chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWELLING IN ARMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included does the patient have any allergies? :: no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On APR-2021, the subject experienced swelling in arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in arms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: DEATHLY ILL; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced deathly ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deathly ill was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING; HIVES ON RIGHT HAND; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced hives on right hand. On 12-APR-2021 21:00, the subject experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on right hand, and the outcome of itching was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Decreased appetite, Headache
Clinical narrative: NO APPETITE; NO TASTE; PAIN IN KIDNEY REGION; CHILLS; SEVERE HEADACHE; FEVER; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced no appetite. On 09-APR-2021, the subject experienced no taste. On 09-APR-2021, the subject experienced pain in kidney region. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) over 100 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, fever, chills, no appetite, no taste, and pain in kidney region. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal pain
Clinical narrative: NO APPETITE; NO TASTE; PAIN IN KIDNEY REGION; CHILLS; SEVERE HEADACHE; FEVER; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced no appetite. On 09-APR-2021, the subject experienced no taste. On 09-APR-2021, the subject experienced pain in kidney region. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) over 100 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, fever, chills, no appetite, no taste, and pain in kidney region. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: SWELLING TO EYES; RED ITCHY BLISTER LIKE RASH; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included muscle ache, and concurrent conditions included high blood pressure, high cholesterol, thyroid disease, horseradish allergy, and cataract. The patient experienced drug allergy when treated with rosuvastatin.  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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, ezetimibe, levothyroxine sodium, lisinopril, and rosuvastatin calcium.  On MAR-2021, the subject experienced swelling to eyes. On MAR-2021, the subject experienced red itchy blister like rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling to eyes on 2021, and was recovering from red itchy blister like rash. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 02:00, the subject experienced body aches. On 08-APR-2021 02:00, the subject experienced fever. On 08-APR-2021 02:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on APR-2021, and the outcome of fever and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; LIGHT HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-202116:30 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 chills, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headache and chills was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: WORST CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On an unspecified date, the subject experienced worst chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worst chills. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Irritability
Clinical narrative: CRANKY/IRRITABLE; FELT TIRED/TIREDNESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose and frequency were not reported from 22-MAR-2021 to 03-APR-2021 for rheumatoid arthritis. No concomitant medications were reported.  On 03-APR-2021, the subject experienced felt tired. On 05-APR-2021, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cranky, and the outcome of felt tired was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Eye swelling, Headache, Pain
Clinical narrative: DRY COUGH; SORE LEGS; CHILLS; FEVER; SWOLLEN EYES; BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced swollen eyes. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore legs. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes on 09-APR-2021, was recovering from body aches, had not recovered from fever, chills, sore legs, and dry cough, and the outcome of headache was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: DRY COUGH; SORE LEGS; CHILLS; FEVER; SWOLLEN EYES; BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced swollen eyes. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced sore legs. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes on 09-APR-2021, was recovering from body aches, had not recovered from fever, chills, sore legs, and dry cough, and the outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt nauseous. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt nauseous on 11-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Fatigue, Headache, Nausea
Clinical narrative: SHAKES; COUGHING; ARMPIT PAIN; HAND/PALM PAIN; HIVES; STRONG HEADACHE; TIREDNESS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNWON) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On APR-2021, the subject experienced shakes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced hand/palm pain. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shakes, strong headache, fever, hives, coughing, nausea, tiredness, armpit pain and hand/palm pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425516, 20210425296 and 20210427112.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor, Urticaria
Clinical narrative: SHAKES; COUGHING; ARMPIT PAIN; HAND/PALM PAIN; HIVES; STRONG HEADACHE; TIREDNESS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNWON) dose was not reported, administered on 09-APR-2021 16:30 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On APR-2021, the subject experienced shakes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced hand/palm pain. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shakes, strong headache, fever, hives, coughing, nausea, tiredness, armpit pain and hand/palm pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425516, 20210425296 and 20210427112.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: FACIAL SWELLING NEAR NOSE; LYMPH NODE SWELLING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced facial swelling near nose. On APR-2021, the subject experienced lymph node swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the facial swelling near nose and lymph node swelling was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Injection site pain
Clinical narrative: BLOOD PRESSURE INCREASED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included death of wife, and concurrent conditions included high blood pressure, stress, and anxiety.  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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced blood pressure increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 05-APR-2021, and had not recovered from blood pressure increased. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Lip discolouration
Clinical narrative: DISCOLOURATION OF LIPS; DRYNESS OF LIPS; HEADACHE; FEVER; DIZZINESS; CHILLS; TIRED; 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 the patient had no known allergies no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced tired. On 30-MAR-2021 11:00, the subject experienced dizziness. On 30-MAR-2021 18:00, the subject experienced fever. On 31-MAR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced dryness of lips. On 10-APR-2021, the subject experienced discolouration of lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 30-MAR-2021 11:30, chills, headache, and fever on 31-MAR-2021, and tired on 04-APR-2021, and had not recovered from discolouration of lips, and dryness of lips. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Pyrexia
Clinical narrative: DISCOLOURATION OF LIPS; DRYNESS OF LIPS; HEADACHE; FEVER; DIZZINESS; CHILLS; TIRED; 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 the patient had no known allergies no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced tired. On 30-MAR-2021 11:00, the subject experienced dizziness. On 30-MAR-2021 18:00, the subject experienced fever. On 31-MAR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced dryness of lips. On 10-APR-2021, the subject experienced discolouration of lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 30-MAR-2021 11:30, chills, headache, and fever on 31-MAR-2021, and tired on 04-APR-2021, and had not recovered from discolouration of lips, and dryness of lips. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: THROBBING PAIN UNDER ARMPIT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos for drug used for unknown indication. On 12-APR-2021, the subject experienced throbbing pain under armpit. Treatment medications (dates unspecified) included: amlodipine besilate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing pain under armpit. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-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 APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Injection site pain, Pyrexia
Clinical narrative: FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 100 F, 101.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.3 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of injection site pain was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Productive cough, Pyrexia, Respiratory tract congestion
Clinical narrative: FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 100 F, 101.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.3 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, HIV test, HIV test false positive, Headache, Oropharyngeal pain
Clinical narrative: SORE THROAT; GENERAL BODY ACHES; HEADACHE; FALSE POSITIVE HIV TEST; PAIN IN ARM/ SORE ARM; TIRED; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastric bypass surgery, and concurrent conditions included nonsmoker, and other pre-existing medical conditions included the patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and 041A21A expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced pain in arm/ sore arm. On 30-MAR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced false positive hiv test. Laboratory data included: HIV test (NR: not provided) Positive, Negative. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced general body aches. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from false positive hiv test on 02-APR-2021, and tired on 2021, was recovering from pain in arm or sore arm, and had not recovered from sore throat, general body aches, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: SORE THROAT; GENERAL BODY ACHES; HEADACHE; FALSE POSITIVE HIV TEST; PAIN IN ARM/ SORE ARM; TIRED; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastric bypass surgery, and concurrent conditions included nonsmoker, and other pre-existing medical conditions included the patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and 041A21A expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced pain in arm/ sore arm. On 30-MAR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced false positive hiv test. Laboratory data included: HIV test (NR: not provided) Positive, Negative. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced general body aches. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from false positive hiv test on 02-APR-2021, and tired on 2021, was recovering from pain in arm or sore arm, and had not recovered from sore throat, general body aches, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: LACK OF FIBROMYALGIA PAIN OR SHOT SEEMS TO HAVE AWAKEN IMMUNE SYSTEM (UNEXPECTED THERAPEUTIC BENEFIT); 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 concurrent conditions included fibromyalgia, and a bile duct liver disease. 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. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the subject experienced lack of fibromyalgia pain or shot seems to have awaken immune system (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of fibromyalgia pain or shot seems to have awaken immune system (unexpected therapeutic benefit) was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARMS AT INJECTION SITE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore arms at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arms at injection site on 10-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Pyrexia, Tinnitus
Clinical narrative: FEVER; VOMITING; DIZZY; RINGING IN EARS; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced ringing in ears. On 09-APR-2021, the subject experienced blood pressure high. On 10-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/75 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, blood pressure high, and fever, and had not recovered from dizzy, and ringing in ears. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FEVER; VOMITING; DIZZY; RINGING IN EARS; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced ringing in ears. On 09-APR-2021, the subject experienced blood pressure high. On 10-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/75 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, blood pressure high, and fever, and had not recovered from dizzy, and ringing in ears. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Nausea, Vomiting
Clinical narrative: SEVER STOMACH PAIN LIKE SOMEONE HAD PUNCHED IN THE STOMACH; VOMITING; FELT FAINT; NAUSEA; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 180 kilograms, and height was 63 inches. The patient's concurrent conditions included alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sever stomach pain like someone had punched in the stomach. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced felt faint. On 02-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever stomach pain like someone had punched in the stomach, vomiting, felt faint, and nausea on 06-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: DIZZINESS; UNSTEADY; NAUSEA; TIREDNESS; HEADACHE; SEVERE BODY ACHE; FELT LIKE FLU; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included brain aneurysm, food allergy to shrimp, almonds, soy, alcohol use socially, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced severe body ache. On 10-APR-2021, the subject experienced felt like flu. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced unsteady. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of headache, dizziness, severe body ache, tiredness, felt like flu and unsteady was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: DIZZINESS; UNSTEADY; NAUSEA; TIREDNESS; HEADACHE; SEVERE BODY ACHE; FELT LIKE FLU; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included brain aneurysm, food allergy to shrimp, almonds, soy, alcohol use socially, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced severe body ache. On 10-APR-2021, the subject experienced felt like flu. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced unsteady. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of headache, dizziness, severe body ache, tiredness, felt like flu and unsteady was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Sensory disturbance
Clinical narrative: PULSATING SENSATION ON LEFT SIDE  OF ABDOMEN; CHILLS; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's past medical history included skin cancer, and concurrent conditions included diabetes, high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced pulsating sensation on left side of abdomen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, and had not recovered from pulsating sensation on left side of abdomen. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hyperhidrosis, Neck pain, Pain
Clinical narrative: PAIN IN RIGHT SIDE OF BODY; PAIN WITH BREATHING; RIGHT SIDE NECK PAIN; SWEATING; JOINT PAIN ON SHOULDERS AND ARM; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in right side of body. On APR-2021, the subject experienced pain with breathing. On APR-2021, the subject experienced right side neck pain. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced joint pain on shoulders and arm. On APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right side of body, pain with breathing, headache, sweating, right side neck pain, and joint pain on shoulders and arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: PAIN IN RIGHT SIDE OF BODY; PAIN WITH BREATHING; RIGHT SIDE NECK PAIN; SWEATING; JOINT PAIN ON SHOULDERS AND ARM; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in right side of body. On APR-2021, the subject experienced pain with breathing. On APR-2021, the subject experienced right side neck pain. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced joint pain on shoulders and arm. On APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right side of body, pain with breathing, headache, sweating, right side neck pain, and joint pain on shoulders and arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pain, Pyrexia
Clinical narrative: ACHY; MIGRAINE; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included brain tumor, and concurrent conditions included asthma, migraine, and allergy. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, migraine, and fever. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Feeling hot, Vital signs measurement
Clinical narrative: Client verbalized feeling hot and flustered.  Client denies other symptoms.  Client seen and assessed by EMT and VS are BP 150/98, HR 74, O2Sat 98%.  Client verbalized that he was ok and felt no need for further evaluation and cleared to go home by EMT.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Headache, Hypoglycaemic seizure, Tongue injury
Clinical narrative: I suffered a severe hypoglycemic seizure which nearly took my life and I believe that it was caused by my recent covid vaccine (moderna). I?m not a diabetic nor have I ever been. I received my second covid vaccine on February 26 and on March 14th at around 6:45 PM and while at work, I suffered a grand mal seizure while working at the Hospital (I?m a respiratory therapist). I was alerted overhead and a team of clinicians rushed to my aid. My glucose was measured and it had decreased to the low 40?s. They had a difficult time getting it to normalize and I ended up being admitted into the ICU. I had a severe tongue laceration and headaches afterwards. Strangely, less than an hour before the seizure, I had eaten a piece of cheesecake so my glucose had no reason to all of a sudden bottom out as it did. There were no other circumstances that could or would have led to a hypoglycemic seizure.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: INJECTION SITE PAIN (FOUR DAYS OF INTERMITTEN SITE PAIN) SWOLLEN AND PAINFUL ARMPIT LYMPH NODES (STILL OCCURING AFTER 5 DAYS)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site nodule
Clinical narrative: Woke Saturday morning around 12:00am with patient and bed sweated wet and patient had chills.  Extremely tired to point could barely move.  Sunday morning still extremely tired, red rash around injection area about three inches around, large knot under armpit of injection site the size of a softball.  Monday morning still tired but not as extreme.  Still had rash at injection site and entire upper arm swollen.  Still had knot below armpit.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Woke Saturday morning around 12:00am with patient and bed sweated wet and patient had chills.  Extremely tired to point could barely move.  Sunday morning still extremely tired, red rash around injection area about three inches around, large knot under armpit of injection site the size of a softball.  Monday morning still tired but not as extreme.  Still had rash at injection site and entire upper arm swollen.  Still had knot below armpit.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Groin pain, Headache, Pain, Pain in extremity
Clinical narrative: body aches, headache, fever, pain in underarm area and groin area, rash and swelling on arm, fatigue
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: body aches, headache, fever, pain in underarm area and groin area, rash and swelling on arm, fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menstruation irregular
Clinical narrative: Change in Menstrual cycle, was not having any periods on IUD started having menstrual cycle again, increase in hot flashes.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen lip
Sex: U
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Illness
Clinical narrative: BODY ACHES; SICKNESS; DISCOMFORT; CHILLS; MASSIVE HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced sickness. On 13-APR-2021, the subject experienced discomfort. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced massive headache. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sickness, discomfort, chills, massive headache, fatigue, and fever on 14-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; SICKNESS; DISCOMFORT; CHILLS; MASSIVE HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced sickness. On 13-APR-2021, the subject experienced discomfort. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced massive headache. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sickness, discomfort, chills, massive headache, fatigue, and fever on 14-APR-2021. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Insomnia, Nausea, Pyrexia
Clinical narrative: 11pm nausea and cold shivers started. I couldn't sleep and by 1am I had a fever of 100.9. I took 1000mg Tylenol at 4:30 am, and at 5:30am have a fever of 102.5. I still cannot sleep, and the fever keeps rising.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Epistaxis, Fatigue, Headache, Thrombosis
Clinical narrative: 5 Blood clots coming from right nostril, headache, fatigue, stomach pains   Nose bleed with clots lasted 15-20 minutes. Headache, fatigue, stomach pains lasted throughout the day.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Palpitations
Clinical narrative: 10 minutes after shot I felt dizzy. The next day I was exhausted and slept all day. The next day I started having intermittent heart palpiations. I still have this throughout the day. I am still having them this morning.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: suffered a massive heart attack the morning following his first dose of Moderna vaccine. He was hospitalized for 21 days, first at Hospital and then . He passed away on February 11, 2021, at .