chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphoedema, Non-Hodgkin's lymphoma
Clinical narrative: Non-Hodgkin Lymphoma; She felt pain in her chest; Lymphedema; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 68-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on Jan2021 (at the end of January) at single dose for covid-19 immunization.  Medical history included neoplasm malignant from an unknown date and unknown if ongoing She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery , ongoing non-hodgkin's lymphoma She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery. The patient's concomitant medications were not reported. The patient experienced non-hodgkin lymphoma, she felt pain in her chest, lymphedema on an unspecified date. The outcome of the events was unknown. She mentioned that she has cancer, non-Hodgkin Lymphoma and is in need of surgery. Consumer is asking for the vaccine efficacy after receiving one dose of the vaccine. Consumer mentioned that after the first dose, she felt pain in her chest and lymphedema, and is worried for her second shot. Consumer is asking about the allowed dosing interval between the first and second dose.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Loss of consciousness, Malaise, Road traffic accident
Clinical narrative: had a serious allergic reaction to her first COVID 19 shot; passed out while driving her car; On the way home she started to feel sick; She had a small accident, hitting a street sign; The next day she started having respiratory symptoms and spent the day in the ER because she was having difficulty breathing.; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A female patient of an unspecified age received her fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a serious allergic reaction to her first COVID 19 shot. She waited after receiving the shot for 15 mins and felt fine. On the way home, she started to feel sick and passed out while driving her car. She had a small accident, hitting a street sign. The next day she started having respiratory symptoms and spent the day in the ER because she was having difficulty breathing. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: break a blood vessel in her left eye; felt sick to her stomach; threw up; Half of the white in her left eye turned solid red; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not provided), via an unspecified route of administration on right arm, at 66-year-old (not pregnant at vaccination), on 15Feb2021 at 15:00 as a single dose for COVID-19 immunization. The vaccine was received in hospital. Medical history included ongoing chronic back pain, high blood pressure. No known allergies were reported. The patient did not experience COVID-19 prior vaccination. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO), fluoxetine hydrochloride (PROZAC), triamterene, baclofen. No other vaccine was received in four weeks. On 21Feb2012 at 12:00 (reported as 6 days later) the patient felt sick to her stomach and threw up which caused her to break a blood vessel in her left eye. Half of the white in her left eye turned solid red. Later she felt fine and was able to eat dinner. The patient did not have COVID-19 test post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information on the batch/lot number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test, Heart rate
Clinical narrative: Patient's heart went out of rhythm and began to beat very rapidly; This is a spontaneous report from a contactable consumer (patient).   A 78-year-old female patient (weight: 71.21 kg, height: 168 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) on the left arm, at single dose, on 17Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder and acid reflux (oesophageal), both from an unspecified date. Concomitant medication included levothyroxine, from an unspecified date, at an unknown dose, for thyroid disorder. On an unspecified date, in Feb2021, the patient's heart went out of rhythm and began to beat very rapidly. No treatment received. Blood test was performed on an unspecified date, in Feb2021 to check vitamin D level, B12 level and thyroid (unknown result). Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse event was unknown at time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: has auto immune disorder; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that patient had first vaccine shot, has auto immune disorder "prethzone" (as reported) then scheduled for 2nd shot this Sunday, and has spoken to HCP.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Body temperature, Chills, Dehydration
Clinical narrative: IBD; Fever of 100.1; Bad nausea; Chills; Dizziness; fell down from the dizziness, lost his footing; Dizziness; fell down from the dizziness, lost his footing/suffered from dizziness before, but that was maybe about a year ago; Dizziness; fell down from the dizziness, lost his footing; dehydrated; This is a spontaneous report from a contactable consumer. A 49-years-old male patient (husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231), via an unspecified route of administration on an unspecified date (49-years-old) at single dose (Left arm) for COVID-19 immunization. Medical history included dizziness. The patient's concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that the app is down, the safety app because they were trying it. Reporter was calling to report side effects.  Reporter and husband, for which they were calling about, they took the Pfizer COVID-19 Vaccine at 7:30 am on an unspecified date. When probed for side effects, reporter stated that the patient experienced Fever of 100.1, really bad nausea, and chills. He also experienced some dizziness, so much that he fell, he fell down from the dizziness, and he lost his footing. Reporter was informed about role of Pfizer Drug Safety. When asked about other medical conditions, reporter stated that he had dizziness, he had suffered from dizziness before, but that was maybe about a year ago, he suffered from occasional dizziness but he may have been dehydrated because he didn't have that much water today. On lab work, reporter stated that actually he did, it said something about the (statement incomplete), he did have blood work, but it said something about he has disposition, well, it's such a small sign of IBD (further details unknown). Reporter stated that they gave him two Tylenols 500 mg each as treatment. The outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Inflammatory bowel disease, Nausea, Pyrexia
Clinical narrative: IBD; Fever of 100.1; Bad nausea; Chills; Dizziness; fell down from the dizziness, lost his footing; Dizziness; fell down from the dizziness, lost his footing/suffered from dizziness before, but that was maybe about a year ago; Dizziness; fell down from the dizziness, lost his footing; dehydrated; This is a spontaneous report from a contactable consumer. A 49-years-old male patient (husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231), via an unspecified route of administration on an unspecified date (49-years-old) at single dose (Left arm) for COVID-19 immunization. Medical history included dizziness. The patient's concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that the app is down, the safety app because they were trying it. Reporter was calling to report side effects.  Reporter and husband, for which they were calling about, they took the Pfizer COVID-19 Vaccine at 7:30 am on an unspecified date. When probed for side effects, reporter stated that the patient experienced Fever of 100.1, really bad nausea, and chills. He also experienced some dizziness, so much that he fell, he fell down from the dizziness, and he lost his footing. Reporter was informed about role of Pfizer Drug Safety. When asked about other medical conditions, reporter stated that he had dizziness, he had suffered from dizziness before, but that was maybe about a year ago, he suffered from occasional dizziness but he may have been dehydrated because he didn't have that much water today. On lab work, reporter stated that actually he did, it said something about the (statement incomplete), he did have blood work, but it said something about he has disposition, well, it's such a small sign of IBD (further details unknown). Reporter stated that they gave him two Tylenols 500 mg each as treatment. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract infection
Clinical narrative: Respiratory infection; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. Medical history included COPD (chronic obstructive pulmonary disease) and disabled. Concomitant medications included budesonide/formoterol fumarate (SYMBICORT) and tiotropium bromide (SPIRIVA).  The patient previously took paracetamol (TYLENOL) prior to the 1st dose. The patient got both doses of the Covid vaccine. He took Tylenol prior to the 1st dose and wanted to know if that would do anything to the vaccine. He was also on an antibiotic from Pfizer for a respiratory infection on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mitral valve prolapse, Palpitations, Paraesthesia
Clinical narrative: mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS).  The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 test, Swelling, Swelling face
Clinical narrative: Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration at right arm at the age of 31-year-old on 13Feb2021 07:00 at single dose for Covid-19 immunisation. Medical history included allergies to Sulfa. There were no concomitant medications in two weeks or other vaccine in four weeks. On Monday 22Feb2021 06:00 AM, the patient woke up in the morning with swelling on the left side of his face over his Jaw. Throughout the day the swelling increased and began to swell on the right side as well. That evening he went to an urgent care and was prescribed an antibiotic. When he woke up in the morning of Tuesday the 23Feb2021 his face was severely swollen and the swelling was going down into his neck on both sides. He went to the emergency room (ER) and was admitted overnight. He was given intravenously (IV) antibiotics, steroids and fluids. All blood tests came back normal and negative(Feb2021). When the swelling went down considerably, he was discharged on Wednesday 24Feb2021 and sent home with a steroid and antibiotic to take orally. Upon waking up this morning, on 25Feb2021 the swelling in his face and neck had returned. Adverse events were resulted in emergency room/department or urgent care and hospitalization. There was no COVID prior vaccination. The COVID tested post vaccination. The patient underwent lab tests included nasal swab was negative on 23Feb2021. The outcome of events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: shortness of breath; A fib; Had water in my lungs; This is a spontaneous report from a contactable consumer (patient self). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration (location: left arm) on 29Jan2021 at age of 70-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes. She had known allergies: Penicillin. The patient had a history of atrial Fib (Atrial fibrillation) but had been in sinus rhythm for a long time. No COVID prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). On 30Jan2021 09:00 AM, after first dose of BNT162B2, she went to the emergency room (ER) with shortness of breath and in A fib (Atrial fibrillation), she also had water in her lungs. The events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient stayed for 5 days in hospital. She received unspecified medications as treatment. COVID tested post vaccination (Nasal Swab) on 22Feb2021 resulted negative. The outcome of events was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: Pneumonia; arm soreness; This is a spontaneous report from a contactable consumer (patient's boyfriend). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient experienced arm soreness after first dose. And she was prescribed azithromycin (ZITHROMAX) and amoxicillin/ clavulanic acid (AUGMENTIN) to take because she was just diagnosed with pneumonia. And it's due for her second dose "tomorrow" 26Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Eye haemorrhage, Headache, Sinus headache
Clinical narrative: Burst blood vessel in her eye; Really bad headache/Her head was throbbing; Chills; Sinus headache; Her ear hurt; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9266, expiration date: 31May2021, via an unspecified route of administration at left arm on 17Feb2021 at a single dose for Covid-19 immunisation. Medical history included migraine diagnosed 35-40 years ago, aneurysm from 01Aug2018 and lung cancer. There were no concomitant medications. The patient reported that she had a really bad headache the next day on 18Feb2021, after getting her first dose of the vaccine on Wednesday, 17Feb2021. She sated that on the 18th she had chills and the really bad headache, and she has a history of migraines and also has an aneurysm in her brain which she doesn't know how long that has been there. She says she also looked in the mirror this morning 19Feb2021, while putting her make up on and saw that a blood vessel had burst in her eye, which could have been from the pressure she had from the headache. She says her second dose is scheduled on 10Mar2021. She says that she had a little headache the afternoon she got the vaccine that went away, then the next morning at 04:00 am her head was throbbing, and she suffers from migraines but this felt like a sinus headache. Her ear hurt and she thought it was more sinus then, and nothing she took for it would alleviate the pain. She says when she got up then she got chills. She says that nothing she did like she normally does helped, like she tried heat and cold it was not going to give. She says that she used ice packs then put heat on her shoulder, and also did a Neti pot, maybe that caused her eye have blood vessel burst in it, she doesn't know. She says that the blood vessel burst in her right eye, which seems to have gotten better since this morning, it is not quite as red. She says it could be that she rubbed it. She says her headache is gone now and her chills are gone. The patient recovered from the events really bad headache/Her head was throbbing and chills on 19Feb2021, for the event burst blood vessel in her eye was recovering. The outcome of the event Sinus headache was not recovered while the outcome of the event ear hurt was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable consumer (patient himself). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration at Left arm on 23Feb2021 12:00 pm (at 46-year-old) at single dose for COVID-19 immunisation in hospital. Medical history included Seminoma from 2011, Suframides allergy. The patient's concomitant medications were not reported. The patient experienced Atrial fibrillation on 25Feb2021 02:30 am. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The events were not resulted in emergency room visit or physician office visit. No treatment received. The outcome of the event was Recovered on 25Feb2021.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Confusional state, Dizziness, Fatigue, Heart rate
Clinical narrative: sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; sudden fatigue; confusion; Chest tightness and pressure; This is a spontaneous report from a contactable healthcare professional (patient herself). A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN9581) on 13Feb2021 12:30 PM, via unknown route of administration, at the age of 24-year-old at single dose in Left arm for COVID-19 immunization. The patient medical history includes known allergies: Penicillin, Sulfur meds. The patient concomitant drug includes desvenlafaxine succinate (PRISTIQ). 10 mins after shot (as reported), the patient experienced sudden feelings of nausea, dizziness, rapid heart rate, sweating, tingly sensation in extremities, sudden fatigue, confusion. Chest tightness and pressure lasting 4 days. All the events reported started at 13Feb2021 12:45 PM, resulted in: [Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization)]. Treatment was reported as no. No COVID prior vaccination. No COVID tested post vaccination. The event outcome of 'Chest tightness and pressure' was recovered on 17Feb2021 and the rest of event was recovered in Feb2021.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between reported events and suspect product BNT162B2 cannot be ruled out.  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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; sudden fatigue; confusion; Chest tightness and pressure; This is a spontaneous report from a contactable healthcare professional (patient herself). A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN9581) on 13Feb2021 12:30 PM, via unknown route of administration, at the age of 24-year-old at single dose in Left arm for COVID-19 immunization. The patient medical history includes known allergies: Penicillin, Sulfur meds. The patient concomitant drug includes desvenlafaxine succinate (PRISTIQ). 10 mins after shot (as reported), the patient experienced sudden feelings of nausea, dizziness, rapid heart rate, sweating, tingly sensation in extremities, sudden fatigue, confusion. Chest tightness and pressure lasting 4 days. All the events reported started at 13Feb2021 12:45 PM, resulted in: [Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization)]. Treatment was reported as no. No COVID prior vaccination. No COVID tested post vaccination. The event outcome of 'Chest tightness and pressure' was recovered on 17Feb2021 and the rest of event was recovered in Feb2021.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between reported events and suspect product BNT162B2 cannot be ruled out.  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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriospasm coronary, Cardiac monitoring
Clinical narrative: coronary artery spasms; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Em9810), on 04Feb2021 04:00 PM (at the age of 41-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant the time of event and at the time of vaccination. The patient's medical history included hypertension, covid prior vaccination and no known allergies. The patient's concomitant medications included buspirone, bupropion and lisinopril. No other vaccines were administered in four weeks prior to vaccination. It was reported that unknown if related but odd that this happened one week after her initial vaccine (11Feb2021 10:00 AM). She was hit with what felt like a heart attack. Emergency room (ER) ruled out heart attack but it was possibly coronary artery spasms. She was getting heart monitor because she continued to have episodes that were decreasing in intensity each time (she got around 2 per week). The event was reported as serious with criteria hospitalization. The patient was hospitalized for one day (Feb2021). Therapeutic measure was taken as a result of the event and included that patient was put on new medicine verapamil. The outcome of the event was resolving.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (reporting for husband) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for  COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter mentioned that they will not get the vaccine scheduled on Wednesday (24Feb2021) as her husband got hospitalized (dates unspecified) because of pneumonia on an unknown date. Reporter was asking if they can extend the date of the second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pemphigoid, Rash erythematous
Clinical narrative: It looks like bullous pemphigoid; he developed an erythematous rash on his extremities which has begun to blister.; he developed an erythematous rash on his extremities which has begun to blister.; This is a spontaneous report from a contactable physician via a sales representative. A 69-year-old male patient received second dose of bnt162b2 (bnt162b2), via an unspecified route of administration from on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included diabetes and parkinson's disease. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation on an unknown date. After received r the second dose of the bnt162b2, two days post doe the patient developed an erythematous rash on his extremities which had begun to blister. It looked like bullous pemphigoid. The event outcome was unknown.; Sender's Comments: Based on the available information and on a reportedly close temporal association,  causality cannot be excluded between the events and the administration of the suspect product BNT162B2 (COVID-19 MRNA VACCINE BIONTECH). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain assessment, Pain in extremity
Clinical narrative: Severe pain episodes; Arm soreness; fatigue; intermittent body pain; intermittent headaches with highest level of pain at 7; This is a spontaneous report from a contactable consumer. A 16-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included neurological issues for over 2yrs. The patient's concomitant medications were not reported. It was reported that, after first dose of vaccine, since Feb2021, the patient experienced arm soreness, fatigue, intermittent body pain, intermittent headaches with highest level of pain at 7, using scale of 0-10, with 0 being no pain. Intermittent pains still continue. The patient had a history of neurological issues for over 2yrs. Severe pain episodes requiring hospitalization in Feb2021. Triggers for episodes have not been determined. The patient was on 25mg amitriptyline QHS (before bed). It's possible that the first dose of the BNT162B2 has triggered the beginning of an episode. Lab data on Feb2021 included pain highest level of pain at 7, using scale of 0-10, with 0 being no pain. The event outcome was reported as unknown.  Information about Batch/Lot number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated
Clinical narrative: relapse of chronic inflammatory demyelinating polyneuropathy; relapse of chronic inflammatory demyelinating polyneuropathy; This is a spontaneous report from a contactable consumer (patient self). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration on 21Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included ongoing chronic inflammatory demyelinating polyneuropathy (CIDP). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. No Covid prior vaccination. There were no concomitant medications. The patient reported he was fine until after the second dose and he was having a relapse of chronic inflammatory demyelinating polyneuropathy on 23Feb2021 12: 00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient was trying to get intravenous immunoglobulin (IVIG) as treatment. Covid was not tested post vaccination. The outcome of event was unknown.  Information on the Lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary embolism, Pulmonary infarction, SARS-CoV-2 test
Clinical narrative: Pulmonary embolisms; lung infarcts in left and right lungs; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL5269), via an unspecified route of administration at site of left arm at 15:00 on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included psoriasis and known allergies: clarithromycin. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date. The patient experienced pulmonary embolisms and lung infarcts in left and right lungs on 11Feb2021. The patient was hospitalized for these events for 2 days. COVID was tested post vaccination (Nasal Swab covid test with negative result on 12Feb2021). No other vaccine received in four weeks. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient received treatment (blood thinners and CT Imaging) for adverse event. No COVID prior vaccination. The outcome of events was recovered in Feb2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Pain in extremity
Clinical narrative: The heels on both feet became painful; Pain was so severe I could not walk for several days; This is a spontaneous report from a contactable consumer.  A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247, via an unspecified route of administration on 03Feb2021 07:30 at SINGLE DOSE for covid-19 immunisation; vaccine location: left arm; dose number: 1; facility type vaccine: hospital and pravastatin (PRAVASTATIN), via an unspecified route of administration from an unspecified date to an unspecified date at UNK for an unspecified indication. The patient medical history and concomitant medications were not reported. In 1971 the patient took rabies vaccine inact (duck embryo) and experienced anaphylactic reaction. Approximately one week after the vaccination, on 07Feb2021 07:30,  the patient experienced "heels on both feet became painful. The pain was so severe I could not walk for several days". The pain was present all day, even all night long. The patient was treated with ibuprofen Outcome: recovering. . Information on Batch/lot has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate decreased, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed.  information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient's age and by the mentioned high blood pressure, known risk factor for  cardiovascular diseases.  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.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Bacterial test positive, Beta haemolytic streptococcal infection, Exposure during pregnancy, Neonatal cystic fibrosis screen, Prenatal screening test
Clinical narrative: Group B Streptococcus; Vaccine exposure during pregnancy; This observational study case was received on 25-Feb-2021 from other health professional and concerned a 25-year-old, pregnant female subject of body weight: 151 lbs, height: 65 inches and body mass index (BMI): 25.1, enrolled, a prospective observational safety study.   The subject's concurrent conditions included body mass index high (BMI: 25.1), body itch and drug allergies. The subject's concomitant medication included OB complete (multivitamin, multimineral) for healthy pregnancy.  The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal history with MCM.    The subject's last menstrual period (LMP) date was 01-Aug-2020, estimated delivery date (EDD) was reported as 08-May-2021 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   On 09-Sep-2020, at gestational age of 5 weeks (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. The batch number reported was P100239705.  On 15-Oct-2020, cystic fibrosis mutation analysis revealed no MCM.  On 23-Oct-2020, first trimester screen revealed no MCM.  On 14-Dec-2020, second sequential screen revealed no MCM.  On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed group B Streptococcus infection.  On 21-Jan-2021, the subject was treated with clindamycin, at a dose of 300 mg, three times a day, orally, until 27-Jan-2021.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'bacterial infection due to streptococcus, group B' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 25-year-old subject was administered Afluria QIV at gestational age of 5 weeks. On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed group B Streptococcus infection. Causal role of the suspect vaccine is assessed as not related, due to biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A 25-year-old subject was administered Afluria QIV at gestational age of 5 weeks. On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed group B Streptococcus infection. Causal role of the suspect vaccine is assessed as not related, due to biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Heart rate decreased, Lacrimation increased, Palpitations
Clinical narrative: Pt reported glossitis, "racing heart", and eye tearing 4 minutes after vaccine administration. Assessed HR at 121 initially; down to 74 after 20 minutes of rest.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, General physical condition abnormal, Glassy eyes, Hyperhidrosis, Thirst
Clinical narrative: Another customer in the store called over to the technician and pharmacist on duty stating the patient looked sick. He had dropped his timer that was counting down his 15 min post dose wait time. Pharmacist approached patient and asked him how he was doing. He was initially non-responsive, eyes were slightly glazed over. I repeatedly asked him his name and how he was doing. He began to respond after prompting, saying he felt very hot and sweaty. He stated he was thirsty and he hadn't eaten anything before his dose. Technician obtained a glass of water and a granola bar for the patient. Patient began to improve just minutes after food and water. He stated he thought he had stood for too long while waiting for his shot and hadn't eaten that morning so he began to feel sick. Patient recovered enough to call his daughter to pick him up from the store. His daughter arrived to pick him up and patient was able to walk out of the store without issue.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Another customer in the store called over to the technician and pharmacist on duty stating the patient looked sick. He had dropped his timer that was counting down his 15 min post dose wait time. Pharmacist approached patient and asked him how he was doing. He was initially non-responsive, eyes were slightly glazed over. I repeatedly asked him his name and how he was doing. He began to respond after prompting, saying he felt very hot and sweaty. He stated he was thirsty and he hadn't eaten anything before his dose. Technician obtained a glass of water and a granola bar for the patient. Patient began to improve just minutes after food and water. He stated he thought he had stood for too long while waiting for his shot and hadn't eaten that morning so he began to feel sick. Patient recovered enough to call his daughter to pick him up from the store. His daughter arrived to pick him up and patient was able to walk out of the store without issue.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza virus test negative, Pyrexia
Clinical narrative: severe fatigue, chills, fever 100.1, abdominal discomfort lasted 3 days
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe fatigue, chills, fever 100.1, abdominal discomfort lasted 3 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pruritus, Throat irritation
Clinical narrative: Itchy throat and skin approx 10 min after injection. After another 3 minutes, felt tightness in chest. No trouble speaking or breathing. Chest tightness resolved spontaneously and itchiness improved upon discharge. No treatment necessary.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: After 9 days the spot on my arm where I received the vaccine began swelling, is red and itchy.  Today (next day) I am experiencing chills and a headache.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: Arm would turn red and splotchy, feel very warm to touch, and extremely itchy.  This would come and go several times throughout the day.   Everything resolved after 3-4 days except for the itchiness which is still occurring at least once a day without the other symptoms.  (Now on day 8)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Red  rash at injection site appearing 6 days after vaccination. Itchy. No swelling.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Woke up on day 5 (2/25) after shot with sore armpit on left side.  It's day 11 (3/3) and symptoms gone.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Body Rash, itching
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Paralysis, Rash, Swelling
Clinical narrative: rash, extreme swelling, severe pain, partial paralysis over 12 hours
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Rash
Clinical narrative: Arm very sore for 2 days. Third day a rash on both arms. Very itchy so I took Benadryl and it subsided. On the third day the chills started around 2:00 in the afternoon. Went to bed with pajamas ,socks ,and a robe in order to keep warm because of the chills. Woke up this morning and the chills were gone and I feel great.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site pain, Nausea, Pain
Clinical narrative: flu like symptoms, body ache, nausea, fatigue. Appeared about 12 hours after second dose and lasted about 24 hours before it resolved.  Arm pain at injection site, resolved 2-3 days after, aleve took away the pain.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lethargy, Musculoskeletal chest pain, Pain, Pain in extremity
Clinical narrative: Sore arm after shot through the night (could not sleep on that side); Sunday, lethargic, very sore arm; Sunday 2/28 nightime extreme inflammatory entire body pain, fever, racing heart.  Could not sleep all night; Monday, 3/1 am, (traveling, so had to go to store) 200mg ibuprofen, could not function out of bed; slept and stayed in bed; 200 mg ibuprofen in PM, intense body paid (like a truck had driven over my entire core body and legs), slight fever; could not sleep more than 2 hours  at a time; Tuesday, continued body paid, but could get up and function.  Still felt like my ribs were broken; took 200 mg ibuprofen.  Today, Thursday, March 4, some residual rib and back pain, no fever.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Sleep disorder
Clinical narrative: Sore arm after shot through the night (could not sleep on that side); Sunday, lethargic, very sore arm; Sunday 2/28 nightime extreme inflammatory entire body pain, fever, racing heart.  Could not sleep all night; Monday, 3/1 am, (traveling, so had to go to store) 200mg ibuprofen, could not function out of bed; slept and stayed in bed; 200 mg ibuprofen in PM, intense body paid (like a truck had driven over my entire core body and legs), slight fever; could not sleep more than 2 hours  at a time; Tuesday, continued body paid, but could get up and function.  Still felt like my ribs were broken; took 200 mg ibuprofen.  Today, Thursday, March 4, some residual rib and back pain, no fever.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Pt. reported feeling SOB with exertion 20 minutes after receiving second dose of COVID 19 vaccine. Pt. was speaking in full unlabored sentences without obvious signs of increased work of breathing.  ACC provider was called to assess and ordered MDI albuterol inhaler/ spacer. Pt. ambulated and was able to maintain Sa02 of 97% while ambulating.  Pt. was observed for 60 minutes and discharged home with grand daughter in no apparent distress and reported improvement of dyspnea.   Pt. did report that she routinely has "sudden" onset of SOB with ambulation and this was not unlike previous episodes other than having just had vaccine administration.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Got home on Saturday morning, no problem after having the shot. Sunday noticed a rash on trunk. Treated herself with Benadryl. Got worse over the next few days, belly, back, groin and armpit. Went to ER, started IV, Solumedrol, Benadryl, Prevacid, followup with pcp.  Seemed to get better. Today, it's worse.  . PCP stated if not better she is to go into the office for an injection.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Tongue numbness/swelling, given PO Benadryl 50 mg and observed for 30 minutes. Symptoms improved, pt. released.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: PT ARRIVED IN OBSERVATION AREA, AND STATED THAT SHE FELT TINGLING AROUND HER LIPS.  VS WERE INITIATED. 3:52PM HR 90 BP 126/64 O2 96%.  MONITIORED VS EVERY TEN MINUTES. PT WAS ADMINESTERED 25 MG OF DIPHEHYDRAMINE 0.5 ML AT 4:05PM. AT 4:30 PT STATED THAT THEY STILL FELT TINGLING. ANOTHER DOSE OF 25MG OF DIPHENHYDRAMINE WAS ADMINESTERED. MONITORED PATIENT FOR AN ADDITIONAL  30 MINUTES. PT WAS ESCORTED BY SPOUSE STABLE.