chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Investigation, Neurological examination, Neuropathy peripheral, Tachycardia
Clinical narrative: Paresthesia in face and limbs, fasciculations in all muscle groups, internal tremor, exercise intolerance; episodes of tachycardia with activity; This is a literature report for the following literature source(s):  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Paresthesia in face and limbs, fasciculations in all muscle groups, internal tremor, exercise intolerance"; TACHYCARDIA (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "episodes of tachycardia with activity". The patient underwent the following laboratory tests and procedures: Biopsy skin: Low small fiber density in distal leg; Skin fiber density distal leg: 0.5; Neurological examination: Normal.Clinical course was reported as the symptom at onset was elevated blood pressure and presyncope and in laboratory tests for EMG-NCV Mild ulnar and median sensory neuropathy, Autonomic testing: Low sudomotor response in feet was noted  No follow-up attempts are possible; 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 be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed 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-202200764439 Same article/patient different drug/event.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hot flush, Myalgia, SARS-CoV-2 test
Clinical narrative: Flush feeling, very warm; chills at night in bed; Muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 at 11:30 as dose 1, single (Lot number: FJ4989) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL; METFORMIN; VICTOZA. The following information was reported: HOT FLUSH (non-serious) with onset 25May2022 at 22:00, outcome "not recovered", described as "Flush feeling, very warm"; MYALGIA (non-serious) with onset 25May2022 at 22:00, outcome "not recovered", described as "Muscle aches"; CHILLS (non-serious) with onset 25May2022 at 22:00, outcome "not recovered", described as "chills at night in bed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hot flush, chills, myalgia.  Additional Information: The patient did not received any other vccines wthin 4 weeks prior to the COVID vaccine. No prior to vaccination, patient was not diagnosed with COVID-19. Yes, since the vaccination the patient had been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Balance disorder, Disturbance in attention, Dizziness
Clinical narrative: Partial seizures; dizziness; can't concentrate; loosing my tastes; loosing my tastes and smell; wobbly as I walk; bad balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Sep2021 as dose number unknown, single (Batch/Lot number: unknown) and on 27Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARTIAL SEIZURES (medically significant), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; AGEUSIA (non-serious), outcome "unknown", described as "loosing my tastes"; ANOSMIA (non-serious), outcome "unknown", described as "loosing my tastes and smell"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "wobbly as I walk"; BALANCE DISORDER (non-serious), outcome "unknown", described as "bad balance".  Clinical course: Patient Assistance: Patient just want to leave a complaint, that after patient got the Pfizer shot 06Sep21 and 27Sep21 at Pharmacy and beside all the other symptom, of loosing patient's tastes and smell patient also had very bad dizziness. The patient was diagnosed with Partial seizures on both patient;s frontal lobs of patient's brain. The patient feel wobbly as patient walk, can't concentrate and patient had bad balance while walking as well. This was hindering patient from working as a normal human being. Hope the was compensation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Partial seizures
Clinical narrative: Partial seizures; dizziness; can't concentrate; loosing my tastes; loosing my tastes and smell; wobbly as I walk; bad balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Sep2021 as dose number unknown, single (Batch/Lot number: unknown) and on 27Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARTIAL SEIZURES (medically significant), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate"; AGEUSIA (non-serious), outcome "unknown", described as "loosing my tastes"; ANOSMIA (non-serious), outcome "unknown", described as "loosing my tastes and smell"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "wobbly as I walk"; BALANCE DISORDER (non-serious), outcome "unknown", described as "bad balance".  Clinical course: Patient Assistance: Patient just want to leave a complaint, that after patient got the Pfizer shot 06Sep21 and 27Sep21 at Pharmacy and beside all the other symptom, of loosing patient's tastes and smell patient also had very bad dizziness. The patient was diagnosed with Partial seizures on both patient;s frontal lobs of patient's brain. The patient feel wobbly as patient walk, can't concentrate and patient had bad balance while walking as well. This was hindering patient from working as a normal human being. Hope the was compensation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 41-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization, reaction(s): "I have permanent hearing loss in my right ear". The following information was reported: TINNITUS (non-serious), outcome "unknown".  Additional information: Consumer stated I have permanent hearing loss in my right ear after pfizer vaccine doses and tinnitus 24/7 since pfizer booster. I think pfizer should pay for my hearing aid. I'm otherwise 41 years old and healthy. Disgusting.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Eczema, Erythema, Rash
Clinical narrative: I have eczema and use Dupixient; rash that is everywhere- big red blotches; rash that is everywhere- big red blotches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "I have eczema and use Dupixient"; RASH (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "rash that is everywhere- big red blotches". Therapeutic measures were taken as a result of eczema, rash, erythema.  Additional information: Patient have eczema and used Dupixient. The vaccine and Dupixient shots worked through shots 1 and 2 but since the booster, not only isn't the Dupixient working but  has a different looking rash that is everywhere big red blotches. The patient asked to have heard of this before and how can it be treated and even topical cremes for eczema are not working.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EN6207), on 26Apr2021 as dose 2, single (Lot number: EW0176), in left arm and on 31Aug2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens Syndrome" (unspecified if ongoing), notes: Sjogrens Syndrome. Concomitant medication(s) included: XIIDRA, start date: 03Jan2022. Past drug history included: Lamisil, reaction(s): "known allergies: Lamisil". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19 Treatment"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: The patient received other medication in 2weeks. Patient had COVID 19 treatment with Paxlovid with start date 25May2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and I still got Covid; had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and I still got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 07May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and I still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive. Subject: Patient Assistance. Customer Verbatim: The patient had both your vaccines last year had Covid in Jan and got boosted with your vaccine on 7May and the patient still got Covid. Took 2 tests and both were positive. The patients only symptom was a little phlegm in his/her throat.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose number unknown, single (Lot number: EL3302) and on 09Feb2021 as dose number unknown, single (Lot number: EN5318) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse Event treatment with PAXLOVID.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2 to all the reported events vaccination failure ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller stated he has been taking Paxlovid since Sunday when he tested positive/ was vaccinated and had booster, still got Covid; Caller stated he has been taking Paxlovid since Sunday when he tested positive/ was vaccinated and had booster, still got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 21Aug2020 as dose 1, single (Lot number: 051732), on 11Sep2020 as dose 2, single (Lot number: 061878) and on 27Oct2021 as dose 3 (booster), single (Lot number: 541035) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Open heart surgery" (unspecified if ongoing), notes: Open heart surgery 4 and a half years ago; "Sleep disorder" (unspecified if ongoing); "liver problems" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "unknown" and all described as "Caller stated he has been taking Paxlovid since Sunday when he tested positive/ was vaccinated and had booster, still got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: Sunday when he tested positive; (24May2022) Positive, notes: He took 2 tests Sunday and took one yesterday that were positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient was in the Pfizer trial for the vaccine and was one of the first people to get the Covid-19 vaccine and was still in the study. He also got the booster in the trial last Oct2021 and still, he had Covid. The patient stated he tested positive for Covid on Sunday (as reported). He notified the lab and the whole bit. They also had him call his doctors and they prescribed him Paxlovid and he thinks it's working. The patient stated he has been taking Paxlovid since Sunday when he tested positive. The patient further stated that he took the test. He took 2 tests Sunday and took one yesterday that were positive. Caller stated he had both doses from the trial, as well as the booster. The patient stated he was on a zillion different medications, he has got quite a few. The names of these medications were not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing), notes: Low thyroid; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment with Paxlovid with treatment start date as 15May2022 and treatment stop date as 18May2022, for indication of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: kidney function down to 30%; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4620420.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 23Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient's concurrent condition was not reported. Vaccination history included: Covid-19 vaccine (Primary Series of immunization completed; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: RENAL IMPAIRMENT (medically significant), outcome "recovered", described as "kidney function down to 30%".  Clinical course: On 23Sep2021, patient started therapy with Covid booster for unknown indication. On unknown date it was reported that patient experienced: kidney function down to 30%. No further information available regarding the reported event(s) described above. Any additional material information received will be forwarded in accordance with agency's policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: she still caught the damn thing; she still caught the damn thing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EM9809, Expiration Date: Jun2021), on 09Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: Jun2021) and on 02Dec2021 as dose 3 (booster), single (Lot number: FH8030), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX. Past drug history included: Biaxin, reaction(s): "a horrible taste". Vaccination history included: Shingles shots (does just fine with those), for Immunization; Flu shot (every year), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "she still caught the damn thing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.The patient was treated with Paxlovid.  Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EM9809, EN6205 and FH8030 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EM9809, EN6205 and FH8030, fill lot EM9807, EN5337 and FH4343, the formulated drug product lot EM9805, EN5326 and FA9187 respectively. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Additional information: The number was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 11:00 as dose 1, single (Lot number: EN6204), in left arm, on 05Apr2021 at 11:00 as dose 2, single (Lot number: ER8737), in left arm and on 18Nov2021 at 16:00 as dose 3 (booster), single (Lot number: F63527) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16May2022 at 07:00, outcome "unknown", COVID-19 (medically significant) with onset 16May2022 at 07:00, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team and product quality group, Program ID: (159558). The reporter is the parent.  A child male patient received BNT162b2 (BNT162B2), on 25May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Today he tested positive for COVID.  Question: Report was filed with agency for child as well as for the reporter herself, however the agent notes that the caller does not have any additional questions regarding herself, only the child. Reporter is a consumer calling in regards to her son who received his booster dose of Pfizer dose COVID, yesterday. Today he tested positive for COVID. She is asking does he need to receive another booster dose and also if it is possible due to the booster dose that the patient received. She states her son asked the question and she wanted to follow through with obtaining the information for him. Reporter also notes that she mentioned to the other agent that 1/2 of his class tested positive so she does not think it is a result of the booster. Reporter wants to know if the patient should get another booster dose due to him now testing positive 1 day after having the vaccination or can you get a booster when you are positive. Report was filed with agency for child as well as for the reporter herself, however the agent notes that the reporter does not have any additional questions regarding herself, only the child.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; fever 101°F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "highly allergic to lactose" (unspecified if ongoing), notes: caller states that she is highly allergic to lactose and would like to know if there is lactose in paxlovid, or if lactose has been used as the source of binder? (she has not yet taken the medication). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "fever 101°F"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: Body temperature: (May2022) 101°F, notes: fever 101°F; SARS-CoV-2 test: (26May2022) positive, notes: Caller is a consumer stating that she has tested positive for COVID this morning.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site vesicles
Clinical narrative: arm hurts more than with previous doses.; injection is red and there is a blister above where the bandaid was; injection is red and there is a blister above where the bandaid was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 16:00 as dose 3 (booster), single (Lot number: FL8095) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5618, Route of Administration: Intramuscular), administration date: 07Dec2021, for COVID-19 immunization, reaction(s): "arm hurts"; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 05Nov2021, for COVID-19 immunization, reaction(s): "arm hurts". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26May2022, outcome "unknown", described as "arm hurts more than with previous doses."; INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE VESICLES (non-serious) all with onset 26May2022, outcome "unknown" and all described as "injection is red and there is a blister above where the bandaid was". Therapeutic measures were not taken as a result of vaccination site pain, injection site erythema, vaccination site vesicles.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not allergic to latex. Patient had no known allergies. Patient was not diagnosed with COVID-19 Prior to vaccination. The patient not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Heart disease congenital, Obesity
Clinical narrative: congenital heart disease; asthma; obesity; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 8-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 1, single (Lot number: FL8094) at the age of 8 years intramuscular, in left deltoid for Covid-19 immunisation. The patient's relevant medical history included: "Heart murmur", start date: 13Nov2019 (ongoing). The patient's family history included: "Asthma" (unspecified if ongoing), notes: Mother and brother with Asthma. There were no concomitant medications. PFIZER/BIONTECH COVID-19 VACCINE DETAILS: Dose: 2nd, Date: 20Apr2022 Time (24hr): 15:35 Anatomical Site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: FL8094. Relevant Tests was none, Specific Relevant Test for Thromboembolic with Thrombocytopenia was none.  The following information was reported: ASTHMA (non-serious) with onset 30Mar2022, outcome "not recovered"; HEART DISEASE CONGENITAL (medically significant) with onset 30Mar2022, outcome "not recovered", described as "congenital heart disease"; OBESITY (non-serious) with onset 30Mar2022, outcome "not recovered".  Comment/narrative: Nursing staff administered Pediatrics Pfizer on 20Apr2022 to patient and missed the 11Mar BUD marking on the box. Vaccine was past the BUD date by 9 days, Pfizer vial expiration date was listed as 31May2022. Patient has been contacted to come back to the facility to be revaccinated, no adverse events have been reported by the patient.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event heart disease congenital 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.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Influenza like illness
Clinical narrative: heart palpitations; insomnia; flu-like symptoms; some parts of the body feeling tired; shot of energy; numbness on left side of face; numbness of the front of tongue and lips; numbness of the front of tongue and lips; fingers feeling a little numb on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset May2022, outcome "unknown", described as "fingers feeling a little numb on the right side"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "flu-like symptoms"; INSOMNIA (non-serious) with onset May2022, outcome "unknown"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset May2022, outcome "unknown" and all described as "numbness of the front of tongue and lips"; HYPOAESTHESIA (non-serious) with onset May2022, outcome "unknown", described as "numbness on left side of face"; ASTHENIA (non-serious) with onset May2022, outcome "unknown", described as "shot of energy"; FATIGUE (non-serious) with onset May2022, outcome "unknown", described as "some parts of the body feeling tired"; PALPITATIONS (non-serious) with onset 25May2022, outcome "unknown", described as "heart palpitations".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Palpitations
Clinical narrative: heart palpitations; insomnia; flu-like symptoms; some parts of the body feeling tired; shot of energy; numbness on left side of face; numbness of the front of tongue and lips; numbness of the front of tongue and lips; fingers feeling a little numb on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset May2022, outcome "unknown", described as "fingers feeling a little numb on the right side"; INFLUENZA LIKE ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "flu-like symptoms"; INSOMNIA (non-serious) with onset May2022, outcome "unknown"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset May2022, outcome "unknown" and all described as "numbness of the front of tongue and lips"; HYPOAESTHESIA (non-serious) with onset May2022, outcome "unknown", described as "numbness on left side of face"; ASTHENIA (non-serious) with onset May2022, outcome "unknown", described as "shot of energy"; FATIGUE (non-serious) with onset May2022, outcome "unknown", described as "some parts of the body feeling tired"; PALPITATIONS (non-serious) with onset 25May2022, outcome "unknown", described as "heart palpitations".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rheumatoid factor, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 15Apr2021 as dose 2, single (Lot number: ER8729) at the age of 45 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Lot number: 076C21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "Vaccine dose number=2,1 Pfizer, Vaccine dose number=3 Moderna" (unspecified if ongoing), notes: Vaccine dose number=2,1 Pfizer, Vaccine dose number=3 Moderna. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "not recovered" and all described as "13May2022- first positive test". The patient underwent the following laboratory tests and procedures: Rheumatoid factor: (12May2022) Negative, notes: first day of symptoms but negative RA test; SARS-CoV-2 test: (13May2022) positive, notes: first positive test. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Anti-viral details product-COVID-19 Treatment, brand-Paxlovid, treatment start date-15May2022, treatment stop date-18May2022, indication-Treatment of COVID-19.Adverse event: 12May - first day of symptoms but negative RA test (while in withheld, withheld; COVID contracted while in the withheld) 13May - first positive test 15May - began Paxlovid 18May - stopped Paxlovid (after 3 days due to side effects) 19May -24May - felt 100% better 24May - tested positive with RA test, though the line was very faint 25May, late afternoon - symptoms returned, nasally stuffiness, post nasal drip causing throat irritation, and feeling run down. no fever, no other symptoms. 26May am- took another RA test, very bold test line appeared quickly. Symptoms are slightly worse than yesterday. Adverse events start date: 25May2022 start time: 11:00 AM. If patient recovered: Recovering If treatment AE: No. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient tested positive for COVID 19; patient tested positive for COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 18Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25May2022, outcome "unknown" and all described as "patient tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive.  Clinical course: Description of Event: This 59-year-old male patient received the Pfizer COVID 19 vaccine on 28Jan2021, 18Feb2021 and a booster dose on 29Oct2021. On 24May2022 the patient developed a headache and fever. On 25May2022 the patient tested positive for COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2020 at 09:00 as dose 1, single (Lot number: Ek9232), in left arm, on 14Jan2021 at 09:00 as dose 2, single (Lot number: Ek9231), in left arm, on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301358a), in right arm and on 11Apr2022 at 16:30 as dose 4 (booster), single (Lot number: Fl9894), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "bph" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral; FLOMAX [TAMSULOSIN HYDROCHLORIDE] oral; FINASTERIDE oral; VASOTEC [ENALAPRILAT]; ASA oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: previous pos; Negative; Positive, notes: antigen; Positive, notes: pcr. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took oral Paxlovid for the treatment of COVID-19 started on 15May2022 and stopped on 20May2022.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: METOPROLOL; ESOMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 12May2022 to 17May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Intervertebral disc protrusion
Clinical narrative: Herniated disks; Ortho joint related side effects; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "Herniated disks"; ARTHROPATHY (non-serious), outcome "unknown", described as "Ortho joint related side effects".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 at 01:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (13May2022) 70/40, notes: 13May - 3rd day the Blood pressure dropped to 70/40 with Paxlovid taken with Azithromycin & Prednisone; SARS-CoV-2 test: (26May2022) Posiitive, notes: 26May The throat cough and Positive COVID continues unabated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient had no known allergies and the patient was not taking any other medications within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Iodine" (unspecified if ongoing), notes: known allergies: Iodine. Concomitant medication(s) included: BENICAR; ULORIC; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive, notes: test Positive, reappeared 4days after testing Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.