chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Moderate pain/ pain was only from her shoulder to her elbow; Moderate pain/ pain was only from her shoulder to her elbow; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm, on 09Apr2021, 12:00 (batch/lot number: EP6955) at the age of 47 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient received the vaccine at a Pharmacy/Drug Store vaccination facility. The patient's medical history included anxiety from an unknown date and ongoing, and pain from an unknown date. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for anxiety from 2019 and ongoing; and paracetamol (TYLENOL) oral taken for pain from 09Apr2021 and ongoing (as reported). There were no prior vaccinations. The patient reported that after the first dose on 09Apr2021, she had moderate pain, nothing serious. The pain was only from her shoulder to her elbow. The outcome of the event "moderate pain/ pain was only from her shoulder to her elbow" was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Faecal calprotectin, Faecal calprotectin increased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient), based on information received by Pfizer (control number: 21K-163-4125990-00). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), intramuscularly, on an unspecified date in 2021, single dose, for COVID-19 immunization. Patient also had Humira (adalimumab) 40mg/0.4mL, solution for injection, pre-filled pen, subcutaneously, (1 every 2 weeks), from an unspecified date (batch/lot# not reported) and ongoing, for an unspecified indication. The patient's medical history and concomitant medications  not reported. On an unspecified date in 2021, patient experienced a flare-up, high fecal calprotectin and twenty loose bowel movement. Patient hospitalized for flare-up, high fecal calprotectin and twenty loose bowel movement from an unspecified date in 2021 to an unknown date. Clinical course of the events as follows: A female patient with events of flare-up, increased loose bowel movement and non-serious high fecal calprotectin with Humira 40mg/0.4mL (adalimumab). No reported medical history. On an unspecified date in 2021, patient experienced flare-up. The patient experienced increased loose bowel movement and high fecal calprotectin. Pfizer Biontech COVID-19 vaccine (Tozinameran) also considered a suspect. The patient experienced flare-up (unknown) and hospitalized on an unspecified date in 2021. High fecal calprotectin of over a thousand. She took the first dose of COVID vaccine and experienced twenty loose bowel movement. Treatment, concomitant drugs, tobacco and alcohol history, medical history and allergies not provided. Primary reporter declined to provide lot number information. The patient underwent lab tests and procedures, which included fecal calprotectin: Over a thousand (high), on an unspecified date in 2021. The outcome of all events was unknown. The reporter's causality for flare-up, increased loose bowel movement and high fecal calprotectin: not provided. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Loss of consciousness, Nausea
Clinical narrative: DOSE 3 (BOOSTER), SINGLE/10Oct2021; Chills and passing out; Very nauseous; Chills and passing out; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:00 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE, dose 3 via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:00 (Batch/Lot Number: Ff2590) as DOSE 3 (BOOSTER), SINGLE at the age of 73-years-old for covid-19 immunisation.  Medical history included none. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation from 05Sep2021 to 05Sep2021; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported; olmesartan taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Feb2021 (lot number: Zn5318, Left arm) for covid-19 immunisation, erythromycin and experienced drug allergies.  Approximately 13 hours after 2nd and 3rd vaccine, patient experienced chills and passing out Very nauseous. Also dose 3 (booster), single/10oct2021 was reported. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.Outcome of chills and passing out, chills and passing out, very nauseous was recovered in Oct2021, of DOSE 3 (BOOSTER), SINGLE/10Oct2021 was unknown. Therapeutic measures were taken as a result of very nauseous.  No follow-up attempts are possible. No further information is expected
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Pyrexia
Clinical narrative: Bells palsy; Fever; This is a spontaneous report from a contactable other hcp (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 23Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 25-years-old for covid-19 immunisation.  Medical history included  none.The patient's concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient experienced bells palsy on 23Jan2021, fever on 23Jan2021. Outcome of events was recovered. No treatment received.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relation, the association between the event of Bell's palsy and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Eosinophilic pneumonia, Proctitis
Clinical narrative: Eosinophilic pneumonia; eosinophilic 'proctitis'; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient experienced eosinophilic pneumonia. The reporter wanted to know If there is any data regarding like an eosinophilic 'proctitis' or eosinophilic pneumonia following the vaccine. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Scratch
Clinical narrative: BOOSTER; scratching/Severe itching; scratching; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 on 13Oct2021 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose and second dose of bnt162b2 (MANUFACTURER UNKNOWN), on unknown date (Batch/Lot Number: Unknown) for covid-19 immunisation. The patient stated that "13Oct I received my booster and I want to say shortly after I started with severe itching, it started in my scalp, I thought it just gonna go crazy scratching and scratching so that subsided I used medicated shampoo (treatment) for you know dry scalp and you know whatever thinking that something in there would help, well it did, so now it's my body I'm scratching beyond scratching, I used creams, I ordered a 'Venobath' (treatment) because now I cannot find it in the stores (Further clarification unknown) and I started taking Benadryl (Treatment) so I am wondering I think it's one of the side effects from the booster. I did had other reactions from the injections". The outcome 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: Acute kidney injury, Biopsy, Blood creatinine, Haematuria, IgA nephropathy
Clinical narrative: IgA nephropathy; Acute kidney injury; gross hematuria; This is a literature report from Kidney International, 2021, Vol 100, Pgs 944-945, entitled "Acute kidney injury with gross hematuria and IgA nephropathy after COVID-19 vaccination". This reporter reported 2 reports; this is the 1 of 2 reports. The full publication has been requested.  We also cared for 2 patients who had prior biopsy-proven IgAN, who developed gross hematuria after their second dose of the Pfizer vaccine, without a preceding COVID-19 infection. Table 1 outlines the clinical data. Our first patient presented 5 days after his second dose, with nonspecific myalgias, chills, headache, dysuria, and gross hematuria within 24 hours of initial symptoms. Previous IgAN flares in this patient were precipitated by upper respiratory infections and were limited to gross hematuria with no AKIs and no requirement for steroids in the past. His postvaccine workup was notable for AKI, with a serum creatinine level of 3.53 mg/dl and a urine protein-creatinine ratio of 3.0. He was empirically started on steroids with recovery to baseline renal function at 1 month and recovery to baseline proteinuria within 2 months. Our second patient developed gross hematuria within 24 hours of receiving his second dose. His hematuria resolved after 3 days with supportive therapy only. To our knowledge, we are the first to report an IgAN flare that has led to an AKI that resolved with steroid therapy. We agree that it is not clear how a nonmucosal immune challenge led to an IgAN; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and IgA nephropathy, Acute kidney injury, Hematuria  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.,Linked Report(s) US-PFIZER INC-202101461686 Same article/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Protein urine, Renal function test, Urine protein/creatinine ratio
Clinical narrative: IgA nephropathy; Acute kidney injury; gross hematuria; This is a literature report from Kidney International, 2021, Vol 100, Pgs 944-945, entitled "Acute kidney injury with gross hematuria and IgA nephropathy after COVID-19 vaccination". This reporter reported 2 reports; this is the 1 of 2 reports. The full publication has been requested.  We also cared for 2 patients who had prior biopsy-proven IgAN, who developed gross hematuria after their second dose of the Pfizer vaccine, without a preceding COVID-19 infection. Table 1 outlines the clinical data. Our first patient presented 5 days after his second dose, with nonspecific myalgias, chills, headache, dysuria, and gross hematuria within 24 hours of initial symptoms. Previous IgAN flares in this patient were precipitated by upper respiratory infections and were limited to gross hematuria with no AKIs and no requirement for steroids in the past. His postvaccine workup was notable for AKI, with a serum creatinine level of 3.53 mg/dl and a urine protein-creatinine ratio of 3.0. He was empirically started on steroids with recovery to baseline renal function at 1 month and recovery to baseline proteinuria within 2 months. Our second patient developed gross hematuria within 24 hours of receiving his second dose. His hematuria resolved after 3 days with supportive therapy only. To our knowledge, we are the first to report an IgAN flare that has led to an AKI that resolved with steroid therapy. We agree that it is not clear how a nonmucosal immune challenge led to an IgAN; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and IgA nephropathy, Acute kidney injury, Hematuria  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.,Linked Report(s) US-PFIZER INC-202101461686 Same article/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid; got covid; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE , dose 2 on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient got the Pfizer vaccine, got covid, got the second Pfizer dose, got covid, and his symptoms were 10 times worse with the second dose. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Pain
Clinical narrative: Crohn's disease flare ups; Felt achy; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Company (manufacturer control number: 21K-163-3912380-00). A contactable 68-year-old female consumer (patient) reporter for herself that a 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, dose 2 and dose 3 (booster), all via intramuscular on an unspecified date at single dose for COVID-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Lot Number: 1138116) and from an unspecified date (Lot Number: 1150237) at citrate free for moderate to severe adult Crohn's disease. Medical history included were none and no known allergies. The patient's concomitant medications were not reported.  The patient experienced Crohn's disease flare ups and felt achy on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of Crohn's disease flare ups was resolved in 2021, the outcome of felt achy was unknown.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Crohn's disease flare ups with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of Felt achy was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product 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.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Crohn's disease and pain and the suspect drug 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 drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: rash on her bilateral upper extremities and the trunk of her body; Booster; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received third dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left deltoid on 20Oct2021 15:00 (Batch/Lot Number: FD0809; Expiration Date: Oct2021) (Vaccination age was 41-year-old) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. Patient received first dose BNT162B2 on 29Dec2020, second dose BNT162B2 on 19Jan2021. None Medical history reported. The patient's concomitant medications were not reported. The patient experienced rash on her bilateral upper extremities and the trunk of her body on 21Oct2021. The event does not require emergency room visit, but caused physician office visit. A doctor prescribed some sort of a steroid. The outcome of event was not recovered. The nurse assessed relatedness of drug to event "rash on her bilateral upper extremities and the trunk of her body" was "Related". Case reported as serious due to Other medically important condition.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Immunisation, Urticaria
Clinical narrative: angioedema; raised red bumps on upper right deltoid / diffuse hives across torso, right leg and arm; Booster; This is a spontaneous report from a contactable Nurse (patient). A 37-year-old no pregnant female patient received third dose of bnt162b2 (BNT162B2) (vaccinated at 37-year-old), via an unspecified route of administration, administered in left arm on 12Oct2021 09:30 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Patient received first dose of BNT162B2 in left arm with Batch/Lot No: EL1283 on 05Jan2021 10:00 AM, second dose of BNT162B2 in left arm with Batch/Lot No: EL8982 on 27Jan2021 10:00 AM. No other vaccine in four weeks. Medical history included sports induced asthma. No covid prior vaccination. Concomitant medications include Multivitamin. On 12Oct2021 17:30, approximately 8 hours post 3rd dose booster vaccine patient developed raised red bumps on upper right deltoid (vaccine was on left arm). Approximately 12hrs post booster dose, developed diffuse hives across torso, right leg and arm, relieved by Zyrtec. Zyrtec was taken for 4 days following incident. 9 days following (21Oct2021) booster dose vaccination developed angioedema relieved by Zyrtec and Pepcid. 15 days following (27Oct2021) booster dose, hives continued on right arm, torso and right hip. Relieved by loratadine. Event resulted in professional office/clinic visit. The outcome of events was recovering. No covid tested post vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation, Lacrimation increased, Magnetic resonance imaging, Palpitations
Clinical narrative: On the 10th day when woke up and had only partial vision in left eye; eyes begin to water; have racing heart palpitations even while lying in bed; major headaches; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 42-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 04Aug2021 16:45 (Batch/Lot Number: 3101) (vaccinated at the same age) as dose 1, single for covid-19 immunisation. Medical history included apnoea. No covid prior vaccination. There were no concomitant medications. Adverse event after receiving the first dose of vaccine: On 06Aug2021 08:00 AM, patient's eyes begin to water, later started to have racing heart palpitations even while lying in bed and major headaches. On the 10th day when woke up and had only partial vision in left eye. Then went to see an eye specialist and had eye drops pat a day Patient had numerous tests and an MRI. The heart palpitations went away after 2 weeks, vision returned after 1 month. Patient still have headaches daily. No covid tested post vaccination. Outcome of watering eye, palpitations, Partial visual loss was recovered with sequel, headache was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: On the 10th day when woke up and had only partial vision in left eye; eyes begin to water; have racing heart palpitations even while lying in bed; major headaches; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 42-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 04Aug2021 16:45 (Batch/Lot Number: 3101) (vaccinated at the same age) as dose 1, single for covid-19 immunisation. Medical history included apnoea. No covid prior vaccination. There were no concomitant medications. Adverse event after receiving the first dose of vaccine: On 06Aug2021 08:00 AM, patient's eyes begin to water, later started to have racing heart palpitations even while lying in bed and major headaches. On the 10th day when woke up and had only partial vision in left eye. Then went to see an eye specialist and had eye drops pat a day Patient had numerous tests and an MRI. The heart palpitations went away after 2 weeks, vision returned after 1 month. Patient still have headaches daily. No covid tested post vaccination. Outcome of watering eye, palpitations, Partial visual loss was recovered with sequel, headache was not recovered.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, Psoriasis, Pyrexia
Clinical narrative: Back ache; Fever; Plaque psoriasis; COVID-19; COVID-19; This is a solicited report FACILITATED COLLECT from a contactable consumer (patient) based on information received by Pfizer from regulatory authority (MFR Control No. # 21K-163-4129870-00).   A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 in Dec2020, back ache, fever, plaque psoriasis on an unspecified date. The action taken in response to the events for risankizumab was unknown. The outcome of event plaque psoriasis was not resolved, outcome of other events was resolved. The reporter's causality for the event of covid-19 with risankizumab was no reasonable possibility. The reporter's causality for the other events with risankizumab was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product 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 events of Drug ineffective, COVID-19, Back pain, Pyrexia and Psoriasis are related to the suspect product BNT162B2 based on plausible temporal relationship.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Dizziness, Eye movement disorder, Face injury
Clinical narrative: Booster; in the pool of blood; passed out; eyes rolled back to head; because in the fall; feeling a bit light headed/ Dizzy; badly bruised; diarrhea; felt very nauseous; very sick; not able to eat; hit her head; hit jaw so badly; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Oct2021 at age of 66-year-old (Batch/lot number FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Concomitant therapy was none. None other Vaccine (Prior to 4 weeks of COVID Vaccine). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced sore arm. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced low grade fever, tired, sore arm. The patient had booster shot last Tuesday and woke up on Wednesday, when woke up on Wednesday morning on Oct2021, she was feeling a bit light headed and dizzy and the next thing she knew she was on the bathroom floor in the pool of blood and then she got herself up and she did not, When she was on the floor she did not know how she got there, when she got herself up, she passed out again, she had never passed out in life. Obviously she am badly bruised and whatever from the fall but she just, she don't know if other people have reported this but she think it is just important because this is the new vaccine and people have made aware of, you know what can happen. She got self on, she was not actually the good thing is she take care of her mother who was 94 and care giver ran upstairs, she heard the patient go down and helped but care giver was very nervous, care giver said the patient eyes rolled back to head, she then because she need to get to the bathroom where she could see, then had diarrhea felt very nauseous and very sick from this from this and the first two vaccine the patient was, you know other than sore arm except second shot she had very, very low grade fever and was just tired you know she thought was not big deal she thought she can take that and this booster shot though absolutely, she actually just  wasn't killed, she know this sounds like she have added but you know she hit her head and whatever. Few days after the patient just took some Advil because the not able to open, not able to eat because in the fall the patient hit jaw so badly, so the only thing the patient had been taking was some Advil, the patient took absolutely before vaccine and took nothing for two or three days after vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465991 Same patient and drug, different events separated in time;US-PFIZER INC-202101465992 Same patient and drug, different events separated in time
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeding disorder, Haemorrhage, Head injury, Illness
Clinical narrative: Booster; in the pool of blood; passed out; eyes rolled back to head; because in the fall; feeling a bit light headed/ Dizzy; badly bruised; diarrhea; felt very nauseous; very sick; not able to eat; hit her head; hit jaw so badly; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Oct2021 at age of 66-year-old (Batch/lot number FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Concomitant therapy was none. None other Vaccine (Prior to 4 weeks of COVID Vaccine). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced sore arm. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced low grade fever, tired, sore arm. The patient had booster shot last Tuesday and woke up on Wednesday, when woke up on Wednesday morning on Oct2021, she was feeling a bit light headed and dizzy and the next thing she knew she was on the bathroom floor in the pool of blood and then she got herself up and she did not, When she was on the floor she did not know how she got there, when she got herself up, she passed out again, she had never passed out in life. Obviously she am badly bruised and whatever from the fall but she just, she don't know if other people have reported this but she think it is just important because this is the new vaccine and people have made aware of, you know what can happen. She got self on, she was not actually the good thing is she take care of her mother who was 94 and care giver ran upstairs, she heard the patient go down and helped but care giver was very nervous, care giver said the patient eyes rolled back to head, she then because she need to get to the bathroom where she could see, then had diarrhea felt very nauseous and very sick from this from this and the first two vaccine the patient was, you know other than sore arm except second shot she had very, very low grade fever and was just tired you know she thought was not big deal she thought she can take that and this booster shot though absolutely, she actually just  wasn't killed, she know this sounds like she have added but you know she hit her head and whatever. Few days after the patient just took some Advil because the not able to open, not able to eat because in the fall the patient hit jaw so badly, so the only thing the patient had been taking was some Advil, the patient took absolutely before vaccine and took nothing for two or three days after vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465991 Same patient and drug, different events separated in time;US-PFIZER INC-202101465992 Same patient and drug, different events separated in time
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of consciousness, Nausea
Clinical narrative: Booster; in the pool of blood; passed out; eyes rolled back to head; because in the fall; feeling a bit light headed/ Dizzy; badly bruised; diarrhea; felt very nauseous; very sick; not able to eat; hit her head; hit jaw so badly; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Oct2021 at age of 66-year-old (Batch/lot number FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Concomitant therapy was none. None other Vaccine (Prior to 4 weeks of COVID Vaccine). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced sore arm. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 66-year-old for covid-19 immunisation and experienced low grade fever, tired, sore arm. The patient had booster shot last Tuesday and woke up on Wednesday, when woke up on Wednesday morning on Oct2021, she was feeling a bit light headed and dizzy and the next thing she knew she was on the bathroom floor in the pool of blood and then she got herself up and she did not, When she was on the floor she did not know how she got there, when she got herself up, she passed out again, she had never passed out in life. Obviously she am badly bruised and whatever from the fall but she just, she don't know if other people have reported this but she think it is just important because this is the new vaccine and people have made aware of, you know what can happen. She got self on, she was not actually the good thing is she take care of her mother who was 94 and care giver ran upstairs, she heard the patient go down and helped but care giver was very nervous, care giver said the patient eyes rolled back to head, she then because she need to get to the bathroom where she could see, then had diarrhea felt very nauseous and very sick from this from this and the first two vaccine the patient was, you know other than sore arm except second shot she had very, very low grade fever and was just tired you know she thought was not big deal she thought she can take that and this booster shot though absolutely, she actually just  wasn't killed, she know this sounds like she have added but you know she hit her head and whatever. Few days after the patient just took some Advil because the not able to open, not able to eat because in the fall the patient hit jaw so badly, so the only thing the patient had been taking was some Advil, the patient took absolutely before vaccine and took nothing for two or three days after vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465991 Same patient and drug, different events separated in time;US-PFIZER INC-202101465992 Same patient and drug, different events separated in time
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: soreness at site of reaction; Fever; fatigue; This is a spontaneous report from a contactable other HCP. A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Oct2021 at 13:00 (age at vaccination: 21-year-old) as DOSE 1, SINGLE for COVID-19 immunisation at pharmacy/ drug store. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine taken for an unspecified indication. On 23Oct2021. On the same day, patient had other vaccine same date product= flu shot. At 21:00, patient had soreness at site of reaction, fever and fatigue on 23Oct2021 at 21:00. Case assessed as non-serious by the reporter. He had not received any other vaccines within 4 weeks prior to COVID vaccination and not received other medication within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and it was unknown if tested since the vaccination. Therapeutic measures were taken as a result as a result of the event with Tylenol. The outcome of events was recovered on an unspecified in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Pain assessment, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; PAIN; This is a solicited report from the marketing program facilitated collect received based on information received by Pfizer (manufacturer control number: 21K-163-4126015-00) from a contactable consumer.  A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date, at 40MG/0.4ML, 1 in 2 week for Crohn's disease. Medical history included ongoing Crohn's disease. No known allergies. Concomitant medication included colecalciferol (VITAMIN D). Historical vaccine included first dose of BNT162B2 intramuscular for COVID-19 immunization.The patient experienced rheumatoid arthritis flare up, medically significant and pain, non-serious in 2021.  The patient underwent lab tests and procedures which included pain assessment: 2/10 on unknown date. The patient was recovering from the event, rheumatoid arthritis flare up and outcome of the event pain is unknown.  The reporter's assessment of the causal relationship of event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious and non-serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, COVID-19, Dizziness, Echocardiogram
Clinical narrative: EF now 34%; Lightheadedness; Sudden drop in BP; Pre ventricular contractions; Pacemaker mediated tachycardia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 09Apr2021 11:00 (Lot Number: ER8737) as single dose for COVID-19 immunization. Medical history included ventricular tachycardia from Nov2019 and ongoing (Ventricular Tachycardia seen on remote heart monitor in Nov2019), cardiomyopathy from Nov2019 and ongoing (Echo- EF 42% cardiac MRI scanning in lateral and apical LV wall), COVID-19 from 10Nov2020 to an unknown date (In Nov2020 my wife contracted Covid-19. Days later I tested positive), arrhythmia from an unknown date. Concomitant medications included metoprolol succinate taken for arrhythmia from Dec2019 and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:00 AM (Lot Number: ER2613) as single dose for COVID-19 immunization and experienced Pacemaker mediated tachycardia and PVCs. No prior vaccination within 4 weeks. The patient experienced sudden drop in BP on 22Apr2021, EF now 34% on 27Jul2021, lightheadedness on 22Apr2021, pre ventricular contractions on Apr2021, and pacemaker mediated tachycardia on Apr2021. The patient reported that, "On 16Mar2021 I received first dose of vaccine within days developed PVCs then what I later discovered was DMT (device mediated tachycardia). Second dose vaccine on 08Apr2021. PVCs and DMT worse. On 22Apr2021 developed sudden severe low BP (lightheaded) while hiking. Stopped all exercise. On 22May2021 Ep changed settings on ICD to stop DMT (PVCs creating feedback loop DMT). In Jun2021 I resumed exercise but still having doubts of PVCs and lightheadedness. Stopped all exercise again. On 27Jul2021 Echo done EF now 34%." The patient underwent lab tests and procedures which included blood pressure measurement: sudden severe low BP on 22Apr2021, COVID-19: positive   on 10Nov2020 (Detected), echocardiogram: EF 42 % on Nov2019, echocardiogram: EF 34 % on Dec2019 (LV dysfunction), echocardiogram: EF 34 % on 27Jul2021, heart rate: low on Oct2019, magnetic resonance imaging heart: non ischemic on Dec2019 (LV dysfunction lateral and apical LV wall). Therapeutic measures were taken as a result of pre ventricular contractions, pacemaker mediated tachycardia. The outcome of the event EF now 34% was unknown, pacemaker mediated tachycardia was recovered with sequelae in May2021, while for other events was recovered with sequelae in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Heart rate, Magnetic resonance imaging heart, Pacemaker generated arrhythmia, Ventricular extrasystoles
Clinical narrative: EF now 34%; Lightheadedness; Sudden drop in BP; Pre ventricular contractions; Pacemaker mediated tachycardia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 09Apr2021 11:00 (Lot Number: ER8737) as single dose for COVID-19 immunization. Medical history included ventricular tachycardia from Nov2019 and ongoing (Ventricular Tachycardia seen on remote heart monitor in Nov2019), cardiomyopathy from Nov2019 and ongoing (Echo- EF 42% cardiac MRI scanning in lateral and apical LV wall), COVID-19 from 10Nov2020 to an unknown date (In Nov2020 my wife contracted Covid-19. Days later I tested positive), arrhythmia from an unknown date. Concomitant medications included metoprolol succinate taken for arrhythmia from Dec2019 and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:00 AM (Lot Number: ER2613) as single dose for COVID-19 immunization and experienced Pacemaker mediated tachycardia and PVCs. No prior vaccination within 4 weeks. The patient experienced sudden drop in BP on 22Apr2021, EF now 34% on 27Jul2021, lightheadedness on 22Apr2021, pre ventricular contractions on Apr2021, and pacemaker mediated tachycardia on Apr2021. The patient reported that, "On 16Mar2021 I received first dose of vaccine within days developed PVCs then what I later discovered was DMT (device mediated tachycardia). Second dose vaccine on 08Apr2021. PVCs and DMT worse. On 22Apr2021 developed sudden severe low BP (lightheaded) while hiking. Stopped all exercise. On 22May2021 Ep changed settings on ICD to stop DMT (PVCs creating feedback loop DMT). In Jun2021 I resumed exercise but still having doubts of PVCs and lightheadedness. Stopped all exercise again. On 27Jul2021 Echo done EF now 34%." The patient underwent lab tests and procedures which included blood pressure measurement: sudden severe low BP on 22Apr2021, COVID-19: positive   on 10Nov2020 (Detected), echocardiogram: EF 42 % on Nov2019, echocardiogram: EF 34 % on Dec2019 (LV dysfunction), echocardiogram: EF 34 % on 27Jul2021, heart rate: low on Oct2019, magnetic resonance imaging heart: non ischemic on Dec2019 (LV dysfunction lateral and apical LV wall). Therapeutic measures were taken as a result of pre ventricular contractions, pacemaker mediated tachycardia. The outcome of the event EF now 34% was unknown, pacemaker mediated tachycardia was recovered with sequelae in May2021, while for other events was recovered with sequelae in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Immunisation
Clinical narrative: immunization; severe headache in back of head; Dizziness/ Feeling of passing out; Neck pain; exhaustion; nausea; chills; This is a spontaneous report from a contactable other health care professional (patient). A 58-year-old non pregnant female patient (nurse) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 27Oct2021 at 13:15 (at the age of 58 years) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 18Jan2021 at 14:15 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in right arm on 28Jan2021 as dose 2, single for COVID-19 immunization. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. On 27Oct2021 the patient experienced Dizziness/ Feeling of passing out, severe headache in back of head, neck pain, exhaustion, nausea, and chills. On   27Oct2021 at 13:15  patient reported booster. The events resulted in emergency room/department or urgent care. Tornadol, benadryl, ibprophen, fluids, all IV were taken as therapeutic measures for the events. The outcome of the events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided  and plausible temporal association, the causality between BNT162B2 and Headache, Dizziness, Neck pain, Fatigue, Nausea, Chills  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.