chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Inflammatory marker increased, SARS-CoV-2 test, Uveitis
Clinical narrative: Fatigue; Chills; Inflammatory marker increased; Sickness; Uveitis flare up; COVID-19 virus test positive; COVID-19; This is a solicited report based on the information received by Pfizer. A contactable physician reported that a 39 year old female with events of non-serious POSITIVE COVID-19, UVEITIS FLARE, PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, COLD, BAD COLD, INFLAMMATION MARKERS HIGH and SICK with HUMIRA (ADALIMUMAB). There was no reported medical history.  On unknown dates, the patient experienced UVEITIS FLARE, PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, BAD COLD, INFLAMMATION MARKERS HIGH and SICK. In January 2020, the patient experienced COLD. In January 2020, the COLD resolved. In December 2020, the patient experienced POSITIVE COVID-19. On unknown dates, POSITIVE COVID-19, UVEITIS FLARE and SICK resolved. COVID-19 VACCINE was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was unsuccessful.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events  of POSITIVE COVID-19 and SICK with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of UVEITIS FLARE and COLD with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, BAD COLD and INFLAMMATION MARKERS HIGH was not provided.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on the batch/lot number requested.; Sender's Comments: As there is no indication of the time interval between the administration of the drug and the onset of events and based on known drug safety profile there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.   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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: There is nonocclusive thrombus in the proximal left femoral vein. There is occlusive thrombus from the mid femur vein to the popliteal and calf veins; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 PM (at age of 58 years old, Lot Number: ER8733) as a single dose for covid-19 immunization. Medical history included hypertension from an unknown date. Concomitant medications included amlodipine, zolpidem, lisinopril. The patient previous took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:00 PM (at age of 58 years old, Lot Number: EN6206) as a single dose for covid-19 immunization. It was reported the patient the left common femoral and great saphenous veins are patent. There was nonocclusive thrombus in the proximal left femoral vein. There was occlusive thrombus from the mid femur vein to the popliteal and calf veins on 22Apr2021 12:00. The patient was hospitalized for 3 days, it was life threatening illness. Treatment received IV heparin. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on 29Apr2021. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included dupilumab (DUPIXENT) taken for pruritus, start and stop dates were not reported. A few days after having the patient's 1st COVID vaccine, she started itching and then one night she woke up and had hives, her skin is pink, and she took diphenhydramine (BENADRYL). She feels better now but she has her 2nd COVID vaccine on 22Apr2021. She has been on dupilumab for about 2 years and never had any itching till a few a days after her COVID vaccine. Per pharmacist notes, patient reported itching and hives about 2 weeks after receiving 1st dose of Pfizer COVID vaccine (unspecified date). Therapeutic measures were taken as a result of itching and hives. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Tested positive for COVID19 on 5/3/2021; Tested positive for COVID19 on 5/3/2021; This is a spontaneous report from a contactable consumer (patient).   A 58-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported ), via an unspecified route of administration, administered in Arm Left on 03Feb2021 (at the age of 58-year-old) as single dose, and first dose via an unspecified route of administration, administered in Arm Left on 13Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, allergy to chemicals (Nickel) from an unknown date and unknown if ongoing. Concomitant medication included irbesartan (IRBESARTAN) taken for an unspecified indication, start and stop date were not reported.   The patient experienced cold-like symptoms (nasopharyngitis) on 28Apr2021 with outcome of recovering, loss of smell (anosmia) on 02May2021 with outcome of recovering.  The patient tested positive for Covid-19 on 03May2021. The patient underwent lab tests and procedures which included Sars-Cov-2 antibody test: positive on 03May2021 (Nasal Swab).  Adverse events result in Emergency room/department or urgent care.   Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive to Covid 19; Tested positive to Covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two different patients (himself and his wife). This is the second of two reports.  This female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, in Apr2021 (16 or 17) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The second dose was planned for 07May2021. Patient's husband asked if she could receive the second dose as she tested positive to COVID-19. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493660 same reporter/product, different patient / event.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Shivers, high fever of 102 F, mild headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: Chills, tiredness, fever starting a few hours post-vaccine.  While I was sleeping, I was woken up by uncontrollable  tremors in the arms, torso, and thighs for about 15 minutes. I took a Tylenol and was able to fall asleep after that.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears ,tinnitus. Still have it three weeks later
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular
Clinical narrative: Severe headaches for the last 6 days since getting the vaccine, and my menstrual cycle began earlier than normal
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed Covid between his first and second dose; Developed Covid between his first and second dose; This is a spontaneous report from a contactable consumer. A male patient in his late 70s/ early 80s received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history included some underlying health issues. Concomitant medications were not reported. Concomitant medications were not reported. The patient developed COVID between his first and second dose, on an unspecified date. The outcome of the event was unknown. The reporter was unsure about what brand of vaccine the patient received.  Information about batch/lot number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Diabetes mellitus, Hyperglycaemia, Pollakiuria, Thirst
Clinical narrative: 2-3 days after shot I became so thirsty drinking up to 2-3 gallons of water a day!  My vision has now became blurry  and I?m having to urinate 10 times a night.  I was in the hospital 2 weeks prior and my chart was fine I?m in the hospital as we speak and I haven hyperglycemia!! Now diabetic after the shot my life has changed!!!
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 2-3 days after shot I became so thirsty drinking up to 2-3 gallons of water a day!  My vision has now became blurry  and I?m having to urinate 10 times a night.  I was in the hospital 2 weeks prior and my chart was fine I?m in the hospital as we speak and I haven hyperglycemia!! Now diabetic after the shot my life has changed!!!
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Vomiting
Clinical narrative: I developed an upset stomach that led to me vomiting and was also very fatigued.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient described feeling dizzy about 15 min after the vaccine. We had her lie down, offered her water & gatorade, monitored her. We took her BP and heart rate. We asked her if she could breathe- she said she could breathe ok. BP was 135/85 and heart rate was 79bpm which was normal. We had her continue lying down and complained that she was feeling worse after another 15min and wanted us to call 911. We did, 911 showed up, took her vitals again which were normal. No hospitalization reqd.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Woke up with extreme pain lower right side of neck and I to my upper back.  This happened two and a half weeks after my first shot and lasted a week. Also last time the tops of my hands felt strange, like the blood inside was hot and tingling.  Lasted a day or two.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Cardiac failure congestive, Dyspnoea, Malaise, Pain in extremity
Clinical narrative: Shortness of breath, leg pain and swelling, generalized malaise, acute coronary syndrome, CHF, fever.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: Shortness of breath, leg pain and swelling, generalized malaise, acute coronary syndrome, CHF, fever.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dysphagia, Dyspnoea, Headache
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Headache-Mild, Additional Details: Patient reports sudden onset of headache, chest tightness and labored breathing. Pt declined benadryl and epi pen on site to treat with benadryl at home. follow up in progress.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Headache-Mild, Additional Details: Patient reports sudden onset of headache, chest tightness and labored breathing. Pt declined benadryl and epi pen on site to treat with benadryl at home. follow up in progress.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Injection site pain, Lethargy, Nausea, Pain
Clinical narrative: Lethargy, aches, nausea/dry heaves, inappetance, pain at injection site
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Lethargy, aches, nausea/dry heaves, inappetance, pain at injection site
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, fever, chills, painful body aches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy, Oesophageal disorder, Pyrexia, Tremor
Clinical narrative: Fever above 105 degrees for 5 days; Enlarged lymph nodes on left side of neck; tremors; causing difficulties breathing; pushing on esophagus; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was unknown and expiry was not reported), via an unspecified route of administration, in Left arm on 04Apr2021 at 13:00 (at the age of 27-years-old) at 1st dose single for COVID-19 immunization. Medical history included environmental allergies and Hashimoto's. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) in two weeks of vaccination. The patient previously took Ceclor and experienced allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient had fever, above 105 degrees for 5 days and unable to reduce with Tylenol, causing tremors; had enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus as per ER physician on 05Apr2021 at 12:00 after the first dose. The events resulted in emergency room/department or urgent care (2 visits to ER needed in first 5 days following vaccine). Residual issues remained. Treatment was given for the events. The outcome of the event fever was recovered with sequel on 10Apr2021 while the other events (enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus) was recovered with sequel in Apr2021. The event tremor was recovered in Apr2021.     No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Follow up report from the first VAERS reported, regarding patient reporting redness from deltoid to elbow. Called patient on 04/29/2021 patient indicated that she has taken Bendryl at night and there was imporvement. Todays follow up call 05/14/2021 patient indicated a few days after the bendaryl, all symptoms had resolved. Currently patient indicated that there is no longer a redness from deltoid to the elbow.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Migraine, Pain, Pyrexia
Clinical narrative: Intense migraine, fever, body aches 12 hours after injection. 25 hours after injection I had swollen lymph nodes in collarbone & armpit & minor migraine. Still have headache 3 days after injection.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Echocardiogram, Ischaemic stroke, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: she had a stroke; ischemic stroke; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00AM, as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, allergic to bees and patient says there are members of her extended family that had strokes but they were almost 100 years old when they had them. her uncle died in October around Thanksgiving and he was 3 months shy of 100. She says they checked her heart and she was fine. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medication's included levothyroxine sodium 50 mg once a day patient has been taking this for probably 5 years for inactive thyroid and General multivitamin for general health, patient says it is recommended by her general practice physician and she has been taking this for maybe 8 years, she guesses. Patient says she had an ischemic stroke 5 days after the second COVID vaccination. She says she is calling to see if there are any records of that happing to other people. She says she has to leave the call in 25 minutes. Patient says she had a stroke then went to the Emergency Room. For the outcome of the ischemic stroke she says there may be some things that she doesn't know. She says her doctor said she was ok and she can go back to what she was doing. Patient says the first shot says BioNTech and the second one just says Pfizer. She says the first one is a sticker and the second one is hand written. Second dose was on 15FEB2021, lot number EN6 then 2 or Z, she says she assumes it is a 2 based on the other lot number, then she thinks 01. For indication patient says she is all for the vaccinations, she thinks it's important to get the vaccine. She says she is the daughter of a physician. She says she is not scared of the vaccine, she believes in it. The patient previously received first dose of (BNT162B2), via an unspecified route of administration, administered in Arm Left, on 25Jan2021 11:00 PM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 19Feb2021 (probably late morning), the patient experienced ischemic stroke and on unspecified date of 2021 she had a stroke. The patient was hospitalized for the events from 19Feb2021 to 21Feb2021. The patient underwent lab tests and procedures which included echocardiogram: unknown, her echocardiogram was fine, magnetic resonance imaging: unknown and ultrasound scan: unknown on 2021. Outcome of the events was unknown.  Follow up (PRD/SRD 04May2021): This is a Follow-up spontaneous report from a contactable consumer.  Follow up(10May2021): This is a Spontaneous report from a Medical information Team. This consumer(patient) reported that: Follow-up attempts are completed. No further information is expected
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: she had a stroke; ischemic stroke; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00AM, as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, allergic to bees and patient says there are members of her extended family that had strokes but they were almost 100 years old when they had them. her uncle died in October around Thanksgiving and he was 3 months shy of 100. She says they checked her heart and she was fine. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medication's included levothyroxine sodium 50 mg once a day patient has been taking this for probably 5 years for inactive thyroid and General multivitamin for general health, patient says it is recommended by her general practice physician and she has been taking this for maybe 8 years, she guesses. Patient says she had an ischemic stroke 5 days after the second COVID vaccination. She says she is calling to see if there are any records of that happing to other people. She says she has to leave the call in 25 minutes. Patient says she had a stroke then went to the Emergency Room. For the outcome of the ischemic stroke she says there may be some things that she doesn't know. She says her doctor said she was ok and she can go back to what she was doing. Patient says the first shot says BioNTech and the second one just says Pfizer. She says the first one is a sticker and the second one is hand written. Second dose was on 15FEB2021, lot number EN6 then 2 or Z, she says she assumes it is a 2 based on the other lot number, then she thinks 01. For indication patient says she is all for the vaccinations, she thinks it's important to get the vaccine. She says she is the daughter of a physician. She says she is not scared of the vaccine, she believes in it. The patient previously received first dose of (BNT162B2), via an unspecified route of administration, administered in Arm Left, on 25Jan2021 11:00 PM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 19Feb2021 (probably late morning), the patient experienced ischemic stroke and on unspecified date of 2021 she had a stroke. The patient was hospitalized for the events from 19Feb2021 to 21Feb2021. The patient underwent lab tests and procedures which included echocardiogram: unknown, her echocardiogram was fine, magnetic resonance imaging: unknown and ultrasound scan: unknown on 2021. Outcome of the events was unknown.  Follow up (PRD/SRD 04May2021): This is a Follow-up spontaneous report from a contactable consumer.  Follow up(10May2021): This is a Spontaneous report from a Medical information Team. This consumer(patient) reported that: Follow-up attempts are completed. No further information is expected
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Facial paralysis
Clinical narrative: she had a stroke; ischemic stroke; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00AM, as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, allergic to bees and patient says there are members of her extended family that had strokes but they were almost 100 years old when they had them. her uncle died in October around Thanksgiving and he was 3 months shy of 100. She says they checked her heart and she was fine. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medication's included levothyroxine sodium 50 mg once a day patient has been taking this for probably 5 years for inactive thyroid and General multivitamin for general health, patient says it is recommended by her general practice physician and she has been taking this for maybe 8 years, she guesses. Patient says she had an ischemic stroke 5 days after the second COVID vaccination. She says she is calling to see if there are any records of that happing to other people. She says she has to leave the call in 25 minutes. Patient says she had a stroke then went to the Emergency Room. For the outcome of the ischemic stroke she says there may be some things that she doesn't know. She says her doctor said she was ok and she can go back to what she was doing. Patient says the first shot says BioNTech and the second one just says Pfizer. She says the first one is a sticker and the second one is hand written. Second dose was on 15FEB2021, lot number EN6 then 2 or Z, she says she assumes it is a 2 based on the other lot number, then she thinks 01. For indication patient says she is all for the vaccinations, she thinks it's important to get the vaccine. She says she is the daughter of a physician. She says she is not scared of the vaccine, she believes in it. The patient previously received first dose of (BNT162B2), via an unspecified route of administration, administered in Arm Left, on 25Jan2021 11:00 PM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 19Feb2021 (probably late morning), the patient experienced ischemic stroke and on unspecified date of 2021 she had a stroke. The patient was hospitalized for the events from 19Feb2021 to 21Feb2021. The patient underwent lab tests and procedures which included echocardiogram: unknown, her echocardiogram was fine, magnetic resonance imaging: unknown and ultrasound scan: unknown on 2021. Outcome of the events was unknown.  Follow up (PRD/SRD 04May2021): This is a Follow-up spontaneous report from a contactable consumer.  Follow up(10May2021): This is a Spontaneous report from a Medical information Team. This consumer(patient) reported that: Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Now has COVID; Now has COVID; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender 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 a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient now has COVID on an unspecified date after first dose.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date. The clinical outcome of the event patient now has COVID was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look.; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation and the patient experienced a few small red spots on her body. The patient experienced pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look on an unspecified date. The outcome of the event was unknown. The 2nd dose, which she received last week (in Apr2021), blew her up with a pretty significant rash all over her body that look like underlying diffused erythema with a multiforma look. She mentioned that she was already given steroids at a fairly moderate amount without improvement. She is considering on giving her a high dose of steroids. She is asking if there have been any reports on this and for any input on the situation. Response: Was going to offer information on the reports of allergic reactions but caller clarified that what happened to the patient was not histamine-mediated. Mentioned to caller that there was no specific data on non-histamine-mediated skin reactions. Offered data on use with immunosuppressive therapy to address higher steroid dose issue but caller mentioned that it will not be helpful. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Considering the plausible temporal association, the reasonable possibility that the event reported as ' Diffused erythema with a multiforma look' (Erythema multiforme) is related to BNT162B2 vaccine cannot be excluded. No alternative explanations were reported.   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 agency, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: died from Pfizer vaccine of anaphylactic reaction; This is a spontaneous report from a non-contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for Covid-19 immunisation. Medical history included hypersensitivity (there was something he was allergic to it's what is used in contrast imaging). Concomitant medications were not reported. The patient had an anaphylactic reaction to the vaccination and through the anaphylactic reaction he passed away. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: Anaphylactic reaction
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID.; had got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID.; This is a spontaneous report from a contactable consumer. This consumer (patient father) reported for a patient that: An unspecified age of male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration, administered on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date,  the patient got his first Pfizer Vaccine this past Friday and then he ended up testing positive on Tuesday for COVID. He had scheduled appointment on May 21st to get his second dose. Since the vaccination, the patient had been tested for COVID-19 with SARS-CoV-2 test and resulted positive on unknown date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: heart arrhythmia; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on Mar2021 (Lot Number: ER8732) (at the age of 43-year-old) as single dose for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced heart arrhythmia on Mar2021. The patient outcome of the event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Muscle injury, Muscle rupture, Muscle strain
Clinical narrative: muscle is tearing away from my arm. I feel like I injured it pretty badly; muscle is tearing away from my arm. I feel like I injured it pretty badly. Burning, sharp, achy pain; Started like a pulled muscle feeling; My arm feels really heavy and painful; My arm feels really heavy and painful; I found where the pain is coming from and its right where the injection site was; muscle is tearing away from my arm; aches and pains on left side of body; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er 8734, expiration date: Jul2021) at the age of 34-years-old, via an unspecified route of administration in left arm on 14Apr2021 at 13:00 at 1st dose, single for COVID-19 immunisation. Medical history included being immunocompromised and rheumatoid arthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cholestyramine. She has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin. The patient received the vaccine at a pharmacy and on the day of the shot (14Apr2021), she experienced aches and pains on left side of body and she was extremely tired for 2 days. On 29Apr2021 at 19:00, 2 weeks and 1 day after first shot, the patient felt like her muscle was tearing away from her arm and felt like she injured it pretty badly. There was a burning, sharp, achy pain which was much worse than that achy feeling after the shot. The onset was very sudden. It started like a pulled muscle feeling. Now, she could not find a position that did not hurt constantly. There were tons of pain when she moves it and the pain seemed to worsen when she leaves it. Her arm felt really heavy and painful down at her side. She thought it was the front of her arm/shoulder, then maybe the back; but she found where the pain was coming from and its right where the injection site was. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "extremely tired" was recovered on 16Apr2021 and not recovered for all other events.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: muscle is tearing away from my arm. I feel like I injured it pretty badly; muscle is tearing away from my arm. I feel like I injured it pretty badly. Burning, sharp, achy pain; Started like a pulled muscle feeling; My arm feels really heavy and painful; My arm feels really heavy and painful; I found where the pain is coming from and its right where the injection site was; muscle is tearing away from my arm; aches and pains on left side of body; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er 8734, expiration date: Jul2021) at the age of 34-years-old, via an unspecified route of administration in left arm on 14Apr2021 at 13:00 at 1st dose, single for COVID-19 immunisation. Medical history included being immunocompromised and rheumatoid arthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cholestyramine. She has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin. The patient received the vaccine at a pharmacy and on the day of the shot (14Apr2021), she experienced aches and pains on left side of body and she was extremely tired for 2 days. On 29Apr2021 at 19:00, 2 weeks and 1 day after first shot, the patient felt like her muscle was tearing away from her arm and felt like she injured it pretty badly. There was a burning, sharp, achy pain which was much worse than that achy feeling after the shot. The onset was very sudden. It started like a pulled muscle feeling. Now, she could not find a position that did not hurt constantly. There were tons of pain when she moves it and the pain seemed to worsen when she leaves it. Her arm felt really heavy and painful down at her side. She thought it was the front of her arm/shoulder, then maybe the back; but she found where the pain was coming from and its right where the injection site was. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "extremely tired" was recovered on 16Apr2021 and not recovered for all other events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood potassium, Hypokalaemia, Laboratory test
Clinical narrative: heart arrhythmia; hypokalemic, low in potassium; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose  via an unspecified route of administration, administered in Arm Left on 17Apr2021 at age of 43-year-old (Lot Number: EW0162) at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL). The patient previously took first dose of bnt162b on 26Mar2021 (lot number: ER8732) for COVID-19 immunization and experienced heart arrhythmia. After the second vaccine in Apr2021, it exponentially increased to the point that she was in the emergency room (ER), the patient was laying flat on the floor and as soon as I get out the arrhythmia started. On an unspecified date in Apr2021 night they were testing and it was arrhythmia. She didn't know if it is related to the vaccine or not but she did not have arrhythmia beforehand and a friend of the patient mentioned that she should call it in.  She underwent many lab tests in Apr2021 because she was in the ER. The lab results showed that she was hypokalemic, low in potassium other then that everything came back fairly normal. The patient was on treatment for arrhythmia on 29Apr2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; Bad headache; Chills; Nausea; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (Grandmother).  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced bad headache, chills, fever and nausea on an unspecified date after vaccination. It was informed that she was in the hospital receiving treatment. At the time of the reporting the patient had not yet recovered from reported events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Gait disturbance, Hypoaesthesia, Musculoskeletal pain, Myalgia
Clinical narrative: Severe muscle soreness (paralyzing); Severe muscle soreness (paralyzing); soreness in tissue and bones; soreness in tissue and bones; unable to walk straight; numbness in hands, arms, and feet.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: EW0162) at the age of 49 years, as 0.3 ml single for covid-19 immunisation.  Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot: EN6207, on 25Mar2021 at 11:00 AM at 0.3 ml single in left arm. Medical history included calcium deposits and mitral valve prolapse, from an unknown date and unknown if ongoing.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  On 15Apr2021 at 18:00 the patient experienced severe muscle soreness (paralyzing), soreness in tissue and bones, unable to walk straight, numbness in hands, arms, and feet (severe symptoms as such for 4 days). The outcome of the events was resolving.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Severe muscle soreness (paralyzing); Severe muscle soreness (paralyzing); soreness in tissue and bones; soreness in tissue and bones; unable to walk straight; numbness in hands, arms, and feet.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: EW0162) at the age of 49 years, as 0.3 ml single for covid-19 immunisation.  Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot: EN6207, on 25Mar2021 at 11:00 AM at 0.3 ml single in left arm. Medical history included calcium deposits and mitral valve prolapse, from an unknown date and unknown if ongoing.  The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported.  On 15Apr2021 at 18:00 the patient experienced severe muscle soreness (paralyzing), soreness in tissue and bones, unable to walk straight, numbness in hands, arms, and feet (severe symptoms as such for 4 days). The outcome of the events was resolving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab covid was tested post vaccination; Nasal Swab covid was tested post vaccination; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 14:00 (Lot Number: EL9262) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left in Jan2021 14:00 (Lot Number: GL0140) as single dose for covid-19 immunisation.Medical history included acute sinusitis. The patient did not have known allergies.The patient's concomitant medications included unspecified products within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. Nasal Swab covid test was tested post vaccination on 21Apr2021 and result was positive.It was also reported that "TESTED POSITIVE FOR COVID-19 ON 23Apr2021" and "event start date 19Apr2021 12:00 PM". The event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The event outcome was resolving.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Contusion, Dizziness, Head injury, Loss of consciousness
Clinical narrative: passed out; Severe abdominal pain; arm was very sore from the injection site; hit my head very hard; I felt the need to vomit; woozy; bruised; This is a spontaneous report from a contactable consumer reporting for herself.     A 33-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient  passed out  on 28Apr2021 02:30 with outcome of recovering , had severe abdominal pain on 28Apr2021 02:30 with outcome of recovering , arm was very sore from the injection site  on 28Apr2021 02:30 with outcome of recovering , hit my head very hard  on 28Apr2021 with outcome of recovering , i felt the need to vomit  on 28Apr2021 with outcome of recovering , woozy on 28Apr2021 with outcome of recovering , bruised  on 28Apr2021 with outcome of recovering.  Loss of consciousness was considered an Important Medical Event.  Course of the event: The patient stated:  At 2:20 am I woke up with severe abdominal pain, and my arm was very sore from the injection site. I got up to take Tylenol since i hadn't taken any yet. While I was trying to read the label I got very dizzy and I tried to walk back to my bed and I passed out onto the floor. When I woke up I felt like I had hit my head very hard, I slowly went back to my bedroom and passed out again and my husband found me unconscious And called 911. When I woke up I felt the need to vomit and have bowl movements so he took me to the bathroom. When the paramedics came I was conscious but very nauseous and woozy. Now I am bruised all over, the bridge of my nose where I hit my face, and knees and elbows".  Follow up information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: passed out; Severe abdominal pain; arm was very sore from the injection site; hit my head very hard; I felt the need to vomit; woozy; bruised; This is a spontaneous report from a contactable consumer reporting for herself.     A 33-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient  passed out  on 28Apr2021 02:30 with outcome of recovering , had severe abdominal pain on 28Apr2021 02:30 with outcome of recovering , arm was very sore from the injection site  on 28Apr2021 02:30 with outcome of recovering , hit my head very hard  on 28Apr2021 with outcome of recovering , i felt the need to vomit  on 28Apr2021 with outcome of recovering , woozy on 28Apr2021 with outcome of recovering , bruised  on 28Apr2021 with outcome of recovering.  Loss of consciousness was considered an Important Medical Event.  Course of the event: The patient stated:  At 2:20 am I woke up with severe abdominal pain, and my arm was very sore from the injection site. I got up to take Tylenol since i hadn't taken any yet. While I was trying to read the label I got very dizzy and I tried to walk back to my bed and I passed out onto the floor. When I woke up I felt like I had hit my head very hard, I slowly went back to my bedroom and passed out again and my husband found me unconscious And called 911. When I woke up I felt the need to vomit and have bowl movements so he took me to the bathroom. When the paramedics came I was conscious but very nauseous and woozy. Now I am bruised all over, the bridge of my nose where I hit my face, and knees and elbows".  Follow up information has been requested.