chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fibrin D dimer, Heart rate, Magnetic resonance imaging
Clinical narrative: Myocarditis; Brief episode of supraventricular tachycardia; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "recovering", described as "Myocarditis"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "recovering", described as "Brief episode of supraventricular tachycardia". The patient underwent the following laboratory tests and procedures: antinuclear antibody: 1:80; blood pressure measurement: 131/83 mmHg; body temperature: 98.9 Fahrenheit; cardiac imaging procedure: delayed hyperenhancement in the lateral epicardium, notes: and in the pericardium and epicardial surface of the anterior and lateral wall (B, arrowheads) consistent with myocarditis by the Lake Louise criteria; c-reactive protein: 3.8 mg/dl; echocardiogram: lvef 25%, mildly dilated rv, notes: and reduced systolic function, moderate mitral regurgitation, no pericardial effusion; lvef 50 to 55%, normal wall motion., notes: RV mildly dilated with mildly reduced function, mild mitral regurgitation; electrocardiogram: sinus rhythm with marked sinus arrhythmia, notes: diffuse ST segment elevation (II, III, aVF, V5 and V6) and ST segment depressions in aVR and V1; fibrin d dimer: 509 ng/ml; heart rate: 83, notes: beats/min; magnetic resonance imaging: unknown results; oxygen saturation: 96 %, notes: on room air; physical examination: unremarkable; polymerase chain reaction: negative; red blood cell sedimentation rate: 20, notes: mm/hr; respiratory viral panel: negative; rheumatoid factor: less than 10; sars-cov-2 antibody test: not performed; troponin: 17.0 ng/ml. Therapeutic measures were taken as a result of myocarditis, supraventricular tachycardia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with 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.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Oxygen saturation, Physical examination, Polymerase chain reaction, Red blood cell sedimentation rate
Clinical narrative: Myocarditis; Brief episode of supraventricular tachycardia; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "recovering", described as "Myocarditis"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "recovering", described as "Brief episode of supraventricular tachycardia". The patient underwent the following laboratory tests and procedures: antinuclear antibody: 1:80; blood pressure measurement: 131/83 mmHg; body temperature: 98.9 Fahrenheit; cardiac imaging procedure: delayed hyperenhancement in the lateral epicardium, notes: and in the pericardium and epicardial surface of the anterior and lateral wall (B, arrowheads) consistent with myocarditis by the Lake Louise criteria; c-reactive protein: 3.8 mg/dl; echocardiogram: lvef 25%, mildly dilated rv, notes: and reduced systolic function, moderate mitral regurgitation, no pericardial effusion; lvef 50 to 55%, normal wall motion., notes: RV mildly dilated with mildly reduced function, mild mitral regurgitation; electrocardiogram: sinus rhythm with marked sinus arrhythmia, notes: diffuse ST segment elevation (II, III, aVF, V5 and V6) and ST segment depressions in aVR and V1; fibrin d dimer: 509 ng/ml; heart rate: 83, notes: beats/min; magnetic resonance imaging: unknown results; oxygen saturation: 96 %, notes: on room air; physical examination: unremarkable; polymerase chain reaction: negative; red blood cell sedimentation rate: 20, notes: mm/hr; respiratory viral panel: negative; rheumatoid factor: less than 10; sars-cov-2 antibody test: not performed; troponin: 17.0 ng/ml. Therapeutic measures were taken as a result of myocarditis, supraventricular tachycardia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with 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.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel, Rheumatoid factor, SARS-CoV-2 antibody test, Supraventricular tachycardia, Troponin
Clinical narrative: Myocarditis; Brief episode of supraventricular tachycardia; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "recovering", described as "Myocarditis"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "recovering", described as "Brief episode of supraventricular tachycardia". The patient underwent the following laboratory tests and procedures: antinuclear antibody: 1:80; blood pressure measurement: 131/83 mmHg; body temperature: 98.9 Fahrenheit; cardiac imaging procedure: delayed hyperenhancement in the lateral epicardium, notes: and in the pericardium and epicardial surface of the anterior and lateral wall (B, arrowheads) consistent with myocarditis by the Lake Louise criteria; c-reactive protein: 3.8 mg/dl; echocardiogram: lvef 25%, mildly dilated rv, notes: and reduced systolic function, moderate mitral regurgitation, no pericardial effusion; lvef 50 to 55%, normal wall motion., notes: RV mildly dilated with mildly reduced function, mild mitral regurgitation; electrocardiogram: sinus rhythm with marked sinus arrhythmia, notes: diffuse ST segment elevation (II, III, aVF, V5 and V6) and ST segment depressions in aVR and V1; fibrin d dimer: 509 ng/ml; heart rate: 83, notes: beats/min; magnetic resonance imaging: unknown results; oxygen saturation: 96 %, notes: on room air; physical examination: unremarkable; polymerase chain reaction: negative; red blood cell sedimentation rate: 20, notes: mm/hr; respiratory viral panel: negative; rheumatoid factor: less than 10; sars-cov-2 antibody test: not performed; troponin: 17.0 ng/ml. Therapeutic measures were taken as a result of myocarditis, supraventricular tachycardia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: vision in left eye is blurry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 10Apr2021, outcome "unknown", described as "vision in left eye is blurry".  Additional information: received 2nd Pfizer vaccine on 01Apr and 9 days later vision in left eye is blurry. Cannot see out of left eye, completely blurry.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: vision in left eye is blurry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 10Apr2021, outcome "unknown", described as "vision in left eye is blurry".  Additional information: received 2nd Pfizer vaccine on 01Apr and 9 days later vision in left eye is blurry. Cannot see out of left eye, completely blurry.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Caller states with the first dose she just had some arm soreness; 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. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller states with the first dose she just had some arm soreness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller states with the first dose she just had some arm soreness; 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. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller states with the first dose she just had some arm soreness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Sinus disorder
Clinical narrative: a sinus issue and it led to mucus; maybe a sore arm a little bit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 20:10 (Lot number: ER8727) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breathing issues" (ongoing); "Inoperable lung cancer", start date: Nov2010 (unspecified if ongoing), notes: Diagnosed Nov2010. She took 2 different chemos for 3.5 years and had 6 weeks of strong radiation; "2 different chemos" (unspecified if ongoing), notes: took 2 different chemos for 3.5 years; "had 6 weeks of strong radiation" (unspecified if ongoing); "Lung issues" (ongoing); "Allergies like in spring and summer" (ongoing). Concomitant medication(s) included: XYZAL. Vaccination history included: Flu shot (she gets the flu shot). The following information was reported: SINUS DISORDER (non-serious) with onset 2021, outcome "unknown", described as "a sinus issue and it led to mucus"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "maybe a sore arm a little bit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinus disorder.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer suspect were none. AE(s) did not require a visit to emergency room or physician office. The patient was not hospitalized. Prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations were none. Takes over the counter product Xyzal every night for the allergies which doesn't always work. The patient had her first dose of Pfizer-BioNTech Covid-19 Vaccine administered on 23Mar2021 and she had maybe a sore arm a little bit which didn't last long, was no big deal and she had no side effects from the first dose. The patient mentioned that about 2 weeks before she was administered the second dose of Pfizer-BioNTech Covid-19 Vaccine she had just started having a sinus issue and it led to mucus. She had tried over the counter which doesn't help so she called primary care doctor to get an antibiotic because she has other medical conditions with breathing issues and lung issues. Her primary care doctor put her on Amoxicillin 500mg 3 times daily started on 12Apr2021, the day before second dose of Pfizer-BioNTech Covid-19 Vaccine. Amoxicillin therapy is ongoing. She can't go to the doctor's office so her appointments are telecom appointments.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Made her tired; she slept like a baby; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8733) as dose 1, single and administration date 23Apr2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Nyquil for sleep, notes: she takes Nyquil to go to sleep. The following information was reported: FATIGUE (non-serious) with onset 02Apr2021 16:00, outcome "unknown", described as "Made her tired"; HYPERSOMNIA (non-serious) with onset 02Apr2021, outcome "unknown", described as "she slept like a baby".  Additional information: Patient (Pt) received her second vaccine and Pt states they just gave her a jab, it was the standard dosage. Pt wanted to give praise and say that it helped her sleep, also stated that she was able to sleep really good with this vaccine. Pt states she actually slept 11 hours. It was wonderful. She doesn't normally sleep more than 4 to 5 hours, her sleeping is horrible. Pt states her doctor wont put her on anything because of the opioid properties, because of being addicted to the medication and sometimes she takes Nyquil to go to sleep. Reports that whatever was in the vaccine into a capsule that would be great. She wants Pfizer to know, if they could come up with a pill that could have the same kind of effects as the shot, that can help people sleep. Pt states she was not reporting it as a bad thing, but as a good thing and was not complaining, she isn't saying she slept so long she was a zombie. Pt states the shots made her tired by 16:00 and she went to bed around 18:30 and woke up at 05:00. She has never had such a good night sleep except for the two nights after she got her vaccine. Pt states if they could do research to get some kind of pill for people like her that would be great. Pt states she really has to go to her appointment (No further information provided).  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "high uric acid" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: FEBUXOSTAT. Past drug history included: Augmentin - amoxicilline when given with Clauvenic acid, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin-amoxicilline when given with Clauvenic Acid (but amoxicilline alone is ok). The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 21Dec2021 09:00, outcome "unknown", described as "pulling on left upper chest". The event "pulling on left upper chest" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of musculoskeletal chest pain. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Febuxostat 40 mg one per day within 2 weeks of vaccination. The patient got the symptom pulling on left upper chest (on the first two doses as well, rushed to ER, but no heart problem was found in the ER). The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for the COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort
Clinical narrative: My legs felt super heavy so I weighed myself to make sure I did not gain weight; my knee area give out and grabbed the edge of the check out conveyor belt area.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "no only had cancer in left breast" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Product: COVID 19 , Brand: Pfizer, Lot number: En6204, Er8734, Lot unknown: False, Administration date: 13Mar2021, Administration time: 11:00 AM, Dose number: 1, Vaccine location: Left arm), administration date: 13Mar2021, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "Felt as if my legs were far more heavy when climbing stairs or walking". The following information was reported: LIMB DISCOMFORT (non-serious) with onset 01May2021 21:00, outcome "not recovered", described as "My legs felt super heavy so I weighed myself to make sure I did not gain weight"; FEELING ABNORMAL (non-serious) with onset 01May2021 21:00, outcome "not recovered", described as "my knee area give out and grabbed the edge of the check out conveyor belt area.". Therapeutic measures were not taken as a result of limb discomfort, feeling abnormal. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Full blood count abnormal, Liver disorder, Product prescribing error
Clinical narrative: She stated she is already passed the 6 weeks since getting the first dose.; liver issues; abnormal blood work results; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PRESCRIBING ERROR (non-serious), outcome "unknown", described as "She stated she is already passed the 6 weeks since getting the first dose."; LIVER DISORDER (non-serious), outcome "unknown", described as "liver issues"; FULL BLOOD COUNT ABNORMAL (non-serious), outcome "unknown", described as "abnormal blood work results". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She explained she has liver issues and following abnormal blood work results, her doctor recommended her to delay her second dose of the Pfizer-BioNTech COVID-19. She stated she is already passed the 6 weeks since getting the first dose. She asked if she would need to restart the vaccination series when getting the second dose later than recommended. If the second dose is given later than 6 weeks (42 days), the vaccination series does not need to be repeated" from CONS-Pfizer-BioNTech COVID-19 Vaccine - timing of Dose 2. can the patient get the vaccine if she have medical conditions document. Added if need be, HCP may call Pfizer to request if there is additional information to assist his clinical decision.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Pharyngitis
Clinical narrative: Strep Throat  like symptoms; Can not eat and bothers him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGITIS (non-serious), outcome "unknown", described as "Strep Throat like symptoms"; EATING DISORDER (non-serious), outcome "unknown", described as "Can not eat and bothers him".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Asthenia, Asthma, Blood glucose increased, Computerised tomogram abdomen abnormal
Clinical narrative: My entire body has itched since August; High fever for 5 days; rash appears makes my skin like leather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "My entire body has itched since August"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "High fever for 5 days"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "rash appears makes my skin like leather". The events "my entire body has itched since august", "high fever for 5 days" and "rash appears makes my skin like leather" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Since taking the Pfizer Booster in Aug2021. The patient had  been in and out of doctors offices, entire body has itched since August. The itching started less than 24 hours after the booster, as well as high fever for 5 days. The patient had another appointment this morning because as the patient can no longer tolerate the itching. Every spot on body where the rash appears makes skin like leather.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Hepatomegaly, Impaired driving ability, Insomnia
Clinical narrative: My entire body has itched since August; High fever for 5 days; rash appears makes my skin like leather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "My entire body has itched since August"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "High fever for 5 days"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "rash appears makes my skin like leather". The events "my entire body has itched since august", "high fever for 5 days" and "rash appears makes my skin like leather" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Since taking the Pfizer Booster in Aug2021. The patient had  been in and out of doctors offices, entire body has itched since August. The itching started less than 24 hours after the booster, as well as high fever for 5 days. The patient had another appointment this morning because as the patient can no longer tolerate the itching. Every spot on body where the rash appears makes skin like leather.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased, Pruritus, Pyrexia
Clinical narrative: My entire body has itched since August; High fever for 5 days; rash appears makes my skin like leather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "My entire body has itched since August"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "High fever for 5 days"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "rash appears makes my skin like leather". The events "my entire body has itched since august", "high fever for 5 days" and "rash appears makes my skin like leather" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Since taking the Pfizer Booster in Aug2021. The patient had  been in and out of doctors offices, entire body has itched since August. The itching started less than 24 hours after the booster, as well as high fever for 5 days. The patient had another appointment this morning because as the patient can no longer tolerate the itching. Every spot on body where the rash appears makes skin like leather.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased, Skin disorder, Skin exfoliation, Splenomegaly, White blood cell count increased
Clinical narrative: My entire body has itched since August; High fever for 5 days; rash appears makes my skin like leather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "My entire body has itched since August"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "High fever for 5 days"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "rash appears makes my skin like leather". The events "my entire body has itched since august", "high fever for 5 days" and "rash appears makes my skin like leather" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Since taking the Pfizer Booster in Aug2021. The patient had  been in and out of doctors offices, entire body has itched since August. The itching started less than 24 hours after the booster, as well as high fever for 5 days. The patient had another appointment this morning because as the patient can no longer tolerate the itching. Every spot on body where the rash appears makes skin like leather.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pruritus, Pyrexia, Rash
Clinical narrative: My entire body has itched since August; High fever for 5 days; rash appears makes my skin like leather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "My entire body has itched since August"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "High fever for 5 days"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "rash appears makes my skin like leather". The events "my entire body has itched since august", "high fever for 5 days" and "rash appears makes my skin like leather" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Since taking the Pfizer Booster in Aug2021. The patient had  been in and out of doctors offices, entire body has itched since August. The itching started less than 24 hours after the booster, as well as high fever for 5 days. The patient had another appointment this morning because as the patient can no longer tolerate the itching. Every spot on body where the rash appears makes skin like leather.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Poor quality sleep
Clinical narrative: then last night I didn't sleep much at all; Diarrhea; headaches; nausea; shivering all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY SLEEP (non-serious), outcome "unknown", described as "then last night I didn't sleep much at all"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "shivering all night".  Additional information:On an unspecified date, patient had diarrhea the first day, had headaches, nausea and then last night she didn't sleep much at all. She was shivering all night. But did not have a fever. Had the first vaccine a month ago and the second one on Tuesday. Thursday, she woke up with a couple of whelps on her arms and then today they were blurring together. This seems to be getting worse. The swelling and itching she did not want to aggravate buy using soap or something. It looked like a rash and was hot to the touch. It wasn't going smaller; it was getting bigger. Patient was asking what she could for it. The first time was minimal symptoms, but the second time was even worse for patient.The patient was allergic to Sulfamides and erythromycin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: High density lipoprotein increased
Clinical narrative: Caller had her blood work done and reports that her HDL went from 50 to 60 to 230.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 08Apr2021 (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: HIGH DENSITY LIPOPROTEIN INCREASED (non-serious), outcome "unknown", described as "Caller had her blood work done and reports that her HDL went from 50 to 60 to 230.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HUMIRA. Vaccination history included: Bnt162b2 (first dose, in left arm; headache and nausea from 08Apr2021, headache was recovered on an unspecified date), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunization, reaction(s): "Headache", "Chills", "Nausea", "Diarrhea", "sore arm". The following information was reported: HEADACHE (non-serious), outcome "recovered" (2021), described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "a sore arm".  Additional information: Patient did not received any vaccine within 4 weeks prior to the COVID-19 vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular vascular disorder
Clinical narrative: I had an eye stroke, without any preexisting conditions or other indicators after months of tests; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administered in arm left, administration date 06Oct2021 (Lot number: 30145ba) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLULAVAL QUADRIVALENT taken for immunization, in the four weeks prior to received vaccine; LISINOPRIL taken for back pain. Past drug history included: Ciproflaxin, reaction(s): "known allergies: Ciproflaxin". Vaccination history included: Bnt162b2 (Dose2, Lot number: er8732), administration date: 31Mar2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose1, lot number: en6199), administration date: 10Mar2021, when the patient was 38 years old, for COVID-19 Immunization. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  The following information was reported: OCULAR VASCULAR DISORDER (hospitalization, disability) with onset 13Oct2021, outcome "recovered with sequelae", described as "I had an eye stroke, without any preexisting conditions or other indicators after months of tests". The patient was hospitalized for ocular vascular disorder (hospitalization duration: 6 day(s)). The event "i had an eye stroke, without any preexisting conditions or other indicators after months of tests" was evaluated at the physician office visit and emergency room visit. Clot Disperal surgery and clot medication were taken as a result of ocular vascular disorder.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (Lot number: en6205) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune/ dysautonomia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; REQUIP; ZOLOFT; WELLBUTRIN; IMVEXXY. Past drug history included: Macrobid, reaction(s): "known allergies: macrobid", notes: known allergies: macrobid, bioxan, levaquin; Bioxan, reaction(s): "known allergies: bioxan"; Levaquin, reaction(s): "known allergies: levaquin". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "migraine headache". Therapeutic measures were not taken as a result of migraine.  Additional Information: The patient was administered dose 1 at 09:15 AM and experienced 10 day migraine headache. The patient reported that no other vaccine was administered in four weeks. The patient had no Covid prior vaccination and had not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she also got Covid right after the vaccine; she also got Covid right after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Nov2021 (Lot number: FH8027) as dose 2, single and administration date 16Oct2021 (Lot number: FF2590) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she also got Covid right after the vaccine". The event "she also got covid right after the vaccine" and "she also got covid right after the vaccine" was evaluated at the emergency room visit.  Clinical course: The reporter called before a couple of times about the poison that she was given 3 months ago, the Pfizer Covid Vaccine. States that she has been to the Emergency Room like three times. Caller states that she also got Covid right after the vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder
Clinical narrative: she also got Covid right after the vaccine; she also got Covid right after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Nov2021 (Lot number: FH8027) as dose 2, single and administration date 16Oct2021 (Lot number: FF2590) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she also got Covid right after the vaccine". The event "she also got covid right after the vaccine" and "she also got covid right after the vaccine" was evaluated at the emergency room visit.  Clinical course: The reporter called before a couple of times about the poison that she was given 3 months ago, the Pfizer Covid Vaccine. States that she has been to the Emergency Room like three times. Caller states that she also got Covid right after the vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: not able to move her right leg.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization.  The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "not able to move her right leg.".  Additional information: Patient was a consumer who received the second dose for Pfizer-BioNTech COVID-19 vaccine 3 months ago and is not able to move her right leg. Patient thought Pfizer is not doing anything about side effects of the vaccine and that other people have been reporting this adverse event on the internet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder
Clinical narrative: not able to move her right leg.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization.  The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "not able to move her right leg.".  Additional information: Patient was a consumer who received the second dose for Pfizer-BioNTech COVID-19 vaccine 3 months ago and is not able to move her right leg. Patient thought Pfizer is not doing anything about side effects of the vaccine and that other people have been reporting this adverse event on the internet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 04Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PAPULAR (non-serious) with onset 04Apr2021, outcome "unknown", described as "red bumps on my chest 4 hours after". Additional information: Patient got the Pfizer shot 04April2021 and patient schedule to get the second shot but patient has question about when got the first shot patient had red bumps on chest 4 hours after so patient was afraid to get second shot because same reaction. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First shot-only pain in arm where injection given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 09:30 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; DEXILANT. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Apr2021 15:00, outcome "recovered", described as "First shot-only pain in arm where injection given". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility type vaccine was Public. No other vaccine in four weeks. No covid prior vaccination. Not tested for Covid post vaccination. There were no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.