chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: uti after first dose; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included urinary tract infections (UTI) from an unknown date and ongoing. Concomitant medications were not reported. The patient reported that she was getting her second vaccine that Thursday (as of 02Mar2021) and was taking cefalexin (KEFLEX) for a UTI. She inquired if that was going to be a problem or if it was okay. She reported she got a UTI after her first dose, but clarified she gets UTIs every month or so, and that it was an ongoing issue. The clinical outcome of UTI was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Malaise, Pain
Clinical narrative: SOB; High fever (103.9-104); Sweating; Chills; Body aches; Not feeling well; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports for the same patient with reoccurring events separated in time.  A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular route administered in the right arm (reported as R deltoid) on 07Jan2021 at the age of 55-years old (Batch/Lot Number: EK9231) as a single dose for COVID-19 immunization at a hospital. Medical history included COVID-19 from Jul2020 to an unknown date (the patient was not admitted to the hospital due COVID-19, treatment included an inhaler and the patient was still experiencing the event), headache from Jul2020 to an unknown date, chills from Jul2020 to an unknown date, not feeling well from Jul2020 to an unknown date. The patient previously received the first dose of BNT162B2 via intramuscular route administered in the right arm (reported as R deltoid) on 17Dec2020 at the age of 55 years-old, (Batch/Lot Number: EK5730) as a single dose for COVID-19 immunisation. After the first dose of BNT162B2, the patient experienced chills, body aches, fever, shortness of breath, tired, headache, at 03.00 am and Not feeling well, lymph node swollen under right arm with severe pain along with injection site pain. The patient did not have any other vaccination within 4 weeks prior to getting the BNT162B2. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication from 2008 and ongoing; estradiol (Manufacturer unknown) taken for an unspecified indication from 2008 and ongoing; hydrochlorothiazide (Manufacturer unknown) taken for an unspecified indication from 2008 and ongoing. On 07Jan2021 at 22:30, after the second dose of BNT162B2, the patient experienced chills, body ache, high fever (103 degree celsius-104), shortness of breath, not feeling well and sweating. The patient continues to have shortness of breath with any activity. The events did not require emergency room or physician office visit. The patient was not hospitalized. Treatment included antipyretic Tylenol/Ibuprofen Oral (PO) 500mg/800mg after the vaccination for fever, an inhaler for shortness of breath. The outcome of chills, high fever was recovered. The outcome of shortness of breath and not feeling well was not recovered. The outcome of body aches, sweating was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020503298 same patient, drug/ different dose, event
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SOB; High fever (103.9-104); Sweating; Chills; Body aches; Not feeling well; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports for the same patient with reoccurring events separated in time.  A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular route administered in the right arm (reported as R deltoid) on 07Jan2021 at the age of 55-years old (Batch/Lot Number: EK9231) as a single dose for COVID-19 immunization at a hospital. Medical history included COVID-19 from Jul2020 to an unknown date (the patient was not admitted to the hospital due COVID-19, treatment included an inhaler and the patient was still experiencing the event), headache from Jul2020 to an unknown date, chills from Jul2020 to an unknown date, not feeling well from Jul2020 to an unknown date. The patient previously received the first dose of BNT162B2 via intramuscular route administered in the right arm (reported as R deltoid) on 17Dec2020 at the age of 55 years-old, (Batch/Lot Number: EK5730) as a single dose for COVID-19 immunisation. After the first dose of BNT162B2, the patient experienced chills, body aches, fever, shortness of breath, tired, headache, at 03.00 am and Not feeling well, lymph node swollen under right arm with severe pain along with injection site pain. The patient did not have any other vaccination within 4 weeks prior to getting the BNT162B2. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication from 2008 and ongoing; estradiol (Manufacturer unknown) taken for an unspecified indication from 2008 and ongoing; hydrochlorothiazide (Manufacturer unknown) taken for an unspecified indication from 2008 and ongoing. On 07Jan2021 at 22:30, after the second dose of BNT162B2, the patient experienced chills, body ache, high fever (103 degree celsius-104), shortness of breath, not feeling well and sweating. The patient continues to have shortness of breath with any activity. The events did not require emergency room or physician office visit. The patient was not hospitalized. Treatment included antipyretic Tylenol/Ibuprofen Oral (PO) 500mg/800mg after the vaccination for fever, an inhaler for shortness of breath. The outcome of chills, high fever was recovered. The outcome of shortness of breath and not feeling well was not recovered. The outcome of body aches, sweating was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020503298 same patient, drug/ different dose, event
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on 2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bell's palsy on 09Feb2021, still going on today 02Mar2021. She was wondering if she should still get the second dose and when. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Palpitations
Clinical narrative: irregular heart beat/a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the caller.; pulse rate was high/a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the caller.; would wake up in the middle of the night with her heart pounding like crazy/a woman stopped her and said she had COVID with the same symptoms; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, 04Mar2021 at single dose for COVID-19 immunization. The patient medical history included heart attack, Covid-19, concomitant medication was not reported. Patient experienced after two days irregular heart beat, wake up in the middle of the night with her heart pounding like crazy, pulse rate was high/a women at the pharmacy tapped her shoulder and told her she had received the vaccine too and experienced the same thing as the caller, wake up in the middle of the night with her heart pounding like crazy. The outcome of event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021297868 same drug/event, different patient;US-PFIZER INC-2021294406 same drug/event, different patient
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bell's palsy, Ear pain, Neck pain, Otorrhoea
Clinical narrative: left eye and left side of mouth was not working/Bell's palsy.; left ear was hurting all day; drainage in patient left ear; neck down to elbow was sore; neck down to elbow was sore/soreness on arm; neck down to elbow was sore; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer  (non-pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history was none. Concomitant medications included metformin and prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 mins after the shot patient neck down to elbow was sore. On 14Mar2021 the soreness on arm went away but patient neck was still sore. 14Mar2021 night there was drainage in patient left ear. On 15Mar2021 patient left ear was hurting all day. 16Mar2021 morning (07: 45 am) patient woke up with no more pain in left ear, but left eye and left side of mouth was not working. Patient went to ER and they said patient have Bell's palsy. Patient had no control of the left side of face by 18Mar2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Event Bell's palsy resulted in emergency room/department or urgent care, disability or permanent damage, and patient received unspecified medications as treatment for the event.  Outcome of events pain in arm/elbow was recovered on 14Mar2021, outcome of event left ear was hurting was recovered on 16Mar2021, outcome of events Bell's palsy and neck pain was not recovered, and outcome of event drainage in patient left ear was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left eye and left side of mouth was not working/Bell's palsy.; left ear was hurting all day; drainage in patient left ear; neck down to elbow was sore; neck down to elbow was sore/soreness on arm; neck down to elbow was sore; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer  (non-pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history was none. Concomitant medications included metformin and prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 mins after the shot patient neck down to elbow was sore. On 14Mar2021 the soreness on arm went away but patient neck was still sore. 14Mar2021 night there was drainage in patient left ear. On 15Mar2021 patient left ear was hurting all day. 16Mar2021 morning (07: 45 am) patient woke up with no more pain in left ear, but left eye and left side of mouth was not working. Patient went to ER and they said patient have Bell's palsy. Patient had no control of the left side of face by 18Mar2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Event Bell's palsy resulted in emergency room/department or urgent care, disability or permanent damage, and patient received unspecified medications as treatment for the event.  Outcome of events pain in arm/elbow was recovered on 14Mar2021, outcome of event left ear was hurting was recovered on 16Mar2021, outcome of events Bell's palsy and neck pain was not recovered, and outcome of event drainage in patient left ear was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: Seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration in right arm on 11Mar2021 at 13:00 as a single dose for COVID-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and COVID-19 (if COVID prior vaccination: Yes). No known allergies. Concomitant medications included metformin; insulin lispro (HUMALOG); metoprolol; amlodipine; atorvastatin; vitamin D; and pioglitazone. The patient also received first dose of BNT162B2 on 18Feb2021 at 01:00 pm (at the age of 79 years old) for COVID-19 immunisation. On 13Mar2021 at 12:00am, the patient experienced seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there. Patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedures which included COVID test: negative on 13Mar2021. The event resulted in emergency room/department or urgent care visit. The patient received treatment for the event. The patient had not yet recovered from the event. The event was assessed as serious (hospitalization).  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Nausea, Pyrexia
Clinical narrative: continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date.  Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vomiting
Clinical narrative: continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date.  Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Laryngeal oedema, Nasal congestion, SARS-CoV-2 test, Scab
Clinical narrative: Swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils.; Swelling of vocal chords followed by need to blow nose; Swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils.; Causes constant congestion.; crusted scabs from nose for over two week timeframe.; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number; EL9264), via an unspecified route of administration administered in left arm on 09Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. Medical history included osteoarthritis, osteoporosis, neuropathy, hypothyroidism, thyroidectomy, hysterectomy, and two recent falls. The patient had no known allergies. Concomitant medication included influenza vaccine (FLU) taken for immunisation. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249) on 19Jan2021 at 04:30 PM administered in the right arm for COVID-19 immunization. The patient experienced swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils. The patient was constantly blowing up bloody clots/crusted scabs from nose for over two week timeframe. At first, was a lot of clots, red blood and scabs. It got better over 14 days, but, still persists. Now clots and scabs are smaller but still frequent. Causes constant congestion. All events started on 05Mar2021 at 12:00 AM. The events resulted in doctor or healthcare professional visit/clinic visit. There was no treatment received for all events. The patient was COVID tested (nasal swab) post vaccination on 09Mar2021 which was negative. The patient had not yet recovered from all events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils.; Swelling of vocal chords followed by need to blow nose; Swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils.; Causes constant congestion.; crusted scabs from nose for over two week timeframe.; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number; EL9264), via an unspecified route of administration administered in left arm on 09Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. Medical history included osteoarthritis, osteoporosis, neuropathy, hypothyroidism, thyroidectomy, hysterectomy, and two recent falls. The patient had no known allergies. Concomitant medication included influenza vaccine (FLU) taken for immunisation. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249) on 19Jan2021 at 04:30 PM administered in the right arm for COVID-19 immunization. The patient experienced swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils. The patient was constantly blowing up bloody clots/crusted scabs from nose for over two week timeframe. At first, was a lot of clots, red blood and scabs. It got better over 14 days, but, still persists. Now clots and scabs are smaller but still frequent. Causes constant congestion. All events started on 05Mar2021 at 12:00 AM. The events resulted in doctor or healthcare professional visit/clinic visit. There was no treatment received for all events. The patient was COVID tested (nasal swab) post vaccination on 09Mar2021 which was negative. The patient had not yet recovered from all events.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia oral, Migraine, Neck pain, Pain in extremity
Clinical narrative: Bell's Palsy started pain up arm and up neck 30 minutes after vaccine; Bad migraine for days leading up to bell's Palsy; numb tongue; dismissed taste; bad neck pain; pain up arm; This is a spontaneous report from a contactable other healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Mar2021 as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. Medical history included obese, diabetes, and high blood pressure. The patient previously took clindamycin and losartan and both experienced drug allergy. It was reported that the patient experienced on 09Mar2021 were bell's palsy started pain up arm and up neck 30 minutes after vaccine, bad migraine for days leading up to bell's palsy, numb tongue, dismissed taste days before, bad neck pain. The patient was perfectly fine weeks before vaccine and not very happy with Pfizer right now this was his first dose. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab): negative on 18Mar2021. The reported events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events as the patient received antivirals and steroids. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of vaccination with BNT162B2 to the reported events bell's palsy, migraine, numb tongue, dismissed taste, neck pain and pain in arm cannot be excluded.   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: SARS-CoV-2 antibody test, Taste disorder
Clinical narrative: Bell's Palsy started pain up arm and up neck 30 minutes after vaccine; Bad migraine for days leading up to bell's Palsy; numb tongue; dismissed taste; bad neck pain; pain up arm; This is a spontaneous report from a contactable other healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Mar2021 as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. Medical history included obese, diabetes, and high blood pressure. The patient previously took clindamycin and losartan and both experienced drug allergy. It was reported that the patient experienced on 09Mar2021 were bell's palsy started pain up arm and up neck 30 minutes after vaccine, bad migraine for days leading up to bell's palsy, numb tongue, dismissed taste days before, bad neck pain. The patient was perfectly fine weeks before vaccine and not very happy with Pfizer right now this was his first dose. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab): negative on 18Mar2021. The reported events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events as the patient received antivirals and steroids. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of vaccination with BNT162B2 to the reported events bell's palsy, migraine, numb tongue, dismissed taste, neck pain and pain in arm cannot be excluded.   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: Dyspnoea, Fatigue, Vascular pain
Clinical narrative: She was having difficulty breathing after receiving the first shot, could not breathe; Very tired afterwards; Carotid artery sore and hurting her; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (reported as 3 weeks ago) as single dose for COVID-19 immunisation. Medical history included she was a cardiac patient and has chronic obstructive pulmonary disease (COPD), immune system disorder (taking Synthroid). The patient's concomitant medications were not reported. It was reported that the patient was having difficulty breathing after receiving the first shot on an unspecified date. She was hard of seeing she couldn't find her albuterol pump, so the daughter gave her oxygen. The daughter spoke to the cardiologist and pneumologist. They advised her that it's not an allergic reaction and the patient can take the second dose of the vaccine. It was further reported that night, the patient woke up out of sleep and was very tired afterwards. The patient never had experienced this before, but her left carotid artery was very sore and hurting her and could not breathe on an unspecified date. It woke her out of a sound sleep. When the patient woke up that night, she was looking for her inhaler. She has an oxygen concentrator. Between that and the albuterol, that helped calm her down. The patient was concerned with any respiratory issues she might have. The patient was terrified if she already was compromised after the first one to get the second shot. She would like some guidance.  She was worried about second shot and the potential for her to have this happen again. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy
Clinical narrative: thyroid eye disease; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 68; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included thyroid problems and was autoimmune; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received her second dose of BNT162B2 on Tuesday 16Mar2021 and the patient needs to start the steroids due to she was diagnosed with thyroid eye disease on unspecified date after the first dose of BNT162B2. The patient had some thyroid problems before the BNT162B2 but was diagnosed after her first dose. The patient wanted to know when can she start taking her steroids and asked of any effects on the efficacy of the BNT162B2. The patient did not take any steroids in between doses. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pneumonia
Clinical narrative: but will not be able to because he is currently hospitalized for Pneumonia and a hear rate of 174.; but will not be able to because he is currently hospitalized for Pneumonia and a hear rate of 174.; This is a spontaneous report from a contactable consumer. An 84-year-old male patient (husband) received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was calling on behalf her husband who was scheduled to receive the 2nd dose of the Pfizer Covid vaccine on 19Mar2021, but will not be able to because he is currently hospitalized for Pneumonia and a hear rate of 174. Patient has been hospitalized since 14Mar2021. The patient received 1st dose "3 weeks ago". The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Inappropriate schedule of product administration, Malaise, Product supply issue
Clinical narrative: ill; fever; was never able to get second dose of booster of vaccine/was able to obtain the vaccine but unfortunately they were out and they are not ordering anymore; was never able to get second dose of booster of vaccine/was able to obtain the vaccine but unfortunately they were out and they are not ordering anymore; pneumonia; tested positive for covid on 14Jan2021; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Jan2021 (at the age of 44-years-old) (Batch/Lot number was not reported) as [SINGLE DOSE] for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Jan2021 (also reported as 13th), the patient tested positive for COVID. Caller stated on the 13th she tested positive, but she does not believe it is related since she had an outbreak at office of where she works at. Caller stated she went to the health clinic where she tested positive on the 25 and was ill with a fever and had been tested positive with COVID and pneumonia so she was never able to get second dose of booster of vaccine. Caller stated she returned to work and they said she was able to obtain the vaccine but unfortunately they were out and they are not ordering anymore because of the shelf life being short and the facility is no longer going with it. Caller stated her physician gave her the go ahead and to get the vaccine with whoever was offering it. Caller stated but she got first dose on 16Jan2021 (pending clarification) and today is 19Mar2021 and at this time it has been too long since she read she is supposed to wait 3 weeks in between dosage but not to obtain after 6 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Jan2021. I tested positive for covid on 14Jan2021. The outcome of the events was unknown.     information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: ill; fever; was never able to get second dose of booster of vaccine/was able to obtain the vaccine but unfortunately they were out and they are not ordering anymore; was never able to get second dose of booster of vaccine/was able to obtain the vaccine but unfortunately they were out and they are not ordering anymore; pneumonia; tested positive for covid on 14Jan2021; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Jan2021 (at the age of 44-years-old) (Batch/Lot number was not reported) as [SINGLE DOSE] for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Jan2021 (also reported as 13th), the patient tested positive for COVID. Caller stated on the 13th she tested positive, but she does not believe it is related since she had an outbreak at office of where she works at. Caller stated she went to the health clinic where she tested positive on the 25 and was ill with a fever and had been tested positive with COVID and pneumonia so she was never able to get second dose of booster of vaccine. Caller stated she returned to work and they said she was able to obtain the vaccine but unfortunately they were out and they are not ordering anymore because of the shelf life being short and the facility is no longer going with it. Caller stated her physician gave her the go ahead and to get the vaccine with whoever was offering it. Caller stated but she got first dose on 16Jan2021 (pending clarification) and today is 19Mar2021 and at this time it has been too long since she read she is supposed to wait 3 weeks in between dosage but not to obtain after 6 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Jan2021. I tested positive for covid on 14Jan2021. The outcome of the events was unknown.     information on about lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Heart rate, Heart rate decreased
Clinical narrative: tunnel vision; Drop in blood pressure and heart rate; Drop in blood pressure and heart rate; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient).  A 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 19Mar2021 12:45 (Batch/Lot Number: Ep6955) as SINGLE DOSE for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. He had no COVID prior vaccination and not tested post vaccination. On 19Mar2021, the patient had drop in blood pressure and heart rate, tunnel vision, dizzy, and nauseous. The patient did not receive any treatment for the events. The patient recovered from the events in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tunnel vision
Clinical narrative: tunnel vision; Drop in blood pressure and heart rate; Drop in blood pressure and heart rate; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient).  A 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 19Mar2021 12:45 (Batch/Lot Number: Ep6955) as SINGLE DOSE for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. He had no COVID prior vaccination and not tested post vaccination. On 19Mar2021, the patient had drop in blood pressure and heart rate, tunnel vision, dizzy, and nauseous. The patient did not receive any treatment for the events. The patient recovered from the events in Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Joint swelling, Movement disorder
Clinical narrative: knee of the leg its swollen; 3 hours later she was disabled from the waste down, she can not move her legs/pain in the knee on the two legs/The knee of the leg its swollen with tremendous pain and she can not walk; pain in the knee on the two legs; can not move her legs; This is a spontaneous report from a contactable consumer (spouse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09Mar2021, single dose for covid-19 immunisation. The patient had her first dose of bnt162b2 for COVID-19 immunisation on 16Feb2021. The patient's medical history and concomitant medications were not reported. Patient, 3 hours after having the vaccination, she was disabled from the waste down, she can not move her legs. She is having pain in the knee on the two legs. The knee of the leg its swollen with tremendous pain and she cannot walk. She is worse every day and that she refuses to go to the hospital or clinic. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Arthralgia, Back pain, Catheterisation cardiac, Dyspnoea
Clinical narrative: EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself).  A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient  saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA).  The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia
Clinical narrative: EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself).  A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient  saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA).  The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Heart rate, Heart rate increased, Hyperhidrosis, Hypoaesthesia
Clinical narrative: face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021.   Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: face numbing/numbness on face; fast heart beat; face numbing burning; sweating; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration, administered in right arm on 05Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and stroke. The patient is not pregnant. It was not sure if there were known allergies. The patient did not receive other vaccine within 4 weeks prior to the COVID vaccine but took other medications in two weeks (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medication. On 05Mar2021, within one hour of the vaccine, the patient experienced face numbing burning, sweating, fast heart beat and numbness on face that will not go away all day every day since the vaccine. The events resulted in Emergency room/department or urgent care and eventually hospitalization on an unspecified date for 2 days. It was unknown if treatment for the events were given. The patient underwent COVID test post vaccination via Blood test/ CBC differential on 05Mar2021 and was negative. The outcome of the events was recovered with sequelae on an unspecified date in Mar2021.   Information about lot/batch number has been requested.