chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FA2596), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 80 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: "Post polio syndrome" (unspecified if ongoing); "Known allergies: Sulfer" (unspecified if ongoing), notes: Known allergies: Sulfer. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Vaccine received Yes, is there any other medication in 2weeks: No, Antiviral details provided as COVID 19 Treatment Brand is Pfizer, Treatment start date is 01Sep2022, Treatment stop date is 05Sep2022, Lot number is 1923792A, Indication for Treatment of COVID-19, Adverse event experienced Feeling rough with rebound on 07Sep2022. Headache, upset stomach, very tired.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; 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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "PCOS" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing); "asthma as cold" (unspecified if ongoing), notes: asthma as cold; "bronchitis when Sick" (unspecified if ongoing), notes: bronchitis when sick,; "migraines" (unspecified if ongoing); "low TSH" (unspecified if ongoing); "bronchitis when Sick" (unspecified if ongoing), notes: bronchitis when sick,; "asthma as cold" (unspecified if ongoing), notes: asthma as cold. Concomitant medication(s) included: METFORMIN taken for polycystic ovaries. Past drug history included: Davocet, reaction(s): "Known allergies: Davocet". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "recovering", 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Aug2022 to 02Sep2022. Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Headache, Herpes zoster, Limb mass, Pain in extremity, Rash
Clinical narrative: your arm gets sore from the shot; I got this rash, it's a hot looking rash on my arm, I do not know my shoulder but it is top on my arm; Headache; it had a big lump on it for a while; I have had shingles before and it feels like it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "MGS" (unspecified if ongoing); "I take this for my 'eyes'" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; PREMARIN taken for eye disorder and a vitamin supplement.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "your arm gets sore from the shot"; RASH (non-serious), outcome "unknown", described as "I got this rash, it's a hot looking rash on my arm, I do not know my shoulder but it is top on my arm"; HEADACHE (non-serious), outcome "unknown"; LIMB MASS (non-serious), outcome "not recovered", described as "it had a big lump on it for a while"; HERPES ZOSTER (non-serious), outcome "recovered", described as "I have had shingles before and it feels like it". Therapeutic measures were taken as a result of pain in extremity, headache.  Additional Information: It was reported that the patient got a Prevnar, the Pneumonia vaccine(Later confirmed as Prevnar 20) and her arm got sore from the shot but few days ago she was little sore it was not as swollen and did had top of it, it had a big lump on it for a while, almost 3 weeks and now she got the rash, it's a hot looking rash on her arm, she do not know her shoulder but it is top on her arm. The patient was asking was there something she need to do about it. And she was still a little sore. The patient also reported that because it was rash and she had shingles before and it feels like it, shingles but it's not coming back, its been like this for a while. The patient reported that for treatment she just took Tylenol. She had headache and it was sore. She took Tylenol and put alcohol in her arm that was it.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: 0151), in left arm, on 24Apr2021 as dose 2, single (Lot number: EL00171), in left arm, on 11Dec2021 as dose 3 (booster), single (Lot number: 33130BA), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Breast cancer survivor; "Known allergies: Penicillin" (unspecified if ongoing). 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 "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; (03Jul2022) Negative; (05Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient got a rebound from using wonderful Paxlovid medicine. I felt good after 5 days, tested negative, but 2 days later tested positive again with symptoms (extremely runny nose). Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid , Treatment start date: 28Jun2022, Treatment stop date: 03Jul2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: en6202), on 30Mar2021 as dose 2, single (Lot number: er8720), on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not received other medication in 2 weeks. No known allergies. Patient received Paxlovid for COVID 19 Treatment From 29Aug2022 to 02Sep2022. It was reported that rebound covid. Patient was feeling well 01Sep to 05Sep and got sick again on 06Sep with worse symptoms than the first 28Aug to 31Aug time period.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: 32030BD) at the age of 52 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: "Recent weight loss revision surgery" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications, also reported as patient not received any other medication in 2weeks. 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 drug ineffective, covid-19 included Paxlovid started from 06Sep2022 and stopped on 09Sep2022. Clinical course was reported as, on 08Sep2022 at 20:00, patient experienced symptoms of Throat had restriction or tightening. Patient not received any treatment for the symptoms and was recovering from symptoms.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), 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: COVID 19 Treatment; (unspecified date) Negative, notes: testing negative 3 days; (09Sep2022) Positive, notes: tested positive and symptoms got worse. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: On 31Aug2022, Patient started Paxlovid for COVID 19 Treatment till 05Sep2022. After taking Paxlovid, testing negative 3 days, symptoms returned , tested positive and symptoms got worse.Other medication in 2 weeks was Unknown.  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, 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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not received other medication in 2 weeks. The patient received Paxlovid for Treatment of COVID-19 on 10Sep2022 and stopped on 11Sep2022, and had adverse event: Metallic taste in mouth, major headache, stiff neck on 10Sep2022 at 11:30 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "Glaucoma" (unspecified if ongoing), notes: Glaucoma as a result of detachted retina, several years ago; "spinal fusion" (unspecified if ongoing), notes: Recent spinal fusion; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Glaucoma as a result of detachted retina" (unspecified if ongoing), notes: Glaucoma as a result of detachted retina, several years ago.; "Mold" (unspecified if ongoing); "allergy to certain eye drops" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flomax, notes: Use flomax. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (09Sep2022) Positive, notes: Restested on 09Sep with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if the patient took other medication in last 2 weeks. Patient took Paxlovid as a treatment from Sep2022 to Sep2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose number unknown, single (Lot number: 4122) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Sep2022, 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; (11Sep2022) positive, notes: Positive test day 6 after last Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
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) from product quality group. The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 25 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: "Hypothyroidism" (unspecified if ongoing); "bandage adhesive" (unspecified if ongoing), notes: Known allergies: bandage adhesive; "Pain" (unspecified if ongoing), notes: Other medication in 2weeks product=for pain,. Concomitant medication(s) included: LEVOTHYROXINE, start date: 11Jul2012; IBUPROFEN taken for pain, start date: 08Sep2022; TYLENOL taken for pain, start date: 08Sep2022; VITAMIN D NOS, start date: 09Sep2022; ZINC [ZINC SULFATE], start date: 09Sep2022. Past drug history included: Vienva for Known allergies: vienva, notes: Known allergies: vienva. 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 drug ineffective, covid-19.  Clinical course: The patient started COVID 19 treatment, brand: Paxlovid from 10Sep2022 till 11Sep2022, Lot number:GC8123.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received nirmatrelvir-ritonavir therapy; received nirmatrelvir-ritonavir therapy; This is a literature report for the following literature source(s). A 31-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received nirmatrelvir-ritonavir therapy". The patient underwent the following laboratory tests and procedures: Body mass index: 22.4 kg/m2; SARS-CoV-2 test: Positive, notes: mild-to-moderate COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Reporter stated that  patients  received nirmatrelvir-ritonavir therapy from 16Apr2022, through 18May2022. Patients were eligible to receive nirmatrelvir-ritonavir if they were diagnosed with mild-to-moderate coronavirus disease 2019 (COVID-19) with symptom onset within 5 days, did not require oxygen therapy or hospital admission.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported events Drug ineffective , covid 19 and the suspect drug cannot be excluded.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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. COVID 19 Treatment with Paxlovid from 02Sep2022 to 05Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 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: "Poor immune system response after bout with infectious disease (not HIV)" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (Sep2022) Positive, notes: Rebound string positive COVID test results and symptom recurrence after 4 days of ending. Patient did not receive any other medication in 2 weeks. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 28Aug2022 to 01Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 21Feb2021 as dose 2, single (Lot number: EN6201), in right arm, in Aug2021 as dose 3 (booster), single (Lot number: EW0182), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Paxlovid", start date: 01Sep2022, stop date: 06Sep2022, notes: Stopped. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had not received any other medication in 2weeks. Patient had received Paxlovid as COVID 19 Treatment from 31Aug2022 to 05Sep2022. 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.; Sender's Comments: Based on available information in the case the reported events DRUG INEFFECTIVE and Covid 19 are assessed as related to suspect drug .
Age: 54.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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: "Overweight" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfonamide, reaction(s): "Known allergies- Sulpha ". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (05Sep2022) Negative; (07Sep2022) Positive; (09Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no other medication in 2 weeks. The patient received Paxlovid from 29Aug2022 to 03Sep2022 for Treatment of COVID-19.   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: Immunisation, Off label use, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Off label use; Booster; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; CLARITINE; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number Fm0698, Other vaccine same date dose number 4, Other vaccine same date vaccine location: Left upper arm), for COVID-19 Immunization, reaction(s): "rash"; Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number Fc3183, Other vaccine same date dose number 3, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "rash"; Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number El183, Other vaccine same date dose number 2, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "rash"; Bnt162b2 (Other vaccine same date product Pfizer, Other vaccine same date lot number Ek5730, Other vaccine same date dose number 1, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "rash". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 10Sep2022 at 06:30, latency 13 hrs after the suspect product(s) administration, outcome "recovering" and all described as "Left arm pruritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previous vaccines and this was the bivalent vaccine"; OFF LABEL USE (non-serious), outcome "unknown"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of vaccination site rash, vaccination site pain, vaccination site pruritus.  Additional information: Facility of vaccine was pharmacy or drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient developed left arm pruritic rash with pain 4x6 cm. Reported as this was only rash after 4 previous vaccines, and this was the bivalent vaccine. Patient treated with tylenol and steroid ointment.
Age: 56.0
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). There were no concomitant medications, reported as no other medication in 2weeks. The patient had no known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 02Sep2022 and stopped on 07Sep2022. Clinical course was reported as, The patient had a rebound of Covid-19 symptoms on 11Sep2022 at 08:00, 4 days after completing treatment. Patient not recovered from rebound symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: I was kind of feeling numbness like muscle ache in my arm; I have some muscle aches a lot in my arm; I was kind of feeling numbness like muscle ache in my arm; I have some muscle aches a lot in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 09Sep2022, outcome "unknown" and all described as "I was kind of feeling numbness like muscle ache in my arm; I have some muscle aches a lot in my arm".  Additional information: Patient just had her shot this morning from Pharmacy and she was kind of feeling numbness like muscle ache in her arm and she was wondering like taking Tylenol for muscle ache would be okay.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 28Aug2022, Treatment stop date: 01Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Somnolence, Vaccination site erythema
Clinical narrative: Raised skin at injection site & red.  Looks like a huge bug bite; Raised skin at injection site & red.  Looks like a huge bug bite; Tiredness; not feeling good; patient slept all afternoon today; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2022 at 15:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 10 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Anatomical location: Left arm; Administration time: 18:15), administration date: 18Nov2021, when the patient was 10-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Anatomical location: Right arm; Administration time: 18:15), administration date: 13Dec2021, when the patient was 10-year-old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 11Sep2022 at 12:00, outcome "recovering" and all described as "Raised skin at injection site & red.  Looks like a huge bug bite"; FATIGUE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering", described as "Tiredness"; MALAISE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering", described as "not feeling good"; SOMNOLENCE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering", described as "patient slept all afternoon today". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, fatigue, malaise, somnolence, headache.  Additional information: The patient had no fever. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Raised skin at injection site & red.  Looks like a huge bug bite; Raised skin at injection site & red.  Looks like a huge bug bite; Tiredness; not feeling good; patient slept all afternoon today; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2022 at 15:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 10 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Anatomical location: Left arm; Administration time: 18:15), administration date: 18Nov2021, when the patient was 10-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Anatomical location: Right arm; Administration time: 18:15), administration date: 13Dec2021, when the patient was 10-year-old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 11Sep2022 at 12:00, outcome "recovering" and all described as "Raised skin at injection site & red.  Looks like a huge bug bite"; FATIGUE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering", described as "Tiredness"; MALAISE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering", described as "not feeling good"; SOMNOLENCE (non-serious) with onset 11Sep2022 at 12:00, outcome "recovering", described as "patient slept all afternoon today". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, fatigue, malaise, somnolence, headache.  Additional information: The patient had no fever. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  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: 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 76-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), 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: "hypertension" (unspecified if ongoing); "high LDL" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. Concomitant medication(s) included: LOSARTAN, start date: Apr2022; GEMTESA, start date: May2022; PANTOPRAZOLE, start date: Jan2021. 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.  Clinical course: Lot number of suspect vaccine was not available/ provided to reporter at the time of report completion. Anti-viral details stated as COVID 19 Treatment with Paxlovid (lot number=GD9502) from 05Sep2022 till 09Sep2022. Recurrence of symptoms 2 days after stopping Paxlovid from 11Sep2022 07:00 hr. No other treatment was provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Computerised tomogram, Laboratory test, SARS-CoV-2 test, Splenomegaly
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Physician). A 79-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot No.: EN6198, Intramuscular, Arm Left), administration date: 26Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot No.: EP6955, Intramuscular, Arm Left), administration date: 19Mar2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "Leukopenia", "Neutropenia". The following information was reported: SPLENOMEGALY (hospitalization, life threatening) with onset 20Jan2022, outcome "not recovered". The event "splenomegaly" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown result; Computerised tomogram: (20Jan2022) Splenomegaly; Labs: (29Jun2021) he had leukopenia and neutropenia, notes: for the first time and this has been persistent since; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown result, notes: diagnosis being confirmed and then treatment will be discussed. Therapeutic measures were taken as a result of splenomegaly included bone marrow biopsy and ultrasound; diagnosis being confirmed and then treatment will be discussed. Clinical course, on labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. Computerized tomogram 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202201150632 Same patient, same drug, different dose; US-PFIZER INC-202201156108 Same patient, same drug, different dose.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Physician). A 79-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 79 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot No.: EN6198, Intramuscular, Arm Left), administration date: 26Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot No.: EP6955, Intramuscular, Arm Left), administration date: 19Mar2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "Leukopenia", "Neutropenia". The following information was reported: SPLENOMEGALY (hospitalization, life threatening) with onset 20Jan2022, outcome "not recovered". The event "splenomegaly" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy bone marrow: (unspecified date) Unknown result; Computerised tomogram: (20Jan2022) Splenomegaly; Labs: (29Jun2021) he had leukopenia and neutropenia, notes: for the first time and this has been persistent since; SARS-CoV-2 test: (08Sep2022) Negative; Ultrasound scan: (unspecified date) Unknown result, notes: diagnosis being confirmed and then treatment will be discussed. Therapeutic measures were taken as a result of splenomegaly included bone marrow biopsy and ultrasound; diagnosis being confirmed and then treatment will be discussed. Clinical course, on labs from 29Jun2021 he had leukopenia and neutropenia for the first time and this has been persistent since. He had his third dose of Pfizer COVID vaccine 18Oct2021. Computerized tomogram 20Jan2022 showed splenomegaly. He had his 4th dose of COVID vaccine 02May2022. On 08Sep2022 he presented to the ED for an unrelated injury and was found to have worsening leukopenia and neutropenia and new blast cells. This patient is scheduled for bone marrow biopsy to confirm leukemia diagnosis. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-202201150632 Same patient, same drug, different dose; US-PFIZER INC-202201156108 Same patient, same drug, different dose.