chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Biopsy skin, Body temperature, Body temperature increased, Colitis
Clinical narrative: BULGE IN BACK; COLONOSCOPY SHOWED INFLAMMATION BUT NOT MAJOR; SICK TASTE IN MOUTH; WEIRD PATCHES OF SKIN THAT WERE FLAKY ON ARMS AND BACK OF HANDS; GUT PAIN; RED SPOTS ON HANDS THAT WERE LIKE PSORIASIS; RASH PSORIAFORM; STABBING PAIN IN SIDE/HURTS WHEN GOES TO THE BATHROOM; BACK PAIN; STRESS; NOT FEELING WELL/FELT SICK; ELEVATED TEMPERATURE; FELT NAUSEOUS; HEADACHE; FELT TIRED AND RUN DOWN; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) 40 mg, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and ankylosing spondylitis. Concomitant medications included alprazolam for drug used for unknown indication. On an unspecified date, the subject experienced bulge in back, colonoscopy showed inflammation but not major, sick taste in mouth, weird patches of skin that were flaky on arms and back of hands, gut pain, red spots on hands that were like psoriasis, rash psoriaform, stabbing pain in side/hurts when goes to the bathroom, back pain, stress, not feeling well/felt sick, elevated temperature, felt nauseous, headache, and felt tired and run down. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Elevated, COVID-19 virus test (NR: not provided) Negative, Colonoscopy (NR: not provided) Not major inflammation, and Skin biopsy (NR: not provided) Negative for cancer, Negative for cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bulge in back, felt tired and run down, weird patches of skin that were flaky on arms and back of hands, gut pain, elevated temperature, back pain, stress, and headache, and the outcome of not feeling well/felt sick, colonoscopy showed inflammation but not major, sick taste in mouth, felt nauseous, red spots on hands that were like psoriasis, rash psoriaform and stabbing pain in side/hurts when goes to the bathroom was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Dermatitis psoriasiform, Dysgeusia, Fatigue, Gastrointestinal pain
Clinical narrative: BULGE IN BACK; COLONOSCOPY SHOWED INFLAMMATION BUT NOT MAJOR; SICK TASTE IN MOUTH; WEIRD PATCHES OF SKIN THAT WERE FLAKY ON ARMS AND BACK OF HANDS; GUT PAIN; RED SPOTS ON HANDS THAT WERE LIKE PSORIASIS; RASH PSORIAFORM; STABBING PAIN IN SIDE/HURTS WHEN GOES TO THE BATHROOM; BACK PAIN; STRESS; NOT FEELING WELL/FELT SICK; ELEVATED TEMPERATURE; FELT NAUSEOUS; HEADACHE; FELT TIRED AND RUN DOWN; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) 40 mg, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and ankylosing spondylitis. Concomitant medications included alprazolam for drug used for unknown indication. On an unspecified date, the subject experienced bulge in back, colonoscopy showed inflammation but not major, sick taste in mouth, weird patches of skin that were flaky on arms and back of hands, gut pain, red spots on hands that were like psoriasis, rash psoriaform, stabbing pain in side/hurts when goes to the bathroom, back pain, stress, not feeling well/felt sick, elevated temperature, felt nauseous, headache, and felt tired and run down. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Elevated, COVID-19 virus test (NR: not provided) Negative, Colonoscopy (NR: not provided) Not major inflammation, and Skin biopsy (NR: not provided) Negative for cancer, Negative for cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bulge in back, felt tired and run down, weird patches of skin that were flaky on arms and back of hands, gut pain, elevated temperature, back pain, stress, and headache, and the outcome of not feeling well/felt sick, colonoscopy showed inflammation but not major, sick taste in mouth, felt nauseous, red spots on hands that were like psoriasis, rash psoriaform and stabbing pain in side/hurts when goes to the bathroom was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Intervertebral disc protrusion, Malaise, Nausea, Pain
Clinical narrative: BULGE IN BACK; COLONOSCOPY SHOWED INFLAMMATION BUT NOT MAJOR; SICK TASTE IN MOUTH; WEIRD PATCHES OF SKIN THAT WERE FLAKY ON ARMS AND BACK OF HANDS; GUT PAIN; RED SPOTS ON HANDS THAT WERE LIKE PSORIASIS; RASH PSORIAFORM; STABBING PAIN IN SIDE/HURTS WHEN GOES TO THE BATHROOM; BACK PAIN; STRESS; NOT FEELING WELL/FELT SICK; ELEVATED TEMPERATURE; FELT NAUSEOUS; HEADACHE; FELT TIRED AND RUN DOWN; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) 40 mg, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and ankylosing spondylitis. Concomitant medications included alprazolam for drug used for unknown indication. On an unspecified date, the subject experienced bulge in back, colonoscopy showed inflammation but not major, sick taste in mouth, weird patches of skin that were flaky on arms and back of hands, gut pain, red spots on hands that were like psoriasis, rash psoriaform, stabbing pain in side/hurts when goes to the bathroom, back pain, stress, not feeling well/felt sick, elevated temperature, felt nauseous, headache, and felt tired and run down. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Elevated, COVID-19 virus test (NR: not provided) Negative, Colonoscopy (NR: not provided) Not major inflammation, and Skin biopsy (NR: not provided) Negative for cancer, Negative for cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bulge in back, felt tired and run down, weird patches of skin that were flaky on arms and back of hands, gut pain, elevated temperature, back pain, stress, and headache, and the outcome of not feeling well/felt sick, colonoscopy showed inflammation but not major, sick taste in mouth, felt nauseous, red spots on hands that were like psoriasis, rash psoriaform and stabbing pain in side/hurts when goes to the bathroom was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test, Skin exfoliation, Stress
Clinical narrative: BULGE IN BACK; COLONOSCOPY SHOWED INFLAMMATION BUT NOT MAJOR; SICK TASTE IN MOUTH; WEIRD PATCHES OF SKIN THAT WERE FLAKY ON ARMS AND BACK OF HANDS; GUT PAIN; RED SPOTS ON HANDS THAT WERE LIKE PSORIASIS; RASH PSORIAFORM; STABBING PAIN IN SIDE/HURTS WHEN GOES TO THE BATHROOM; BACK PAIN; STRESS; NOT FEELING WELL/FELT SICK; ELEVATED TEMPERATURE; FELT NAUSEOUS; HEADACHE; FELT TIRED AND RUN DOWN; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) 40 mg, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and ankylosing spondylitis. Concomitant medications included alprazolam for drug used for unknown indication. On an unspecified date, the subject experienced bulge in back, colonoscopy showed inflammation but not major, sick taste in mouth, weird patches of skin that were flaky on arms and back of hands, gut pain, red spots on hands that were like psoriasis, rash psoriaform, stabbing pain in side/hurts when goes to the bathroom, back pain, stress, not feeling well/felt sick, elevated temperature, felt nauseous, headache, and felt tired and run down. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Elevated, COVID-19 virus test (NR: not provided) Negative, Colonoscopy (NR: not provided) Not major inflammation, and Skin biopsy (NR: not provided) Negative for cancer, Negative for cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bulge in back, felt tired and run down, weird patches of skin that were flaky on arms and back of hands, gut pain, elevated temperature, back pain, stress, and headache, and the outcome of not feeling well/felt sick, colonoscopy showed inflammation but not major, sick taste in mouth, felt nauseous, red spots on hands that were like psoriasis, rash psoriaform and stabbing pain in side/hurts when goes to the bathroom was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative 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: Unknown) 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 reporter stated that her husband had blood clot after vaccination. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210508168-COVID-19 VACCINE AD26.COV2.SI-BLOOD CLOT. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: BLURRED VISION; HEADACHE; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced blurred vision. On 04-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and headache on 05-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Gait inability, Malaise, Pain
Clinical narrative: LOT OF PAIN IN MY FEET AND LEG(VEIN); VEINS ARE BIGGER AND IT IS PAINFULLY; FEELING PAIN IN THE CHEST; I COULDN'T WALK; COULD NOT DO ANYTHING ELSE BESIDES SLEEP; A LOT OF PAIN IN MY BODY AND LEGS; FEELING SICK; PAIN IN MY KNEE; PAIN IN LEG; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 lot of pain in my feet and leg (vein). On APR-2021, the subject experienced veins are bigger and it is painfully. On APR-2021, the subject experienced feeling pain in the chest. On APR-2021, the subject experienced i couldn't walk. On APR-2021, the subject experienced could not do anything else besides sleep. On APR-2021, the subject experienced a lot of pain in my body and legs. On APR-2021, the subject experienced feeling sick. On APR-2021, the subject experienced pain in my knee. On APR-2021, the subject experienced pain in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lot of pain in my feet and leg(vein), and veins are bigger and it is painfully, and the outcome of could not do anything else besides sleep, a lot of pain in my body and legs, pain in my knee, feeling pain in the chest, i couldn't walk, feeling sick and pain in leg 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vascular pain, Vasodilatation
Clinical narrative: LOT OF PAIN IN MY FEET AND LEG(VEIN); VEINS ARE BIGGER AND IT IS PAINFULLY; FEELING PAIN IN THE CHEST; I COULDN'T WALK; COULD NOT DO ANYTHING ELSE BESIDES SLEEP; A LOT OF PAIN IN MY BODY AND LEGS; FEELING SICK; PAIN IN MY KNEE; PAIN IN LEG; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 lot of pain in my feet and leg (vein). On APR-2021, the subject experienced veins are bigger and it is painfully. On APR-2021, the subject experienced feeling pain in the chest. On APR-2021, the subject experienced i couldn't walk. On APR-2021, the subject experienced could not do anything else besides sleep. On APR-2021, the subject experienced a lot of pain in my body and legs. On APR-2021, the subject experienced feeling sick. On APR-2021, the subject experienced pain in my knee. On APR-2021, the subject experienced pain in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lot of pain in my feet and leg(vein), and veins are bigger and it is painfully, and the outcome of could not do anything else besides sleep, a lot of pain in my body and legs, pain in my knee, feeling pain in the chest, i couldn't walk, feeling sick and pain in leg 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness, Injection site pain, Nipple disorder, Nipple pain
Clinical narrative: RHEUMATOID ARTHRITIS; NIPPLE RIGIDITY/HARD; TENDER NIPPLES; BREASTS SWELLING; BREASTS TENDERNESS; LEFT ARM TENDERNESS (INJECTION SITE PAIN); This spontaneous report received from a patient concerned a 57 year old White and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included pulmonary embolism (left side of the lung), and concurrent conditions included lyme disease, alcoholic, non-smoker, and menopause, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug usage. The patient was previously treated with enoxaparin for pulmonary embolism (left side of the lung- difficulty/trouble in breathing, chest pain and stroke-like symptoms), and Pradaxa (dabigatran etexilate mesilate) for pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included natural hormones for menopause (antiaging to keep menstrual period as long as possible). The patient felt left arm tenderness (injection site pain) not immediately but 1 day after the patient took vaccine, on 10-APR-2021. The patient had soreness of the arm and the pain was tolerable. Patient stated that on 25-APR-2021, nipple was hard as rock, mostly left nipple (nipple rigidity/hard and tender nipples). Patient called doctor and was prescribed Primrose (Oenothera Biennis) oil pill. On the same day, patient experienced breasts swelling and tenderness, which was worse on the left breast and right breast had minimal pain. Patient stated that wearing bra and T-shirt was painful. The doctor had prescribed anti-depressant to the patient, but patient had refused to take it, not unless needed. On 05-MAY-2021, the patient was diagnosed with rheumatoid arthritis. Patient felt inflammation and pain mostly in the hand. Patient was prescribed meloxicam for rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm tenderness (injection site pain) on 23-APR-2021, had not recovered from nipple rigidity/hard, and tender nipples, and the outcome of breasts swelling, rheumatoid arthritis and breasts tenderness was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210421576.; Sender's Comments: V0:20210509036- covid-19 vaccine ad26.cov2.s-Rheumatoid arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS; NIPPLE RIGIDITY/HARD; TENDER NIPPLES; BREASTS SWELLING; BREASTS TENDERNESS; LEFT ARM TENDERNESS (INJECTION SITE PAIN); This spontaneous report received from a patient concerned a 57 year old White and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included pulmonary embolism (left side of the lung), and concurrent conditions included lyme disease, alcoholic, non-smoker, and menopause, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug usage. The patient was previously treated with enoxaparin for pulmonary embolism (left side of the lung- difficulty/trouble in breathing, chest pain and stroke-like symptoms), and Pradaxa (dabigatran etexilate mesilate) for pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included natural hormones for menopause (antiaging to keep menstrual period as long as possible). The patient felt left arm tenderness (injection site pain) not immediately but 1 day after the patient took vaccine, on 10-APR-2021. The patient had soreness of the arm and the pain was tolerable. Patient stated that on 25-APR-2021, nipple was hard as rock, mostly left nipple (nipple rigidity/hard and tender nipples). Patient called doctor and was prescribed Primrose (Oenothera Biennis) oil pill. On the same day, patient experienced breasts swelling and tenderness, which was worse on the left breast and right breast had minimal pain. Patient stated that wearing bra and T-shirt was painful. The doctor had prescribed anti-depressant to the patient, but patient had refused to take it, not unless needed. On 05-MAY-2021, the patient was diagnosed with rheumatoid arthritis. Patient felt inflammation and pain mostly in the hand. Patient was prescribed meloxicam for rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm tenderness (injection site pain) on 23-APR-2021, had not recovered from nipple rigidity/hard, and tender nipples, and the outcome of breasts swelling, rheumatoid arthritis and breasts tenderness was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210421576.; Sender's Comments: V0:20210509036- covid-19 vaccine ad26.cov2.s-Rheumatoid arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Fatigue, Feeling abnormal
Clinical narrative: CHEST PAIN; MUSCLE WEAKNESS; CHILLS; FATIGUE; FOGGY HEADED; WAS UNABLE TO SLEEP; FEVER; This spontaneous report received from a patient concerned a 35 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 09:50 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced foggy headed. On 29-APR-2021, the subject experienced was unable to sleep. On 29-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 29-APR-2021 17:00, the subject experienced muscle weakness. On 29-APR-2021 17:00, the subject experienced chills. On 29-APR-2021 17:00, the subject experienced fatigue. On 30-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle weakness, fatigue, and chest pain, had not recovered from foggy headed, and fever, and the outcome of was unable to sleep and chills was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Muscular weakness, Pyrexia
Clinical narrative: CHEST PAIN; MUSCLE WEAKNESS; CHILLS; FATIGUE; FOGGY HEADED; WAS UNABLE TO SLEEP; FEVER; This spontaneous report received from a patient concerned a 35 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 09:50 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced foggy headed. On 29-APR-2021, the subject experienced was unable to sleep. On 29-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 29-APR-2021 17:00, the subject experienced muscle weakness. On 29-APR-2021 17:00, the subject experienced chills. On 29-APR-2021 17:00, the subject experienced fatigue. On 30-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle weakness, fatigue, and chest pain, had not recovered from foggy headed, and fever, and the outcome of was unable to sleep and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Chills, Nausea, Pyrexia, Sjogren's syndrome
Clinical narrative: AUTOIMMUNE DISEASE THAT FLARED UP; SJOGREN'S SYNDROME; SEVERE VOMITING; CHILLS; FEVER; SEVERE NAUSEA; 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 autoimmune disease. The patient was not pregnant at time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 43AZ114(9), expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported that on an unspecified date she had an autoimmune disease that was flared up, chills, fever, muscle and joint pain, swelling of hand and face, pain in her wrists, knees, elbows, hands, neck, and shoulders. Severe nausea and vomiting, swollen nodes in her armpits and groin area and are very painful. Also had severe fatigue. Patient also reported that she diagnosed with Sjogren's syndrome by an ophthalmologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the autoimmune disease that flared up, chills, fever, severe nausea, severe vomiting and Sjogren's syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210509147- COVID-19 VACCINE AD26.COV2.S-autoimmune disease that flared up. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE  20210509147- COVID-19 VACCINE AD26.COV2.S- Sjogren's syndrome. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: AUTOIMMUNE DISEASE THAT FLARED UP; SJOGREN'S SYNDROME; SEVERE VOMITING; CHILLS; FEVER; SEVERE NAUSEA; 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 autoimmune disease. The patient was not pregnant at time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 43AZ114(9), expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported that on an unspecified date she had an autoimmune disease that was flared up, chills, fever, muscle and joint pain, swelling of hand and face, pain in her wrists, knees, elbows, hands, neck, and shoulders. Severe nausea and vomiting, swollen nodes in her armpits and groin area and are very painful. Also had severe fatigue. Patient also reported that she diagnosed with Sjogren's syndrome by an ophthalmologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the autoimmune disease that flared up, chills, fever, severe nausea, severe vomiting and Sjogren's syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210509147- COVID-19 VACCINE AD26.COV2.S-autoimmune disease that flared up. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE  20210509147- COVID-19 VACCINE AD26.COV2.S- Sjogren's syndrome. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fibrin D dimer
Clinical narrative: SEVERE CHEST PAIN ON RIGHT RIBCAGE AND LEFT HAND SIDE; This spontaneous report received from a consumer concerned a 71 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included rheumatoid arthritis since approximately 14 years, penicillin and IV contrast solution allergy, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and 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: Unknown, and expiry date: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included adalimumab (Humira) for rheumatoid arthritis. On APR-2021, four to five days after the vaccination, the patient experienced mild soreness or discomfort initially and progressively worsened over time. Later the symptoms developed into a severe chest pain on right hand side of the ribcage, and it hurt to breath and move; the patient felt relieved only while lying flat. The patient had visited emergency room and physician room for severe chest pain on right ribcage and left-hand side. The patient went to the hospital after 6 to 7 days after the vaccination and got admitted. The patient was put on blood thinner immediately after the admission as the staff thought the patient had blood clot. On performing D-dimer test, the levels showed 3.49 (units unspecified) and was identified that the patient had no clots. The patient was discharged from the hospital on 28-APR-2021. The patient was pain free for 2 days; However, she started experiencing severe pain on left hand side of the chest on the day before reporting. The patient stated that the pain moved over. Rheumatologist suggested the patient to take Ibuprofen for the chest pain. The patient had reached out to her rheumatologist who advised the patient to take ibuprofen for the pain in her chest; However, the patient did not take before chest pain started. It was reported that the patient would be seeing the rheumatologist the next day of the report. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from severe chest pain on right ribcage and left-hand side. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210509152-covid-19 vaccine ad26.cov2.s -severe chest pain on right ribcage and left-hand side.. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Headache, Heavy menstrual bleeding
Clinical narrative: HEAVY AND LONG MENSTRUAL BLEEDING; HEADACHE; This spontaneous report received from a patient concerned a 44 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 03-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 or 10-APR-2021 the patient had Heavy and long menstrual bleeding with large blood clots. Patient went to emergency room on 17-APR-2021 and was given Medroxyprogesterone (Provera) which minimized the bleeding but didn't stop it. On 02-MAY-2021 the bleeding started back heavier with the blood clots once again. Patient again visited ER and injection was given to stop the bleeding (lupron) and Megestrol was prescribed. On 04-MAY-2021, Laboratory data included: Biopsy (NR: not provided) patient did not note diagnosis. On an unspecified date, patient experienced headache. Treatment medications (dates unspecified) included: leuprorelin acetate, medroxyprogesterone acetate, and megestrol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy and long menstrual bleeding and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509200-covid-19 vaccine ad26.cov2.s-heavy and long menstrual bleeding . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient via social media through a company representative 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: Unknown expiry: 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, upon vaccination the patient was sick and hospitalized for two days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509801-COVID-19 VACCINE AD26.COV2.S-Sick. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Amenorrhoea, Pregnancy test
Clinical narrative: MISSED PERIODS; 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 ustekinumab (solution for infusion, intravenous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 01-MAY-2021, the subject experienced missed periods. Laboratory data (dates unspecified) included: Pregnancy test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of missed periods was not reported. This report was non-serious. This case, from the same reporter is linked to 20210510755.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: BODY ACHES; PAIN IN THE LEG; This spontaneous report received from a consumer concerned a 22 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: Unk) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and pain in the leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the leg and body aches was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: LINGERING  MEDICINAL/ IRON TASTE IN MOUTH; MILD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine for prophylactic vaccination.  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 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced lingering medicinal/ iron taste in mouth. On MAY-2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lingering medicinal/ iron taste in mouth, and the outcome of mild headache was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Muscle tightness, Musculoskeletal pain, Pain in extremity, Ultrasound scan
Clinical narrative: TIGHTNESS IN HAMSTRINGS; BUTT PAIN; PAIN IN THIGHS AND CALVES AND ARM; GREAT DIFFICULTY IN MOVING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included polio, and concurrent conditions included arthritis in the arms, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with abaloparatide. 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-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced great difficulty in moving. On 15-MAR-2021, the subject experienced tightness in hamstrings. On 15-MAR-2021, the subject experienced butt pain. On 15-MAR-2021, the subject experienced pain in thighs and calves and arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) no blood clots, not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tightness in hamstrings, pain in thighs and calves and arm, and butt pain, and the outcome of great difficulty in moving was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509287.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and feverish skin at the injection site
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, Chills, Headache
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: After about 10-15 minutes of vaccination patient stated she was dizzy.  She was given some water to drink.  Then she said her dizziness was getting worse and was having a really bad headache.  I asked if I can call an ambulance for her to take her to ER she refused worrying about the cost.  Her mother was contacted and was notified of the situation.  Once patient started getting worse and started having visual changes with flashing lights, 911 was called immeidately and paramedics took over.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Photopsia, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: After about 10-15 minutes of vaccination patient stated she was dizzy.  She was given some water to drink.  Then she said her dizziness was getting worse and was having a really bad headache.  I asked if I can call an ambulance for her to take her to ER she refused worrying about the cost.  Her mother was contacted and was notified of the situation.  Once patient started getting worse and started having visual changes with flashing lights, 911 was called immeidately and paramedics took over.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Nausea, Swelling face, Swollen tongue, Vomiting
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site rash
Clinical narrative: Rash on arm near injection site about a week after getting the shot.  And frankly left shoulder has been sore / felt off since injection
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Flushing
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild, Additional Details: post 20mins vaccination
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Syncope, Tachycardia
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild, Additional Details: post 20mins vaccination
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, COVID-19, Dizziness, Electrocardiogram normal, Gait inability
Clinical narrative: Feeling like I would black out on 4/8, then on 4/11, early morning (3am) felt extreme lightheadedness and  naseous, couldn't walk.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: Feeling like I would black out on 4/8, then on 4/11, early morning (3am) felt extreme lightheadedness and  naseous, couldn't walk.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; NAUSEA; 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.5 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, body aches, and nausea. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Hyperventilation
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt. fainted right after getting vaccinated.  B/P 110/70, HR 74, R 19.  Pt stated, "I faint most of the time when I see needles."  At 3:10 pm pt. stated, "I feel better now."  Pt. is alert and oriented x4.  3:26 pm pt stated , "I'm ok now I want to go  home."  Pt. went home at 3:25 pm.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anal pruritus, Genital erythema, Genital rash, Pruritus genital, Rash
Clinical narrative: Moderna COVID-19 Vaccine EUA Itch and then rash, espcially near anus/genital. When first began I had to take a shower and it was the middle of the night. This morning (5/10/2021) at 6:30 AM genital area was red/rashy and slightly itch. I also had a slight itch on back and torso. Slight rash near underarms of both arms. I applied some body lotion and that eased the itch.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Herpes zoster, Influenza like illness, Pain
Clinical narrative: Shingles.  Symptoms began 3 days after 2nd Moderna COVID vaccine. These included waves of chills sensation through left leg and groin lymph node areas, as well as fatigue, achiness, and general flu-like symptoms. 6 days later (5/9), the first sign of rash/blister broke out.   My doctor performed a house visit to confirm shingles and prescribed ValACYclovir. I am on my 2nd day of this medication.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Shingles.  Symptoms began 3 days after 2nd Moderna COVID vaccine. These included waves of chills sensation through left leg and groin lymph node areas, as well as fatigue, achiness, and general flu-like symptoms. 6 days later (5/9), the first sign of rash/blister broke out.   My doctor performed a house visit to confirm shingles and prescribed ValACYclovir. I am on my 2nd day of this medication.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypotension, Visual impairment
Clinical narrative: Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient felt faint after void vaccine. She had some changes in vision and sat down to relax and drink an orange juice. Vitals were examined. (BP: 90/56 & 90/60; pulse: 62). Parents stated that patient has a history of feeling faint after vaccine administration. Patient was able to walk out under own power. A follow up call was placed and the parents stated that the patient was stable and doing well.