chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Feeling hot, Genital rash, Pruritus, Rash
Clinical narrative: ITCHING ALL OVER BODY; SKIN FEELS HOT; GENITAL RASH; BREAK OUT ON FACE; RASH ON FACE, BACK, EAR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, smoker, allergy to clindamycin and allergy to zithromax. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching all over body. On 06-APR-2021, the subject experienced skin feels hot. On 06-APR-2021, the subject experienced genital rash. On 06-APR-2021, the subject experienced break out on face. On 06-APR-2021, the subject experienced rash on face/back/ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over body, skin feels hot, rash on face/back/ear, genital rash, and break out on face. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Depression, Dysgeusia, Electrocardiogram normal, Head discomfort
Clinical narrative: ITCHING ALL OVER BODY; SKIN FEELS HOT; GENITAL RASH; BREAK OUT ON FACE; RASH ON FACE, BACK, EAR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, smoker, allergy to clindamycin and allergy to zithromax. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching all over body. On 06-APR-2021, the subject experienced skin feels hot. On 06-APR-2021, the subject experienced genital rash. On 06-APR-2021, the subject experienced break out on face. On 06-APR-2021, the subject experienced rash on face/back/ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over body, skin feels hot, rash on face/back/ear, genital rash, and break out on face. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Impaired work ability, Nausea
Clinical narrative: ITCHING ALL OVER BODY; SKIN FEELS HOT; GENITAL RASH; BREAK OUT ON FACE; RASH ON FACE, BACK, EAR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, smoker, allergy to clindamycin and allergy to zithromax. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching all over body. On 06-APR-2021, the subject experienced skin feels hot. On 06-APR-2021, the subject experienced genital rash. On 06-APR-2021, the subject experienced break out on face. On 06-APR-2021, the subject experienced rash on face/back/ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over body, skin feels hot, rash on face/back/ear, genital rash, and break out on face. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: ITCHING ALL OVER BODY; SKIN FEELS HOT; GENITAL RASH; BREAK OUT ON FACE; RASH ON FACE, BACK, EAR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, smoker, allergy to clindamycin and allergy to zithromax. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching all over body. On 06-APR-2021, the subject experienced skin feels hot. On 06-APR-2021, the subject experienced genital rash. On 06-APR-2021, the subject experienced break out on face. On 06-APR-2021, the subject experienced rash on face/back/ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over body, skin feels hot, rash on face/back/ear, genital rash, and break out on face. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: RASH; 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced rash. On 05-APR-2021, Laboratory data included: Blood test (NR: not provided) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Myalgia
Clinical narrative: JOINT INFLAMMATION (KNUCKLES  AND ANKLES); PAINS IN NECK AND SHOULDERS; PROGRESSIVE MUSCULAR ACHES/MUSCLE ACHES AND PAINS WHICH  INCREASED OVER TIME; This spontaneous report received from a patient concerned a 56 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced joint inflammation (knuckles and ankles). On MAR-2021, the subject experienced pains in neck and shoulders. On MAR-2021, the subject experienced progressive muscular aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the progressive muscular aches, pains in neck and shoulders and joint inflammation (knuckles and ankles) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: BODY ACHE; CHILLS; HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 17:00 PM  for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, headache and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Headache, Hypertension
Clinical narrative: BLOOD PRESSURE 30 POINTS HIGH 135/80; PAIN AT INJECTION SITE; HEADACHE; FEVER 100F; NAUSEA; BLOOD PRESSURE DROPPED; BODY ACHES; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on the Left Arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced blood pressure dropped. On 18-MAR-2021, the patient experienced body aches. On 18-MAR-2021, the patient experienced pain at injection site. On 18-MAR-2021, the patient experienced headache. On 18-MAR-2021, the patient experienced fever 100f. On 18-MAR-2021, the patient experienced nausea. On 03-APR-2021, the patient experienced blood pressure 30 points high 135/80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure dropped on 01-APR-2021, body aches, headache, and nausea on 24-MAR-2021, pain at injection site on 03-APR-2021, and fever 100f on 22-MAR-2021, and had not recovered from blood pressure 30 points high 135/80. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: BLOOD PRESSURE 30 POINTS HIGH 135/80; PAIN AT INJECTION SITE; HEADACHE; FEVER 100F; NAUSEA; BLOOD PRESSURE DROPPED; BODY ACHES; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on the Left Arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced blood pressure dropped. On 18-MAR-2021, the patient experienced body aches. On 18-MAR-2021, the patient experienced pain at injection site. On 18-MAR-2021, the patient experienced headache. On 18-MAR-2021, the patient experienced fever 100f. On 18-MAR-2021, the patient experienced nausea. On 03-APR-2021, the patient experienced blood pressure 30 points high 135/80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure dropped on 01-APR-2021, body aches, headache, and nausea on 24-MAR-2021, pain at injection site on 03-APR-2021, and fever 100f on 22-MAR-2021, and had not recovered from blood pressure 30 points high 135/80. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Pain, Palpitations
Clinical narrative: FATIGUE; BODY ACHES; HEART PALPITATIONS; LOW GRADE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included g6pd deficiency.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced heart palpitations. On 28-MAR-2021, the subject experienced low grade. On 29-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, heart palpitations, low grade, and fatigue on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: FEELING DIZZY AND LIGHT HEADED; This spontaneous report received from a consumer concerned a female of unspecified age (local case ID# 2021270545). 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 administration, and batch number were not reported) frequency 1 total, 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 patient experienced feeling dizzy and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling dizzy and light headed was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: HEADACHE; FEELING UNWELL; FEVER; FEELING SLUGGISH; VOMITED; EXCESSIVE THIRST; BODY ACHES; ARM SORENESS/ARM ACHES; This spontaneous report received from a patient concerned a 54 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: 1808609, and expiry: not reported) dose was not reported, administered on 05-APR-2021 15:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced arm soreness/arm aches. On 06-APR-2021, the subject experienced feeling sluggish. On 06-APR-2021, the subject experienced vomited. On 06-APR-2021, the subject experienced excessive thirst. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.2 (units unspecified). On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from feeling sluggish, arm soreness/arm aches, excessive thirst, fever, vomited, feeling unwell, and body aches. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness, Thirst, Vomiting
Clinical narrative: HEADACHE; FEELING UNWELL; FEVER; FEELING SLUGGISH; VOMITED; EXCESSIVE THIRST; BODY ACHES; ARM SORENESS/ARM ACHES; This spontaneous report received from a patient concerned a 54 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: 1808609, and expiry: not reported) dose was not reported, administered on 05-APR-2021 15:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced arm soreness/arm aches. On 06-APR-2021, the subject experienced feeling sluggish. On 06-APR-2021, the subject experienced vomited. On 06-APR-2021, the subject experienced excessive thirst. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.2 (units unspecified). On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from feeling sluggish, arm soreness/arm aches, excessive thirst, fever, vomited, feeling unwell, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH GOT WORSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included rash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced rash got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash got worse. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Electric shock sensation, Headache, Injection site erythema, Injection site pain
Clinical narrative: HARDNESS AT INJECTION SITE; SKIN INDURATION; INJECTION SITE REDNESS; LETHARGIC; ACHING; LOW FEVER; HEADACHE; LEFT ARM PIT SORES / BURNING PAIN TO LEFT ARM; SHOCK FEELING; DOESN'T FEEL GOOD TO GO; BURNING SENSATION; PAIN IN ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperlipidemia, allergic to penicillin, and codeine allergy. The patient was previously treated with codeine. 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 04-APR-2021 for prophylactic vaccination in left arm. The batch number was not reported and has been requested. Concomitant medications included paracetamol for aches, and fever. On 04-APR-2021, the subject experienced burning sensation. On 04-APR-2021, the subject experienced pain in arm. On 05-APR-2021, the subject experienced lethargic. On 05-APR-2021, the subject experienced aching. On 05-APR-2021, the subject experienced shock feeling. On 05-APR-2021, the subject experienced doesn't feel good to go. On 05-APR-2021, the subject experienced low fever. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced left arm pit sores / burning pain to left arm. On 06-APR-2021, the subject experienced hardness at injection site. On 06-APR-2021, the subject experienced skin induration. On 06-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, aching, and low fever, and had not recovered from left arm pit sores / burning pain to left arm, lethargic, hardness at injection site, shock feeling, doesn't feel good to go, burning sensation, pain in arm, injection site redness, and skin induration. This report was non-serious. This case, from the same reporter is linked to 20210412133.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Lethargy, Malaise, Pain, Pain in extremity
Clinical narrative: HARDNESS AT INJECTION SITE; SKIN INDURATION; INJECTION SITE REDNESS; LETHARGIC; ACHING; LOW FEVER; HEADACHE; LEFT ARM PIT SORES / BURNING PAIN TO LEFT ARM; SHOCK FEELING; DOESN'T FEEL GOOD TO GO; BURNING SENSATION; PAIN IN ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperlipidemia, allergic to penicillin, and codeine allergy. The patient was previously treated with codeine. 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 04-APR-2021 for prophylactic vaccination in left arm. The batch number was not reported and has been requested. Concomitant medications included paracetamol for aches, and fever. On 04-APR-2021, the subject experienced burning sensation. On 04-APR-2021, the subject experienced pain in arm. On 05-APR-2021, the subject experienced lethargic. On 05-APR-2021, the subject experienced aching. On 05-APR-2021, the subject experienced shock feeling. On 05-APR-2021, the subject experienced doesn't feel good to go. On 05-APR-2021, the subject experienced low fever. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced left arm pit sores / burning pain to left arm. On 06-APR-2021, the subject experienced hardness at injection site. On 06-APR-2021, the subject experienced skin induration. On 06-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, aching, and low fever, and had not recovered from left arm pit sores / burning pain to left arm, lethargic, hardness at injection site, shock feeling, doesn't feel good to go, burning sensation, pain in arm, injection site redness, and skin induration. This report was non-serious. This case, from the same reporter is linked to 20210412133.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin induration
Clinical narrative: HARDNESS AT INJECTION SITE; SKIN INDURATION; INJECTION SITE REDNESS; LETHARGIC; ACHING; LOW FEVER; HEADACHE; LEFT ARM PIT SORES / BURNING PAIN TO LEFT ARM; SHOCK FEELING; DOESN'T FEEL GOOD TO GO; BURNING SENSATION; PAIN IN ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperlipidemia, allergic to penicillin, and codeine allergy. The patient was previously treated with codeine. 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 04-APR-2021 for prophylactic vaccination in left arm. The batch number was not reported and has been requested. Concomitant medications included paracetamol for aches, and fever. On 04-APR-2021, the subject experienced burning sensation. On 04-APR-2021, the subject experienced pain in arm. On 05-APR-2021, the subject experienced lethargic. On 05-APR-2021, the subject experienced aching. On 05-APR-2021, the subject experienced shock feeling. On 05-APR-2021, the subject experienced doesn't feel good to go. On 05-APR-2021, the subject experienced low fever. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced left arm pit sores / burning pain to left arm. On 06-APR-2021, the subject experienced hardness at injection site. On 06-APR-2021, the subject experienced skin induration. On 06-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, aching, and low fever, and had not recovered from left arm pit sores / burning pain to left arm, lethargic, hardness at injection site, shock feeling, doesn't feel good to go, burning sensation, pain in arm, injection site redness, and skin induration. This report was non-serious. This case, from the same reporter is linked to 20210412133.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Somnolence
Clinical narrative: SLEEPINESS; FATIGUE/VERY TIRED; HEADACHE; FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered to left deltoid on 06-APR-2021 for prevention covid 19. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-APR-2021, the subject experienced sleepiness. On 06-APR-2021, the subject experienced fatigue/very tired. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, sleepiness, and fatigue/very tired, and the outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Somnolence
Clinical narrative: SLEPT WHOLE DAY UNTIL 5PM; DIZZY; HEADACHE; COULDNT SLEEP; FATIGUE; 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: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced couldnt sleep. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced slept whole day until 5pm. On 06-APR-2021, the subject experienced dizzy. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, was recovering from fatigue, and the outcome of dizzy, couldnt sleep and slept whole day until 5pm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Night sweats
Clinical narrative: NIGHT SWEATING; INTENSE FATIGUE; 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: not reported) 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 night sweating, and intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense fatigue and night sweating was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410723.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ITCHY RED RASH ON NECK, HANDS AND ARMS; This spontaneous report received from a patient concerned a 50 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: not reported) dose was not reported, administered on 04-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itchy red rash on neck, hands and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy red rash on neck, hands and arms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 concurrent conditions included menstruation. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Feeling cold, Feeling hot, Headache
Clinical narrative: DIFFICULTY BREATHING; DIFFICULTY IN SPEAKING; FEELS  AWFUL; FEELING HOT; FEELING COLD; MUSCLE ACHES; 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered 1 total on 06-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced difficulty breathing. On 06-APR-2021, the subject experienced difficulty in speaking. On 06-APR-2021, the subject experienced feels awful. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced feeling cold. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling cold, muscle aches, feels awful, difficulty breathing, feeling hot and difficulty in speaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Speech disorder
Clinical narrative: DIFFICULTY BREATHING; DIFFICULTY IN SPEAKING; FEELS  AWFUL; FEELING HOT; FEELING COLD; MUSCLE ACHES; 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered 1 total on 06-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced difficulty breathing. On 06-APR-2021, the subject experienced difficulty in speaking. On 06-APR-2021, the subject experienced feels awful. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced feeling cold. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, feeling cold, muscle aches, feels awful, difficulty breathing, feeling hot and difficulty in speaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; 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 alcohol consumption 8 - 10 drinks, and smoking 4 - 6 cigarettes, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Insomnia, Malaise
Clinical narrative: DIZZINESS; WEAKNESS; FELT SICK; HEADACHE; PAIN ON RIGHT ARM; SLEEPLESSNESS; 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 concurrent conditions included sulfa allergy, and naproxen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 10:45 AM on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced pain on right arm. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced weakness. On 04-APR-2021, the subject experienced felt sick. On 04-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 was recovering from headache, dizziness, and weakness, and the outcome of sleeplessness, pain on right arm and felt sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: DIZZINESS; WEAKNESS; FELT SICK; HEADACHE; PAIN ON RIGHT ARM; SLEEPLESSNESS; 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 concurrent conditions included sulfa allergy, and naproxen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 10:45 AM on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced pain on right arm. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced weakness. On 04-APR-2021, the subject experienced felt sick. On 04-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 was recovering from headache, dizziness, and weakness, and the outcome of sleeplessness, pain on right arm and felt sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDERDOSE; This spontaneous report received from a pharmacist 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 07-APR-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 testosterone. On 07-APR-2021, the subject experienced underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of underdose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: SPIKED A TEMPERATURE/TEMPERATURE; This spontaneous report received from a patient concerned a 69 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 07:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 07-APR-2021 01:00, the subject experienced spiked a temperature/temperature. Laboratory data included: Body temperature (NR: not provided) 99.3 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Body temperature, Chills, Coronavirus test
Clinical narrative: MENTAL FOG; BODY PAIN AND BODY ACHES; FEVER OF 101; WEAKNESS; TERRIBLE HEADACHE; TIREDNESS; CHILLS; This spontaneous report received from a consumer concerned a 69 year old male. The patient's weight was 79.38 kilograms, and height was 180 centimeters. The patient's past medical history included had coronavirus prior to the shot, and concurrent conditions included emphysema. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 16:30 to the left upper arm in the muscle for prophylactic vaccination. No concomitant medications were reported. On JUN-2020, Laboratory data included: Coronavirus test (NR: not provided) negative (units unspecified). On 13-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced body pain and body aches. On 14-MAR-2021, the subject experienced fever of 101. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced terrible headache. On 14-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 101. On an unspecified date, the subject experienced mental fog. Laboratory data (dates unspecified) included: Blood test (NR: not provided) excellent (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain and body aches, chills, and fever of 101 on 16-MAR-2021, and weakness, and terrible headache on 15-MAR-2021, was recovering from tiredness, and had not recovered from mental fog. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: MENTAL FOG; BODY PAIN AND BODY ACHES; FEVER OF 101; WEAKNESS; TERRIBLE HEADACHE; TIREDNESS; CHILLS; This spontaneous report received from a consumer concerned a 69 year old male. The patient's weight was 79.38 kilograms, and height was 180 centimeters. The patient's past medical history included had coronavirus prior to the shot, and concurrent conditions included emphysema. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 16:30 to the left upper arm in the muscle for prophylactic vaccination. No concomitant medications were reported. On JUN-2020, Laboratory data included: Coronavirus test (NR: not provided) negative (units unspecified). On 13-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced body pain and body aches. On 14-MAR-2021, the subject experienced fever of 101. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced terrible headache. On 14-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 101. On an unspecified date, the subject experienced mental fog. Laboratory data (dates unspecified) included: Blood test (NR: not provided) excellent (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain and body aches, chills, and fever of 101 on 16-MAR-2021, and weakness, and terrible headache on 15-MAR-2021, was recovering from tiredness, and had not recovered from mental fog. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: INJECTION SITE RASH; INJECTION SITE ITCHING; This spontaneous report received from a health care professional concerned a 32 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, intramuscular, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced injection site rash. On APR-2021, the subject experienced injection site itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site rash, and injection site itching. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: SORENESS; PAIN AT THE INJECTION SIDE; SWOLLEN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and ace inhibitors allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced soreness. On 03-APR-2021, the subject experienced pain at the injection side. On 03-APR-2021, the subject experienced swollen at the injection site. The patient had not recovered from pain at the injection side, swollen at the injection site, and soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a patient concerned a 17 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: Unknown) dose was not reported, administered on 06-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 an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; PAIN AT INJECTION SITE; 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: Unk) dose was not reported, administered on 07-APR-2021 to Left Arm for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced headache and pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and pain at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; 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 was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: BODY ACHE; CHILLS; SORE ARM; HEADACHE; TIRED; 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) 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 body ache, chills, sore arm, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills, headache, sore arm and tired was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Angiogram normal, Cardiac failure, Catheterisation cardiac abnormal
Clinical narrative: death Narrative:  70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.