chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: who received the booster dose of the of the Pfizer BioNtech (Comirnaty) vaccine and contracted COVID-19 infection.; who received the booster dose of the of the Pfizer BioNtech (Comirnaty) vaccine and contracted COVID-19 infection.; This is a spontaneous report from a non-contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient mentioned that he tested positive for COVID and wants to know more information on the reported lack of efficacy of the booster dose on an unspecified date. Patient added that he stayed at home, with no contact and has been very careful. He was in his senior and when the vaccine was authorized, he got his booster. He mentioned that he was quite shocked. He declined to speak with  at first and says that he is just curious where Pfizer stands on this. He was thinking about going to the media regarding the efficacy of the third dose. He does not want to keep being transferred and if it continues, he was ready to go to a lawyer. Pfizer needs to be able to talk on behalf of this and not transfer him around everything, that was typical for a large corporate company. He was giving Pfizer a chance and he does not want to but he may have to go to a lawyer who will publicize all of that. He was informed that the transferring agent had sent him to the department regarding the medical information. He states that he wants to speak with . He was not blaming this  agent he was just shocked. He thought that he has done all that he could. He has stayed inside for a year and he did not talk to anyone at all, not even for deliveries, and then he got the third shot, he is older, and then he gets COVID. He thinks that Pfizer knows more about COVID then they are disclosing is his guess. He was unable to obtain phone number because he was sick and in bed on and does not have a pen. If the call disconnects, he will have to find another way to contact them. The patient underwent lab tests and procedures which included Covid-19 test: positive on an unspecified date. Outcome of event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Colitis ulcerative, Drug ineffective, Haemorrhage, Stress
Clinical narrative: COVID-19; COVID-19; Drug effect decreased; Stress; Colitis ulcerative aggravated; Bleeding; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Company (Mfr. Control No.: 21K-163-3988258-00).  A 63-year-old female patient (same age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization; and adalimumab (HUMIRA), subcutaneous from Sep2016 (Batch/Lot number was not reported) to Oct2020, at 40 mg, subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for colitis ulcerative. No relevant medical history. The patient's concomitant medications were not reported. On unknown dates, the patient experienced humira completely stopped working, COVID-19, and stressed. In 2021, the patient experienced bleeding. On 13Mar2021, the patient experienced ulcerative colitis flare ups. In May2021, the ulcerative colitis flare Ups resolved. In 2021, the bleeding resolved. Pfizer BionTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 11Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 08Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with Prednisone. The outcome of event Colitis ulcerative aggravated was recovered in May2021; outcome of bleeding was recovered in 2021; outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with BNT162B2 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.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on information provided in the case but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: COVID-19; COVID-19; Drug effect decreased; Stress; Colitis ulcerative aggravated; Bleeding; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Company (Mfr. Control No.: 21K-163-3988258-00).  A 63-year-old female patient (same age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 11Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization; and adalimumab (HUMIRA), subcutaneous from Sep2016 (Batch/Lot number was not reported) to Oct2020, at 40 mg, subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for colitis ulcerative. No relevant medical history. The patient's concomitant medications were not reported. On unknown dates, the patient experienced humira completely stopped working, COVID-19, and stressed. In 2021, the patient experienced bleeding. On 13Mar2021, the patient experienced ulcerative colitis flare ups. In May2021, the ulcerative colitis flare Ups resolved. In 2021, the bleeding resolved. Pfizer BionTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 11Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 08Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with Prednisone. The outcome of event Colitis ulcerative aggravated was recovered in May2021; outcome of bleeding was recovered in 2021; outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with BNT162B2 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.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on information provided in the case but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited for 6 straight days every time she tried to eat; This is a spontaneous report from a contactable consumer or other non-HCP (parent reported for daughter). A 14-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 13Sep2021 as dose 1, single (at the age of 14-years-old) for COVID-19 immunization. Vaccination Facility type was reported as Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient had not been tested for covid post vaccination. Medical history included COVID-19 and known allergies were reported as unknown. Concomitant medication included sertraline hydrochloride (ZOLOFT). On an unspecified date in 2021, the patient experienced vomited for 6 straight days every time she tried to eat. The patient only stopped after taking Zofran and she took it for a week. Patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 05Oct2021 as dose 2, single for COVID-19 immunization. The outcome of the event was resolved on an unspecified date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint lock, Osteoarthritis, Pain, SARS-CoV-2 test
Clinical narrative: I was unable to move from a sitting position without severe pain on my left side and groin; my left knee was locking up; did have a degree of osteoarthritis/after the vaccine it was exacerbated; left in a lot of pain in my knees and hip; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EWO202, Expiration date: Not reported), via an unspecified route of administration in right arm on 03Jun2021 at 12:00 (at the age of 60-years-old) as dose 2, single for COVID-19 immunization in a hospital. Medical history included osteoarthritis. The patient was allergic to penicillin and shell fish. Concomitant medications/other medications received by the patient in two weeks included duloxetine; pantoprazole and eletriptan hydrobromide (RELPAX). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EWO175, Expiration date: Not reported), via an unspecified route of administration in left arm on 12May2021 at 15:00 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Three days after her second shot on 05Jun2021, the patient was unable to move from a sitting position without severe pain on her left side and groin and also her left knee was locking up. The patient did have a degree of osteoarthritis. However, she felt that after the vaccine it was exacerbated where she was currently left in a lot of pain in her knees and hip. The patient received treatment with a steroid shot to the hip and had a series of five gel shots for the events which resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. Post-vaccination, the patient was tested for COVID-19 by nasal swab method in 2021 with the negative result. The outcome of these events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Chills
Clinical narrative: BP spiked today(Oct 5) about 1:30PM, from normal to 185/68; headache; body aches; chills; fever (over102 for about 12 hours, 102.4 at peak); queasy stomach (no vomiting); profuse sweating; feeling woozy-headed; sensitivity to loud/sharp noise,visual sensation of flashing lights.; sensitivity to loud/sharp noise,visual sensation of flashing lights.; general fatigue; dizziness; chest discomfort; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female non pregnant patient received bnt162b2 (COMIRNATY), Left arm on 27Sep2021 11:30 AM at age of 72-year-old DOSE 3 (BOOSTER), SINGLE (Lot number: FC3182) for covid-19 immunisation. Medical history: HPB, SVT, Hypothyroidism (all treated). nausea reactions to anesthesia. No covid prior vaccination. Concomitant medications included flecainide acetate, lisinopril, levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient previously received received bnt162b2 (COMIRNATY) Left arm on 10Feb2021 10:00 AM at age of 71-year-old as DOSE 1, single (lot number: EL9265) for covid-19 immunisation, Right arm on 03Mar2021 10:00 AM as DOSE 2, single (lot number: EN6200) for covid-19 immunisation. Only sore arm and a bit of fatigue with 1st dose, sore arm only for 2nd dose. On 28Sep2021 10:00 AM About 20 hours after 3rd dose the patient developed fever (over102 for about 12 hours, 102.4 at peak), severe headache, body aches, chills, queasy stomach (no vomiting), profuse sweating. The above continued approx 36 hrs., fever lessened after 24 hrs. Post-fever continued feeling woozy-headed, had sensitivity to loud/sharp noise, visual sensation of flashing lights in 2021. At this writing 8 days after 3rd dose the patient still have general fatigue, some dizziness, queasy stomach, some chest discomfort in 2021. Concerned about heart (have SVT). BP spiked today (05Oct2021) about 1:30PM, from normal to 185/68, lasting only a few minutes. No covid tested post vaccination. No treatments received. Outcome of the event queasy stomach (no vomiting), feeling woozy-headed, general fatigue, dizziness, chest discomfort was not recovered. Outcome of the event BP spiked today (Oct 5) about 1:30PM, from normal to 185/68 was recovered. Outcome of the event fever (over102 for about 12 hours, 102.4 at peak) was recovering. Outcome of other events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hyperacusis
Clinical narrative: BP spiked today(Oct 5) about 1:30PM, from normal to 185/68; headache; body aches; chills; fever (over102 for about 12 hours, 102.4 at peak); queasy stomach (no vomiting); profuse sweating; feeling woozy-headed; sensitivity to loud/sharp noise,visual sensation of flashing lights.; sensitivity to loud/sharp noise,visual sensation of flashing lights.; general fatigue; dizziness; chest discomfort; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female non pregnant patient received bnt162b2 (COMIRNATY), Left arm on 27Sep2021 11:30 AM at age of 72-year-old DOSE 3 (BOOSTER), SINGLE (Lot number: FC3182) for covid-19 immunisation. Medical history: HPB, SVT, Hypothyroidism (all treated). nausea reactions to anesthesia. No covid prior vaccination. Concomitant medications included flecainide acetate, lisinopril, levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient previously received received bnt162b2 (COMIRNATY) Left arm on 10Feb2021 10:00 AM at age of 71-year-old as DOSE 1, single (lot number: EL9265) for covid-19 immunisation, Right arm on 03Mar2021 10:00 AM as DOSE 2, single (lot number: EN6200) for covid-19 immunisation. Only sore arm and a bit of fatigue with 1st dose, sore arm only for 2nd dose. On 28Sep2021 10:00 AM About 20 hours after 3rd dose the patient developed fever (over102 for about 12 hours, 102.4 at peak), severe headache, body aches, chills, queasy stomach (no vomiting), profuse sweating. The above continued approx 36 hrs., fever lessened after 24 hrs. Post-fever continued feeling woozy-headed, had sensitivity to loud/sharp noise, visual sensation of flashing lights in 2021. At this writing 8 days after 3rd dose the patient still have general fatigue, some dizziness, queasy stomach, some chest discomfort in 2021. Concerned about heart (have SVT). BP spiked today (05Oct2021) about 1:30PM, from normal to 185/68, lasting only a few minutes. No covid tested post vaccination. No treatments received. Outcome of the event queasy stomach (no vomiting), feeling woozy-headed, general fatigue, dizziness, chest discomfort was not recovered. Outcome of the event BP spiked today (Oct 5) about 1:30PM, from normal to 185/68 was recovered. Outcome of the event fever (over102 for about 12 hours, 102.4 at peak) was recovering. Outcome of other events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Photophobia, Pyrexia
Clinical narrative: BP spiked today(Oct 5) about 1:30PM, from normal to 185/68; headache; body aches; chills; fever (over102 for about 12 hours, 102.4 at peak); queasy stomach (no vomiting); profuse sweating; feeling woozy-headed; sensitivity to loud/sharp noise,visual sensation of flashing lights.; sensitivity to loud/sharp noise,visual sensation of flashing lights.; general fatigue; dizziness; chest discomfort; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female non pregnant patient received bnt162b2 (COMIRNATY), Left arm on 27Sep2021 11:30 AM at age of 72-year-old DOSE 3 (BOOSTER), SINGLE (Lot number: FC3182) for covid-19 immunisation. Medical history: HPB, SVT, Hypothyroidism (all treated). nausea reactions to anesthesia. No covid prior vaccination. Concomitant medications included flecainide acetate, lisinopril, levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient previously received received bnt162b2 (COMIRNATY) Left arm on 10Feb2021 10:00 AM at age of 71-year-old as DOSE 1, single (lot number: EL9265) for covid-19 immunisation, Right arm on 03Mar2021 10:00 AM as DOSE 2, single (lot number: EN6200) for covid-19 immunisation. Only sore arm and a bit of fatigue with 1st dose, sore arm only for 2nd dose. On 28Sep2021 10:00 AM About 20 hours after 3rd dose the patient developed fever (over102 for about 12 hours, 102.4 at peak), severe headache, body aches, chills, queasy stomach (no vomiting), profuse sweating. The above continued approx 36 hrs., fever lessened after 24 hrs. Post-fever continued feeling woozy-headed, had sensitivity to loud/sharp noise, visual sensation of flashing lights in 2021. At this writing 8 days after 3rd dose the patient still have general fatigue, some dizziness, queasy stomach, some chest discomfort in 2021. Concerned about heart (have SVT). BP spiked today (05Oct2021) about 1:30PM, from normal to 185/68, lasting only a few minutes. No covid tested post vaccination. No treatments received. Outcome of the event queasy stomach (no vomiting), feeling woozy-headed, general fatigue, dizziness, chest discomfort was not recovered. Outcome of the event BP spiked today (Oct 5) about 1:30PM, from normal to 185/68 was recovered. Outcome of the event fever (over102 for about 12 hours, 102.4 at peak) was recovering. Outcome of other events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Eye pain, Headache
Clinical narrative: Tunnel Vision; Pain behind eyes; blurry vision; black vision; nausea; sweating; headache; dizziness; dry heaving; vomitting; shakiness; chills; metallic taste in mouth; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:00 (Batch/Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Non-alcoholic fatty liver disease, gallbladder removed from 2011, covid, and known allergies: penicillin and codeine. Patient is non-pregnant at time of vaccination. There were no concomitant medications. The patient experienced tunnel vision, pain behind eyes, blurry vision, black vision, nausea, sweating, headache, dizziness, dry heaving, vomitting, shakiness, chills, and metallic taste in mouth and all on 04Oct2021 06:30 with outcome of not recovered. Events resulted in Emergency room/department or urgent care. Treatment was received for all events. Sedated at ER with medication for optical migraine. No COVID tested post vaccination.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported event Tunnel vision cannot be completely excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Retching, Tremor, Tunnel vision
Clinical narrative: Tunnel Vision; Pain behind eyes; blurry vision; black vision; nausea; sweating; headache; dizziness; dry heaving; vomitting; shakiness; chills; metallic taste in mouth; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:00 (Batch/Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Non-alcoholic fatty liver disease, gallbladder removed from 2011, covid, and known allergies: penicillin and codeine. Patient is non-pregnant at time of vaccination. There were no concomitant medications. The patient experienced tunnel vision, pain behind eyes, blurry vision, black vision, nausea, sweating, headache, dizziness, dry heaving, vomitting, shakiness, chills, and metallic taste in mouth and all on 04Oct2021 06:30 with outcome of not recovered. Events resulted in Emergency room/department or urgent care. Treatment was received for all events. Sedated at ER with medication for optical migraine. No COVID tested post vaccination.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported event Tunnel vision cannot be completely excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment, Vomiting
Clinical narrative: Tunnel Vision; Pain behind eyes; blurry vision; black vision; nausea; sweating; headache; dizziness; dry heaving; vomitting; shakiness; chills; metallic taste in mouth; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 03Oct2021 11:00 (Batch/Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Non-alcoholic fatty liver disease, gallbladder removed from 2011, covid, and known allergies: penicillin and codeine. Patient is non-pregnant at time of vaccination. There were no concomitant medications. The patient experienced tunnel vision, pain behind eyes, blurry vision, black vision, nausea, sweating, headache, dizziness, dry heaving, vomitting, shakiness, chills, and metallic taste in mouth and all on 04Oct2021 06:30 with outcome of not recovered. Events resulted in Emergency room/department or urgent care. Treatment was received for all events. Sedated at ER with medication for optical migraine. No COVID tested post vaccination.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported event Tunnel vision cannot be completely excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Capillary leak syndrome
Clinical narrative: partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 patients. This is a 2nd of 2 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported the patient with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination. The most recent, the physician was considering trying to get IVIG treatment. The event outcome was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event capillary leak syndrome and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202101324800 same product, reporter and event, different patients.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid ptosis, SARS-CoV-2 test
Clinical narrative: Diagnosed as Ptosis; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 48-years-old on 08May2021 (Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemochromatosis. No Covid prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 48-years-old on 09Apr2021 for COVID-19 immunization. The patient experienced In June started having slightly droopy left eye, which has gotten worse over time. Diagnosed as Ptosis. Left eye only. Hasn't gotten better, has slowly gotten worse over last several months. Adverse event start date: 04Jun2021. No treatment received for the event. The patient underwent lab tests and procedures which included sars-cov-2 PCR: negative on 26Sep2021 Nasal Swab. Outcome of event was not recovered. The event resulted in: [Doctor or other healthcare professional office/clinic visit, Disability or permanent damage]  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Coma, Myocardial infarction
Clinical narrative: My husbands cousin had a major heart attack and is in a coma.; My husbands cousin had a major heart attack and is in a coma.; This is a spontaneous report from a non-contactable consumer. This consumer reported for a patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported husband's cousin had a major heart attack and is in a coma. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed symptoms on 25Sep2021 and became sero positive for COVID-19; developed symptoms on 25Sep2021 and became sero positive for COVID-19; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients (uncle and aunty). This is the 1st (uncle) of 2 reports. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No Covid prior vaccination. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient received the Pfizer BioNTech vaccine booster (completing the series of 3) and developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date, thus qualifying as a lack of efficacy AE (adverse event). The events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. Therapeutic measures were taken as a result of the events included regeneron monoclonal antibodies. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, Covid-19 and BNT162B2.,Linked Report(s) : US-PFIZER INC-202101326365 same reporter/drug/event, different patient
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle strain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: it felt like a pulled muscle; couldn't hardly lift her arm/still hurts very bad; couldn't hardly lift her arm/still hurts very bad; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years, via an unspecified route of administration in left arm on 30Mar2021 at 11:00 at single dose for COVID-19 immunization, at pharmacy or drug store. Medical history was none. The patient was not pregnant at time of vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) and simvastatin. On 30Mar2021 at 11:00, after her vaccine, she went to the car and opened her door and it felt like a pulled muscle. She couldn't hardly lift her arm and it had not gotten any better. It still hurts very bad. AE resulted in disability or permanent damage. No treatment received. COVID-19 virus test (nasal swab) was negative on 01Sep2021. The patient received second single dose of BNT162B2 in left arm on 27Apr2021 at 11:00 for COVID-19 immunization. Outcome of the events was not recovered/not resolved.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: broken tooth; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Support. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced broken tooth in 2021 and had a dental implant today (06Oct2021). Outcome of event was unknown. The patient was prescribed with "Afrin for his right nostril because his dental implant was on the upper right side"; prescribed with Chlorhexidine mouth wash. The patient was scheduled for his booster or third dose of the Pfizer COVID-19 vaccine tomorrow and wanted to know if there would be an interaction with Afrin and Chlorhexidine mouth was with the vaccine. The patient was also prescribed with Naproxen Sodium 550mg 1 tablet every 12 hours as pain medication, and Cephalexin 500mg 1 capsule every 6 hours as antibiotic.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Her son was diagnosed positive; Son is completely vaccinated; Her son was diagnosed positive; Son is completely vaccinated; This is a spontaneous report from a Pfizer-sponsored program Support. This is the 2nd case out of 2 cases. A contactable consumer reported for a patient (Son) that the male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced her son was diagnosed positive; son is completely vaccinated on an unspecified date with outcome of unknown. She mentioned that, she got the booster shot today, without even knowing that, her son was diagnosed positive and she was exposed to his like there is no face mask and his son is completely vaccinated(Not further confirmed which vaccine he received) as well and right now, he has the symptoms of COVID-19 virus right now. She want to know how does it matters and she added that, If any, in case they will not be infected, they will be visiting a person, who is immunocompromised, who is vaccinated as well. She wants to know and she wants to ask if there are possibility, They can carry the virus even though the immunocompromised person is already vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, SARS-CoV-2 test, Supraventricular tachycardia
Clinical narrative: SVT episode with a heart rate over 210 bpm; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 23Mar2021 16:45 (Lot Number: ER8727) as dose 2, single (at age of 46-years-old) for covid-19 immunisation. No pregnant at time of vaccination. No other vaccine in four weeks. Medical history included allergies. No Covid prior vaccination. Concomitant medications included montelukast sodium (SINGULAIR); levocetirizine dihydrochloride (XYZAL) taken for allergies. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 02Mar2021 16:30 administered in Arm Right (at age of 46-years-old) for COVID-19 immunization. The patient experienced SVT episode with a heart rate over 210 bpm (hospitalization) on 21May2021 10:30. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for SVT episode with a heart rate over 210 bpm for 1 days. She never had SVT before or any heart conditions. The event treatment induced medication to slow down her heart and stop SVT. The patient underwent lab tests and procedures which included heart rate: 210 bpm on 21May2021, rapid test: negative Nasal Swab on 19Jan2021. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out and collapsed to the floor in his apartment's bathroom; passed out and collapsed to the floor in his apartment's bathroom; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 12:00 (Batch/Lot number was not reported) as dose 2, single (at age of 35-years-old) for covid-19 immunisation. Medical history was none. Known allergies: none. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 12:00 administered in Arm Right (at age of 35-years-old) for COVID-19 immunization. On 26Mar2021 23:00, later that evening on the date he got the second shot, he passed out and collapsed to the floor in his apartment's bathroom. This incident occurred as he was in the process of urinating. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Outcome of the events was recovered with sequelae.    The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: Administered Fluarix intranasally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 18-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3SE27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intranasal) and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route.On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the nurse. The nurse supervisor called in to report and stated clinical staff inadvertently administered Fluarix intranasally to a patient instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Arm pain; Arm tingling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and tingling of extremity. On an unknown date, the outcome of the pain in arm and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and tingling of extremity to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient's husband.  The age at the vaccination was not reported. The reporter stated that patient received Shingrix vaccine and was experiencing arm pain and tingling. The reporter did not provide any further information and abandoned the call. The reporter did not consented to follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Injection site pain, Limb discomfort, Nausea
Clinical narrative: LEFT ARM FELT HEAVY AND HARD TO LIFT ARM WITHOUT FELLING PAIN; NAUSEOUS; SORE ARM ON THE SITE OF INJECTION/PAIN IN ARM WHEN LIFTING; LOW FEVER; WEIRD TASTE IN MOUTH; CHILLS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On 09-SEP-2021, the patient experienced weird taste in mouth. On 09-SEP-2021, the patient experienced chills. On 09-SEP-2021, the patient experienced sore arm on the site of injection/pain in arm when lifting. On 09-SEP-2021, the patient experienced low fever. On 10-SEP-2021, the patient experienced nauseous. On 10-OCT-2021, the patient experienced left arm felt heavy and hard to lift arm without felling pain. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth on 12-SEP-2021, chills, low fever, and nauseous on 10-SEP-2021, and sore arm on the site of injection/pain in arm when lifting on SEP-2021, and was recovering from left arm felt heavy and hard to lift arm without felling pain. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LEFT ARM FELT HEAVY AND HARD TO LIFT ARM WITHOUT FELLING PAIN; NAUSEOUS; SORE ARM ON THE SITE OF INJECTION/PAIN IN ARM WHEN LIFTING; LOW FEVER; WEIRD TASTE IN MOUTH; CHILLS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On 09-SEP-2021, the patient experienced weird taste in mouth. On 09-SEP-2021, the patient experienced chills. On 09-SEP-2021, the patient experienced sore arm on the site of injection/pain in arm when lifting. On 09-SEP-2021, the patient experienced low fever. On 10-SEP-2021, the patient experienced nauseous. On 10-OCT-2021, the patient experienced left arm felt heavy and hard to lift arm without felling pain. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird taste in mouth on 12-SEP-2021, chills, low fever, and nauseous on 10-SEP-2021, and sore arm on the site of injection/pain in arm when lifting on SEP-2021, and was recovering from left arm felt heavy and hard to lift arm without felling pain. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: AFTER GETTING THE JANSSEN COVID-19 VACCINE PAIN FROM HIP DISAPPEARED AND TSH LEVEL GET NORMAL; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hip surgery, and concurrent conditions included: extremely low tsh level, alcohol user, non smoker, and pain on surgical area (pain felt all day), and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced after getting the janssen covid-19 vaccine pain from hip disappeared and tsh level get normal. On 31-JUL-2021, Laboratory data included: TSH (NR: not provided) 1.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after getting the janssen covid-19 vaccine pain from hip disappeared and tsh level get normal was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced tenderness around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced tenderness around the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     NO medical history information was reported.  The patient's past medical history included Hypertension since an unknown date and Diabetes since an unknown date.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (experienced tenderness around the site). At the time of the report, VACCINATION SITE PAIN (experienced tenderness around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant medications reported were Blood Pressure Medications, and Diabetes Medications.  No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced tenderness around the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     NO medical history information was reported.  The patient's past medical history included Hypertension since an unknown date and Diabetes since an unknown date.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (experienced tenderness around the site). At the time of the report, VACCINATION SITE PAIN (experienced tenderness around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant medications reported were Blood Pressure Medications, and Diabetes Medications.  No Treatment information for the event was provided.