chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antiphospholipid antibodies, Biopsy, Cytomegalovirus test, Epstein-Barr virus test
Clinical narrative: HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine; This is a literature report for the following literature source(s): Journal of Pediatric and Adolescent Gynecology, 2022; Vol:35(2), pgs:234, DOI:10.1016/j.jpag.2022.01.110.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "post-menarchal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VULVAL ULCERATION (medically significant), outcome "recovered", described as "HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Negative, notes: For ANCA associated vasculitis, Further testing was; Antiphospholipid antibodies: Negative, notes: Further testing was; Biopsy: demonstrating chronic inflammation; Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Herpes simplex test: Negative, notes: vulvar ulcers reported; HIV antibody: Negative; behcets: Negative, notes: disease, Further testing was; Negative, notes: Further testing was; Polymerase chain reaction: Negative; Treponema test: Negative. Therapeutic measures were taken as a result of vulval ulceration.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event VULVAL ULCERATION and BNT162B2.  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-202201104494 Same Article/drug/event and different patient;US-PFIZER INC-PV202200052891 Same Article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: HIV antibody, Herpes simplex test, Investigation, Polymerase chain reaction, Treponema test
Clinical narrative: HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine; This is a literature report for the following literature source(s): Journal of Pediatric and Adolescent Gynecology, 2022; Vol:35(2), pgs:234, DOI:10.1016/j.jpag.2022.01.110.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "post-menarchal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VULVAL ULCERATION (medically significant), outcome "recovered", described as "HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Negative, notes: For ANCA associated vasculitis, Further testing was; Antiphospholipid antibodies: Negative, notes: Further testing was; Biopsy: demonstrating chronic inflammation; Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Herpes simplex test: Negative, notes: vulvar ulcers reported; HIV antibody: Negative; behcets: Negative, notes: disease, Further testing was; Negative, notes: Further testing was; Polymerase chain reaction: Negative; Treponema test: Negative. Therapeutic measures were taken as a result of vulval ulceration.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event VULVAL ULCERATION and BNT162B2.  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-202201104494 Same Article/drug/event and different patient;US-PFIZER INC-PV202200052891 Same Article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Vulval ulceration
Clinical narrative: HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine; This is a literature report for the following literature source(s): Journal of Pediatric and Adolescent Gynecology, 2022; Vol:35(2), pgs:234, DOI:10.1016/j.jpag.2022.01.110.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "post-menarchal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VULVAL ULCERATION (medically significant), outcome "recovered", described as "HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Negative, notes: For ANCA associated vasculitis, Further testing was; Antiphospholipid antibodies: Negative, notes: Further testing was; Biopsy: demonstrating chronic inflammation; Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Herpes simplex test: Negative, notes: vulvar ulcers reported; HIV antibody: Negative; behcets: Negative, notes: disease, Further testing was; Negative, notes: Further testing was; Polymerase chain reaction: Negative; Treponema test: Negative. Therapeutic measures were taken as a result of vulval ulceration.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event VULVAL ULCERATION and BNT162B2.  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-202201104494 Same Article/drug/event and different patient;US-PFIZER INC-PV202200052891 Same Article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Culture, Cytomegalovirus test, Epstein-Barr virus test
Clinical narrative: Multiple vulvar ulcers; This is a literature report.   Background: Vulvar ulcers have been associated with viral and bacterial infections and accompanying prodromal symptoms. These ulcers have been reported during infection with SARS-CoV-2. Authors describe a case of adolescent female who developed vulvar ulcers after COVID-19 vaccination without SARS-CoV-2 infection. Case: A 13 year old post-menarchal female with celiac disease and one prior episode of vulvar ulcer presented with fevers, chills, myalgias, vulvar pain and dysuria one day after receiving the second dose of the Pfizer-BioNTech Covid-19 Vaccine. Multiple vulvar ulcers were noted. She was treated with topical lidocaine, ibuprofen, and acetaminophen. She re-presented three days later urinary retention and pain. An indwelling catheter was placed and she was treated with cefalexin and prednisone. Vulvar culture was positive for corynebacterium and the work-up including HSV, EBV, CMV, ANCA, HLA B27, and ANA were negative. She was discharged after five days and reported resolution of symptoms and healing of the ulcers on day 14. Comments: These cases illustrate the association of vulvar ulcers with Pfizer-BioNTech Covid-19 vaccination in adolescent female. Future investigation is needed to understand optimal treatment modalities without disruption of vaccination efficacy and immune response.; Sender's Comments: Based on the available information provided, the causal association between the reported event Vulval ulceration and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available. 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-PV202200052891 Same article/drug/event and different patient;US-PFIZER INC-202201104493 Same article/drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: HLA-B*27 assay, Herpes simplex test, Vulval ulceration
Clinical narrative: Multiple vulvar ulcers; This is a literature report.   Background: Vulvar ulcers have been associated with viral and bacterial infections and accompanying prodromal symptoms. These ulcers have been reported during infection with SARS-CoV-2. Authors describe a case of adolescent female who developed vulvar ulcers after COVID-19 vaccination without SARS-CoV-2 infection. Case: A 13 year old post-menarchal female with celiac disease and one prior episode of vulvar ulcer presented with fevers, chills, myalgias, vulvar pain and dysuria one day after receiving the second dose of the Pfizer-BioNTech Covid-19 Vaccine. Multiple vulvar ulcers were noted. She was treated with topical lidocaine, ibuprofen, and acetaminophen. She re-presented three days later urinary retention and pain. An indwelling catheter was placed and she was treated with cefalexin and prednisone. Vulvar culture was positive for corynebacterium and the work-up including HSV, EBV, CMV, ANCA, HLA B27, and ANA were negative. She was discharged after five days and reported resolution of symptoms and healing of the ulcers on day 14. Comments: These cases illustrate the association of vulvar ulcers with Pfizer-BioNTech Covid-19 vaccination in adolescent female. Future investigation is needed to understand optimal treatment modalities without disruption of vaccination efficacy and immune response.; Sender's Comments: Based on the available information provided, the causal association between the reported event Vulval ulceration and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available. 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-PV202200052891 Same article/drug/event and different patient;US-PFIZER INC-202201104493 Same article/drug/event and different patient;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site vesicles
Clinical narrative: Round 1/4 inch blister at injection site; Sore left arm; Redness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: 03, Manufacturer: Unknown;), for Covid-19 immunization; Covid-19 vaccine (Dose number: 02, Manufacturer: Unknown;), for Covid-19 immunization; Covid-19 vaccine (Dose number: 01, Manufacturer: Unknown;), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 25Aug2022, outcome "not recovered", described as "Redness at injection site"; VACCINATION SITE VESICLES (non-serious) with onset 25Aug2022, outcome "not recovered", described as "Round 1/4 inch blister at injection site"; PAIN IN EXTREMITY (non-serious) with onset 25Aug2022, outcome "not recovered", described as "Sore left arm". Therapeutic measures were not taken as a result of vaccination site vesicles, pain in extremity, vaccination site erythema.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to 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 received any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was reported as 29Aug2022. Events happened 3 1/2 months after shot. Dose received: More than 3. No Known allergies.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 13:00 as dose 2, 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) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "Hives from high dose anti inflammatory meds and some antibiotics" (unspecified if ongoing); "Hives from high dose anti inflammatory meds and some antibiotics" (unspecified if ongoing); "Hives from high dose anti inflammatory meds and some antibiotics" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment start date:18Aug2022 treatment stop date:23Aug2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound of Covid (positive test) 4 days after testing negative after Paxlovid treatment; COVID 19 Treatment; COVID 19 Treatment; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in right arm, on 25Aug2021 as dose 3 (booster), single (Lot number: EW0183), in right arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Roux-n-y weight loss surgery", start date: 2009 (unspecified if ongoing); "breast cancer", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 21Aug2022; GUAIFENESIN & CODEINE, stop date: 20Aug2022; ONDANSETRON; ALBUTEROL [SALBUTAMOL]; ANASTROZOLE; LEVOTHYROXINE; SUMATRIPTAN; PRILOSEC [OMEPRAZOLE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Rebound of Covid (positive test) 4 days after testing negative after Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: Rebound of Covid (positive test) 4 days after testing negative after Paxlovid; (30Aug2022) Positive, notes: Rebound of Covid (positive test) 4 days after testing negative after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical Course: It was reported that, patient took other medication in 2 weeks. Rebound of Covid (positive test) 4 days after testing negative after Paxlovid treatment. No known allergies. Patient was treated with Paxlovid from 21Aug2022 to 25Aug2022
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2021 as dose 3, (booster) single at the age of 53 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 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. Additional information: Patient had no Known allergies.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Rebound of symptoms (mild) and positive antigen test 2 days after completing medication.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 31May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 71 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: "high BP" (unspecified if ongoing); "PVC's" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; LIPITOR; CETIRIZINE. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 26Aug2022 at 10:00, outcome "recovering", described as "Rebound of symptoms (mild) and positive antigen test 2 days after completing medication."; 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: rebound of symptoms (mild) and positive antigen test 2 days after completing medication. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Patient received Anti viral treatment from 20Aug2022 to 25Aug2022.
Age: 82.0
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).  An 83-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cad" (unspecified if ongoing); "htn" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL; FAMOTIDINE; AZELASTINE; MELATONIN. Past drug history included: Dorzolamide, reaction(s): "Known allergies: dorzolamide". 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. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose number unknown, 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: DISEASE RECURRENCE (medically significant) with onset 29Aug2022 at 12:00, outcome "recovering", described as "Rebound Covid"; 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: (29Aug2022) positive, notes: Rebound Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. On 24Aug2022 patient received treatment of COVID 19 as Paxlovid till 29Aug2022. No known allergies to the patient.   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: Breast tenderness, Menstruation irregular
Clinical narrative: breast tenderness; irregular periods; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious), outcome "unknown"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular periods".  Additional information: It was reported that the event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200053735 same report/product/ae, different patient;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever; Chills; fatigue; muscle aches; headache; nausea; vomiting; diarrhea; cough; body aches; sore throat; congestion nose; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2021 at 18:15 as dose 2, single (Lot number: EW0150) at the age of 31 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: ER8731; Route of Administration: Intramuscular; Anatomical location: Arm Left; Administration Time: 11:15), administration date: 07Apr2021, when the patient was 31-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 22Aug2022, outcome "recovering"; PYREXIA (non-serious) with onset 22Aug2022, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 22Aug2022, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 22Aug2022, outcome "recovering", described as "congestion nose"; COUGH (non-serious) with onset 22Aug2022, outcome "recovering"; DIARRHOEA (non-serious) with onset 22Aug2022, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 22Aug2022, outcome "recovering"; HEADACHE (non-serious) with onset 22Aug2022, outcome "recovering"; MYALGIA (non-serious) with onset 22Aug2022, outcome "recovering", described as "muscle aches"; NAUSEA (non-serious) with onset 22Aug2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 22Aug2022, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 22Aug2022, outcome "recovering", described as "sore throat"; VOMITING (non-serious) with onset 22Aug2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, myalgia, headache, nausea, vomiting, diarrhoea, cough, pain, oropharyngeal pain, nasal congestion, rhinorrhoea.  Additional information: The reporter assessed the events as non-serious. The patient did not received any other vaccine within four weeks of suspect vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Fever; Chills; fatigue; muscle aches; headache; nausea; vomiting; diarrhea; cough; body aches; sore throat; congestion nose; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2021 at 18:15 as dose 2, single (Lot number: EW0150) at the age of 31 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: ER8731; Route of Administration: Intramuscular; Anatomical location: Arm Left; Administration Time: 11:15), administration date: 07Apr2021, when the patient was 31-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 22Aug2022, outcome "recovering"; PYREXIA (non-serious) with onset 22Aug2022, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 22Aug2022, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 22Aug2022, outcome "recovering", described as "congestion nose"; COUGH (non-serious) with onset 22Aug2022, outcome "recovering"; DIARRHOEA (non-serious) with onset 22Aug2022, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 22Aug2022, outcome "recovering"; HEADACHE (non-serious) with onset 22Aug2022, outcome "recovering"; MYALGIA (non-serious) with onset 22Aug2022, outcome "recovering", described as "muscle aches"; NAUSEA (non-serious) with onset 22Aug2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 22Aug2022, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 22Aug2022, outcome "recovering", described as "sore throat"; VOMITING (non-serious) with onset 22Aug2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, myalgia, headache, nausea, vomiting, diarrhoea, cough, pain, oropharyngeal pain, nasal congestion, rhinorrhoea.  Additional information: The reporter assessed the events as non-serious. The patient did not received any other vaccine within four weeks of suspect vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever; Chills; fatigue; muscle aches; headache; nausea; vomiting; diarrhea; cough; body aches; sore throat; congestion nose; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2021 at 18:15 as dose 2, single (Lot number: EW0150) at the age of 31 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: ER8731; Route of Administration: Intramuscular; Anatomical location: Arm Left; Administration Time: 11:15), administration date: 07Apr2021, when the patient was 31-year-old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 22Aug2022, outcome "recovering"; PYREXIA (non-serious) with onset 22Aug2022, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 22Aug2022, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 22Aug2022, outcome "recovering", described as "congestion nose"; COUGH (non-serious) with onset 22Aug2022, outcome "recovering"; DIARRHOEA (non-serious) with onset 22Aug2022, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 22Aug2022, outcome "recovering"; HEADACHE (non-serious) with onset 22Aug2022, outcome "recovering"; MYALGIA (non-serious) with onset 22Aug2022, outcome "recovering", described as "muscle aches"; NAUSEA (non-serious) with onset 22Aug2022, outcome "recovering"; RHINORRHOEA (non-serious) with onset 22Aug2022, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 22Aug2022, outcome "recovering", described as "sore throat"; VOMITING (non-serious) with onset 22Aug2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, myalgia, headache, nausea, vomiting, diarrhoea, cough, pain, oropharyngeal pain, nasal congestion, rhinorrhoea.  Additional information: The reporter assessed the events as non-serious. The patient did not received any other vaccine within four weeks of suspect vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BELL'S PALSY (medically significant), outcome "recovered with sequelae". The event "bell's palsy" required emergency room visit. Therapeutic measures were taken as a result of bell's palsy.  Clinical information: It was reported that patient had no Known allergies. Patient did not receive any other vaccine within four weeks of vaccination. Patient had not taken other medication in two weeks of vaccination. Patient had not COVID prior to vaccination and not tested for COVID post vaccination. The device date was mentioned as 30Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Symptom recurrence
Clinical narrative: symptoms returned on Friday through Sunday; COVID 19 Treatment; COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=24/Nov/2021,; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 2 (booster), single (Lot number: FH8030) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1802072), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin for Known allergies: Erythromycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech, vaccine_administration_date=24/Nov/2021,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; SYMPTOM RECURRENCE (medically significant) with onset 26Aug2022 at 06:00, outcome "recovered" (28Aug2022), described as "symptoms returned on Friday through Sunday". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of symptom recurrence. Clinical Course: Patient was treated with Paxlovid for COVID 19 Treatment from 18Aug2022 to 22Aug2022. Patient also reported that she had symptoms resolved after five days of Paxlovid, finished on a Monday. She continued to isolate/work from home and symptoms returned on Friday through Sunday.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: 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) (Consumer or other non HCP).  A 54-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: "Cancer survivor" (unspecified if ongoing), notes: Cancer survivor. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown whether the patient was taking any other medication in 2 weeks. It was unknown if the patient had allergies. It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 14:00 as dose 1, single (Lot number: EL0140), in left arm, on 26Jan2021 at 13:00 as dose 2, single (Lot number: EL3302), in left arm, on 27Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Pcn" (unspecified if ongoing), notes: known allergies: Pcn. Concomitant medication(s) included: SYNTHROID, start date: 15Aug2012; PRESERVISION AREDS 2, start date: 15Sep2016. Past drug history included: Sonata, reaction(s): "drug allergy", notes: known allergies: sonata. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: other medication details: other medication in 2weeks brand=Synthroid. other medication in 2weeks brand=PreserVision Areds2. Yes patient taking  other medications/products within 2 weeks of starting COVID-19 treatment. Yes patient previously receive a COVID-19 Vaccine. Reported Event: Recurrent covid symptoms after taking Paxlovid with positive covid test after 3 negative tests. Anti viral details: product=COVID-19 Treatment. brand=Paxlovid. treatment start date=17Aug2022. treatment stop date=22Aug2022. Indication=Treatment of COVID-19; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events vaccination failure and COVID 19 and the suspect vaccine BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin lesion, Urticaria
Clinical narrative: rash; Welts; Itching; raised lesions; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "Itching"; URTICARIA (non-serious) with onset 2022, outcome "unknown", described as "Welts"; SKIN LESION (non-serious) with onset 2022, outcome "unknown", described as "raised lesions"; RASH (non-serious) with onset 2022, outcome "unknown".  Additional information: The reporter stated that, a 12 year old female there at the clinic for her second COVID Pfizer vaccine. She has had the first one 3 months ago at one of the local schools and she developed a rash on her entire body that resulted in welts and severe itching. The question was, should she have another vaccine or not. On paraphrasing the concern, Reporter stated, Rash with welts, raised lesions and severe itching.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Began experiencing symptoms again 26Aug and tested positive again by antigen test on 28Aug; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY; AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "not recovered", described as "Began experiencing symptoms again 26Aug and tested positive again by antigen test on 28Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative by antigen test at end of paxlovid treatment; (unspecified date) Positive, notes: Rebound Covid infection; (unspecified date) Positive; (28Aug2022) Positive, notes: Began experiencing symptoms again 26Aug and tested positive again by antigen test on 28Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Patient started the Paxlovid treatment on 07Aug2022 and stopped on 12Aug2022 for COVID-19. Rebound Covid infection.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events vaccination failure and COVID 19 and Disease recurrence the suspect vaccine BNT162B2
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had four of your COVID-19 vaccinations/ taking Paxlovid now; Had four of your COVID-19 vaccinations/ taking Paxlovid now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had four of your COVID-19 vaccinations/ taking Paxlovid now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Even that he got Covid once vaccinated. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking Paxlovid (Nirmatrelvir tablets; ritonavir tablets) as treatment for Covid-19 on an unknown date.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), on 10Mar2021 as dose 2, single (Lot number: EN6206) and on 15Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 66 years 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 23Aug2022, outcome "unknown" and all described as "Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient use Paxlovid for the treatment of covid 19. Reporter stated that she originally tested positive for Covid 19 on Tuesday 23Aug2022, and she did not know if she was still testing positive or not, she had not retested. Caller also corrects that she started Paxlovid on Wednesday 24Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy with the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy with the shot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech / Paxlovid treatment; Pfizer / BioNTech / Paxlovid treatment; This is a spontaneous report received from a contactable Consumer. The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 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: "Mitral valve prolapse" (unspecified if ongoing). There were no concomitant medications. It was reported that patient received Paxlovid from 17Aug2022 to 23Aug2022 for COVID-19 treatment. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Outcome of the events was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 1, single (Lot number: FH8020) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 07Aug2022, stop date: 11Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Aug2022) Positive; (29Aug2022) Positive; (29Aug2022) Positive; (26Aug2022) Negative; (26Aug2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 22Aug2022 to 26Aug2022 .