chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in right arm, on 30Apr2021 as dose 2, single (Lot number: EW0153), in right arm and on 20Nov2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Environmental allergies" (unspecified if ongoing); "Skin issues" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin".  The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 27Apr2022, outcome "recovered with sequelae" (16May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Negative, notes: Tested negative on antigen on 30Apr; (08May2022) Negative, notes: tested negative on antigen before I left; (09May2022) Positive, notes: Tested positive on a PCR and two antigen tests on 9May; (16May2022) Positive, notes: Continued to test positive on antigen tests; (30Apr2022) Positive, notes: Tested negative on antigen on 30Apr, but positive on PCR; (05May2022) Negative, notes: Tested negative on PCR on antigen tests on 5May; (09May2022) Positive, notes: Tested positive on a PCR and two antigen tests on 9May. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received treatment with anti-viral product brand paxlovid, treatment start date 30apr2022, treatment stop date 04may2022. The patient got Covid from an outdoor event on 27Apr. Symptoms started on 29Apr. Tested negative on antigen on 30Apr, but positive on PCR. Started Paxlovid on 30Apr. Tested negative on PCR on antigen tests on 5May. Was distanced and masked up until my flight on 8May,  tested negative on antigen before she left. Tested positive on a PCR and two antigen tests on 9May. Continued to test positive on antigen tests through 16May. Symptoms changed from round one to round two. Round one: mostly sore throat with some cough, fever, chills, diarrhea, nausea, brain fog, body aches. Round two: mostly nasal congestion with some diarrhea, sore throat, nausea.
Age: 26.0
Sex: F
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 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 in two weeks..It was reported that  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Treatment of COVID-19; (13May2022) Positive, notes: Relapse 5 days after finishing paxlovid. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive covid test; positive covid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 16 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: "allergy to nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "positive covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (16May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment/Reoccurrence of Covid symptoms after completing paxlovid dose; COVID 19 Treatment/Reoccurrence of Covid symptoms after completing paxlovid dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: 01Jun2020; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment/Reoccurrence of Covid symptoms after completing paxlovid dose". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes. Did you/the patient previously receive a COVID-19 Vaccine?: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 1, single (Lot number: FL0007), in left arm and on 07Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bactrum, reaction(s): "Known allergies: Bactrum", notes: Known allergies: Bactrum. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 15May2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: COVID test type post vaccination: Nasal Swab; (17May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Children's multivitamin, unsure of anything else. On 17May2022, tested positive for COVID-19 on 2 different home tests. Sore throat first began on the evening on Sunday, 15May2022. On Monday, 16May2022 he didn't go to school due to feeling under the weather (sore throat and nasal congestion). Treatment received for the adverse event was cold medicine so far ongoing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Relapse of Covid symptoms 4 days after completing Paxlovid; Relapse of Covid symptoms 4 days after completing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Relapse of Covid symptoms 4 days after completing Paxlovid". 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 with Paxlovid from 07May2022 to 11May2022. No Known allergies.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Drug Ineffective and COVID-19 cannot be totally excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Tested Positive for COVID after receiving Comirnaty COVID 19 Vaccine; Tested Positive for COVID after receiving Comirnaty COVID 19 Vaccine; 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 45-year-old male patient received BNT162b2 (COMIRNATY), on 15Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 05Feb2022 as dose 2, single (Lot number: EL3247), in right arm and as dose 3 (booster), single (Lot number: 3708D) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic tendencies" (ongoing), notes: he has asthmatic tendencies; "cat allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity; MUCINEX taken for hypersensitivity; ADVIL [IBUPROFEN] taken for hypersensitivity. Vaccination history included: Fluzone quadrivalent (he did get the flu vaccine before his booster, about two weeks before the booster). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022 at 07:15, outcome "not recovered" and all described as "Tested Positive for COVID after receiving Comirnaty COVID 19 Vaccine". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Negative, notes: He stated that he tested last night and was negative; (17May2022) Positive.  Clinical course: He stated that he works for Pfizer and he tried to do his reporting responsibilities online. He stated both his daughter and he received. He stated that he received the vaccine plus the booster and as of this morning he tested and was positive for COVID. He stated that he tested last night and was negative. The caller clarified the vaccine he received as COMIRNATY, COVID 19 Vaccine and COVID 19 Booster Vaccine.  His first dose of COVID 19 Vaccine was on 15Jan2021 and his second dose of COVID 19 Vaccine was on 05Feb2021. He stated he received both doses of vaccine at the Pfizer OHW there in (Withheld). He stated his third one was at (Withheld). He clarified that he got the first two doses from Pfizer with a nurse there at (Withheld). He stated he felt different than yesterday, since he tested negative last night. He stated he felt like he has a head cold. He stated that his was more sinuses. He clarified that has more head than chest.  He stated that ear to ear and up was where he feels he was most messed up. He clarified that his has worsened. He stated no change he hasn't even gotten ahold of his HCP yet. AE did not require emergency room or physician office.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling cold, Myalgia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11; Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11; A little more congested in her chest; it feels like a cold; muscle aches; Sore arm from needle stick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1, single (Lot number: FK5618), in arm and on 07Dec2021 as dose 2, single (Lot number: FK5127) at the age of 11 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC ALLERGY; MUCINEX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022 at 21:00, outcome "not recovered" and all described as "Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "A little more congested in her chest"; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore arm from needle stick"; FEELING COLD (non-serious) with onset 2022, outcome "unknown", described as "it feels like a cold"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: He stated that his daughter tested positive on 16May2022 and it is ongoing. He stated she is very positive, she retested and still had two little red lines on the test kit. The caller stated that his daughters would have been vaccinated in afternoon on those days. He clarified to after school if he remembering correctly. He stated that they tested together when they were confirming if they had a false positive last night. He stated his daughter was trying to do school from home and he is getting complaints. States she had not received her booster as of yet. He stated that his daughter tested positive on 16May2022 and it was ongoing. He stated she was very positive, she retested and still had two little red lines on the test kit. He states his daughter was a little more congested in her chest. He clarified that it feels like a cold to her as well. He clarified that his daughters state has persisted. He stated she was doing pretty good either way. He clarified that she definitely has not gotten worse. She was doing well in general. He stated she has no tightness, nothing other than feeling like a cold, maybe muscle aches. The HCP told him to push water and make sure his daughter is comfortable and if she gets worse to let the HCP know. The events were not required Emergency Room or Physician Office visit.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccination site pain
Clinical narrative: Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11; Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11; A little more congested in her chest; it feels like a cold; muscle aches; Sore arm from needle stick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1, single (Lot number: FK5618), in arm and on 07Dec2021 as dose 2, single (Lot number: FK5127) at the age of 11 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC ALLERGY; MUCINEX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022 at 21:00, outcome "not recovered" and all described as "Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "A little more congested in her chest"; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore arm from needle stick"; FEELING COLD (non-serious) with onset 2022, outcome "unknown", described as "it feels like a cold"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: He stated that his daughter tested positive on 16May2022 and it is ongoing. He stated she is very positive, she retested and still had two little red lines on the test kit. The caller stated that his daughters would have been vaccinated in afternoon on those days. He clarified to after school if he remembering correctly. He stated that they tested together when they were confirming if they had a false positive last night. He stated his daughter was trying to do school from home and he is getting complaints. States she had not received her booster as of yet. He stated that his daughter tested positive on 16May2022 and it was ongoing. He stated she was very positive, she retested and still had two little red lines on the test kit. He states his daughter was a little more congested in her chest. He clarified that it feels like a cold to her as well. He clarified that his daughters state has persisted. He stated she was doing pretty good either way. He clarified that she definitely has not gotten worse. She was doing well in general. He stated she has no tightness, nothing other than feeling like a cold, maybe muscle aches. The HCP told him to push water and make sure his daughter is comfortable and if she gets worse to let the HCP know. The events were not required Emergency Room or Physician Office visit.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 17:00 as dose 1, single (Lot number: EN6204), in left arm, on 27Mar2021 at 17:00 as dose 2, single (Lot number: ER8727), in left arm and on 23Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FC3182) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "knonw allergies: phenergan". The following information was reported: VACCINATION FAILURE (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: (13May2022) Negative; (14May2022) Negative; (17May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received other medication in 2 weeks. COVID 19 Treatment: Paxlovid, treatment start date: 08May2022 and stop date: 13May2022. Started 08May, did fine was feeling great. 13May tested negative, 14May tested negative. That night started coughing, got very hoarse but still felt ok otherwise. On 15May called Dr and got more benzonate 200 mg. But felt fine otherwise. Still occasional cough and runny nose and hoarse. On Tues 17May in the evening on top of everything her throat started hurting. Took another test and it was positive in less than a min.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: 2 weeks after my 1st booster - pneumonia 2 weeks after my 2nd booster Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.  The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "2 weeks after my 1st booster - pneumonia 2 weeks after my 2nd booster Pneumonia".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 2, single (Lot number: EP7534) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 3 (booster), single (Lot number: O48F21A), 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: YAZ; SPIRONOLACTONE. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "tested positive for covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: (6 days after testing positive); negative, notes: I tested negative; positive, notes: I began feeling ill and again tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The day after caller finished a full course of Paxlovid, (6 days after testing positive), caller tested negative. caller exited isolation and resumed normal activities. Twenty-five days later, caller began feeling ill and again tested positive for covid. Paxlovid treatment start date on 17Apr2022 and end date on 22Aapr2022 for covid-19 treatment. Caller prescribed another course of Paxlovid.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: product=COVID 19 Treatment; product=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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Nov2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CITALOPRAM, start date: 01May2021, stop date: 18May2022; ZYRTEC ALLERGY, start date: 01Nov2021, stop date: 18May2022; SPIRONOLACTONE, start date: 05Feb2022, stop date: 18May2022. The following information was reported: VACCINATION FAILURE (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "product=COVID 19 Treatment"; COVID-19 (medically significant), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "product=COVID 19 Treatment,". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Within 20 minutes of my first dose, I had a horrible taste in my mouth. It is temporarily relieved by eating/drinking, but it immediately comes back. It's especially bad in the mornings when I wake up. I'm concerned I'm going to vomit. I would not take Paxlovid again because of this side effect. It's worse than being sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
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.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thalassemia moderate" (unspecified if ongoing), notes: Moderate; "mitral valve prolapse" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (May2022) Positive, notes: My covid symptoms fully returned and I tested positive again on day 4-5 after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patients covid symptoms fully returned and he tested positive again on day 4-5 after completing Paxlovid. His symptoms are near the same and he is worried and don't know what to do. The patient did have known allergies. The patient did not receive any Other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Magnetic resonance imaging
Clinical narrative: Left Hand Numbness, Left Arm Numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14-year-old patient received BNT162b2 (BNT162B2), on 23Jun2021 as dose 1, single (Lot number: EW0179, Expiration Date: Aug2021) at the age of 14 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (medically significant) with onset 23Jun2021 at 13:30, outcome "not recovered", described as "Left Hand Numbness, Left Arm Numbness". The patient underwent the following laboratory tests and procedures: Muscle/Nerve Test: (09Oct2021) Negative; Magnetic resonance imaging: (09Oct2021) Negative; (09Oct2021) Negative. Therapeutic measures were not taken as a result of hypoaesthesia.Clinical course: Specific relevant test For thromboembolic events with thrombocytopenia was None. Adverse events Term: Left Hand Numbness Onset date: 23Jun2021, Term: Left Arm Numbness Onset date: 14Jul2021 Did the events require the initiation of new medication/ other treatment/ procedure was reported as no.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Investigation
Clinical narrative: allergic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ET6955) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 29Mar2021, outcome "unknown", described as "allergic reaction". The patient was hospitalized for hypersensitivity (start date: 29Mar2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: Allergy Testing: Unknown Results, notes: States he had some allergy testing, he doesn't know.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Emotional distress, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: finding out I tested positive; finding out I tested positive; I was an emotional wreck after the exposure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Crohn's patient" (ongoing), notes: I am an Inflectra Crohn's patient. Concomitant medication(s) included: INFLECTRA [INFLIXIMAB] taken for crohn's disease. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "finding out I tested positive"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "I was an emotional wreck after the exposure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Patient was on Inflectra Crohn's patient and received the Pfizer COVID vaccine. The patient was unfortunately exposed to COVID last week. This was an emotional wreck after the exposure and then finding out tested positive. The patient received Paxlovid immediately. It was a miracle worker. The patient basically bleed Pfizer blue at this point with all medicines patient was on, but, the patient just wanted to send a heartfelt THANK YOU for putting my Crohn's in remission, developing a great vaccine and now a life-saving antiviral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Accident, Psoriasis
Clinical narrative: Tragic accident; Psoriasis flare-up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4278961-00 (AbbVie).  A 32-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since 19Jan2022 (Batch/Lot number: unknown), subcutaneous for psoriasis, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENT (medically significant), outcome "unknown", described as "Tragic accident"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for risankizumab was unknown. Therapeutic measures were taken as a result of psoriasis. The patient had flares of Psoriasis. He had tragic accident and investigation and that he had ok  Skyrizi injection on 19Jan2022, had spots break out over his body. Since he was covid vaccinated he was not able to keep his skin clear especially spots on his chest and back. He used clobetasol cream and it would go away after a few days and stay gone for 2 to 3 weeks since he had started Skyrizi. But before Skyrizi he would not clear at all. He stated that a couple weeks ago he started getting five or six spots on his legs and back that were dry and not red which were much better for him and his doctor said it was okay since his injection due next week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was not related to covid vaccine. The patient was treated with Clobetasol.  The reporter's assessment of the causal relationship of "tragic accident" and "psoriasis flare-up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the event(s) of Tragic accident and flares of Psoriasis was not provided with Skyrizi (Risankizumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known disease pathophysiology, the events of psoriasis and accident are assessed as not related to BNT162B2 and psoriasis is more likely due to underlying medical condition and accident was mostly a incident event.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site mass, Vaccination site swelling
Clinical narrative: It has grown a little each day and is spreading out. It is not as red today, but has expanded about half an inch since yesterday; 3 inches below the injection site she has a thick lump that is red and it is growing; 2 inches above the injection site she got a large swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 14May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: covid-19 vaccine (First dose: , Date: 19Mar2021, Lot number: ER2613, Expire: 31Jul2021), administration date: 19Mar2021, when the patient was 77-year-old, for Covid-19 immunization, reaction(s): "The previous Covid vaccines affected her tachycardia"; covid-19 vaccine (Second dose: , Date 16Apr2021, Lot: ER8730, Expire: 31Jul2021), administration date: 16Apr2021, when the patient was 77-year-old, for Covid-19 Immunization, reaction(s): "The previous Covid vaccines affected her tachycardia". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 15May2022 at 12:00, outcome "recovering", described as "2 inches above the injection site she got a large swelling"; VACCINATION SITE MASS (non-serious) with onset 16May2022 at 06:30, outcome "not recovered", described as "3 inches below the injection site she has a thick lump that is red and it is growing"; PERIPHERAL SWELLING (non-serious) with onset 16May2022 at 06:30, outcome "not recovered", described as "It has grown a little each day and is spreading out. It is not as red today, but has expanded about half an inch since yesterday".  Additional Information: Caller reported she had a weird reaction to the booster of the Pfizer Covid 19 Vaccine that she didn't have to the other two doses. Per caller she experienced swelling about 2 inches above injection site the next day. The swelling has gone down quite a bit but its still there. About 3 inch below site she developed a thick lump that is red and growing. It's extremely warm and sensitive to touch. Caller marked the area with a black marker to monitor the swelling. It appears to have grown each day and is spreading out. Caller wanted to know if there have been reports of the issue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (18May2022): This is a spontaneous follow-up report received from the same contactable consumer. This 78-year-old female consumer reported that: Updated information included: Reporter information (salutation added).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Runny nose; mild fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: ADDERALL. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19"; RHINORRHOEA (non-serious) with onset 2022, 9 days 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Runny nose"; PYREXIA (non-serious) with onset 2022, 9 days 10 hrs after the suspect product(s) administration, outcome "unknown", described as "mild fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course of the events: Other medication in 2 weeks: Yes. Other medication details: other medication in 2weeks product-Adderall. other medication in 2weeks product-Hailey Birth Control. No Known allergies. Reaction/event as reported by primary source: Testing positive on at home rapid test on day 10, Runny nose, mild fever. the patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
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) from product quality group. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ew0158), in left arm, on 02May2021 as dose 2, single (Lot number: ew0173), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: 33026bd), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hashimotos thyroiditis" (unspecified if ongoing); "allergy related asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ESTRADIOL; PROGESTERONE; VENTOLIN HFA. 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 outcome: She completed 5 days of Paxlovid last night from 13May2022 to 17May2022 and she still testing positive for covid this morning.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: travel then husband had covid 11May then she got it sx 16May and then PCR positive 17May.; travel then husband had covid 11May then she got it sx 16May and then PCR positive 17May.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 65-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247), on 16Nov2021 as dose 3 (booster), single (Lot number: FF2589) and on 22Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "unknown" and all described as "travel then husband had covid 11May then she got it sx 16May and then PCR positive 17May.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: It was unknown If other vaccine were received in four weeks. Covid prior vaccination was unknown. Covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EN6201), in left arm, on 13Mar2021 at 12:00 as dose 2, single (Lot number: EN6204), in left arm, on 20Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 19Feb2022 at 02:00 as dose 4 (booster), single (Lot number: FJ6369) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Allergy to penicillin" (unspecified if ongoing); "Allergy to Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxycilin for Allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After completing Paxlovid I am now at day 11 from my first positive test; Positive, notes: still testing positive and running a low-grade fever. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had not received other medication in 2 weeks. The patient had received, anti viral COVID 19 treatment, on 08May2022, and treatment stop on 12May2022, (Lot number: FY4422) for treatment of COVID-19. Reporter stated, after completing Paxlovid I am now at day 11 from my first positive test, and day 10 since starting Paxlovid. I am still testing positive and running a low-grade fever. Nothing too serious but I'm exhausted and wondering how long I should expect to have it. Adverse event start on 13May2022 12:00 AM, with not recovered outcome and patient had not received adverse event treatment. Patient had known allergies with penicilin, amoxycilin and sulfa.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid 19 test positive; Covid 19 test positive; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An elderly patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6200), in right deltoid, on 22Mar2021 as dose 2, single (Lot number: EN6208), in left deltoid and on 27Aug2021 as dose 3 (booster), single (Lot number: FD8448), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing); "CKD" (ongoing); "DM2" (ongoing); "CAD" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022, outcome "unknown" and all described as "Covid 19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive.  Clinical course: Patient age at time of vaccination was 82 years. The Pfizer product had not a casual effect to adverse events. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications. Specific relevant test for thromboembolic events with thrombocytopenia was none. Prior vaccination (within 4 weeks) was none. Patient was given 2 doses of Pfizer Comirnaty booster shots on same day in office setting. One dose of 0.3ml given by Nurse (Name withheld) on 28Apr2022, lot FM9992 on RD. Subsequently ARNP, (Name withheld) was unaware patient already received vaccine booster and gave patient 2nd dose of vaccine, same lot FM9992 on RD as well.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event vaccination failure and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; cough; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset 18May2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cough.  Additional information: It was unknown if patient had covid prior vaccination. Patient had covid test post vaccination.   No follow-up attempts are possible. No further information is expected.