chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Chest discomfort, Ventricular extrasystoles
Clinical narrative: ongoing arrhythmia with constant; chest continues to feel tigh; three PVCs; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (ongoing arrhythmia with constant) and VENTRICULAR EXTRASYSTOLES (three PVCs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VENTRICULAR EXTRASYSTOLES (three PVCs) (seriousness criterion medically significant). On an unknown date, the patient experienced ARRHYTHMIA (ongoing arrhythmia with constant) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest continues to feel tigh). On 17-Mar-2021, VENTRICULAR EXTRASYSTOLES (three PVCs) had resolved. At the time of the report, ARRHYTHMIA (ongoing arrhythmia with constant) and CHEST DISCOMFORT (chest continues to feel tigh) outcome was unknown.            On February 17, patient was detected with PVCs during a physical examination at physician's office. One month later prior to colonoscopy, on March 17, a ECG rhythm strip showed three PVCs. On an unspecified date, the patient was referred to a cardiologist. Cardiologist ordered a nuclear stress test and echocardiogram.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded On an unspecified dare, the patient began a one week patch monitoring protocol.  No concomitant medication information was reported. No treatment information was reported.   This case was linked to MOD-2021-238998 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Basedow's disease, Cardiac disorder, Endocrine ophthalmopathy, Thyrotoxic crisis, Transient ischaemic attack
Clinical narrative: graves' disease; thyroid storm; thyroid eye; TIA; heart disease; This spontaneous case was reported by a consumer and describes the occurrence of BASEDOW'S DISEASE (graves' disease), THYROTOXIC CRISIS (thyroid storm), ENDOCRINE OPHTHALMOPATHY (thyroid eye) and TRANSIENT ISCHAEMIC ATTACK (TIA) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BASEDOW'S DISEASE (graves' disease) (seriousness criterion medically significant), THYROTOXIC CRISIS (thyroid storm) (seriousness criterion medically significant), ENDOCRINE OPHTHALMOPATHY (thyroid eye) (seriousness criterion medically significant), TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant) and CARDIAC DISORDER (heart disease). At the time of the report, BASEDOW'S DISEASE (graves' disease), THYROTOXIC CRISIS (thyroid storm), ENDOCRINE OPHTHALMOPATHY (thyroid eye), TRANSIENT ISCHAEMIC ATTACK (TIA) and CARDIAC DISORDER (heart disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Very limited information regarding the events has been provided at this time. Further information have been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information have been request.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Colonoscopy, Cough
Clinical narrative: patient's blood pressure went up to 186/patient's blood pressure wasn't going down; Nausea; Dizzy; patient's head hurts/huge headache; had pain in left eye/Patient's eyes were sore; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; patient couldn't get warm/patient got very cold again; patient started to have twitching and then patient's body started to move involuntarily; patient started to have twitching and then patient's body started to move involuntarily; just absolutely exhausted; patient's cough went up again; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient had the COVID vaccine, patient's second vaccine this morning (01Mar2021), patient had the first one three weeks ago. After half an hour, patient's blood pressure went up to 186 and the patient still cannot understand if that happen after the vaccine and the patient ended up in the ER and stayed with the nurse at the COVID location but the patient's blood pressure wasn't going down and patient's pulse was 100. The patient ended up at the ER and had pain in left eye, nausea, patient was 'striving' (not clarified), patient couldn't get warm. Patient was dizzy. The patient started to have twitching and then patient's body started to move involuntarily and then they released the patient at 2 (unspecified). The patient got home and just absolutely exhausted, which the patient thought was from the symptoms patient had, so the patient got very cold again, the patient's cough went up again and huge headache, in every part of patient's body, patient's skin and joints were in "very so much pain". Patient's eyes were sore and patient's head hurts. Patient took Neorelax (treatment). Patient had 4 times problems with the colonoscopy. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 186 (half an hour patient's blood pressure went up to 186), colonoscopy: unknown result, heart rate: 100. Therapeutic measures were taken as a result of patient's head hurts/huge headache (headache) which included Neorelax. The event patient's blood pressure went up to 186/patient's blood pressure wasn't going down resulted in emergency room visit. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Eye pain, Fatigue, Feeling cold
Clinical narrative: patient's blood pressure went up to 186/patient's blood pressure wasn't going down; Nausea; Dizzy; patient's head hurts/huge headache; had pain in left eye/Patient's eyes were sore; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; patient couldn't get warm/patient got very cold again; patient started to have twitching and then patient's body started to move involuntarily; patient started to have twitching and then patient's body started to move involuntarily; just absolutely exhausted; patient's cough went up again; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient had the COVID vaccine, patient's second vaccine this morning (01Mar2021), patient had the first one three weeks ago. After half an hour, patient's blood pressure went up to 186 and the patient still cannot understand if that happen after the vaccine and the patient ended up in the ER and stayed with the nurse at the COVID location but the patient's blood pressure wasn't going down and patient's pulse was 100. The patient ended up at the ER and had pain in left eye, nausea, patient was 'striving' (not clarified), patient couldn't get warm. Patient was dizzy. The patient started to have twitching and then patient's body started to move involuntarily and then they released the patient at 2 (unspecified). The patient got home and just absolutely exhausted, which the patient thought was from the symptoms patient had, so the patient got very cold again, the patient's cough went up again and huge headache, in every part of patient's body, patient's skin and joints were in "very so much pain". Patient's eyes were sore and patient's head hurts. Patient took Neorelax (treatment). Patient had 4 times problems with the colonoscopy. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 186 (half an hour patient's blood pressure went up to 186), colonoscopy: unknown result, heart rate: 100. Therapeutic measures were taken as a result of patient's head hurts/huge headache (headache) which included Neorelax. The event patient's blood pressure went up to 186/patient's blood pressure wasn't going down resulted in emergency room visit. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Heart rate, Muscle twitching, Nausea, Pain
Clinical narrative: patient's blood pressure went up to 186/patient's blood pressure wasn't going down; Nausea; Dizzy; patient's head hurts/huge headache; had pain in left eye/Patient's eyes were sore; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; patient couldn't get warm/patient got very cold again; patient started to have twitching and then patient's body started to move involuntarily; patient started to have twitching and then patient's body started to move involuntarily; just absolutely exhausted; patient's cough went up again; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient had the COVID vaccine, patient's second vaccine this morning (01Mar2021), patient had the first one three weeks ago. After half an hour, patient's blood pressure went up to 186 and the patient still cannot understand if that happen after the vaccine and the patient ended up in the ER and stayed with the nurse at the COVID location but the patient's blood pressure wasn't going down and patient's pulse was 100. The patient ended up at the ER and had pain in left eye, nausea, patient was 'striving' (not clarified), patient couldn't get warm. Patient was dizzy. The patient started to have twitching and then patient's body started to move involuntarily and then they released the patient at 2 (unspecified). The patient got home and just absolutely exhausted, which the patient thought was from the symptoms patient had, so the patient got very cold again, the patient's cough went up again and huge headache, in every part of patient's body, patient's skin and joints were in "very so much pain". Patient's eyes were sore and patient's head hurts. Patient took Neorelax (treatment). Patient had 4 times problems with the colonoscopy. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 186 (half an hour patient's blood pressure went up to 186), colonoscopy: unknown result, heart rate: 100. Therapeutic measures were taken as a result of patient's head hurts/huge headache (headache) which included Neorelax. The event patient's blood pressure went up to 186/patient's blood pressure wasn't going down resulted in emergency room visit. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: patient's blood pressure went up to 186/patient's blood pressure wasn't going down; Nausea; Dizzy; patient's head hurts/huge headache; had pain in left eye/Patient's eyes were sore; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; in every part of patient's body, patient's skin and joints were in "very so much pain"; patient couldn't get warm/patient got very cold again; patient started to have twitching and then patient's body started to move involuntarily; patient started to have twitching and then patient's body started to move involuntarily; just absolutely exhausted; patient's cough went up again; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient had the COVID vaccine, patient's second vaccine this morning (01Mar2021), patient had the first one three weeks ago. After half an hour, patient's blood pressure went up to 186 and the patient still cannot understand if that happen after the vaccine and the patient ended up in the ER and stayed with the nurse at the COVID location but the patient's blood pressure wasn't going down and patient's pulse was 100. The patient ended up at the ER and had pain in left eye, nausea, patient was 'striving' (not clarified), patient couldn't get warm. Patient was dizzy. The patient started to have twitching and then patient's body started to move involuntarily and then they released the patient at 2 (unspecified). The patient got home and just absolutely exhausted, which the patient thought was from the symptoms patient had, so the patient got very cold again, the patient's cough went up again and huge headache, in every part of patient's body, patient's skin and joints were in "very so much pain". Patient's eyes were sore and patient's head hurts. Patient took Neorelax (treatment). Patient had 4 times problems with the colonoscopy. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 186 (half an hour patient's blood pressure went up to 186), colonoscopy: unknown result, heart rate: 100. Therapeutic measures were taken as a result of patient's head hurts/huge headache (headache) which included Neorelax. The event patient's blood pressure went up to 186/patient's blood pressure wasn't going down resulted in emergency room visit. Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Lip swelling, Swelling face
Clinical narrative: bp decreased; lightheadedness; facial swelling; lip swelling; tongue swelling; This is a spontaneous report from a non-contactable other HCP. A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 52-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 18Mar2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, After rest and water, her bp decreased, still not normotensive. She felt like her dizziness was subsiding until we stood her up. Blood pressure increased. She sat back down, given more water, pb and cracker and lozenge. The reported seriousness of the adverse events was non-serious. At 11:21 she reported lightheadedness was mild. She was ambulated around bay but reports increased lightheadedness/dizziness. No sob, cp was reported. Patient feels well overall otherwise. Dizziness, facial swelling, lip swelling and tongue swelling were to be observed. On an unspecified date in Mar2021, the outcome of the event blood decreased was resolved while that of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported blood pressure decreased cannot be completely excluded based on information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: bp decreased; lightheadedness; facial swelling; lip swelling; tongue swelling; This is a spontaneous report from a non-contactable other HCP. A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 52-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 18Mar2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, After rest and water, her bp decreased, still not normotensive. She felt like her dizziness was subsiding until we stood her up. Blood pressure increased. She sat back down, given more water, pb and cracker and lozenge. The reported seriousness of the adverse events was non-serious. At 11:21 she reported lightheadedness was mild. She was ambulated around bay but reports increased lightheadedness/dizziness. No sob, cp was reported. Patient feels well overall otherwise. Dizziness, facial swelling, lip swelling and tongue swelling were to be observed. On an unspecified date in Mar2021, the outcome of the event blood decreased was resolved while that of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported blood pressure decreased cannot be completely excluded based on information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 antibody test, Sinus disorder
Clinical narrative: Drug ineffective; HCP confirmed he has covid; his head and eyes felt like it was going to pop out; sinus issues; This is a spontaneous report from a non-contactable consumer or other non HCP (Patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history included sinus issues from an unknown date patient stated he has the same sinus issues every year. The patient's concomitant medications were not reported. The patient was due for second Pfizer covid vaccine shot on 01Apr2021. Had went to the doctor as he had sinus issues, his head and eyes felt like it was going to pop out. Stated he has the same sinus issues every year. On Tuesday, the health care professional (HCP) confirmed he has covid. He has to quarantine 10 days from when he got it. He would be finished his quarantine by his second appointment (the day before). Read on CDC website that he can get the shot as long as he is off of quarantine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. (Patient, Husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number: Not reported), via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported on behalf of her husband, the patient who was tested positive to COVID-19 after the first dose on an unspecified date with outcome of unknown. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The reporter stated that the second dose was on 08Apr2021. She was asking as well what to bring for the second dose. The outcome of the events were unknown.  Follow up (10Apr2021): This follow up contains no new medically significant information.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acetabulum fracture, Asthenia, Blood cholesterol, Blood cholesterol decreased, Blood pressure measurement
Clinical narrative: Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fall, Fracture pain, Gait disturbance, Hip fracture
Clinical narrative: Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Lethargy, Malaise, Pain in extremity, Upper limb fracture
Clinical narrative: Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb, X-ray of pelvis and hip
Clinical narrative: Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Accident, Foot fracture, Pain in extremity, Peripheral swelling
Clinical narrative: Fractured her left foot; Accident; Swelling (left foot); Pain (left foot); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, in 2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient would be getting her second Pfizer COVID-19 shot in 2 days. In 2021, the patient had an accident and now was taking medications. In 2021, the patient fractured her left foot and she was taking naproxen 500 mg for the swelling and the pain. The patient wanted to be sure that it wouldn't be an issue to get her shot as she read online that anti-inflammatories can reduce the effectiveness. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Headache, Inflammation
Clinical narrative: Still feel discomfort in my arm if I pressed on it; Feeling miserable; Inflamed/Stiff neck from inflammation; Inflamed/Stiff neck from inflammation; Could not sleep on that side for the first week; Arm that was so sore; Fatigue; Headache; Optic neuritis flared in my left eye; virus triggered a flare up that knocked her off her feet; Cold; Virus triggered a flare up that knocked me off my feet. I had no sensation of touch or temperature in my left foot; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing relapsing remitting multiple sclerosis/MS diagnosed in 1981 (for 45 years). She has managed her disease with hormones for the past 30 years. Concomitant medications were not reported. She had the most unusual couple of weeks. In Apr2021, three weeks ago she caught a cold rare for her, but she was pretty run down. Cold symptoms did not last in her body, but the virus triggered a flare up that knocked her off her feet. She had no sensation of touch or temperature in left foot and optic neuritis flared in left eye in Apr2021. Worst of all she had that overwhelming fatigue that accompanies a flare up. She woke up Monday (19Apr2021) feeling miserable and inflamed. She was scheduled to get her second Pfizer vaccination at noon. She read that the shot does not make MS conditions worse so she decided to go ahead with her appointment. She had a moderate reaction to her first shot. A headache that lasted a week, a very stiff neck from inflammation, and an arm that was so sore that she could not sleep on that side for the first week in Apr2021. She could still feel discomfort in arm if she pressed on it as she left for her second shot on 19Apr2021. The outcome of event headache, could not sleep was recovered in Apr2021; discomfort in my arm was not recovered; for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once more information regarding event onset and vaccination date is available. Also underlying multiple sclerosis was confounder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Musculoskeletal stiffness, Nasopharyngitis, Optic neuritis
Clinical narrative: Still feel discomfort in my arm if I pressed on it; Feeling miserable; Inflamed/Stiff neck from inflammation; Inflamed/Stiff neck from inflammation; Could not sleep on that side for the first week; Arm that was so sore; Fatigue; Headache; Optic neuritis flared in my left eye; virus triggered a flare up that knocked her off her feet; Cold; Virus triggered a flare up that knocked me off my feet. I had no sensation of touch or temperature in my left foot; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing relapsing remitting multiple sclerosis/MS diagnosed in 1981 (for 45 years). She has managed her disease with hormones for the past 30 years. Concomitant medications were not reported. She had the most unusual couple of weeks. In Apr2021, three weeks ago she caught a cold rare for her, but she was pretty run down. Cold symptoms did not last in her body, but the virus triggered a flare up that knocked her off her feet. She had no sensation of touch or temperature in left foot and optic neuritis flared in left eye in Apr2021. Worst of all she had that overwhelming fatigue that accompanies a flare up. She woke up Monday (19Apr2021) feeling miserable and inflamed. She was scheduled to get her second Pfizer vaccination at noon. She read that the shot does not make MS conditions worse so she decided to go ahead with her appointment. She had a moderate reaction to her first shot. A headache that lasted a week, a very stiff neck from inflammation, and an arm that was so sore that she could not sleep on that side for the first week in Apr2021. She could still feel discomfort in arm if she pressed on it as she left for her second shot on 19Apr2021. The outcome of event headache, could not sleep was recovered in Apr2021; discomfort in my arm was not recovered; for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once more information regarding event onset and vaccination date is available. Also underlying multiple sclerosis was confounder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensory loss
Clinical narrative: Still feel discomfort in my arm if I pressed on it; Feeling miserable; Inflamed/Stiff neck from inflammation; Inflamed/Stiff neck from inflammation; Could not sleep on that side for the first week; Arm that was so sore; Fatigue; Headache; Optic neuritis flared in my left eye; virus triggered a flare up that knocked her off her feet; Cold; Virus triggered a flare up that knocked me off my feet. I had no sensation of touch or temperature in my left foot; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included ongoing relapsing remitting multiple sclerosis/MS diagnosed in 1981 (for 45 years). She has managed her disease with hormones for the past 30 years. Concomitant medications were not reported. She had the most unusual couple of weeks. In Apr2021, three weeks ago she caught a cold rare for her, but she was pretty run down. Cold symptoms did not last in her body, but the virus triggered a flare up that knocked her off her feet. She had no sensation of touch or temperature in left foot and optic neuritis flared in left eye in Apr2021. Worst of all she had that overwhelming fatigue that accompanies a flare up. She woke up Monday (19Apr2021) feeling miserable and inflamed. She was scheduled to get her second Pfizer vaccination at noon. She read that the shot does not make MS conditions worse so she decided to go ahead with her appointment. She had a moderate reaction to her first shot. A headache that lasted a week, a very stiff neck from inflammation, and an arm that was so sore that she could not sleep on that side for the first week in Apr2021. She could still feel discomfort in arm if she pressed on it as she left for her second shot on 19Apr2021. The outcome of event headache, could not sleep was recovered in Apr2021; discomfort in my arm was not recovered; for other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once more information regarding event onset and vaccination date is available. Also underlying multiple sclerosis was confounder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Seizure
Clinical narrative: only seized twice; chronic leg and back pain are uncomfortable; chronic leg and back pain are uncomfortable; This is a spontaneous report from a Pfizer- sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced seized only twice, the chronic leg and back pain are uncomfortable, but it was worth it. The clinical outcome of the seized only twice, the chronic leg and back pain are uncomfortable were unknown.   No follow-up attempts are possible. Information about lot/batch number were requested.