chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose 1, This man was boosted, he had all three doses), for Covid-19 immunization; Bnt162b2 (Dose 2, This man was boosted, he had all three doses), for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal". The patient date of death was unknown. Reported cause of death: "Cardiac arrest". It was not reported if an autopsy was performed.  Clinical Course: It was reported that caller just read a case report about an older man who died of cardiac arrest after his Pfizer COVID-19 Vaccines. This man was boosted, he had all three doses. Caller does not have any further information about this man to provide. For his COVID-19 Vaccines are unknown. States this was from a article and the first case reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Cardiac arrest
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "COVID-19". The patient was hospitalized for covid-19, drug ineffective (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown); both single dose, for immunization; reaction(s): migraine/second one gave him a 5-day migraine. The patient experienced asthenia (weakness and pain in both legs)/pain in extremity, with outcome of unknown. Additional information: Caller verified the product was the Pfizer COVID-19 vaccine booster dose. "The second one gave him a 5-day migraine." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood gases abnormal, Chest X-ray, Computerised tomogram, Electrocardiogram, Feeling abnormal
Clinical narrative: felt kind of bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 38-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, 0.3 ml single (Lot number: EN6199, Expiration Date: Jun2021) at the age of 37 years, in left deltoid and on 26Mar2021 as dose 2, 0.3 ml single (Lot number: EN6206, Expiration Date: Jun2021), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension, Takes medication for that. It was managed. Been at least 5 years; "High BMI Is overweight, but not 600lbs" (unspecified if ongoing); "High BMI Is overweight, but not 600lbs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt kind of bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Not provided. Did any AE(s) require a visit to Emergency Room/ Physician Office: No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Please specify Antipyretic Use (around the date(s) of Vaccination): Sure patient did in the day or two after. Caller states they all felt kind of bad after getting the vaccine, so probably patient did take an antipyretic. Caller clarified they all felt bad after getting their COVID-19 Vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200842587 Same patient and drug, different event separated in time;
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin, Ultrasound scan, White blood cell count
Clinical narrative: felt kind of bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 38-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, 0.3 ml single (Lot number: EN6199, Expiration Date: Jun2021) at the age of 37 years, in left deltoid and on 26Mar2021 as dose 2, 0.3 ml single (Lot number: EN6206, Expiration Date: Jun2021), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension, Takes medication for that. It was managed. Been at least 5 years; "High BMI Is overweight, but not 600lbs" (unspecified if ongoing); "High BMI Is overweight, but not 600lbs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt kind of bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): Not provided. Did any AE(s) require a visit to Emergency Room/ Physician Office: No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. AE(s) following prior vaccinations: None. Please specify Antipyretic Use (around the date(s) of Vaccination): Sure patient did in the day or two after. Caller states they all felt kind of bad after getting the vaccine, so probably patient did take an antipyretic. Caller clarified they all felt bad after getting their COVID-19 Vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200842587 Same patient and drug, different event separated in time;
Age: 19.0
Sex: M
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 20-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose number unknown, single (Lot number: EN6201) at the age of 19 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: Other medical history: Autoimmune. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (08Jun2022) Negative, notes: Covid 19 Neg on the 9; (11Jun2022) positive, notes: Covid 19 positive again on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 31May2022. Stop date of treatment for COVID-19 was 04Jun2022.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. 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: DEATH (death, medically significant), outcome "fatal", CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" and all described as "Caller stated that she knows 2 patients who have died and 2 patients who had stroke.". The patient date of death was unknown. Reported cause of death: "Caller stated that she knows 2 patients who have died and 2 patients who had stroke". It was not reported if an autopsy was performed. Reporter who was a nurse for 30 years wanted to know if and when the COMIRNATY-labeled vaccine will be available and stated that she did not want to get the EUA-approved Pfizer COVID-19 vaccines due to liability and that she is not an "experimental rat". Reporter stated that she knows 2 patients who have died and 2 patients who had stroke. Unable to gather more information on patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the serious events 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.; Reported Cause(s) of Death: Caller stated that she knows 2 patients who have died and 2 patients who had stroke
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive on 05Jun; positive on 05Jun; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cardiomyopathy hyper-trophy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "positive on 05Jun". The event "positive on 05jun" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive; (10Jun2022) Positive; (11Jun2022) Negative; (14Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No other medications the patient received within 2 weeks of vaccination. Clinical course: Began feeling ill 31May (congestion/cough) tested positive on 05Jun. New to area so went to ER (emergency room) and they gave me Paxlovid. Took for 5 days. Friday 10Jun still positive and congestion/cough returned. 11Jun tested negative but still congestion and cough. Not feeling better and on 14Jun tested positive again. Feeling horrible congested to the max and can not stop coughing. May go back to ER (emergency room) tomorrow if not better. No treatment was given.  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 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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Lot number: Ff2590), 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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative, notes: 5 days after feeling better and 2 days after testing negative; (14Jun2022) Positive, notes: The patient developed Covid symptoms and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 04Jun2022 to 08Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. 5 days after feeling better and 2 days after testing negative,  the patient developed COVID symptoms and tested positive again.
Sex: M
Vaccine: COVID19
Symptoms: Oliguria, Prostatic disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). An 81-year-old male patient received the 4th (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Jun 14, 2022, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 3rd (booster) dose of the COVID-19 vaccine and the COVID-19 vaccine (primary immunization series complete, manufacturer unknown); all single dose, for immunization. The patient experienced oliguria (after the shot he is urinating less frequent/not enough), onset Jun 2022, with outcome of unknown and prostatic disorder (having prostate problems), onset Jun 15, 2022, with outcome of unknown. Additional information: He indicated he received the second booster of the Pfizer COVID-19 vaccine and is having prostate problems. He used to urinate very often but after the shot he is urinating less frequent (not enough). He is not sure if it is due to the shot. He asked if there is any history of the vaccine causing prostate problems. He did not present this effect after the first, second or third dose. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for covid post vaccination status and interested in evusheld.; Positive for covid post vaccination status and interested in evusheld; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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), outcome "unknown", described as "Positive for covid post vaccination status and interested in evusheld."; COVID-19 (medically significant), outcome "unknown", described as "Positive for covid post vaccination status and interested in evusheld". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive for covid. Clinical course was reported as, Patients at risk for vaccine break through. Positive for covid post vaccination status and interested in evusheld. Reporter stated, Patient will receive the paxlovid protocol. And asks is there any guide as to how long to wait for additional vaccines post paxlovid therapy.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Covid 19 and Drug ineffective cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid-19; contracted Covid-19; 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 parent.  An adult female patient 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 included: "Down Syndrome" (unspecified if ongoing); "open heart surgery" (unspecified if ongoing), notes: when she was 3 months old and that she is a minor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 13Jun2022, outcome "unknown" and all described as "contracted Covid-19".  Clinical course: The seriousness of the events was reported as non-serious. The patient had no fever just swollen throat and headaches.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Facial discomfort, Facial pain, Hypoaesthesia, Pain in extremity
Clinical narrative: sore arm/Hand pain; the right side of her face feels like someone punched her under my eye; right eye is hurting a lot; right side of her face is hurting and is also numb; right side of her face is hurting and is also numb; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose 2 (booster), single (Lot number: FM7553) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Johnson & johnson (1st Vaccine), for COVID-19 Immunization. The following information was reported: EYE PAIN (non-serious) with onset Jun2022, outcome "unknown", described as "right eye is hurting a lot"; FACIAL PAIN (non-serious), HYPOAESTHESIA (non-serious) all with onset Jun2022, outcome "unknown" and all described as "right side of her face is hurting and is also numb"; PAIN IN EXTREMITY (non-serious) with onset Jun2022, outcome "unknown", described as "sore arm/Hand pain"; FACIAL DISCOMFORT (non-serious) with onset Jun2022, outcome "unknown", described as "the right side of her face feels like someone punched her under my eye". Therapeutic measures were not taken as a result of pain in extremity, facial discomfort, eye pain, facial pain, hypoaesthesia.  Additional information: The caller is a patient (consumer) reporting an adverse event, she is also a Pharmacy tech, so she has medical knowledge, she had the Pfizer (Booster) COVID Vaccine Monday of this week and had a sore arm and hand pain for 2 to 3 days and now today she said, she feels like her right side of her face that somebody punched her and then her eye hurting a lot and her face is numb on the right side only. She said that this is the first Pfizer (Booster) shot (COVID Vaccine) that she got. Her (consumer) first vaccine (unspecified vaccine) was Johnson & Johnson. She was getting this (Pfizer COVID Vaccine) as a Booster, she also has a 7-year-old daughter that she wants to report having a hand pain and headache for 2 days after this (Pfizer COVID Vaccine) Vaccine on Monday and that is all the information I have."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid has made my husband and I both feel better after the first 2 doses; Paxlovid has made my husband and I both feel better after the first 2 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), 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), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid has made my husband and I both feel better after the first 2 doses". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Result Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. Caller states "my husband and I both had 4 Pfizer Covid19 shots." "Paxlovid had made my husband and I both feel better after the first 2 doses."  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: Myalgia, Pain
Clinical narrative: He too started a couple days later experiencing these type of situation, these type of pains; he too has suffered from that and to this day;; still have that in our muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJ9943) and as dose 2, single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "He too started a couple days later experiencing these type of situation, these type of pains; he too has suffered from that and to this day;"; MYALGIA (non-serious), outcome "unknown", described as "still have that in our muscles". Therapeutic measures were not taken as a result of pain, myalgia. Additional Information: Reporter stated, "Sometimes I don't hear really well. Well, you know, I had the second booster I believe it was like 05Apr and so that mean my fourth shot okay, my fourth Pfizer shot. I had the two regular you know, in the beginning, I had everything recorded in my little card and everything and now I had the first booster and then I had the second booster I think it was like maybe 8 months later. So, I did not had any reactions to the first three but on this particular second booster, I have had a terrible reaction to my muscles and my joints and I have been fighting this since, well I got the shot on 05Apr, it seems like the 6th was fine I had no, by the way I had no, I don't remember you know, anything major with the other ones like red arms or anything like that but this one the first day nothing, second day same nothing but the third day I could not move, I could not get out of bed. My muscles and joints were like frozen, and I just could not move out of bed and it took me quite a while to find and I am an active person by the way it's not like I am not an active person and so, I don't remember exactly how it finally happened. I think, I kept rubbing my leg or trying to make it move or helping it to move with both of my hands, but it was hard to do that too because the main muscles in my upper arms were so sore and my legs. So, when I would stand up it seems like it was just intense pain that went from my I guess just under my shoulders. I guess it was around through the bicep starts you know, the bicep and all the way down my body and I could hardly walk." Treatment for Adverse Event: Reporter stated, "No, he did not. He did not take it; he did not go to the doctor. I went to the doctor and, but he did not, but he experiences the same muscle but not as intense as mine but in the same area the biceps and the hips and the lower back." No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site rash
Clinical narrative: The patient involved developed a rash all over the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 2-month-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 13Jun2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "The patient involved developed a rash all over the injection site".  Additional information: Pharmaceutical Rep calling in to report an adverse event with Prevnar 13 on behalf of a clinic. The patient involved developed a rash all over the injection site. They are not 100% sure that Prevnar 13 caused the rash because he also received 4 vaccines total at that same time. The patient received all 4 vaccines, including the Prevnar 13, on 13Jun2022.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient was tested covid post vaccination.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "recovered" (Jun2022) and all described as "Contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID test type post vaccination: Unknown. It was unknown if 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: Based on the information currently available, a possible contributory role of the suspect drug to  the reported events Vaccination failure, COVID-19 cannot be completely excluded based on temporal association and known drug safety profile
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: BNT162B2: Paxlovid:Treatment of COVID-19; BNT162B2: Paxlovid:Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 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. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Apr2022, stop date: 15Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "BNT162B2: Paxlovid Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported as no for the Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect. Anti-viral details reported as COVID 19 Treatment, Paxlovid Treatment start date was 02Jun2022, Treatment stop date was 06Jun2022, Indication was treatment of 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 the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 57.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 71-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: El9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: En6206), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: Ff3839), in left arm and on 08Apr2022 at 10:00 as dose 4 (booster), single (Lot number: Fk9896) at the age of 71 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Know allergies: Sulfa. The patient's concomitant medications were not reported. No other medication received in 2 weeks of vaccination. The following information was reported: VACCINATION FAILURE (medically significant), 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 covid-19 with Paxlovid from 04Jun2022 to 08Jun2022.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: BNT162B2: Paxlovid:Treatment of COVID-19; BNT162B2: Paxlovid: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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 27Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (May2022) and all described as "BNT162B2: Paxlovid:Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had COVID treatment of Anti viral details (Pfizer) from 09May2022 to 10Jun2022. All COVID symptoms returned on the 5th day.  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
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Immunoglobulins
Clinical narrative: Suffered an auto immune reaction from her second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A 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 (Dose 1), for COVID-19 immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Suffered an auto immune reaction from her second dose". The event "suffered an auto immune reaction from her second dose" required physician office visit. The patient underwent the following laboratory tests and procedures: Immunoglobulins: 85 or 85.9. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose abnormal, Discomfort, Dyspnoea, Exercise tolerance decreased
Clinical narrative: Difficulty controlling blood glucose; Shortness of breath; unable to lay down at night; swelling in legs; swelling all over; not able to exercise; weakness/tiredness; weakness/tiredness; palpitations; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: Fc3183) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Ace Inhibitors allergy" (unspecified if ongoing), notes: Ace Inhibitors allergy. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: BLOOD GLUCOSE ABNORMAL (non-serious), outcome "recovered with sequelae", described as "Difficulty controlling blood glucose"; DYSPNOEA (non-serious), outcome "recovered with sequelae", described as "Shortness of breath"; DISCOMFORT (non-serious), outcome "recovered with sequelae", described as "unable to lay down at night"; PERIPHERAL SWELLING (non-serious), outcome "recovered with sequelae", described as "swelling in legs"; SWELLING (non-serious), outcome "recovered with sequelae", described as "swelling all over"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "recovered with sequelae", described as "not able to exercise"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "recovered with sequelae" and all described as "weakness/tiredness"; PALPITATIONS (non-serious), outcome "recovered with sequelae". The events "difficulty controlling blood glucose", "shortness of breath", "unable to lay down at night", "swelling in legs", "swelling all over", "not able to exercise", "weakness/tiredness" and "palpitations" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested positive for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Peripheral swelling, SARS-CoV-2 test, Swelling
Clinical narrative: Difficulty controlling blood glucose; Shortness of breath; unable to lay down at night; swelling in legs; swelling all over; not able to exercise; weakness/tiredness; weakness/tiredness; palpitations; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: Fc3183) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Ace Inhibitors allergy" (unspecified if ongoing), notes: Ace Inhibitors allergy. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: BLOOD GLUCOSE ABNORMAL (non-serious), outcome "recovered with sequelae", described as "Difficulty controlling blood glucose"; DYSPNOEA (non-serious), outcome "recovered with sequelae", described as "Shortness of breath"; DISCOMFORT (non-serious), outcome "recovered with sequelae", described as "unable to lay down at night"; PERIPHERAL SWELLING (non-serious), outcome "recovered with sequelae", described as "swelling in legs"; SWELLING (non-serious), outcome "recovered with sequelae", described as "swelling all over"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "recovered with sequelae", described as "not able to exercise"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "recovered with sequelae" and all described as "weakness/tiredness"; PALPITATIONS (non-serious), outcome "recovered with sequelae". The events "difficulty controlling blood glucose", "shortness of breath", "unable to lay down at night", "swelling in legs", "swelling all over", "not able to exercise", "weakness/tiredness" and "palpitations" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested positive for COVID-19.
Age: 57.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 18Feb2021 as dose 2, single (Lot number: 031M20A), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 045J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "scented soaps" (unspecified if ongoing); "milk fat" (unspecified if ongoing); "walnuts" (unspecified if ongoing); "tomatoes" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: Jan2013; OMEPRAZOL, start date: Jan2013. Past drug history included: Bacitracin, reaction(s): "Known allergies: bacitracin". 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) Unknown results, notes: Treatment of COVID-19; (08Jun2022) Positive, notes: On day 8 my antigen home covid-19 test showed as very faintly positive; (11Jun2022) Positive, notes: I took another home test on day 11 and it showed a very dark positive line. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: adverse event: On day 8 my antigen home covid-19 test showed as very faintly positive and I was feeling pretty good with only minor coughing and stuffy nose. By day 10, my cough got worse, I began sneezing more and the congestion got a lot worse. I took another home test on day 11 and it showed a very dark positive line. My fever did not return, but the congestion and coughing still continues through today, day 15.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "recovered".  Additional information: A male patient called and stated, "Our COVID booster almost took out his legs, and he don't appreciate that". Caller also stated, "(incomprehensible words) product was a good one and (incomprehensible words) was a piece of crap and if he had the money, he'd do us for". Caller also added, he got the same effect for the COVID booster, weakness and pain on both legs". "he don't need that". Caller verified that the product was the Pfizer COVID-19 vaccine booster dose and mentioned that "the first two of the vaccine, the second one gave him a 5-day migraine which is understandable because it's (incomprehensible words) family".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 at 15:45 as dose 1, single (Lot number: EW0153), in left arm, on 01May2021 at 11:15 as dose 2, single (Lot number: EW8736), in left arm and on 11Nov2021 at 14:30 as dose 3 (booster), single (Lot number: FH8028) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TAMSULOSIN, start date: Jan2017, stop date: 30Mar2022; SYNTHROID, start date: Jan2005; LORATADINE, start date: Jan2017; IBUPROFEN. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Antiviral details: COVID 19 Treatment with Brand Pfizer/paxlovid, Treatment start date on 01Apr2022 and treatment stop date on 05Apr2022, Lot numberFY4422.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: SARS-CoV-2 test: (2022) positive, notes: Have continued to test positive for 16 days on rapid test (home test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medications in 2weeks. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 01Jun2022, treatment stop date: 05Jun2022, indication: treatment of COVID-19. Adverse event: Have continued to test positive for 16 days on rapid test (home test). Developed fever, body aches, headache, cough and runny nose 5 days post end of treatment of Paxlovid. Symptoms continue on day 10 post end of treatment. Adverse event start date: 10Jun2022 and patient recovered. Device timestamp: 15Jun2022.