BACK PAIN (pain was in her back), PAIN IN EXTREMITY (pain was going down to leg), INCOMPLETE COURSE OF VACCINATION (Missed 2nd dose) and ARTHRALGIA (hip started hurting very bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) herniated disc at the back.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  Treatment medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity
Clinical narrative: herniated disc at the back; couldn't walk or get out of bed; Missed 2nd dose; hip started hurting very bad; pain was in her back; pain was going down to leg; This spontaneous case was reported by a patient and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (herniated disc at the back) and GAIT INABILITY (couldn't walk or get out of bed) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hip arthritis (for last 15 years).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (herniated disc at the back) (seriousness criterion hospitalization), GAIT INABILITY (couldn't walk or get out of bed) (seriousness criterion hospitalization), BACK PAIN (pain was in her back), PAIN IN EXTREMITY (pain was going down to leg) and ARTHRALGIA (hip started hurting very bad). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Missed 2nd dose). The patient was hospitalized on sometime in April 2021 due to INTERVERTEBRAL DISC PROTRUSION. The patient was treated with Surgery (surgery of herniated disc) for Intervertebral disc protrusion; Surgery for Back pain and Surgery for Pain in extremity. At the time of the report, INTERVERTEBRAL DISC PROTRUSION (herniated disc at the back), GAIT INABILITY (couldn't walk or get out of bed), BACK PAIN (pain was in her back), PAIN IN EXTREMITY (pain was going down to leg), INCOMPLETE COURSE OF VACCINATION (Missed 2nd dose) and ARTHRALGIA (hip started hurting very bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) herniated disc at the back.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  Treatment medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Bone pain, Dyspnoea, Gait disturbance, Malaise
Clinical narrative: bones hurt which was very painful; hard time breathing; uncontrolled bowel movement in the car; didn't feel better; urinated; started to have the shakes; couldn't walk; screaming in pain again; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt which was very painful), DYSPNOEA (hard time breathing), ANAL INCONTINENCE (uncontrolled bowel movement in the car), MALAISE (didn't feel better), MICTURITION URGENCY (urinated), TREMOR (started to have the shakes), GAIT DISTURBANCE (couldn't walk) and PAIN (screaming in pain again) in a 62-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, the patient experienced BONE PAIN (bones hurt which was very painful) (seriousness criterion hospitalization), DYSPNOEA (hard time breathing) (seriousness criterion hospitalization), ANAL INCONTINENCE (uncontrolled bowel movement in the car) (seriousness criterion hospitalization), MALAISE (didn't feel better) (seriousness criterion hospitalization), MICTURITION URGENCY (urinated) (seriousness criterion hospitalization), TREMOR (started to have the shakes) (seriousness criterion hospitalization), GAIT DISTURBANCE (couldn't walk) (seriousness criterion hospitalization) and PAIN (screaming in pain again) (seriousness criterion hospitalization). At the time of the report, BONE PAIN (bones hurt which was very painful), DYSPNOEA (hard time breathing), ANAL INCONTINENCE (uncontrolled bowel movement in the car), MALAISE (didn't feel better), MICTURITION URGENCY (urinated), TREMOR (started to have the shakes), GAIT DISTURBANCE (couldn't walk) and PAIN (screaming in pain again) outcome was unknown.            Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Micturition urgency, Pain, Tremor
Clinical narrative: bones hurt which was very painful; hard time breathing; uncontrolled bowel movement in the car; didn't feel better; urinated; started to have the shakes; couldn't walk; screaming in pain again; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt which was very painful), DYSPNOEA (hard time breathing), ANAL INCONTINENCE (uncontrolled bowel movement in the car), MALAISE (didn't feel better), MICTURITION URGENCY (urinated), TREMOR (started to have the shakes), GAIT DISTURBANCE (couldn't walk) and PAIN (screaming in pain again) in a 62-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, the patient experienced BONE PAIN (bones hurt which was very painful) (seriousness criterion hospitalization), DYSPNOEA (hard time breathing) (seriousness criterion hospitalization), ANAL INCONTINENCE (uncontrolled bowel movement in the car) (seriousness criterion hospitalization), MALAISE (didn't feel better) (seriousness criterion hospitalization), MICTURITION URGENCY (urinated) (seriousness criterion hospitalization), TREMOR (started to have the shakes) (seriousness criterion hospitalization), GAIT DISTURBANCE (couldn't walk) (seriousness criterion hospitalization) and PAIN (screaming in pain again) (seriousness criterion hospitalization). At the time of the report, BONE PAIN (bones hurt which was very painful), DYSPNOEA (hard time breathing), ANAL INCONTINENCE (uncontrolled bowel movement in the car), MALAISE (didn't feel better), MICTURITION URGENCY (urinated), TREMOR (started to have the shakes), GAIT DISTURBANCE (couldn't walk) and PAIN (screaming in pain again) outcome was unknown.            Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Antibody test, Pneumonia, Viral titre decreased
Clinical narrative: Pneumonia; Viral titer decreased; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (Pneumonia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and VIRAL TITRE DECREASED (Viral titer decreased). At the time of the report, PNEUMONIA (Pneumonia) and VIRAL TITRE DECREASED (Viral titer decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: inconclusive (Inconclusive) Viral titer decreased, Less than 60 of titer in blood.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications were not provided. Treatment information was not provided.  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 MOD-2021-198286 (Patient Link).; 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: Myalgia
Clinical narrative: dementia; bed ridden all of sudden after Moderna vaccine; He is not able to work; not able to eat by hand; became weak; Body aches/ sore arm which was worst on next day; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in 2017. Concurrent medical conditions included Dementia (dementia and stroke together in 2017) since 2017 and Diabetes. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, METFORMIN, AMANTADINE, LISINOPRIL and GLIPIZIDE for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), BEDRIDDEN (bed ridden all of sudden after Moderna vaccine), GAIT INABILITY (He is not able to work), MOVEMENT DISORDER (not able to eat by hand), ASTHENIA (became weak) and MYALGIA (Body aches/ sore arm which was worst on next day). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) on 29-May-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 28-May-2021 at an unspecified dose and frequency. At the time of the report, DEMENTIA (dementia), BEDRIDDEN (bed ridden all of sudden after Moderna vaccine), GAIT INABILITY (He is not able to work), MOVEMENT DISORDER (not able to eat by hand), ASTHENIA (became weak) and MYALGIA (Body aches/ sore arm which was worst on next day) outcome was unknown.            Treatment medication not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Wife called in on behalf of husband and report that, patient received Moderna vaccine 2nd dose on 28 May 2021 in right arm and same day afternoon he has sore arm and worst on next day. After that he had body ache and dementia. He had dementia and stroke together in 2017. He is bed ridden all of sudden after Moderna vaccine. He is not able to walk, not able to eat by hand and he became weak and he is able to do all by himself earlier before vaccine. On 28 May 2021 he took Tylenol and on 29 May 2021 he took Ibuprofen and on 30 May 2021 he took his regular medicine which are Aspirin, Metformin, Atorvastatin, Amantadine, Lisinopril and Glipizide.  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.; 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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood glucose abnormal, Blood pressure measurement, Chills
Clinical narrative: Woke up on floor/ Past out; Anxiety; Fall; Little weak; Foggy head; Shiver; Headache; Nausea; Throw up; Concussion; Buzzing in ears; Did not eat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 02-Jun-2021, the patient experienced ASTHENIA (Little weak) and FEELING ABNORMAL (Foggy head). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) (seriousness criterion medically significant), ANXIETY (Anxiety) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out), CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), ASTHENIA (Little weak), FEELING ABNORMAL (Foggy head), ANXIETY (Anxiety), FALL (Fall), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose abnormal: abnormal (abnormal) abnormal. On 01-Jun-2021, Blood pressure measurement: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported .  Treatment information was not provided.  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.; 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.