chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Jul2022 to 19Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6198), on 03Apr2021 as dose 2, single (Lot number: EN6206), on 01Nov2021 as dose 3 (booster), single (Lot number: 30145BA) and on 06Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: diagnosed for 5-10 years. The patient's family history included: "Covid" (unspecified if ongoing), notes: one of his brothers also had Covid and it took him months to get his taste and smell back. Concomitant medication(s) included: ADARBI taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "diagnosed with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Tested Positive for COVID after 4 Vaccines. Therapeutic measures were taken as a result of vaccination failure, covid-19. Caller states he was calling to report a benefit of Paxlovid. Stated he was diagnosed with Covid on Monday 18Jul2022, given Paxlovid medication, started the medication on Tuesday morning, 19Jul2022. The patient received Paxlovid (NDC number of Paxlovid: 0069-1085-30, Expiry Date: Mar2023, Batch/lot number: GC9447) three in the morning and three in the evening for COVID-19. Caller reported that by Monday 18Jul2022, he had already lost his sense of taste and smell due to the Covid. Stated that he was only on his fourth day of Paxlovid treatment and his taste and smell are back. States he noticed it a little bit yesterday but this morning when he ate breakfast his apple tasted like an apple and his milk tasted like milk, states he called his whole family to tell them. Caller stated he was worried because one of his brothers also had Covid and it took him months to get his taste and smell back. Caller did not know if it was because of the medication but he wanted to make sure Pfizer was aware of this potential benefit. The sample of the product was not available to be returned. The report was not related to a study or programme.
Age: 23.0
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 24-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 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 included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Anti-viral Paxlovid for Covid-19 treatment from 24Jul2022 to 25Jul2022, (Lot number: Gc0529). When taking Paxlovid the medication created a horrible taste in his mouth starting about 1-2 hours after taking the dose. This was also happening to his partner and matter if we eat or not. Adverse events start date: 24Jul2022, Adverse event start time 02:30 PM. Patient was recovering. Received no treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 23Jul2022 at 13:00 as dose 4 (booster), single (Lot number: FP7150) at the age of 56 years, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Jul2022 at 10:00, outcome "recovering", described as "General Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 24Jul2022 at 10:00, outcome "recovering", described as "Injection Site Pain"; MYALGIA (non-serious) with onset 24Jul2022 at 10:00, outcome "recovering", described as "Muscle Soreness". Therapeutic measures were taken as a result of fatigue, vaccination site pain, myalgia. Additional information: The patient took 600 mg Ibuprofen as treatment for adverse events. There were no other vaccine in four weeks. There was no covid prior to vaccination. The patient was not tested for covid post vaccination.
Age: 57.0
Sex: F
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 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 05Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: Other medical history: Cancer more than 20 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (21Jul2022) Negative, notes: home test showed negative on 21Jul; (24Jul2022) Positive, notes: home test showed positive again on 24Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive and other medication in 2weeks. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 13Jul2022, Treatment stop date: 17Jul2022. Adverse event: No adverse event, home test showed negative on 21Jul. But runny nose started again on 23Jul, home test showed positive again on 24Jul. Which is exactly a week after I finished 5 days of paxlovid. No fever, a little bit cough. No treatment will given to AE. Patient have no known allergies:   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
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 73-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing); "stents" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CLOPIDOGREL; BABY ASPIRIN; METOPROLOL; TADALAFIL, stop date: 13Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with anti viral Paxlovid from 13Jul2022 to 18Jul2022 for the treatment of COVID 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; CELEXA [CITALOPRAM HYDROBROMIDE]; WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: After a positive covid test, I took paxlovid for 5 days; (Jul2022) Negative, notes: My symptoms went away and I tested negative; (Jul2022) Positive, notes: One week later, covid symptoms returned and I am testing positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received anti viral treatment with PAXLOVID from 09Jul2022 to 13Jul2022 for COVID-19. After a positive covid test, patient took Paxlovid for 5 days. Her symptoms went away and she tested negative. One week later, covid symptoms returned and she was now testing positive for covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech 05Jul2022/ Treatment of COVID-19  08Jul2022; Pfizer / BioNTech 05Jul2022/ Treatment of COVID-19  08Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (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), 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. There were no concomitant medications. No other medication in 2 weeks.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Pfizer / BioNTech 05Jul2022/ Treatment of COVID-19 08Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jul2022) Negative, notes: Prior Negative result; (Jul2022) Positive, notes: Positive test following Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound of COVID symptoms and positive test following Paxlovid treatment and prior negative result. COVID 19 Treatment included Paxlovid, treatment start date=08Jul2022 and treatment stop date=12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound CoVid after paxlovid treatment with negative test on day 8. Symptoms returned on day 10 with positive test day 13; Rebound CoVid after paxlovid treatment with negative test on day 8.  Symptoms returned on day 10 with positive test day 13; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: Ek 5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: El 3248), in left arm and on 04Sep2021 as dose 3 (booster), single (Lot number: Fe 3592) at the age of 48 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: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Rebound CoVid after paxlovid treatment with negative test on day 8. Symptoms returned on day 10 with positive test day 13"; COVID-19 (medically significant), outcome "not recovered", described as "Rebound CoVid after paxlovid treatment with negative test on day 8.  Symptoms returned on day 10 with positive test day 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Symptoms returned on day 10 with positive test day 13; (21Jul2022) Negative, notes: Rebound CoVid after paxlovid treatment with negative test on day 8. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not had any known allergies. Received Paxlovid as treatment on 14Jul2022 till 18Jul2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Off label use, Vaccination site urticaria
Clinical narrative: A little tenderness under my left arm - closer to rib cage; Red raised very itchy spot on my arm at the site of the injection.; Patient received dose 4 of Comirnaty; Patient received dose 4 of Comirnaty; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 23Jul2022 at 15:30 as dose 4 (booster), single (Batch number: FJ4989), in the left arm, at the age of 67 years, for COVID-19 immunisation. Relevant medical history included: "Pemphigus foliaceous" (unspecified if ongoing), notes: Pemphigus Foliaceous but has been in remission basically since Rituximab in 2016/2017. Concomitant medications included: LOSARTAN; AMLODIPINE; PREMARIN and COQ10. Past drug history included: Cyclosporine, reaction: "Drug allergy"; Hydrochlorothiazide, reaction: "Drug allergy"; Tetracycline, reaction: "Drug allergy" and Rituximab, for Pemphigus foliaceus, notes: Rituximab in 2016/2017. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation and COVID-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 23Jul2022 at 15:30, outcome "unknown", and all described as "Patient received dose 4 of Comirnaty"; VACCINATION SITE URTICARIA (non-serious) with onset 23Jul2022 at 20:30, outcome "not recovered", described as "However, later that day I noticed that I had a red raised very itchy spot on my arm at the site of the injection"; AXILLARY PAIN (non-serious) with onset 25Jul2022, outcome "unknown", described as "I am also noticing a little tenderness under my left arm - closer to rib cage". Therapeutic measures were not taken as a result of vaccination site urticaria and axillary pain.  Additional information: The patient was pretty healthy generally. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient said that it was about the size of a silver dollar. She would say that it was even itchier the following day. She had never experienced a reaction to any other vaccine, COVID-19 or otherwise. This was a first. She was also noticing a little tenderness under her left arm - closer to rib cage, but she could not see anything. (This was first observed on the morning of, Monday, July 25). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction to Pfizer COVID 19 Vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mast Cell Disease" (unspecified if ongoing), notes: Mast Cell Disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 21Apr2021, outcome "unknown", described as "Anaphylactic reaction to Pfizer COVID 19 Vaccine". The event "anaphylactic reaction to pfizer covid 19 vaccine" required emergency room visit.  Clinical course: Patient Age at Time of Vaccination in Years was unknown, she believes mid-30s. Event reported as Anaphylactic Reaction to Pfizer BioNTech, clarified to Pfizer COVID 19 Vaccine. She does not believe it was Comirnaty yet. Outcome was reported that the patient believed it resolved, she was unsure if it completely resolved, or it her acquaintance has lasting effects. The acquaintance didn't mention lasting results but didn't specify. Concomitant medications were unknown. The acquaintance did tell her, and she wrote down that the acquaintance has mast cell disease and is randomly allergic to things. That may be a different part of the survey. She clarified that she doesn't know if the acquaintance takes medication for that, she doesn't know what disease entails. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None, first dose. The acquaintance did say she got the second dose. Unknown NDC/lot/expiry or date of second dose. Patient visited Emergency Room. Her acquaintance went to the hospital and the hospital wanted to admit her and she did not and signed a form. Confirmed the acquaintance was not hospitalized. The hospital made the acquaintance sign a form because she refused to be admitted. 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) and AE(s) following prior vaccinations was reported as Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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) (Physician).  A 34-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 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: "Post concussion syndrome" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE oral. Past drug history included: Known allergies: sucralose, reaction(s): "Allergy", notes: Known allergies: Sucralose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Jul2022, Treatment stop date: 05Jul2022, Indication: Treatment of COVID-19. Had mild rebound symptoms and had positive antigen test for COVID 4 days after completing the 5 day course of Paxlovid. He initially tested negative after completing his course of Paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Plantar fasciitis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 at 11:00 AM as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 21Sep2021, when the patient was 42-year-old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Nov2021 at 11:00, outcome "unknown", described as "Dose 1: 21Sep2021; Dose 2: 09Nov2021"; PLANTAR FASCIITIS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Severe Plantar fasciitis". The event "severe plantar fasciitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of plantar fasciitis. Additional information: Event was treated with Ultrasound therapy and scrapping. The patient received no other vaccination in four weeks. The patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: sulfa meds" (unspecified if ongoing), notes: Known allergies: sulfa meds. The patient took 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: (25Jul2022) Positive, notes: Rebound. 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.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 61.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6198), in right arm, on 25Mar2021 as dose 2, single (Lot number: Er8730), in right arm, on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. The following information was reported: VACCINATION FAILURE (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: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received vaccine. Other medication in 2 weeks as concomitant. Patient received anti-viral treatment for COVID 19 with Paxlovid from 11Jul2022 to 16Jul2022. It was reported that covid rebound. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, 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 52-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 05Feb2021 as dose 2, single (Lot number: EL9265) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Dec2020, stop date: 25Jul2022; ENALAPRIL, start date: 01Dec2020, stop date: 25Jul2022.   The following information was reported: VACCINATION FAILURE (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: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19. Clinical course: There were no known allergies reported. Anti viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 12Jul2022, treatment stop date: 16Jul2022, indication: treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with onset 2022, , outcome "unknown" and all described as "Covid 19 rebound infection after taking Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. the patient was previously received a COVID-19 Vaccine. The patient was taking Paxlovid as Treatment from 04Jul2022 to 08Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: When I first teste positive, I was asymptomatic; (2022) Positive, notes: Recurrence of infection with more syptoms than I had at onset. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid Covid-19 treatment from 07Jul2022 to 11Jul2022.  Clinical course: The patient had no known allergies. The patient had no other medical history. The patient did not receive any other medication in 2 weeks of vaccination. Patient was asymptomatic when she first tested positive.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 12:00 as dose 1, single (Lot number: EP7554), in right arm, on 12Apr2021 at 12:00 as dose 2, single (Lot number: EW0153), in right arm, on 09Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH8027), in right arm and on 12Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing); "seasonal allergies in spring" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Jul2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jul2022. The following information was reported: VACCINATION FAILURE (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: (16Jul2022) Negative, notes: Tested negative on Sat 16Jul; (23Jul2022) Positive, notes: took another test on 23Jul - positive again. Therapeutic measures were taken as a result of covid-19 included Anti-viral medication Paxlovid. The patient did not have any known allergies.  .
Age: 40.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 40 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 included: "Psoriatic Arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benzonatate, reaction(s): "Known allergies: Benzonatate", notes: Known allergies: Benzonatate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reportedly the patient did not receive other medication in 2weeks. On 12Jul2022 the received antiviral for Covid-19 treatment (stop date 16Jul2022).   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 infection; COVID 19 infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207), as dose 2, single (Lot number: ER8734) and on 12Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "sinus pressure" (unspecified if ongoing), notes: sinus pressure due to COVID 19 returned. Concomitant medication(s) included: MONTELUKAST; LOW-OGESTREL; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; EXCEDRIN MIGRAINE; BUDESONIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "recovered" (19Jul2022) and all described as "COVID 19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Last positive test taken was 18Jul2022; (24Jul2022) Negative, notes: I tested negative for COVID 19 24Jul2022. Therapeutic measures were taken as a result of covid-19.  Clinical course: Current age: 40 years. Other medication details. Other medication in 2 weeks product: Montelukast, Low-Ogestrel, Budesonide, Nexium, Excedrine Migraine. Adverse event: 4 days after completing the Paxlovid antiviral my sinus pressure due to COVID 19 returned. I continued to test positive from the completion of the antiviral to the return of symptoms. I took over the counter medication to alleviate symptoms, and I tested negative for COVID 19 24Jul2022. Last positive test taken was 18Jul2022. Adverse event start date: 15Jul2022, If patient recovered: recovered. Adverse event stop date: 19Jul2022   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 13:00 as dose 2 (booster), single (Lot number: FD0809), in right arm and on 15Apr2022 at 15:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Mar2021 at 14:00 as dose 1, single (Lot number: 1805022), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Hypertension" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Aging" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel, Adhesive; "Known allergies: Adhesive" (unspecified if ongoing), notes: Known allergies: Nickel, Adhesive; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 16Jan2010; CARVEDILOL, start date: 06Jun2019; ROSUVASTATIN CALCIUM, start date: 21May2022; XARELTO, start date: 21May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient had received Other medication in 2weeks. Patient had received Paxlovid from 19Jul2022 to 23Jul2022 as a treatment of covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Suspected COVID-19
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 13:00 as dose 2 (booster), single (Lot number: FD0809), in right arm and on 15Apr2022 at 15:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Mar2021 at 14:00 as dose 1, single (Lot number: 1805022), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Hypertension" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Aging" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel, Adhesive; "Known allergies: Adhesive" (unspecified if ongoing), notes: Known allergies: Nickel, Adhesive; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 16Jan2010; CARVEDILOL, start date: 06Jun2019; ROSUVASTATIN CALCIUM, start date: 21May2022; XARELTO, start date: 21May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient had received Other medication in 2weeks. Patient had received Paxlovid from 19Jul2022 to 23Jul2022 as a treatment of covid-19.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection location; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 24Jul2022 as dose 3 (booster), single (Lot number: FLZ757) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FKS618), administration date: 11Nov2021, when the patient was 7-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FKS618), administration date: 02Dec2021, when the patient was 7-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Jul2022, outcome "unknown", described as "sore arm at injection location". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Gait disturbance, Heart rate
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 16:00 as dose 3 (booster), single (Lot number: FJ1618) at the age of 61 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "PE", start date: 2013 (unspecified if ongoing), notes: PE in 2013; "Low oxygen levels" (unspecified if ongoing), notes: Low oxygen levels (avg. 87); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: XARELTO. Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Leg Right, Vaccine Administration Time: 03:00 AM), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization; Pfizer (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 25Apr2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2022, outcome "not recovered", described as "Can't walk for long periods of time"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "Hard to get breath on occasion"; HEART RATE INCREASED (non-serious) with onset 2022, outcome "not recovered", described as "Heart beating faster avg. 103 resting"; CHEST DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "Righting feeling around chest sometimes"; ASTHENIA (non-serious) with onset 2022, outcome "not recovered", described as "Very low energy". The events "heart beating faster avg. 103 resting", "righting feeling around chest sometimes", "hard to get breath on occasion", "can't walk for long periods of time" and "very low energy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chest discomfort, dyspnea, gait disturbance, asthenia. Additional information: patient had heart beat faster than average 103 resting and righting feeling around chest sometimes and was hard to get breath on occasion. patient can't walk for long periods of time and had very low energy.