chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had COVID-19 after vaccines; Had COVID-19 after vaccines; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302), on 12Feb2021 as dose 2, single (Lot number: EM9809) and on 28Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing); "Antilipid" (ongoing); "Blood pressure" (ongoing). Concomitant medication(s) included: CRESTOR oral taken for blood cholesterol abnormal, lipids abnormal (ongoing); AMLODIPINE oral taken for blood pressure abnormal (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Feb2022, outcome "recovered" (2022) and all described as "Had COVID-19 after vaccines". The patient underwent the following laboratory tests and procedures: Biopsy: unknown results, notes: Declined to provide any test results; Blood test: Nothing turned up; SARS-CoV-2 test: Positive. Clinical course: Caller provided product as Crestor, clarified to Generic Crestor. Lowest dosage. Taken for quite some time and hasn't changed. Amlodipine: Low dose blood pressure medicine. Started 2 years ago maybe. About 4 or 5 months after her last Pfizer vaccine dose she got COVID-19 and developed the same thing (unusual lip reaction) in her upper and lower lips but was worse. Was advised to not have 4th dose, booster, due to this. Acute illness about a week, then lingering weakness following it. Not serious, like having a virus with a low-grade fever. Most recent dose that preceded her symptoms. Was 6 months after the covid-19 vaccine booster before she got covid-19 and then had the lip reaction.  suspects the covid-19 infection itself caused her lip reaction, not the covid-19 vaccine booster. Takes a low dose blood pressure medicine and cholesterol medicine that were taken prior to any of the covid-19 Vaccines. No other medical conditions, healthy as a bear. Investigations: Testing: Because of the concern with the lip, she went to several different physicians.  First the primary care provider who recommended an ENT. Had an ENT consult who found no explanation. All providers are pointing their fingers at covid-19 infection. Went to dermatologist who didn't know anything either, recommended a biopsy and blood work. Nothing turned up on any blood work. Decided to do a biopsy. Declined to provide any test results.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test, Lip disorder
Clinical narrative: Had COVID-19 after vaccines; Had COVID-19 after vaccines; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302), on 12Feb2021 as dose 2, single (Lot number: EM9809) and on 28Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing); "Antilipid" (ongoing); "Blood pressure" (ongoing). Concomitant medication(s) included: CRESTOR oral taken for blood cholesterol abnormal, lipids abnormal (ongoing); AMLODIPINE oral taken for blood pressure abnormal (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Feb2022, outcome "recovered" (2022) and all described as "Had COVID-19 after vaccines". The patient underwent the following laboratory tests and procedures: Biopsy: unknown results, notes: Declined to provide any test results; Blood test: Nothing turned up; SARS-CoV-2 test: Positive. Clinical course: Caller provided product as Crestor, clarified to Generic Crestor. Lowest dosage. Taken for quite some time and hasn't changed. Amlodipine: Low dose blood pressure medicine. Started 2 years ago maybe. About 4 or 5 months after her last Pfizer vaccine dose she got COVID-19 and developed the same thing (unusual lip reaction) in her upper and lower lips but was worse. Was advised to not have 4th dose, booster, due to this. Acute illness about a week, then lingering weakness following it. Not serious, like having a virus with a low-grade fever. Most recent dose that preceded her symptoms. Was 6 months after the covid-19 vaccine booster before she got covid-19 and then had the lip reaction.  suspects the covid-19 infection itself caused her lip reaction, not the covid-19 vaccine booster. Takes a low dose blood pressure medicine and cholesterol medicine that were taken prior to any of the covid-19 Vaccines. No other medical conditions, healthy as a bear. Investigations: Testing: Because of the concern with the lip, she went to several different physicians.  First the primary care provider who recommended an ENT. Had an ENT consult who found no explanation. All providers are pointing their fingers at covid-19 infection. Went to dermatologist who didn't know anything either, recommended a biopsy and blood work. Nothing turned up on any blood work. Decided to do a biopsy. Declined to provide any test results.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back; severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE" (unspecified if ongoing); "other autoimmune diseases" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "I have had this severe burning pain in my hands, feet, extremeties and somewhat in my abdomen and in my back", "I have had this severe burning pain in my hands, feet, extremeties and somewhat in my abdomen and in my back", "severe generalized burning type pain/I have had this severe burning pain in my hands, feet, extremities and somewhat in my abdomen and in my back", "I have had this severe burning pain in my hands, feet, extremeties", "pruritus in my feet, hands, extremities, & occasionally in the abdomen & back"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses"; Bnt162b2, bnt162b2 omi ba.4-5 (Dose 3), for Covid-19 immunization, reaction(s): "severe generalized burning type pain", "occasional pruritus in my feet, hands, extremities, & occasionally in the abdomen & back". The following information was reported: PAIN (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen and back". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: With the initial Pfizer vaccine & the 3rd booster dose (modified for defense against the omicron virus), patient suffered from severe generalized burning type pain with occasional pruritus in feet, hands, extremities, and occasionally in the abdomen & back. These symptoms were unresponsive to OTC meds, partially responsive to oxycodone, & usually require short term use of prednisone. These symptoms occurred 6-7 days after the injection on both occasions. Patient reported minimal symptoms with the 2nd, 3rd and 4th doses; these symptoms only occurred with the 1st and the 5th doses.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medications within two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GJ2824) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (06Nov2022) Negative, notes: After treating with Paxlovid, I tested negative on 6Nov and again on 8Nov; (08Nov2022) Negative, notes: After treating with Paxlovid, I tested negative on 6Nov and again on 8Nov; (10Nov2022) Positive, notes: On 10Nov, I felt my lymph nodes swelling again, and took a test late at night which was positive; (11Nov2022) Positive, notes: I tested positive again the morning of 11Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Nov2022 to 06Nov2022. Clinical course included: Patient had received other medication in 2weeks.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 3:Pfizer / Dose Number: 2:Moderna / Dose Number: 1: Jansen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 at 16:00 as dose 3 (booster), single (Lot number: Fp7139) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Oct2021 at 16:00 as dose 2 (booster), single (Lot number: 066F21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Mar2021 at 13:00 as dose 1, single (Lot number: 1805020), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: Jan2022, stop date: 29Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Aug2022 at 16:00, outcome "unknown", described as "Dose Number: 3:Pfizer / Dose Number: 2:Moderna / Dose Number: 1: Jansen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative for Covid for 3 days; Positive, notes: Positive test and return of symptoms on day 5; Negative, notes: tested negative for covid via Home Binax Now test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the 2 days after completion of Paxlovid, tested negative for covid via Home Binax Now test. Continued to test negative for Covid for 3 days. Positive test and return of symptoms on day 5 following completing Paxlovid. Symptoms include headache, chills, congestion, Symptoms include headache, chills, congestion, tightness in chest, cough.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, treatment was started on 31Oct2022 and stopped on 04Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: is now experiencing fever and a runny nose; is now experiencing fever and a runny nose; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 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: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), RHINORRHOEA (non-serious) all with onset 2022, outcome "unknown" and all described as "is now experiencing fever and a runny nose".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; FATIGUE (non-serious), outcome "recovered". Therapeutic measures were taken as a result of pyrexia, fatigue.  Additional information: The caller was asking about the side effects of the Pfizer Covid 19 vaccine, because he was going to receive it the day after the report. Caller stated that he received all 3 Pfizer vaccines and did not have major side effect. Caller mentioned that he had fever and fatigue for a 1 day and he took Tylenol for it. Caller verified that he was looking for information on side effects of the Pfizer COVID Vaccine Bivalent formulation. As per caller he was 70 years old and had no health issues.  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: Heart rate, Heart rate increased
Clinical narrative: a friend had the booster with blood thinners and it caused her heart to go fast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood thinner" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "a friend had the booster with blood thinners and it caused her heart to go fast". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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) (Pharmacist).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Vertigo" (unspecified if ongoing); "known allergies: Bee stings" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures (PAXLOVID)  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.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Flushing, Influenza like illness, Loss of consciousness, Neck injury
Clinical narrative: passed out; flu like symptoms; sudden huge pain under her sternum; hit her neck really hard and was in a lot of pain; she felt fluish and the next day pretty fluish; 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 75-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hearing loss" (unspecified if ongoing), notes: she has hearing loss. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (Manufacturer unknown)), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (Manufacturer unknown)), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms"; NECK INJURY (non-serious) with onset 2021, outcome "unknown", described as "hit her neck really hard and was in a lot of pain"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "passed out"; FLUSHING (non-serious) with onset 2021, outcome "unknown", described as "she felt fluish and the next day pretty fluish"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sudden huge pain under her sternum". The events "hit her neck really hard and was in a lot of pain" required emergency room visit.  Clinical Course: Reported as, Female consumer stated that she had the first COVID 19 booster dose a year ago and that night she self like she had flu like symptoms that were worse the next day. She was in the kitchen and got a huge pain under her sternum and passed out and hit the side of the dishwasher door with a handle sticking out and hurt her neck. She hit her neck really hard and was in a lot of pain. She went to the ER and they checked her neck to make sure it wasnt broke. She said they checked her heart at that time too. She was never diagnosed with myocardia or pericarditis but wonders if that was the issue. She mentioned this to her doctor last summer and he didn't think much of it. After reading this she is concerned about the new vaccine. She also mentioned getting COVID in August after having the vaccines. Caller stated it was hard to hear, she has hearing loss. Clarified has had hearing loss for a long time and it is not related. She signed up to get another COVID vaccine and it recently came out, she hadn't seen it until last week or 2, about myocarditis or pericarditis, an inflammation of the heart. She was now 76 years old and was 75 when she last had the vaccine in the afternoon and that night she felt fluish and the next day pretty fluish.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 85 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, NDC, LOT, EXP of previous dose: unknown), administration date: 05Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, NDC, LOT, EXP of previous dose: unknown), administration date: 25Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, NDC, LOT, EXP of previous dose: unknown), administration date: 29Sep2021, when the patient was 84-year-old, for COVID-19 immunization.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset Nov2022, outcome "unknown". The event "pulmonary embolism" required emergency room visit.  Clinical Course: There was a correlation between the Bivalent Pfizer COVID 19 vaccine (does not know specific cap color) and blood clots. Caller says and clarifies the patient did not get the vaccine here, the patient's wife was calling in, he got his 4th dose of COVID vaccine on 02Nov2022 and it was the bivalent and then 07Nov2022 he went to the ER and had a pulmonary embolism so the wife was calling today asking if there is a correlation between the two. Doctor wanted to check on giving this patient the COVID vaccine. Patient got the COVID vaccine 02Nov2022. Went to the emergency room 07Nov2022, with pulmonary embolis.  Patient's wife was calling to see if there was a correlation between the COVID vaccine and the pulmonary embolism. Unable to clarify which formulation of the COVID vaccine caller was referring to, stating she only knows it was the Pfizer COVID vaccine. Clarified that patient went to the emergency room 07Nov2022 but unknown if patient was admitted to hospital. Clarified that this COVID vaccine patient received 02Nov2022 was the Bivalent COVID vaccine. When caller looked up patient's vaccine in their system, states that under manufacturer, it states it is unknown but, patient's wife states that it was the Pfizer Bivalent vaccine the patient received. Prior Vaccinations within 4 weeks nothing noted in chart, unless they got it somewhere else. Does not know for sure.; Sender's Comments: Based on the limited information, the serious event Pulmonary embolism cannot be excluded fully for the suspect product BNT162B2, BNT162B2 OMI BA.4-5. 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: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had symptoms next Saturday and tested positive two days ago on Wednesday; I had symptoms next Saturday and tested positive two days ago on Wednesday; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 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 09Nov2022, outcome "unknown" and all described as "I had symptoms next Saturday and tested positive two days ago on Wednesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Nov2022) Positive, notes: tested positive two days ago on Wednesday. Clinical course: Patient mentioned that he never had COVID the whole pandemic for 3 years, he was very careful, always wear a mask, keep social distance, hygienic, so he was really surprised. "I've known of 4 cases where people turn up positive COVID tests after the booster, myself, two patients, one received it last Thursday and then had COVID like symptoms throughout the week. I am waiting her to call me about the results. I also spoke to a patient this morning a friend also got a bivalent the day after. Personally, I did some research and found an article news where someone also got the booster on 04Oct and got very sick and tested positive for COVID test in the past week. It seems unusual the frequency of people reporting COVID".   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.,Linked Report(s) : US-PFIZER INC-202201296629 same reporter/drug/event, different patients;US-PFIZER INC-202201296628 same reporter/drug/event, different patients;US-PFIZER INC-202201296630 same reporter/drug/event, different patients;
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Biopsy lip, Biopsy salivary gland, Dermatitis
Clinical narrative: Dermatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history included: "History CA of bladder", start date: 31Aug2020 (ongoing), notes: Treatment Vit BCG Immunotherapy; "Anxiety" (ongoing); "Depression" (ongoing). Concomitant medication(s) included: BUSPIRONE oral taken for anxiety (ongoing); ESCITALOPRAM oral taken for depression (ongoing); LORAZEPAM oral taken for depression (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Anatomical site of injection: Left arm; Lot number: EL9264), administration date: 07Feb2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Anatomical site of injection: Left arm; Lot number: EN6203), administration date: 27Feb2021, for COVID-19 immunisation. The following information was reported: DERMATITIS (non-serious) with onset 25Mar2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient age at time of vaccination: 68-69 (years). Biopsy of lip and L buccal cheek resulted in dermatitis, could be due to drug reaction. Vaccination facility type for 1st dose 2nd dose 3rd/Booster was Hospital.
Age: 33.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Hypoaesthesia, Muscular weakness, Off label use, Product use issue
Clinical narrative: Complete numbness in hands and associated weakness; Complete numbness in hands and associated weakness; Administration date: 11Nov2022, dose number: 5; other vaccine same date product: Flu vaccine/other vaccine same date vaccine date: 11Nov2022; Administration date: 11Nov2022, dose number: 5; other vaccine same date product: Flu vaccine/other vaccine same date vaccine date: 11Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 11Nov2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Post partum twins" (unspecified if ongoing), notes: Post partum twins. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies. Vaccination history included: Covid-19 vaccine (Dose 4; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2022, outcome "unknown" and all described as "Administration date: 11Nov2022, dose number: 5; other vaccine same date product: Flu vaccine/other vaccine same date vaccine date: 11Nov2022"; MUSCULAR WEAKNESS (non-serious), HYPOAESTHESIA (non-serious) all with onset 12Nov2022, outcome "recovering" and all described as "Complete numbness in hands and associated weakness". Therapeutic measures were not taken as a result of muscular weakness, hypoaesthesia. Additional information: Other vaccine in four weeks: Unknown. COVID prior vaccination: Unknown. COVID tested post vaccination: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Persistent postural-perceptual dizziness
Clinical narrative: Patient later developed PPPD Persistent Postural Perceptual Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: PERSISTENT POSTURAL-PERCEPTUAL DIZZINESS (hospitalization, disability), outcome "unknown", described as "Patient later developed PPPD Persistent Postural Perceptual Dizziness". The event "patient later developed pppd persistent postural perceptual dizziness" required physician office visit and emergency room visit. Clinical course: The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was unknown that the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Getting COVID in August after having the vaccines; Getting COVID in August after having the vaccines; 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 female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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'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 "Getting COVID in August after having the vaccines".  Clinical Information: Female consumer states that she had the first COVID 19 booster dose a year ago.She also mentions getting COVID in August after having the vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID rapid antigen test was positive; COVID rapid antigen test was positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID rapid antigen test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Negative; (Nov2022) Positive.  Additional information: She developed a sore throat yesterday 10Nov2022 with negative rapid antigen COVID test at that time. Continued to have sore throat and throat congestion today, with possible low grade fever. Took another COVID rapid antigen test which was positive. She has been evaluated by her primary care physician and is following his recommendations. This is being reported as a breakthrough infection following the Comirnaty bivalent booster vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200102394 Same patient/vaccine, different dose/event;
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Batch/Lot number: unknown), on 13Dec2021 as dose 2, single (Batch/Lot number: unknown), on 14May2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2012, stop date: 12Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Positive test 7 days after negative test. The negative test was taken 7 days after start of Paxlovid; (Nov2022) Positive, notes: Positive test 7 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Oct2022 to 04Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; 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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 13:00 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 at 12:00 as dose 2, single (Lot number: ER8727), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Strawberries and birch" (unspecified if ongoing); "Known allergies: Strawberries and birch" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: 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 43-year-old male patient received BNT162b2 (BNT162B2), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Syringomyelia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Rapid antigen tests turned positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: patient had known allergies: no, Other medication in 2 weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1=PModerna, Dose 2=Modernah, Dose 3= Moderna and dose 4= Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 11:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 at 14:30 as dose 1, single (Lot number: 013A21A), in right arm, on 01Apr2021 at 14:00 as dose 2, single (Lot number: 002821A), in left arm and on 27Aug2021 at 11:00 as dose 3 (booster), single (Lot number: 009D21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer survivor" (unspecified if ongoing); "Thyroid Cancer survivor" (unspecified if ongoing); "Chronic Sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Oct2022, outcome "unknown", described as "Dose 1=PModerna, Dose 2=Modernah, Dose 3= Moderna and dose 4= Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Nov2022) tested positive; (13Nov2022) tested positive, notes: tested Positive with a dark line similar to 1st day I tested positive; (Nov2022) barely detectable line. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient's symptoms started getting better on 11Nov2022 and Covid test showed a barely detectable line. On 13Nov2022, symptoms returned (chest tightness & congestion, runny nose, slight fever) and tested Positive with a dark line similar to 1st day I tested positive (01Nov2022). The patient doesn't know if this was "Paxlovid rebound" but wanted to share info with Pfizer.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 4 cases where people turn up positive COVID tests after the booster; 4 cases where people turn up positive COVID tests after the booster; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE and COVID-19, all medically significant with onset 2022, outcome "unknown" and all described as "4 cases where people turn up positive COVID tests after the booster". The reporting physician mentioned that he knew of 4 cases where people turn up positive COVID tests after the booster: himself; two patients; then another one who received it last Thursday and then had COVID like symptoms throughout the week. He was waiting for her to call him about the results. He also spoke to a patient this morning, a friend who also got a bivalent the day after. He did some research and found an article news where someone also got the booster on 04Oct2022 and got very sick and tested positive for COVID test in the past week. It seemed unusual the frequency of people reporting COVID. This case was considered as non-serious by the reporter. The patient underwent the following laboratory tests and procedures: COVID tests: (2022) Positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event 4 cases where people turn up positive COVID tests after the booster cannot be excluded based on temporal association and available information.,Linked Report(s) : US-PFIZER INC-202201296261 same reporter/drug/event, different patients;