chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Streptobacillus infection, Streptococcus test
Clinical narrative: however she tested positive with her Strep test yesterday (03May2021) and she also started to take Azithromycin yesterday.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (mother) reported for a 16-year-old female patient reported that patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Batch/Lot number and expiration date were not reported), via unspecified route on 15Apr2021 at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient was scheduled to get the 2nd dose of the vaccine on 06May2021, however she tested positive with her Strep test yesterday (03May2021) and she also started to took Azithromycin yesterday. (name) wanted to know if her daughter could still take the 2nd dose on the scheduled date. The outcome of the events was unknown  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, in arm left, on 08Apr2021 16:00 (at the age of 36-year-old), at single dose, for COVID-19 immunization. Medical history included cholesterol, anxiety, depression, and Barrera esophagus. No known allergies. Concomitant medications included unspecified medication (patient received other medications within 2 weeks of vaccination). The patient previously received 1st dose of BNT162B2 for Covid-19 immunization, in left arm. The patient experienced Bell's palsy a month after 2nd shot on 03May2021, and received Steroids and antivirus medicine as treatment. The event caused Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior vaccination. On 04May2021, patient had negative Covid test post vaccination with Nasal swab. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pneumonia, Pyrexia
Clinical narrative: Pneumonia; headaches; fever; fatigue; chills; This is a spontaneous report from a contactable consumer (reporting for himself). A 75-years-old male patient received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced headache, fever, fatigue and chills. On 20Feb2021, the patient experienced pneumonia. The patient was recommended to get the Bamlanivimab infusion, which the patient did. The patient was told to wait 90 days after the infusion before getting his second dose of the series. The patient stated his 90 days will be up in about a week or so. The outcome of the event headache was recovered on 17Feb2021; fever and chills was recovered on 18Feb2021; fatigue was recovered on 20Feb2021; and pneumonia was recovered on 10Mar2021.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Laboratory test, Oxygen saturation decreased
Clinical narrative: multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pressure; decreased oxygen saturation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 at 10:30 (at age of 47 years old, no pregnant, Lot Number: EW0151) as a single dose for covid-19 immunization. Medical history included hypertension, known allergies Amoxicillin, sulfa, Keflex. Concomitant medications included losartan and omeprazole. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Apr2021 at 09:00, reported at 11 days post vaccine experienced shortness of breath, elevated heart rate, elevated blood pressure, decreased oxygen saturation. Diagnosed with multiple bilateral pulmonary embolism. No typical risk factors. Awaiting results of tests for protein s deficiency/factor 5/lupus. No family history of any. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care/ Life Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized from 26Apr2021 to 29Apr2021. The treatment received with IV heparin, now oral warfarin and Lovenox shots. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 test): negative on 28Apr2021, negative on 30Apr2021 and pending result on 02May2021. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pressure; decreased oxygen saturation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 at 10:30 (at age of 47 years old, no pregnant, Lot Number: EW0151) as a single dose for covid-19 immunization. Medical history included hypertension, known allergies Amoxicillin, sulfa, Keflex. Concomitant medications included losartan and omeprazole. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Apr2021 at 09:00, reported at 11 days post vaccine experienced shortness of breath, elevated heart rate, elevated blood pressure, decreased oxygen saturation. Diagnosed with multiple bilateral pulmonary embolism. No typical risk factors. Awaiting results of tests for protein s deficiency/factor 5/lupus. No family history of any. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care/ Life Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized from 26Apr2021 to 29Apr2021. The treatment received with IV heparin, now oral warfarin and Lovenox shots. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 test): negative on 28Apr2021, negative on 30Apr2021 and pending result on 02May2021. The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test positive
Clinical narrative: 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; This is a spontaneous report from a contactable pharmacist via medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Jan2021 (at the age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Jan2021-positive. It was reported as the patient received her first Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. She then received a "plasma transfusion on 28Jan2021. She is now returning for her second vaccine dose today 06May2021. The reporter asked if is this ok since it has been 90 days and does her first dose need to be repeated. Therapeutic measures were taken as a result of the event covid-19. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm at the age of 34-year-old on 04Apr2021 15:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included asthma, pernicious anaemia, Polycystic ovarian syndrome, Hashimots thyroiditis, Atopic dermatitis. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 07Mar2021 15:00 at left arm for COVID-19 Immunization. The most recent COVID-19 vaccine was administered at Hospital. No other vaccines within 4 weeks prior to the COVID vaccine received by patient, other medications the patient received within 2 weeks of vaccination confirmed yes but not specified and stated more than there was room for here. The patient experienced bell's palsy on 04May2021 12:00. The event resulted in Emergency room/department or urgent and Doctor or other healthcare professional office/clinic visit, no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.  No follow-up attempts are possible. Information about batch/lot number can not be requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Burning sensation, Electric shock sensation, Lymphadenopathy
Clinical narrative: Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different parts and electric shock sensation; Pins and needles in different parts and electric shock sensation; Neck lymph nodes inflammation; Body temperature swings from cold to hot and the other way around; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 58-year-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171 expiry date: unknown) dose 2 via an unspecified route of administration in left arm on 29Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. The patient did not have any medical history. She had known allergies: hives with yellow fever vaccine 7 years prior to this re-port. Concomitant medication in two weeks included EMERGEN-C (MINERALS NOS, QUERCETIN, THIOCTIC ACID, VITAMINS NOS). The patient received first dose of BNT162B2 (solution for injection, lot number: EW0151 expiry date: unknown) via an unspecified route of administration in left arm on 08Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. She did not receive any other vaccine same date of suspect product or within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05May2021 09:00 AM, She experienced extremely strong pain and burning in legs, arms and different part of the body, pins and needles in different parts and electric shock sensation, neck lymph nodes inflammation, body temperature swings from cold to hot and the other way around. This was the second day, and she did not have relief yet. It was stated that Tylenol 500mg and Ibuprofen 200mg did not relief absolutely anything. On an unknown date, the patient was hospitalized. The patient did not receive any treatment for other events. The patient underwent lab tests and procedures included Body temperature:  swings from cold to hot on 05May2021. The outcome of all events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different parts and electric shock sensation; Pins and needles in different parts and electric shock sensation; Neck lymph nodes inflammation; Body temperature swings from cold to hot and the other way around; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 58-year-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171 expiry date: unknown) dose 2 via an unspecified route of administration in left arm on 29Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. The patient did not have any medical history. She had known allergies: hives with yellow fever vaccine 7 years prior to this re-port. Concomitant medication in two weeks included EMERGEN-C (MINERALS NOS, QUERCETIN, THIOCTIC ACID, VITAMINS NOS). The patient received first dose of BNT162B2 (solution for injection, lot number: EW0151 expiry date: unknown) via an unspecified route of administration in left arm on 08Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. She did not receive any other vaccine same date of suspect product or within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05May2021 09:00 AM, She experienced extremely strong pain and burning in legs, arms and different part of the body, pins and needles in different parts and electric shock sensation, neck lymph nodes inflammation, body temperature swings from cold to hot and the other way around. This was the second day, and she did not have relief yet. It was stated that Tylenol 500mg and Ibuprofen 200mg did not relief absolutely anything. On an unknown date, the patient was hospitalized. The patient did not receive any treatment for other events. The patient underwent lab tests and procedures included Body temperature:  swings from cold to hot on 05May2021. The outcome of all events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: had rapid test that was Covid positive on 05May; headache; congestion and stuffy nose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 27Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05May2021, the patient experienced had rapid test that was covid positive on 05May. On an unspecified date in 2021, the patient experienced headache, congestion and stuffy nose. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller's daughter received 1st Pfizer vaccine on 27Apr. Daughter had negative Covid test the day prior to receiving 1st shot. Daughter had rapid test that was Covid positive on 05May with headache, congestion and stuffy nose. On 26Apr2021, the patient underwent lab test which included covid-19 test: negative and on 05May2021, the patient underwent lab test which included covid-19 test: negative. The patient did not receive any treatment for the events. The clinical outcomes of the had rapid test that was Covid positive on 05May, headache, congestion and stuffy nose were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, Nasopharyngitis, Oropharyngeal discomfort
Clinical narrative: Said her son startedexperiencing symptoms like cold,congestion, headache and scratchy throat on 05/02/2021and her son tested positive today05/05/2021.; Cold; Headache; Scratchy throat; Congestion; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient with unspecified age that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 25Apr2021 at 1st dose, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The consumer was calling on behalf of her son, got the first dose of the vaccine on 25Apr2021, and the second dose is scheduled 16May2021 (correct dosing schedule). Consumer said her son started experiencing symptoms like cold, congestion, headache and scratchy throat on 02May2021 and her son tested positive today 05May2021. Consumer wanted to know if we recommend getting her son's second dose as scheduled. Were any unaddressed medical questions referred or forwarded to Medical Information; Yes. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient missed her 2nd Dose of the COVID-19 on 03May2021, because she tested positive with COVID 19 after her first shot of the COVID 19 Vaccine on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date. The outcome of the events was unknown.  Information on the  lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Product administered at inappropriate site, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Tinnitus, Vomiting
Clinical narrative: Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: full body rash from the neck down; itchy and burned like crazy; burned like crazy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported as rash after first dose and the patient received the first dose of the Pfizer Covid-19 vaccine on 10Apr2021, in which he reports everything went fine. On 21Apr2021, he broke out in a full body rash from the neck down, which was described as "itchy and burned like crazy." He states he took Benadryl for a few days, in which the pruritus went away, but the rash remained present. He states that he went to a dermatologist and internist, in which he was prescribed to take prednisone for 6 or 7 days, and the prednisone made the rash go away. He states he was scheduled for his second dose this past Saturday, in which the internist advised him to hold off since they were not 100 % sure if he should receive the second dose. He states he researched pictures online that presented rashes, and states his rash looked like the pictures, only more intense. He is asking if he should receive the second dose or not. He wanted to know what the efficacy after one dose is and asked how long he can wait to take the second dose. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovering.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Basilar artery thrombosis, Coma
Clinical narrative: coma; Basilar artery thrombosis; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 10:00 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included metronidazole; sulfasalazine; lamotrigine and trazodone all taken for an unspecified indication, start and stop date were not reported. On 29Apr2021 06:00, 10 days after the first shot, the patient experienced come due to a basilar artery thrombosis. The event required emergency room/department or urgent care visit where the patient was subsequently brought to the ICU. The patient received unspecified treatment for the events. The outcome of the event was not recovered.  Follow up attempts needed. Further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Monoplegia, Pain in extremity
Clinical narrative: Paralysis of left arm.; Extreme pain in left shoulder and arm for 6 weeks and counting.; Extreme pain in left shoulder and arm for 6 weeks and counting.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 23Mar2021 at 09:00 (Lot Number: EP6955) at the age of 36-year-old as SINGLE DOSE for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced paralysis of left arm, extreme pain in left shoulder and arm for 6 weeks and counting. The patient visited to the emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit due to the reported events. Therapeutic measure was taken for the reported events included unspecified medication and physical therapy. The outcome was reported as not recovered for the reported events.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dysstasia, Gait inability, Monoplegia
Clinical narrative: Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd week to stand or walk; Unable at 2 nd week to stand or walk; Began to have pain in hip that progressed to severe pain and parlaying leg and foot; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 15:30 (at the age of 27 years) as unknown dose, single for COVID-19 immunization. Medical history included obesity and mental illness. Concomitant medications included aripiprazole (ABLIFY), sertraline hydrochloride (ZOLOFT), metformin, bupropion hydrochloride (WELLBUTRIN), simvastatin and lisinopril. The patient did not 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, it was unknown if the patient was tested for COVID-19. The patient was hospitalized on 27Apr2021 for an unknown reason and began to have pain in hip that progressed to severe pain and parlaying leg and foot on 03May2021. Unable at the second week to stand or walk. These adverse events result in emergency room (ER) or department or urgent care. The patient's hospitalization was prolonged and the patient was disability as a result of these events. It was unknown if the treatment was received by the patient due to these events. It was reported that the duration of hospitalization was 10 days discharged on 07May2021 (also reported as continued, CLARIFICATION PENDING). The outcome of all these events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dysstasia, Gait inability, Hypoaesthesia, Laboratory test
Clinical narrative: Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd week to stand or walk; Unable at 2 nd week to stand or walk; Began to have pain in hip that progressed to severe pain and parlaying leg and foot; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 15:30 (at the age of 27 years) as unknown dose, single for COVID-19 immunization. Medical history included obesity and mental illness. Concomitant medications included aripiprazole (ABLIFY), sertraline hydrochloride (ZOLOFT), metformin, bupropion hydrochloride (WELLBUTRIN), simvastatin and lisinopril. The patient did not 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, it was unknown if the patient was tested for COVID-19. The patient was hospitalized on 27Apr2021 for an unknown reason and began to have pain in hip that progressed to severe pain and parlaying leg and foot on 03May2021. Unable at the second week to stand or walk. These adverse events result in emergency room (ER) or department or urgent care. The patient's hospitalization was prolonged and the patient was disability as a result of these events. It was unknown if the treatment was received by the patient due to these events. It was reported that the duration of hospitalization was 10 days discharged on 07May2021 (also reported as continued, CLARIFICATION PENDING). The outcome of all these events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: patient passed away, due to what was being told as possible blood clot in lungs; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Lot Number: ER8633) (at the age of 70-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient did not experienced COVID-19 prior or post vaccination.  The patient passed away, due to what was being told as possible blood clot in lungs (on 07May2021). The event was serious (fatal) and required emergency room visit. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: blood clot in his lungs
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Maternal exposure during pregnancy
Clinical narrative: Bell's Palsy; The patient was pregnant at the time of vaccination/Delivery date would be on 06Jun2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm, on 24Mar2021 (Lot Number: ER8132, at the age of 44-year-old) as single dose, for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 03Mar2021 (Lot Number: EN6199, at the age of 44-year-old) as single dose for covid-19 immunization and experienced pregnant at the time of vaccination. The patient was pregnant at the time of vaccination. Gestation period was 30. Delivery date would be on 06Jun2021. The patient experienced bell's palsy on 08May2021. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care due to the event. Treatment included steroid prescription. Patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Patient had no other vaccine in four weeks. The outcome of the event Bell's Palsy was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Off label use, Throat tightness, Wheezing
Clinical narrative: 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; Received First dose on 03Apr2021, Second dose on 17Apr2021; Received First dose on 03Apr2021, Second dose on 17Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Apr2021 17:00 (at age of 55 years old) (Lot Number: EW0172) as single dose for covid-19 immunisation. The patient other medical history was none. No known allergies. The patient's concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 03Apr2021 17:00 (Lot Number: EW0150), also at age of 55 years old for covid-19 immunization. The patient reported that 2 hours after 2nd dose, he started to cough and wheeze and felt his throat was closing. He didn't want to go to the hospital and it felt better after his wife gave him diphenhydramine (BENADRYL). Adverse event start date was reported as on 24Apr2021 19:00 (CLARIFICATION PENDING). Events were reported as non-serious. AE treatment was reported as "no" (CLARIFICATION PENDING). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered in Apr2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, Tobacco user
Clinical narrative: he had some issue not like headache just mental issue that he didn't feel like in head; he started smoking after again after quitting; This is a spontaneous report from a contactable consumer. This consumer reported for a 70-year-old male patient. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0171 and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 27Apr2021 at 16:27, as a single dose for COVID-19 immunization. The patient's medical history included COPD, Schizophrenia, UTI (took antibiotics), traumatic brain injury (when he was 16 or 17) and indwelling urinary catheter. Concomitant medication included Haloperidol for Schizophrenia, salbutamol (ALBUTEROL) for COPD, Diazepam, Trazodone for sleeping, and Ipratropium (Nebulizer). The reporter (care giver) stated that, the reporter spoke with a gentleman this morning about the adverse reaction that the reporter's partner had, he was nonverbal that's why the reporter was calling to check. The patient had his vaccine in the evening at 04:27, on 27Apr2021. He had around 08:30 quarter 9 and we were driving home around 9 o'clock and the reporter asked to patient that was he feeling weird, and the patient said yes. The reporter asked how the patient feeling weird. The patient said, in his head because he had this problem with his brain from his accident done, it was a little tricky because it was been years to start functioning in a way that he could relate to. The patient felt weird and low and he said his head, so he had some issue not like headache just mental issue that he didn't feel like in head, and he said today that's starting to go away that because the reporter asked him the question so the reporter just wondering if, he suggest when the reporter talk to the man early this morning and reported it. An hour, he took all the medicine he was taking and also his information. The reporter was wondering, he told the reporter to contact him for medical information and he gave the reporter this no to call him and he transfer the reporter and the reporter already too busy. The reporter already been over the phone so, the reporter would like to know if the reporter could help him to move this out of his system if that happen and the reporter would probably ask him not to have the second vaccine. The reporter wanted to know how he feel about that. When the reporter goes off, he was not the happy person actually. The patient started smoking after again after quitting 20 years ago after the vaccine. The reporter also stated that the patient said he was little better. The patient took little bit of Ganja by mouth not smoking it, that he made Ganja medicine and took little bit of that. He was taking it some of the local dispensary CBD and THC. The patient did not receive any treatment for the events. There was not a product complaint to report. There was a medical information request.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, Body temperature, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: fever of 103/104; Oxigen level of 82 / 84; No antibodies against COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, in Jan2021, at single dose, for COVID-19 immunisation. Patient had no known allergies or other medical history. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), lamotrigine (LAMICTAL), simvastatin (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on unknown date in right arm. The patient experienced fever of 103/104 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, oxygen level of 82 / 84 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, no antibodies against COVID-19 (life threatening) on 03May2021 with outcome of unknown. The events pyrexia and oxygen saturation decreased required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia and oxygen saturation decreased and included treatment with oxygen, antibiotics, fluids. After 8 hours the patient was sent to the ICU. The patient underwent lab tests and procedures which included body temperature: 103 on 02May2021, body temperature: 104 on 02May2021, oxygen saturation: 84 on 02May2021, oxygen saturation: 82 on 02May2021, COVID-19 antibody test: negative on 03May2021.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: fever of 103/104; Oxigen level of 82 / 84; No antibodies against COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, in Jan2021, at single dose, for COVID-19 immunisation. Patient had no known allergies or other medical history. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), lamotrigine (LAMICTAL), simvastatin (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on unknown date in right arm. The patient experienced fever of 103/104 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, oxygen level of 82 / 84 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, no antibodies against COVID-19 (life threatening) on 03May2021 with outcome of unknown. The events pyrexia and oxygen saturation decreased required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia and oxygen saturation decreased and included treatment with oxygen, antibiotics, fluids. After 8 hours the patient was sent to the ICU. The patient underwent lab tests and procedures which included body temperature: 103 on 02May2021, body temperature: 104 on 02May2021, oxygen saturation: 84 on 02May2021, oxygen saturation: 82 on 02May2021, COVID-19 antibody test: negative on 03May2021.  The information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration at the age of 43-year-old administered in left arm on 24Mar2021 18:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. The patient previously took the first dose of BNT162B2 and administered in left arm at the age of 43-year-old on 24Feb2021 18:00 (Lot Number: EL9261) for covid-19 immunisation. Medical history included hypertension. No known allergies. Concomitant medication included bisoprolol fumarate, hydrochlorothiazide (ZIAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with bell's palsy on 06May2021 05:00. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Therapeutic measures were taken as a result of diagnosed with bell's palsy as treatment of antiviral and steroids. The outcome of the event was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in arm left on 26Jan2021 at the age of 43-years-old (Lot Number: EL3247) as single dose, 2nd dose via an unspecified route of administration, administered in arm right on 15Feb2021 at the age of 43-years-old (Lot Number: EL3247) as single dose, for COVID-19 Immunization. Patient was not pregnant. The patient's medical history was not reported. There was no any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Reported event was COVID-19 confirmed by positive COVID-19 test, with onset date 05May2021. COVID 19 test on 07May2021 was positive. There was not any treatment for AE. The outcome of event was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for covid 19; She tested positive for covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Right Arm on 06Apr2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 25Apr2021 the patient tested positive for covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Apr2021. Therapeutic measures were taken as a result of tested positive for covid 19. The outcome of event was unknown.   Follow-up (10May2021): New Information received from the contactable consumer includes updated events and dates, questions regarding events.  Information on the lot/batch number has been requested.