chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid Treatment of COVID-19/Drug Ineffective; Paxlovid Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. Patient received the vaccination. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies Pencillin. Patient known allergies included Penicillin. Patient other medical history inlcuded Anemia, anxiety disorderConcomitant medication(s) included: LORAZEPAM. Other medication in 2 weeks included LORAZEPAM.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Paxlovid Treatment of COVID-19/Drug Ineffective"; COVID-19 (medically significant), outcome "unknown", described as "Paxlovid Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Patient received Paxlovid from 12May2022 to an unspecified date in May2022 (Lot number-Fy7031) for the treatment of COVID-19. Patient experienced Metallic taste in the mouth and diarrhea on 13May2022 and did not receive any treatment for it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: starting COVID-19 treatment. Did you/the patient previously receive a COVID-19 Vaccine?: Yes; starting COVID-19 treatment. Did you/the patient previously receive a COVID-19 Vaccine?: Yes; 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK5730), on 22Jan2021 as dose 2, single (Lot number: EL3246) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF841) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 30Apr2022, stop date: 05May2022; ESCITALOPRAM, start date: 30Apr2022, stop date: 05May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "starting COVID-19 treatment. Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative at day 9 after symptoms; Positive, notes: Now am testing positive with symptoms on day 15. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, 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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 08:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right 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 included: "Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs (as child). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, which included Paklovid, regular 5 day treatment, from 10May2022 to 14May2022. Headache and nausea - Day 3 felt almost normal but then on Day 4 of Treatment felt general malaise with bad headache and slight nausea and stayed in bed resting, could not concentrate. Although did not impact appetite as was still hungry and ate 3 meals a day. Note my dosing sch was noon and midnight-started noon 5-10. Still feel off on Day 5.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
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 74-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose number unknown, single (Lot number: EL9269), in left arm, on 21Mar2021 as dose number unknown, single (Lot number: EP7534), in left arm and on 21Oct2021 as dose number unknown, single (Lot number: 32030BD) at the age of 73 years, in left arm 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) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Within 3 days after 10 days of isolation from initial contamination; (04May2022) Positive, notes: experienced new symptoms and tested positive. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient did not had any known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 13Mar2021 as dose 2, single (Lot number: EN6199), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 60 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL, start date: 01Oct2020. Past drug history included: Relafen, reaction(s): "Known allergies: Relafen".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 31-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 at 17:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", 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; (12May2022) Positive, notes: started testing positive on rapid test again 5 days after finishing Paxlovid. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 26Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR, start date: 03May2022; BISOPROLOL; TRUVADA. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12May2022) Negative, notes: Tested negative day 9 and was symptom free; (15May2022) Positive, notes: Tested positive again day 12 and cold symptoms. Therapeutic measures were taken as a result of covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech vaccine administration date=04May2021/ COVID 19 Treatment start date=13May2022; Pfizer / BioNTech vaccine administration date=04May2021/ COVID 19 Treatment start date=13May2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "GRED" (unspecified if ongoing); "PASC" (unspecified if ongoing), notes: long covid/PASC. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 01Dec2020.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech vaccine administration date=04May2021/ COVID 19 Treatment start date=13May2022".Therapeutic measures were taken as a result of covid-19. The patient received Paxlovid as other medication in 2weeks for COVID-19 treatment. Treatment start date was reported as 13May2022 and stop date was 15May2022. The list of other medication patient received in 2 weeks was Metoprolol start date: 01Dec2020; Methyl prednisone pack start date: 11May2022; Azithromycin (zpack) start date: 11May2022.Device timestamp: 15May2022  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 currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 13:15 as dose number unknown, single (Lot number: ENG200), in left arm and on 24Mar2021 at 13:15 as dose number unknown, single (Lot number: ENG204) at the age of 62 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "DCIS Breast Cancer Diagnosis", start date: 2015 (unspecified if ongoing), notes: DCIS Breast Cancer Diagnosis in 2015; "Asthma" (unspecified if ongoing), notes: recovered and diagnosis on Asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Mar2022, outcome "not recovered" and all described as "I had symptoms of Covid Beginning on 05Mar22 and on that date I tested positive that evening". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: I had symptoms of Covid Beginning on 05Mar22 and on that date I tested positive that evening; (08May2022) Negative, notes: I felt good on the fourth and fifth day of taking Paxlovid and I tested negative on the following two consecutive days; (09May2022) Negative, notes: I felt good on the fourth and fifth day of taking Paxlovid and I tested negative on the following two consecutive days; (15May2022) Positive, notes: I began having symptoms again on 14May and 15May22. I tested positive again on 15May. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: If vaccine received- Yes; other medication in 2 weeks- unknown. Adverse event: I had symptoms of Covid Beginning on 05Mar22 and on that date I tested positive that evening. I started taking Paxlovid on the afternoon of 5May22 and took it as instructed for 5 days. I felt good on the fourth and fifth day of taking Paxlovid and I tested negative on the following two consecutive days. I began having symptoms again on 14May and 15May22. I tested positive again on 15May. Known allergies- No
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Drug ineffective, Suspected COVID-19
Clinical narrative: I was down for like a week; but I did have COVID last month; but I did have COVID last month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 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) all with onset Apr2022, outcome "unknown" and all described as "but I did have COVID last month"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I was down for like a week".  Clinical course: Consumer stated, "Yeah, it is the booster shot, the COVID-19 booster shot from Pfizer and consumer stated, "I just want to know if I got this shot too soon because I did have COVID last month but, and I did have (incomplete sentence). I took the Pfizer both shots like a year ago like in April and then I got both shot (COVID-19 vaccine) and then I got booster now, but I did have COVID last month, I was down for like a week."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FL59893) at the age of 52 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 was not reported. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of covid-19, drug ineffective and treatment with Paxlovid. It was also reported that 5 days of Paxlovid treatment, patient  was really feeling much better. A day after he stopped, started to feel sick again and Covid seemed to get worse. It's now a week since he finished the full Paxlovid treatment and he still have a runny nose, head congestion, diarrhea, sneezing, and coughing. This seems to be the "rebound" effect the media described No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech 06/Apr/2022 / COVID 19 Treatment; Pfizer / BioNTech 06/Apr/2022 / 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 36-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FM698) at the age of 36 years, in left 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: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech 06/Apr/2022 / COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: testing positive again on rapid antigen; (06May2022) negative, notes: Tested negative starting Day 3 of taking Paxlovid (06May2022); (unspecified date) negative, notes: continued to test negative on rapid antigen; (15May2022) positive, notes: 15May2022 (7 days after finishing Paxlovid / 12 days after first testing positive for COVD. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech administration date=12Oct2021; COVID 19 Treatment start date=06May2022; Pfizer / BioNTech administration date=12Oct2021; COVID 19 Treatment start date=06May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right 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 included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech administration date=12Oct2021; COVID 19 Treatment start date=06May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; negative; positive. Therapeutic measures were taken as a result of drug ineffective. No other medication in 2 weeks. No known allergies. After taking Paxlovid for 5 days, symptoms resolved and tested negative 3 days in a row. On the 5th day after my treatment, patient had symptoms and testing positive again.  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: Blood pressure measurement, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left 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 bp" (unspecified if ongoing), notes: (not on any listed "do not give with" meds except trazadone); "Known allergies: Penicillin" (unspecified if ongoing); "obesity" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; LISINOPRIL; HYDROCHLOROTHIAZIDE; GoLo supplement. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Mild increased; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of suspected covid-19. Patient received other medication in 2 weeks was trazadone, GoLo supplement, Lisinopril, Hydrochlorothiazide. Severe altered bitter taste, nausea progressive with each dose, shaky and weaker with last 2 doses, loose stool and 1 diarrhea, mild fever after last dose, shortness of breath upon exertion. "Severe flu like symptoms last 48 hours of dose regiment. Improved 24 hours after last dose except still shaky with some weakness and SOB. (not diabetic) Mild increased BP. COVID 19 Treatment: Paxlovid. Treatment start date: 09May2022, treatment stop date: 14May2022.  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: Autoimmune disorder, Blood cortisol, Blood pressure measurement, Contusion, Investigation
Clinical narrative: Autoimmune disease; Bruises on her arms "like an old lady"; Low B12; Platelet count that went up, then down; Platelet count that went up, then down; 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 52-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: The only medications she takes is one for her blood pressure and one for her thyroid; "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot (Verbatim:Crazy spike in blood pressure), administration date: 2020, for Immunization, reaction(s): "Crazy spike in blood pressure"; Flu shot (Verbatim:Cortisol spike), administration date: 2020, for Immunization, reaction(s): "Cortisol spike". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease"; CONTUSION (non-serious), outcome "unknown", described as "Bruises on her arms "like an old lady""; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "Low B12"; PLATELET COUNT INCREASED (non-serious), PLATELET COUNT DECREASED (non-serious), outcome "unknown" and all described as "Platelet count that went up, then down". The patient underwent the following laboratory tests and procedures: Blood cortisol: (2020) Spike; Blood pressure measurement: (2020) crazy spike; Evaluated: (unspecified date) Unknown results, notes: HCPs evaluated for a thyroid tumor; Platelet count: (unspecified date) that went up; (unspecified date) It went Down; Vitamin B12: (unspecified date) Low. Clinical course included patient is asking if there is a variation in the recommendations for timing of dose 2 of the COVID vaccine in light of her autoimmune disease. Patient also mentions that she gets the flu shot every year, but in 2020, shortly after she got it, she had a "crazy spike in blood pressure", as well as a cortisol spike, so much so that her HCPs evaluated for a thyroid tumor. She also mentions that, seemingly unrelated to a medication, she has noticed bruises on her arms "like an old lady", but was found to have low B12 and a platelet count that went up, then down. She states the only medications she takes is one for her blood pressure and one for her thyroid. E-transmitted to Agency for AE information for a non-Pfizer product, as did not realize until call had ended.  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: Platelet count, Platelet count decreased, Platelet count increased, Vitamin B12, Vitamin B12 decreased
Clinical narrative: Autoimmune disease; Bruises on her arms "like an old lady"; Low B12; Platelet count that went up, then down; Platelet count that went up, then down; 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 52-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: The only medications she takes is one for her blood pressure and one for her thyroid; "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot (Verbatim:Crazy spike in blood pressure), administration date: 2020, for Immunization, reaction(s): "Crazy spike in blood pressure"; Flu shot (Verbatim:Cortisol spike), administration date: 2020, for Immunization, reaction(s): "Cortisol spike". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune disease"; CONTUSION (non-serious), outcome "unknown", described as "Bruises on her arms "like an old lady""; VITAMIN B12 DECREASED (non-serious), outcome "unknown", described as "Low B12"; PLATELET COUNT INCREASED (non-serious), PLATELET COUNT DECREASED (non-serious), outcome "unknown" and all described as "Platelet count that went up, then down". The patient underwent the following laboratory tests and procedures: Blood cortisol: (2020) Spike; Blood pressure measurement: (2020) crazy spike; Evaluated: (unspecified date) Unknown results, notes: HCPs evaluated for a thyroid tumor; Platelet count: (unspecified date) that went up; (unspecified date) It went Down; Vitamin B12: (unspecified date) Low. Clinical course included patient is asking if there is a variation in the recommendations for timing of dose 2 of the COVID vaccine in light of her autoimmune disease. Patient also mentions that she gets the flu shot every year, but in 2020, shortly after she got it, she had a "crazy spike in blood pressure", as well as a cortisol spike, so much so that her HCPs evaluated for a thyroid tumor. She also mentions that, seemingly unrelated to a medication, she has noticed bruises on her arms "like an old lady", but was found to have low B12 and a platelet count that went up, then down. She states the only medications she takes is one for her blood pressure and one for her thyroid. E-transmitted to Agency for AE information for a non-Pfizer product, as did not realize until call had ended.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took a home test (Binax) yesterday 15May2022 and it was positive; I took a home test (Binax) yesterday 15May2022 and it was positive; 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), on 10May2022 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "I took a home test (Binax) yesterday 15May2022 and it was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive.  Clinical course: The patient stated that he received the second booster of the Pfizer-BioNTech COVID-19 Vaccine last tuesday 10May2022. His wife was diagnosed with COVID last monday 09May2022. She took a PCR test and it turned out positive. He took a home test (Binax) yesterday 15May2022 and it was positive and asked is there any correlation with people receiving the vaccine an getting a false positive and his understanding is that the vaccine puts in a fake spike protein, and asked is that right, like a synthetic spike on the COVID-19 vaccine , would that be picked up as an antigen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Suspected COVID-19; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 330268d) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COQ 10; ROSUVASTATIN, stop date: 15May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Suspected COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid (Lot number: Fp6522) from 15May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Echovirus test, Electrocardiogram, Pericarditis
Clinical narrative: pericarditis; pericarditis pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Sep2021 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: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant) with onset 11Sep2021, outcome "unknown"; ANGINA PECTORIS (medically significant) with onset 11Sep2021, outcome "recovered" (12Sep2021), described as "pericarditis pain". Therapeutic measures were taken as a result of pericarditis, angina pectoris.  Clinical course- The patient received Pfizer COVID-19 booster on 03Sep and was then diagnosed with pericarditis on 11Sep for 90 days. The patient have rheumatoid arthritis being treated with Humira and methotrexate and tramadol daily for avoiding pain.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Pericarditis
Clinical narrative: pericarditis; pericarditis pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Sep2021 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: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant) with onset 11Sep2021, outcome "unknown"; ANGINA PECTORIS (medically significant) with onset 11Sep2021, outcome "recovered" (12Sep2021), described as "pericarditis pain". Therapeutic measures were taken as a result of pericarditis, angina pectoris.  Clinical course- The patient received Pfizer COVID-19 booster on 03Sep and was then diagnosed with pericarditis on 11Sep for 90 days. The patient have rheumatoid arthritis being treated with Humira and methotrexate and tramadol daily for avoiding pain.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 11Mar2022 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (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 15May2022 at 21:00, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. The action taken for CoviD-19 vaccine miRNA (miRNA 1273) was unknown. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from 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 10Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 at 16:00 as dose 3 (booster) single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. No known allergies. COVID 19 Treatment with Paxlovid from 04May2022 to 09May2022. Patient had severe head cold, watery eyes, sneezing, scratchy throat, headache started on 15May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lacrimation increased, Nasopharyngitis, Sneezing, Throat irritation
Clinical narrative: product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from 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 10Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 at 16:00 as dose 3 (booster) single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. No known allergies. COVID 19 Treatment with Paxlovid from 04May2022 to 09May2022. Patient had severe head cold, watery eyes, sneezing, scratchy throat, headache started on 15May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right 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: LISINOPRIL. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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; Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: report about covid treatment was Yes. if vaccine received reported as Yes. other medication in 2weeks reported as Yes. anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 03May2022, treatment stop date: 08May2022, indication: Treatment of COVID-19. other medication details: other medication in 2weeks product: Lisinopril. Five days after ending Paxlovid treatment, rapid tested positive for Covid. No symptoms at all since the first two days of originally testing positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group and Regulatory Authority. The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 03Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 60 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN, start date: Dec2018. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", described as "indication=Treatment of COVID-19"; COVID-19 (medically significant) with onset May2022, outcome "not recovered", described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative; (May2022) positive; (17May2022) positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: The patient Took Paxlovid within 12 hours of first symptom (within 8 hours of testing positive). Took full course of drug. Tested negative for COVID with antigen test on Day 6. Started feeling slight cold like symptoms on Day 8 with full blown symptoms on Day 9, body aches, chills, bad head cold. Tested positive on Day 12 with antigen test (first day tested since symptoms started). No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID rebound.; COVID rebound.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 23Feb2021 as dose 2, single (Lot number: en6200), in left arm, on 07Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 16Mar2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MDS" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; ARANESP, start date: 16Jun2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID rebound.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Negative; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: 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 reported as no. if vaccine received reported as Yes. other medication in 2weeks reported as Yes. anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 07May2022, treatment stop date: 11May2022, indication: Treatment of COVID-19. COVID rebound. I tested negative and felt great 2 days ago. Today I woke up and felt awful. Retested and came up positive in less than one minute. I am immune compromised and have MDS. Awaiting word on whether or not my oncologist will prescribe another round. known allergies reported as no. Did you/the patient previously receive a COVID-19 Vaccine reported as yes.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW015B), on 01May2021 as dose 2, single (Lot number: EW0172) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 52 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "tested positive on 16May with rapid AG". The event "tested positive on 16May with rapid ag" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. No follow-up attempts are possible. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 30-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 at 12:00 as dose 1, single (Lot number: EL3249), in right arm, on 18Feb2021 at 12:00 as dose 2, single (Lot number: EN9581), in left arm and on 28Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 30 years, in right arm for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 08Apr2022, outcome "not recovered" and all described as "I tested positive again for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) positive; (12Apr2022) Negative; (16May2022) positive. Therapeutic measures were taken as a result of Covid-19. Clinical Course: Other medication in 2 weeks was reported as no. Adverse event: patient received a positive COVID diagnosis on 08Apr2022 and began treatment of Paxlovid on the same day. Patient tested negative on 12Apr2022. On 16May2022 patient tested positive again for COVID. Anti viral details product COVID-19 Treatment, brand Paxlovid, treatment start date 08Apr2022, treatment stop date 12Apr2022, indication Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.