chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnambulism
Clinical narrative: she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe; feeling drugged; felt really dizzy/got dizzy when she got up and started moving around doing stuff; the left side of her body went numb; her arm, left side of her body, leg and face felt dead, numb and weird; she "went out" for the night; lightheaded; weakness in the left arm; still feeling weak; chills at night; This is a spontaneous report from a Pfizer Sponsored Patient Support Program COVAX US Support via a contactable consumer (patient). Follow-up received on 20Apr2021 was processed together along with initial information.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), intramuscular, administered in arm left on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021, immediately after the vaccine she felt really dizzy and the left side of her body went numb, also she felt super relaxed right after the vaccine, stating when in the car she had to remind herself to breathe and described it as feeling drugged. On an unspecified in Apr2021, the patient experienced chills at night, nothing closed or was swollen however her husband had to help her up the stairs because her arm, left side of her body, leg and face felt dead, numb, and weird. On an unspecified in Apr2021, she "went out" for the night. On an unspecified in Apr2021 (on Saturday), she was dizzy and lightheaded and left side of her body was still weird, numb and on Sunday she felt totally normal and got dizzy when she got up and started moving around doing stuff. She was getting better, but her left arm was still weak and had to think about moving it and she was still feeling dizzy when moving around and still having weakness in the left arm. The patient was wondering how long this was going to last, if the second shot was going to be worse and as she had a side effect after the first dose of the vaccine, should she get the second dose though she didn't have any severe reaction to the COVID-19 vaccine first dose. However, she had pretty bad reaction like lightheaded (on an unspecified date in Apr2021), arm and face numbness and chills after the first dose had been given and until about 10 days and now, she was still feeling weak and numb. She was wondering if she still needed to get her second dose of the vaccine given the side effects. She was advised to consult her health care professional on taking the second dose. The outcome was recovered on an unspecified date in Apr2021 for lightheaded and chills at night, unknown for all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Chest X-ray, Computerised tomogram, Electrocardiogram, Emergency care examination
Clinical narrative: Bell's Palsy left side of face; right side of his face went numb; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 09:25 as a single dose for COVID-19 immunization.  Medical history included hypertension and high cholesterol both under control from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines within 4 weeks. Concomitant medications included rosuvastatin calcium (CRESTOR); losartan potassium (LOSARTIN) and latanoprost (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient was tested for COVID post vaccination on 16Mar2021 via a nasal swab with a result of negative. On 16Mar2021 at 11:30 AM, the patient experienced Bell's Palsy on the left side of his face and at the same time the right side of his face went numb. The event caused the patient to go to the emergency room/department or urgent care. The patient started to recover after 3 weeks. The patient was given a 6 day steroid dose and an 7 day anti viral. The outcome of the events was recovering.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Bell's Palsy left side of face; right side of his face went numb; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 09:25 as a single dose for COVID-19 immunization.  Medical history included hypertension and high cholesterol both under control from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines within 4 weeks. Concomitant medications included rosuvastatin calcium (CRESTOR); losartan potassium (LOSARTIN) and latanoprost (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient was tested for COVID post vaccination on 16Mar2021 via a nasal swab with a result of negative. On 16Mar2021 at 11:30 AM, the patient experienced Bell's Palsy on the left side of his face and at the same time the right side of his face went numb. The event caused the patient to go to the emergency room/department or urgent care. The patient started to recover after 3 weeks. The patient was given a 6 day steroid dose and an 7 day anti viral. The outcome of the events was recovering.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Bell's Palsy left side of face; right side of his face went numb; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 09Mar2021 at 09:25 as a single dose for COVID-19 immunization.  Medical history included hypertension and high cholesterol both under control from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines within 4 weeks. Concomitant medications included rosuvastatin calcium (CRESTOR); losartan potassium (LOSARTIN) and latanoprost (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient was tested for COVID post vaccination on 16Mar2021 via a nasal swab with a result of negative. On 16Mar2021 at 11:30 AM, the patient experienced Bell's Palsy on the left side of his face and at the same time the right side of his face went numb. The event caused the patient to go to the emergency room/department or urgent care. The patient started to recover after 3 weeks. The patient was given a 6 day steroid dose and an 7 day anti viral. The outcome of the events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Conjunctival haemorrhage, Differential white blood cell count, Full blood count, International normalised ratio
Clinical narrative: Subconjunctival hemorrhage; This is a spontaneous report from a contactable consumer. A 42-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42 years, via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:30 (Batch/Lot Number: EP7533) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia from an unknown date and unknown if ongoing, DCIS & LCIS-removed on 24Feb2021, and known allergies to Benadryl, NSAIDs, sulfa and Vicodin. Concomitant medications included tramadol, methocarbamol and oxycodone all taken for an unspecified indication, start and stop date were not reported. The patient previously took Benadryl and Vicodin and had for drug allergies. The patient experienced subconjunctival hemorrhage on 11Apr2021. The event was not treated but resulted emergency room/department or urgent care visit. The outcome of the event was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Subconjunctival hemorrhage; This is a spontaneous report from a contactable consumer. A 42-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42 years, via an unspecified route of administration, administered in Arm Right on 08Apr2021 14:30 (Batch/Lot Number: EP7533) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia from an unknown date and unknown if ongoing, DCIS & LCIS-removed on 24Feb2021, and known allergies to Benadryl, NSAIDs, sulfa and Vicodin. Concomitant medications included tramadol, methocarbamol and oxycodone all taken for an unspecified indication, start and stop date were not reported. The patient previously took Benadryl and Vicodin and had for drug allergies. The patient experienced subconjunctival hemorrhage on 11Apr2021. The event was not treated but resulted emergency room/department or urgent care visit. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Full blood count, Haemoglobin, Hemiparesis
Clinical narrative: SWOLLEN RIGHT LEG; PAIN IN CALF AREA; RIGHT TEMPORAL PAIN/HEADACHE; HORRIBLE STOMACH PAIN; PLATELET LEVEL DROPPED 10 POINTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced platelet level dropped 10 points. On APR-2021, the subject experienced horrible stomach pain. Laboratory data included: Platelet count (NR: not provided) no findings, dropped 10 point, and Ultrasound scan (NR: not provided) no findings. On 11-APR-2021, the subject experienced swollen right leg. On 11-APR-2021, the subject experienced pain in calf area. On 11-APR-2021, the subject experienced right temporal pain/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen right leg, pain in calf area, and right temporal pain/headache, and the outcome of platelet level dropped 10 points and horrible stomach pain was not reported. This report was non-serious. This case, from the same reporter is linked to.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscular weakness, Pain in extremity
Clinical narrative: SWOLLEN RIGHT LEG; PAIN IN CALF AREA; RIGHT TEMPORAL PAIN/HEADACHE; HORRIBLE STOMACH PAIN; PLATELET LEVEL DROPPED 10 POINTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced platelet level dropped 10 points. On APR-2021, the subject experienced horrible stomach pain. Laboratory data included: Platelet count (NR: not provided) no findings, dropped 10 point, and Ultrasound scan (NR: not provided) no findings. On 11-APR-2021, the subject experienced swollen right leg. On 11-APR-2021, the subject experienced pain in calf area. On 11-APR-2021, the subject experienced right temporal pain/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen right leg, pain in calf area, and right temporal pain/headache, and the outcome of platelet level dropped 10 points and horrible stomach pain was not reported. This report was non-serious. This case, from the same reporter is linked to.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity, Peripheral swelling, Platelet count
Clinical narrative: SWOLLEN RIGHT LEG; PAIN IN CALF AREA; RIGHT TEMPORAL PAIN/HEADACHE; HORRIBLE STOMACH PAIN; PLATELET LEVEL DROPPED 10 POINTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced platelet level dropped 10 points. On APR-2021, the subject experienced horrible stomach pain. Laboratory data included: Platelet count (NR: not provided) no findings, dropped 10 point, and Ultrasound scan (NR: not provided) no findings. On 11-APR-2021, the subject experienced swollen right leg. On 11-APR-2021, the subject experienced pain in calf area. On 11-APR-2021, the subject experienced right temporal pain/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen right leg, pain in calf area, and right temporal pain/headache, and the outcome of platelet level dropped 10 points and horrible stomach pain was not reported. This report was non-serious. This case, from the same reporter is linked to.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Ultrasound scan
Clinical narrative: SWOLLEN RIGHT LEG; PAIN IN CALF AREA; RIGHT TEMPORAL PAIN/HEADACHE; HORRIBLE STOMACH PAIN; PLATELET LEVEL DROPPED 10 POINTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced platelet level dropped 10 points. On APR-2021, the subject experienced horrible stomach pain. Laboratory data included: Platelet count (NR: not provided) no findings, dropped 10 point, and Ultrasound scan (NR: not provided) no findings. On 11-APR-2021, the subject experienced swollen right leg. On 11-APR-2021, the subject experienced pain in calf area. On 11-APR-2021, the subject experienced right temporal pain/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen right leg, pain in calf area, and right temporal pain/headache, and the outcome of platelet level dropped 10 points and horrible stomach pain was not reported. This report was non-serious. This case, from the same reporter is linked to.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Cyst removal, Dizziness, Dyspnoea, Knee operation
Clinical narrative: PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged.  Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Pulmonary embolism, Troponin normal
Clinical narrative: PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged.  Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Knee operation, Pulmonary thrombosis
Clinical narrative: PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged.  Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged.  Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Hypertension, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged.  Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Ultrasound scan
Clinical narrative: PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged.  Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Dyspnoea, Echocardiogram, Laboratory test
Clinical narrative: Pericarditis; Pleuritis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0162), via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 62-years-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor, fibromyalgia, migraines, depression, Barrett's Esophagus, hiatal hernia, restless leg syndrome (RLS), asthma, hypothyroidism, moderate sleep apnea, osteoarthritis, valvular heart disease, hyperlipidemia, degenerative disc disease (DDD), osteopenia, benign essential tremor, hypertension (HTN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported, but the patient did receive other unspecified medications within two weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient previously took morphine, pregabalin (LYRICA) and methylphenidate hydrochloride (CONCERTA) and experienced allergies. On 15Apr2021 at 21:30, the patient had shortness of breath and chest pain and could only tolerate leaning forward. She went to the emergency room and was admitted to the hospital for pericarditis and pleuritis. She was informed not to take the second vaccine as it would kill her. The patient was hospitalized as of an unspecified date for 2 days and treated with steroids, anti-inflammatory and pain medication. Since the vaccination, the patient was tested for COVID-19 via nasal swab on 16Apr2021 with negative results. The clinical outcome of pericarditis and pleuritis was resolving.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Pleurisy
Clinical narrative: Pericarditis; Pleuritis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0162), via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 62-years-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor, fibromyalgia, migraines, depression, Barrett's Esophagus, hiatal hernia, restless leg syndrome (RLS), asthma, hypothyroidism, moderate sleep apnea, osteoarthritis, valvular heart disease, hyperlipidemia, degenerative disc disease (DDD), osteopenia, benign essential tremor, hypertension (HTN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported, but the patient did receive other unspecified medications within two weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient previously took morphine, pregabalin (LYRICA) and methylphenidate hydrochloride (CONCERTA) and experienced allergies. On 15Apr2021 at 21:30, the patient had shortness of breath and chest pain and could only tolerate leaning forward. She went to the emergency room and was admitted to the hospital for pericarditis and pleuritis. She was informed not to take the second vaccine as it would kill her. The patient was hospitalized as of an unspecified date for 2 days and treated with steroids, anti-inflammatory and pain medication. Since the vaccination, the patient was tested for COVID-19 via nasal swab on 16Apr2021 with negative results. The clinical outcome of pericarditis and pleuritis was resolving.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Pleurisy, SARS-CoV-2 test
Clinical narrative: Pericarditis; Pleuritis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0162), via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 62-years-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor, fibromyalgia, migraines, depression, Barrett's Esophagus, hiatal hernia, restless leg syndrome (RLS), asthma, hypothyroidism, moderate sleep apnea, osteoarthritis, valvular heart disease, hyperlipidemia, degenerative disc disease (DDD), osteopenia, benign essential tremor, hypertension (HTN). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported, but the patient did receive other unspecified medications within two weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient previously took morphine, pregabalin (LYRICA) and methylphenidate hydrochloride (CONCERTA) and experienced allergies. On 15Apr2021 at 21:30, the patient had shortness of breath and chest pain and could only tolerate leaning forward. She went to the emergency room and was admitted to the hospital for pericarditis and pleuritis. She was informed not to take the second vaccine as it would kill her. The patient was hospitalized as of an unspecified date for 2 days and treated with steroids, anti-inflammatory and pain medication. Since the vaccination, the patient was tested for COVID-19 via nasal swab on 16Apr2021 with negative results. The clinical outcome of pericarditis and pleuritis was resolving.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arterial thrombosis, Cardiac operation, Chest pain, Decreased appetite, Dyspnoea
Clinical narrative: 2 days later had chest pain.  admitted 4/6/21 for  acute ST MI and had stents in LAD/RCA
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Myocardial infarction, Pain in extremity
Clinical narrative: 2 days later had chest pain.  admitted 4/6/21 for  acute ST MI and had stents in LAD/RCA
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Carotid artery stent insertion, Catheterisation cardiac abnormal, Chest pain, Coronary artery disease, Myocardial infarction
Clinical narrative: 2 days later had chest pain.  admitted 4/6/21 for  acute ST MI and had stents in LAD/RCA
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arterial occlusive disease, Asthenia, Chest pain, Cold sweat, Dyspepsia
Clinical narrative: 2 days later had chest pain.  admitted 4/6/21 for  acute ST MI and had stents in LAD/RCA
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Gastrooesophageal reflux disease, Myocardial infarction
Clinical narrative: 2 days later had chest pain.  admitted 4/6/21 for  acute ST MI and had stents in LAD/RCA
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombosis, Vomiting
Clinical narrative: 2 days later had chest pain.  admitted 4/6/21 for  acute ST MI and had stents in LAD/RCA
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Bladder catheterisation, Blood creatinine normal, Calculus bladder, Cholelithiasis
Clinical narrative: Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation.  Medical history was none.  Known allergies was none.  The patient did not have Covid prior to vaccination.  No other vaccine was given in last four weeks.  There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering.  Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021.  Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner.    Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation.  Medical history was none.  Known allergies was none.  The patient did not have Covid prior to vaccination.  No other vaccine was given in last four weeks.  There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering.  Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021.  Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner.    Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin, Hydronephrosis, Prostatomegaly, Pulmonary embolism, Renal cyst
Clinical narrative: Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation.  Medical history was none.  Known allergies was none.  The patient did not have Covid prior to vaccination.  No other vaccine was given in last four weeks.  There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering.  Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021.  Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner.    Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan with contrast, Ultrasound Doppler abnormal, Urinary retention, Urogram abnormal
Clinical narrative: Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation.  Medical history was none.  Known allergies was none.  The patient did not have Covid prior to vaccination.  No other vaccine was given in last four weeks.  There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering.  Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021.  Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner.    Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 antibody test, Urinary tract infection
Clinical narrative: Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer.   A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation.  Medical history was none.  Known allergies was none.  The patient did not have Covid prior to vaccination.  No other vaccine was given in last four weeks.  There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering.  Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021.  Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epicondylitis, Fatigue, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: fatique; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatique and sore arm in 2021 with outcome of unknown. The patient was scheduled for her second vaccine 21 days after but then the clinic offered her an appointment for 4 days earlier. She was calling to ask if that was ok to do, she still was scheduled for the 21 days though.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatique; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatique and sore arm in 2021 with outcome of unknown. The patient was scheduled for her second vaccine 21 days after but then the clinic offered her an appointment for 4 days earlier. She was calling to ask if that was ok to do, she still was scheduled for the 21 days though.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Thrombosis
Clinical narrative: Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no previous health conditions prior to vaccination/stroke. He also states he experienced chills, fatigue, headache, nausea and breathlessness after first dose.
Age: 53.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Cerebrovascular accident, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no previous health conditions prior to vaccination/stroke. He also states he experienced chills, fatigue, headache, nausea and breathlessness after first dose.
Age: 53.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Nausea
Clinical narrative: Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no previous health conditions prior to vaccination/stroke. He also states he experienced chills, fatigue, headache, nausea and breathlessness after first dose.