chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood magnesium normal, Blood potassium decreased, Blood sodium decreased, Blood triglycerides increased, Cerebrovascular accident
Clinical narrative: severe Bell's palsy; dose number=3; This is a spontaneous report from a contactable nurse. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Nov2021 10:00 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 09Nov2021 10:00, outcome "unknown", described as "dose number=3"; BELL'S PALSY (hospitalization) with onset 10Nov2021 10:00, outcome "recovering", described as "severe Bell's palsy". The patient was hospitalized for immunisation, bell's palsy (hospitalization duration: 2 days). The events "dose number=3" and "severe bell's palsy" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were taken as a result of bell's palsy. The patient received treatment with valacyclovir (VALTREX) and prednisone.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dental caries, Ear discomfort, Electrocardiogram abnormal, Eyelid function disorder, Facial paralysis
Clinical narrative: severe Bell's palsy; dose number=3; This is a spontaneous report from a contactable nurse. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Nov2021 10:00 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 09Nov2021 10:00, outcome "unknown", described as "dose number=3"; BELL'S PALSY (hospitalization) with onset 10Nov2021 10:00, outcome "recovering", described as "severe Bell's palsy". The patient was hospitalized for immunisation, bell's palsy (hospitalization duration: 2 days). The events "dose number=3" and "severe bell's palsy" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were taken as a result of bell's palsy. The patient received treatment with valacyclovir (VALTREX) and prednisone.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: High density lipoprotein decreased, Hypoaesthesia, Lip injury, Low density lipoprotein increased, Magnetic resonance imaging head normal
Clinical narrative: severe Bell's palsy; dose number=3; This is a spontaneous report from a contactable nurse. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Nov2021 10:00 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 09Nov2021 10:00, outcome "unknown", described as "dose number=3"; BELL'S PALSY (hospitalization) with onset 10Nov2021 10:00, outcome "recovering", described as "severe Bell's palsy". The patient was hospitalized for immunisation, bell's palsy (hospitalization duration: 2 days). The events "dose number=3" and "severe bell's palsy" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were taken as a result of bell's palsy. The patient received treatment with valacyclovir (VALTREX) and prednisone.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Troponin increased, Vertebral artery occlusion
Clinical narrative: severe Bell's palsy; dose number=3; This is a spontaneous report from a contactable nurse. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Nov2021 10:00 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 09Nov2021 10:00, outcome "unknown", described as "dose number=3"; BELL'S PALSY (hospitalization) with onset 10Nov2021 10:00, outcome "recovering", described as "severe Bell's palsy". The patient was hospitalized for immunisation, bell's palsy (hospitalization duration: 2 days). The events "dose number=3" and "severe bell's palsy" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were taken as a result of bell's palsy. The patient received treatment with valacyclovir (VALTREX) and prednisone.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Immunisation, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: severe Bell's palsy; dose number=3; This is a spontaneous report from a contactable nurse. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Nov2021 10:00 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 09Nov2021 10:00, outcome "unknown", described as "dose number=3"; BELL'S PALSY (hospitalization) with onset 10Nov2021 10:00, outcome "recovering", described as "severe Bell's palsy". The patient was hospitalized for immunisation, bell's palsy (hospitalization duration: 2 days). The events "dose number=3" and "severe bell's palsy" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were taken as a result of bell's palsy. The patient received treatment with valacyclovir (VALTREX) and prednisone.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: LEFT SHOULDER PAIN; DIFFICULTY MOVING SHOULDER; This spontaneous report received from a health care professional concerned a 55 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus, and hypertension. Also, patient never had adverse drug reaction following any previous vaccination. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, 1 in total for prophylactic vaccination. Patient experienced drug allergy when treated with levofloxacin.  The patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A, and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total, on left arm, for prophylactic vaccination (booster dose).  Concomitant medications included Metformin, Metoprolol, and Ramipril.  On an unspecified date, the patient experienced left shoulder pain, and difficulty moving shoulder continuing 4 days post vaccine. Patient is taking anti inflammatories, icing shoulder, and performing gentle range of motion stretches.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left shoulder pain, and difficulty moving shoulder. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypokinesia
Clinical narrative: LEFT SHOULDER PAIN; DIFFICULTY MOVING SHOULDER; This spontaneous report received from a health care professional concerned a 55 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus, and hypertension. Also, patient never had adverse drug reaction following any previous vaccination. The patient was previously treated with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, 1 in total for prophylactic vaccination. Patient experienced drug allergy when treated with levofloxacin.  The patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A, and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total, on left arm, for prophylactic vaccination (booster dose).  Concomitant medications included Metformin, Metoprolol, and Ramipril.  On an unspecified date, the patient experienced left shoulder pain, and difficulty moving shoulder continuing 4 days post vaccine. Patient is taking anti inflammatories, icing shoulder, and performing gentle range of motion stretches.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left shoulder pain, and difficulty moving shoulder. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, Syncope
Clinical narrative: I was not doing any physical activity and noticed that my right pinky knuckle was as swollen to the size of a grape and a little green/blue.  I went to urgent care and was diagnosed with cellulitis, prescribed antibiotics and ibuprofen.  The swelling went down in about 2 days and then turned a purple color.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Peripheral swelling, Skin discolouration
Clinical narrative: I was not doing any physical activity and noticed that my right pinky knuckle was as swollen to the size of a grape and a little green/blue.  I went to urgent care and was diagnosed with cellulitis, prescribed antibiotics and ibuprofen.  The swelling went down in about 2 days and then turned a purple color.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Arthralgia, Blood test, C-reactive protein increased, Chills
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Joint range of motion decreased, Joint swelling, Joint warmth
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Quality of life decreased, Red blood cell sedimentation rate increased, Respiratory tract congestion
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Weight decreased, White blood cell count increased
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, C-reactive protein increased, Chills, Headache
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lower respiratory tract congestion, Metabolic function test normal, Musculoskeletal stiffness, Oropharyngeal pain, Pyrexia
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate increased, Skin warm, Swelling, Weight decreased, White blood cell count increased
Clinical narrative: headache, fever, chills, extreme joint pain, swelling, stiffness, hot to touch, sore throat, chest congestion, weight loss X 2 months.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Right lower lobe infectious or inflammatory pneumonia, COVID-19 positive on admit 11/17   Patient received vaccine at an Outside Facility. Lot number unknown
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Right lower lobe infectious or inflammatory pneumonia, COVID-19 positive on admit 11/17   Patient received vaccine at an Outside Facility. Lot number unknown
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: COVID diagnosed on 11/19/2021 who is s/p monoclonal antibody (casirivimab-imdevimab) infusion November 22. He returned home following his infusion and he was noted to have right sided weakness and slurred speech (lasted 30-45 minutes) and therefore he was brought to the Emergency Department for further evaluation.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysarthria, Hemiparesis
Clinical narrative: COVID diagnosed on 11/19/2021 who is s/p monoclonal antibody (casirivimab-imdevimab) infusion November 22. He returned home following his infusion and he was noted to have right sided weakness and slurred speech (lasted 30-45 minutes) and therefore he was brought to the Emergency Department for further evaluation.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: swelling in right arm from elbow up to an including right neck. Body aches, nausea, pain in right neck and right fingers. Diddiculty turning neck due to pain and swelling. Symptoms lasted for 3 days Called PCP and they had her take claritin, benadry and tylenol to treat the swelling, and pain.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Neck pain, Pain, Pain in extremity, Swelling
Clinical narrative: swelling in right arm from elbow up to an including right neck. Body aches, nausea, pain in right neck and right fingers. Diddiculty turning neck due to pain and swelling. Symptoms lasted for 3 days Called PCP and they had her take claritin, benadry and tylenol to treat the swelling, and pain.
Age: 34.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: PANIC SYMPTOMS; BLURRED VISION; This spontaneous report received from a patient concerned a 34 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 1A22811 expiry: Unknown) dose was not reported, 1 total, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, since this period patient had a reaction and lived with persistent headaches, blurred vision until now. After three different hospitals and four different specialist doctors was diagnosed with panic symptoms and had been treating with psychiatry doctor psychology and through drugs Rivotril (clonazepam) and Exodus (escitalopram) but headaches are controlled however the blurred vision persists. Laboratory data (dates unspecified) included: Lab test found to be good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from panic symptoms, and blurred vision. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211162464-Covid-19 vaccine ad26.cov2.s-Panic symptoms, Blurred vision. 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: 34.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Panic attack, Vision blurred
Clinical narrative: PANIC SYMPTOMS; BLURRED VISION; This spontaneous report received from a patient concerned a 34 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 1A22811 expiry: Unknown) dose was not reported, 1 total, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, since this period patient had a reaction and lived with persistent headaches, blurred vision until now. After three different hospitals and four different specialist doctors was diagnosed with panic symptoms and had been treating with psychiatry doctor psychology and through drugs Rivotril (clonazepam) and Exodus (escitalopram) but headaches are controlled however the blurred vision persists. Laboratory data (dates unspecified) included: Lab test found to be good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from panic symptoms, and blurred vision. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211162464-Covid-19 vaccine ad26.cov2.s-Panic symptoms, Blurred vision. 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: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram head normal, Condition aggravated, Dry eye, Dysphagia
Clinical narrative: Facial paralysis, Bell's palsy started the day after patient had her booster vaccine. She initially went to one Emergency Department and was worked up there, but not given steroids. She went to Emergency Department on 11/28/2021 and was placed in observation status. She was seen by a Hospitalist and a Neurologist. She had a MRI that was negative, so she was discharged home.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Facial paralysis, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: Facial paralysis, Bell's palsy started the day after patient had her booster vaccine. She initially went to one Emergency Department and was worked up there, but not given steroids. She went to Emergency Department on 11/28/2021 and was placed in observation status. She was seen by a Hospitalist and a Neurologist. She had a MRI that was negative, so she was discharged home.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Facial paralysis, Bell's palsy started the day after patient had her booster vaccine. She initially went to one Emergency Department and was worked up there, but not given steroids. She went to Emergency Department on 11/28/2021 and was placed in observation status. She was seen by a Hospitalist and a Neurologist. She had a MRI that was negative, so she was discharged home.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood magnesium, Computerised tomogram, Differential white blood cell count, Facial paralysis
Clinical narrative: Facial paralysis, Bell's palsy started the day after patient had her booster vaccine. She initially went to one Emergency Department and was worked up there, but not given steroids. She went to Emergency Department on 11/28/2021 and was placed in observation status. She was seen by a Hospitalist and a Neurologist. She had a MRI that was negative, so she was discharged home.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Magnetic resonance imaging, Metabolic function test, SARS-CoV-2 test, Troponin
Clinical narrative: Facial paralysis, Bell's palsy started the day after patient had her booster vaccine. She initially went to one Emergency Department and was worked up there, but not given steroids. She went to Emergency Department on 11/28/2021 and was placed in observation status. She was seen by a Hospitalist and a Neurologist. She had a MRI that was negative, so she was discharged home.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Facial paralysis, Bell's palsy started the day after patient had her booster vaccine. She initially went to one Emergency Department and was worked up there, but not given steroids. She went to Emergency Department on 11/28/2021 and was placed in observation status. She was seen by a Hospitalist and a Neurologist. She had a MRI that was negative, so she was discharged home.
Age: 11.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient (11 years old 5 months) was mistakenly given the adult covid vaccine intended for 12 and up instead of the pediatric vaccine for ages 5-11. The patients mother was notified upon discovery.  No adverse events reported to us at this time.
Age: 11.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient (11 years old 5 months) was mistakenly given the adult covid vaccine intended for 12 and up instead of the pediatric vaccine for ages 5-11. The patients mother was notified upon discovery.  No adverse events reported to us at this time.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dysphagia, Dyspnoea, General physical health deterioration
Clinical narrative: Patient covid +as of 3 days ago and coming in with generalized pain and weakness.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental status changes
Clinical narrative: Patient covid +as of 3 days ago and coming in with generalized pain and weakness.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient covid +as of 3 days ago and coming in with generalized pain and weakness.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Administration of improperly stored vaccines.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: she noticed a rash in both arms, legs and the back/ Rash (inflammation and redness)/ eliminated the rash but not the redness generated by it; Fever; Flue like symptoms; Sore throat; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches), RASH (she noticed a rash in both arms, legs and the back/ Rash (inflammation and redness)/ eliminated the rash but not the redness generated by it) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches) and PYREXIA (Fever). On 20-Nov-2021, the patient experienced RASH (she noticed a rash in both arms, legs and the back/ Rash (inflammation and redness)/ eliminated the rash but not the redness generated by it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown and RASH (she noticed a rash in both arms, legs and the back/ Rash (inflammation and redness)/ eliminated the rash but not the redness generated by it) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  She took some Benadryl worked and eliminated the rash but not the redness generated by it.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: My hair started falling out. It's gotten worse in last month, or so.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (My hair started falling out. It's gotten worse in last month, or so.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced ALOPECIA (My hair started falling out. It's gotten worse in last month, or so.). At the time of the report, ALOPECIA (My hair started falling out. It's gotten worse in last month, or so.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395776, MOD-2021-395763, MOD-2021-395825 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Substantially increased rest heart rate and heart palpitations.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus began approximately 1 hour after the vaccine was administered. Initially the Tinnitus was severe but gradually became moderate after a day or two. Moderate tinnitus persists to the time of reporting, approximately 3 months after the vaccine was administered.  Note: I had very minor tinnitus prior to receiving the vaccine. The tinnitus is the "ringing" type.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My period was 5 days early. I'm always regular at 28 days and this time was only 23 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Full blood count, Heavy menstrual bleeding, Metabolic function test, Serum ferritin
Clinical narrative: Noted with prolonged menstruation of over 10 days. Menstruation started on 11/7/21 and continued with moderate to heavy flow until provider visit on 11/18/21. Menstruation is usually regular (approximately 4-5 days total), occurs around the same time of the month (between 6th-8th of month). This is first time patient?s menstruation was longer than 5 days.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse event report.  I'm report this form due to the fact that the patient is 17yo.  Pfizer vaccine is approved for 18yo and over.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Patient presented with an itchy rash on chest and shoulders about 2 weeks post vaccinations (booster dose). The skin at the rash appears raised. Rash has traveled access his body affecting his ankles, calves, neck, forearms, buttocks, shoulders and chest. The rash has not subsided to date. Antihistamines temporarily alleviate itching.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Confusional state, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Dizziness, hypertension, hyperglycemia, difficulty walking, dysphasia, fever, shortness of breath, dyspnea, fatigue, confusion, headache (not relieved by Naproxen, Acetaminophen, or Percocet). Lasted from 0630 to 2200 on Monday, November 1st, 2021.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hyperglycaemia, Hypertension, Pyrexia
Clinical narrative: Dizziness, hypertension, hyperglycemia, difficulty walking, dysphasia, fever, shortness of breath, dyspnea, fatigue, confusion, headache (not relieved by Naproxen, Acetaminophen, or Percocet). Lasted from 0630 to 2200 on Monday, November 1st, 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory normal, Electrocardiogram normal, Palpitations, Sleep disorder, Vaccine positive rechallenge
Clinical narrative: Woke up with really strong heart palpitations that went on for almost 2 days and then faded slowly over one week. So strong that they woke me up several times and were quite intense.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: administer. Pharmacist administered single dose of adult epinephrine at 11:29 am and 911 called. Patient evaluated by EMS at the store and asked to be transfer the nearest emergency room for further evaluation. Patient refused to go to the ER and walk out of the store.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Mild headache starting about 18 hours after vaccination & lasting throughout the day worsening around 24 hours after vaccination. Acetaminophen was then given resulting in reduction of headache pain prior to bedtime.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Pollakiuria, Protein urine, Red blood cells urine positive, Urine analysis
Clinical narrative: Began to notice blood in urine and increased in amount of blood in urine over time. Somewhat increase in frequency of urination as well.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cells urine
Clinical narrative: Began to notice blood in urine and increased in amount of blood in urine over time. Somewhat increase in frequency of urination as well.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: square patch of redness  (1.25 by 1..25)  symmetric on the left arm where the shot was given.  It is itchy off and on. On Sunday Nov 28, the section  left hard and itchy.  i  did not see the red patch until yesterday Nov 29 2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Feeling cold, Gaze palsy, Pain
Clinical narrative: Body aches, fatigue, headache, pain in left armpit, random twinges throughout body,  sensitivity to cold, etc.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Disorientation, Electroencephalogram, Gait disturbance, Magnetic resonance imaging head
Clinical narrative: Slow to walk, until not able to walk, started staring and was disoriented,
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Staring, Thrombosis
Clinical narrative: Slow to walk, until not able to walk, started staring and was disoriented,
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dysgeusia, Headache
Clinical narrative: Daily massive headache almost like I am dehydrated.  Also have a metallic taste in my mouth all the time now. Never had any of these issues before the vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, started in hands and feet and has become full body. Comes and goes
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Pain
Clinical narrative: Widespread joint pain and stiffness. Presently   Joint tenderness. Difficult walking..pain
Age: 53.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Chills, headache, 102° fever, tiredness, sore arms at injection site
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage subcutaneous, Injection site pain, Pruritus, Rash, Rash macular
Clinical narrative: Pain in the site of injection X 1 month Generalized rashes Streaks of subcutaneous bleed Generalized skin hyphae and blots  Severe generalized itching
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: Pain in the site of injection X 1 month Generalized rashes Streaks of subcutaneous bleed Generalized skin hyphae and blots  Severe generalized itching
Age: 33.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Cheat pain. Started quickly and got moderate within an hour.  Lasted for over 7 days. Right in center of chest under sternum. Felt like a tightness in my heart area.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Nasal disorder, Sinus disorder
Clinical narrative: After the 2nd dose, which was administered on November 24, I have had a constant headache and nasal/sinus issues. Last night, while working, my nose began to continuously leak a bloody mucus liquid.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Gaze palsy, Heart rate increased
Clinical narrative: As with second dose, booster resulted in typical fever/chills, fatigue, brain fog. Second does resulted in headaches after first day. Unknown if booster shot will have the same (has not been 24 hours since booster shot).  Reporting adverse event of increased heart rate. I had an increased heart rate after second dose and have it again with fever and chills. Despite laying down and resting, HR has been about 92. Typically/usually, HR is in the 60s/70s? Unfortunately I don?t have a clear baseline. HR was taken with an app on the phone (after I could feel my heart pounding). Unfortunately I don?t have a pulse ox handy right now.  It distinctly reminds me of having tachycardia during a pregnancy 5+ years ago (ultrasound and follow ups indicated no specific issue). HR was over 100 in those episodes.   From reading some reports online, I should mention I have never had covid. As far as I?m aware.   The tachycardia during pregnancy was hypothesized to be related to the stress of pregnancy on my body. I assume something similar happens with vaccine response.   Shot administered approx 9:30am. Didn?t check HR until approximately 9:30pm but may have started sooner.   No treatment. If similar to 2nd dose, it will resolved in the first 24 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: As with second dose, booster resulted in typical fever/chills, fatigue, brain fog. Second does resulted in headaches after first day. Unknown if booster shot will have the same (has not been 24 hours since booster shot).  Reporting adverse event of increased heart rate. I had an increased heart rate after second dose and have it again with fever and chills. Despite laying down and resting, HR has been about 92. Typically/usually, HR is in the 60s/70s? Unfortunately I don?t have a clear baseline. HR was taken with an app on the phone (after I could feel my heart pounding). Unfortunately I don?t have a pulse ox handy right now.  It distinctly reminds me of having tachycardia during a pregnancy 5+ years ago (ultrasound and follow ups indicated no specific issue). HR was over 100 in those episodes.   From reading some reports online, I should mention I have never had covid. As far as I?m aware.   The tachycardia during pregnancy was hypothesized to be related to the stress of pregnancy on my body. I assume something similar happens with vaccine response.   Shot administered approx 9:30am. Didn?t check HR until approximately 9:30pm but may have started sooner.   No treatment. If similar to 2nd dose, it will resolved in the first 24 hours.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was administered a second dose of Hepatitis A too early. PT had no adverse side effects or reactions. VAERS is being submitted due to administration error only.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Chest pain, Fatigue, Pain in extremity
Clinical narrative: heart/chest pain; heart/chest pain; fatigue; weakness; pain in my limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), CHEST PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "heart/chest pain"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain in my limbs". Clinical source as follows: the patient had two Pfizer shots (end of Apr and early May). The patient had not felt the same sense. Patient had had heart/chest pain, fatigue, weakness and pain in his/her limbs, among a variety of other troubling symptoms. The patient was working with his/her doctors to try to pinpoint exactly what was going on.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: HIBV, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; No additional adverse event; This spontaneous case report has been received from an office manager, referring to a two child patients. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On an unknown date the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB)  which was exposed to a cold chain breach, (strength, vaccination scheme, route and anatomical location of administration were not reported; lot # T042014 has been verified as valid lot number and expiration date established as 23-JUL-2023)  for prophylaxis.     Also pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, vaccination scheme, route and anatomical location of administration were not reported; lot # T009743 has been verified as valid lot number and expiration date reported as 13-MAR-2021, but established as 27-JAN-2022)  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, vaccination scheme, route and anatomical location of administration were not reported; lot # 1821247 has been verified as valid lot number and expiration date established as 23-JUL-2022)  for prophylaxis; were also exposed to a cold chain breach   The vaccines were exposed for 3 hours and 15 minutes and the reported maximum temperature excursion reached was 49.7 degrees Fahrenheit (ºF).  information about if a temperature excursion was called with a data logger nor previous temperature excursion was reported. No adverse event was reported.
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; that vaccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 01-NOV-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032321, expiration date 22-SEP-2022 (short expiration date reported as 15-OCT-2021) for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that that vaccines were previously short dated for 1 month after excursion and then were administered after the short date.  The vaccine was stored at the temperature that was reported as 55.9 degrees of Fahrenheit for 30 minutes. There was no previous temperature excursion reported. The date of excursion was provided as 15-SEP-2021.