chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Multisystem inflammatory syndrome in children; fever started 24 hrs lasted for 80 hours ( range from 101-103.5); vomited 2 times; diarrhea on Monday and Tuesday; rash and its getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-month-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 13 months for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 19Jul2022, outcome "unknown", described as "rash and its getting worse"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown", described as "Multisystem inflammatory syndrome in children "; PYREXIA (non-serious), outcome "recovered", described as "fever started 24 hrs lasted for 80 hours ( range from 101-103.5)"; INFANTILE VOMITING (non-serious), outcome "unknown", described as "vomited 2 times"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea on Monday and Tuesday". The patient underwent the following laboratory tests and procedures: Body temperature: 101-103.5, notes: So that was 80 hours of fever between 101 and 103.5 approximately. Clinical course: Caller's son who is 13 months old got the Covid vaccine on Friday at doctor's office. He had fever that started 24 hours after getting the vaccine and then lasted until last night. So that was 80 hours of fever between 101 and 103.5 approximately. He vomited twice, once on Sunday and once on Monday. He had diarrhea on Monday and Tuesday and then he started getting rashes yesterday. Rashes are getting worse. Has rashes in a lot of places today. Caller was wondering if there was any information on if this is normal. He also stated that he read 2 % of the people who have received the Pfizer covid vaccine have experienced Multisystem inflammatory syndrome and rash. Identification of the case safety report Serious: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2022 at 11:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ehlers danlos syndrome" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "seafood allergy" (unspecified if ongoing); "yellow dye" (unspecified if ongoing), notes: Yellow dye number 5. Concomitant medication(s) included: LEXAPRO; LITHIUM; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BACLOFEN. Vaccination history included: BNT162b2 (Dose Number: 3 booster, Batch/Lot No: FN2590, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 22Oct2021, when the patient was 50-year-old, for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown.), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) all with onset 17Jul2022 at 02:00, outcome "not recovered" and all described as "migraine headaches bilateral". The event "migraine headaches bilateral" required physician office visit. Therapeutic measures were taken as a result of headache, migraine. Additional information: Dose number 1 (Lot FN2590) given at left arm on  22Oct2021 and dose number 2 (Lot FN2908) given at Left arm on 15Jul2022. The patient did not get these side effects with first pfizer booster. Prescriptions for ubrelvy and Imitrex as treatment of adverse events.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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: "HTN" (unspecified if ongoing), notes: HTN; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "Known allergies: S" (unspecified if ongoing), notes: Known allergies: S; "Known allergies: ACEI" (unspecified if ongoing), notes: Known allergies: ACEI. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported events and the suspect drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion
Clinical narrative: Pacemaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown", described as "Pacemaker".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A fib that has worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A fib that has worsened". Clinical course: The patient had the Pfizer COVID-19 vaccine on schedule as recommended by the CDC. The patient has had heart issues after receiving the vaccine.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: en6208), in right arm, on 13Oct2021 as dose 2, single (Lot number: FH8020), in left arm and on 20Feb2022 as dose 3 (booster), single (Lot number: EN5318), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25May2022 as dose 4 (booster), single (Lot number: cvs3951), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa and Cephalosporins; "Known allergies: Cephalosporins" (unspecified if ongoing), notes: Known allergies: Sulfa and Cephalosporins. Concomitant medication(s) included: SYNTHROID, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Limb discomfort, Nervousness, Seizure, Vomiting
Clinical narrative: I was feeling like I was having a seizure; after the second dose and the booster, exactly 12 hours after receiving the dose my arms started flying around out of control; I threw up; Diarrhea; I am kind of scared to get the fourth booster; 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 69-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Reaction: I threw up), for Covid-19 immunization, reaction(s): "I threw up"; Bnt162b2 (DOSE 2, SINGLE, Reaction: I was feeling like I was having a seizure), for Covid-19 immunization, reaction(s): "I was feeling like I was having a seizure"; Bnt162b2 (DOSE 2, SINGLE, Reaction: Diarrhea), for Covid-19 immunization, reaction(s): "Diarrhea"; Bnt162b2 (DOSE 2, SINGLE, Reaction: pain and swelling in the extremities), for Covid-19 immunization, reaction(s): "pain and swelling in the extremities", "pain and swelling in the extremities". The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I was feeling like I was having a seizure"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "after the second dose and the booster, exactly 12 hours after receiving the dose my arms started flying around out of control"; VOMITING (non-serious), outcome "unknown", described as "I threw up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; NERVOUSNESS (non-serious), outcome "unknown", described as "I am kind of scared to get the fourth booster". The patient had a question about a reaction to the COVID shot, the second and the booster shot, exactly 12 hours after she got the shot her arm started flying out of control, it lasted with less than a minute, but it was kind of scary like she was feeling like she was having a seizure or something and then she threw up and had the diarrhea. She knew that the diarrhea and throwing up were common, but she was concerned about her arm. The way that just kind of flew out of control and now she was wondering if that was a common side effect. She had not heard anybody else have that reaction. The patient wanted to know whether it was nervous system reaction, or a basic common reaction and she was kind of scared to get the forth booster. Patient stated that her doctor wasn't aware of anything. Patient stated that she was told that the only information we had were pain and swelling in the extremities. Patient mentioned that she might not get the next booster dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid; she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid; 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 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient reported that she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid. Caller voiced "she had no immunity from the shots didn't work or now it has been to long spaced out. Is what she was thinking. Does that sound like what's happened or could she had just got one that the shots didn't work? Caller voiced that she has taken three Pfizer Covid 19 Vaccines since covid started. Per caller she thinks the last one was probably the very end of Oct. Caller asking now that she has covid and has taken the three Pfizer Covid Vaccines. The patient started Paxlovid and has taken 2 pills of Paxlovid, she also started with the evening dose of Paxlovid and has stopped taking Paxlovid as of now and has missed a few days of the Paxlovid as of now. She also reported her history of A-fib and asked if it was okay to take Paxlovid with Sotalol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 50-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown booster, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTURER UNKNOWN" (where X=1, 2, or number unknown)), for covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti viral details product: COVID 19 Treatment, Paxlovid from 26May2022 to 30May2022, other medication in 2weeks product: Mucinex from 24May2022 to 25May2022  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 13:30 as dose 1, single (Lot number: ER8727), in left arm, on 14Apr2021 at 10:00 as dose 2, single (Lot number: EW0153), in left arm, on 11Oct2021 at 17:30 as dose 3 (booster), single (Lot number: Fh8020), in left arm and on 16Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma-reactive airways" (unspecified if ongoing), notes: Asthma-reactive airways; "Known Allergies: Eggplant" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; TOPIRAMATE; PROGESTERONE; ESTRADIOL. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan", notes: Phenergen; Morphine, reaction(s): "Known allergies: Morphine", notes: Morpheme; Demerol, reaction(s): "Known allergies: Demerol"; Codeine, reaction(s): "Known allergies: codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Testing positive with home test still (20Jul2022); (06Jul2022) Positive, notes: Tested positive on 06Jul2022(symptomatic for several days prior to positive test). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Tested positive on 06Jul2022 (symptomatic for several days prior to positive test). First dose in evening on 06Jul2022. Felt better (15Jul2022) then on 186Jul2022 got fever, chills, sweats, congestion, scratchy throat, exhaustion, diarrhea. Never checked if patient  tested negative ever but testing positive with home test still (20Jul2022). Fever gone but still congested, very tired, general malaise, sweats. During this time, my lingering cough/lungs have continued to clear well, though. The patient received Paxlovid from 05Jul2022 to 11Jul2022 for treatment of COVID 19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: vaccination failure; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER2613), in right arm, on 12Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "History of asthma" (unspecified if ongoing); "History of asthma in childhood that flares up when I'm sick" (unspecified if ongoing); "Depression" (unspecified if ongoing), notes: anxiety; "ADHD" (unspecified if ongoing); "Carrier of A1AT deficiency" (unspecified if ongoing); "Low A1AT serum levels" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: DEXMETHYLPHENIDATE, start date: Jan2011; DESVENLAFAXINE SUCCINATE, start date: Jan2011. Past drug history included: Demerol, reaction(s): "Known allergies: demerol". The following information was reported: COVID-19 (medically significant) with onset 09Jul2022, outcome "not recovered", described as "tested positive for covid"; VACCINATION FAILURE (medically significant) with onset 09Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (11Jul2022) Positive; (16Jul2022) Negative; (20Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid as treatment from 11 Jul2022 to 16Jul2022.  Clinical Course: The patient received other medication Dexmethylphenidate in past 2 weeks. First symptoms started 09Jul2022 (sore throat), tested positive for covid on 11Jul2022 and started paxlovid that evening. Covid symptoms from 11Jul to 15Jul were fever, brain fog, headache, sore throat, cough, chest tightness, muscle aches, and fatigue. I was testing negative on a rapid by 16Jul2022 (but still feeing fatigue, some cough, some brain fog despite testing negative). Congestion started on 19Jul2022 and morning of 20Jul2022 had muscle aches, headache, congestion, sore throat and took a rapid test and it came back strongly positive.  No followup attemps are possible. No further information received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 22Apr2021 as dose 2, single (Lot number: EW0175) and on 12Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information includes the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was treated with antiviral treatment from 10Jul2022 to 14Jul2022 for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Product administered at inappropriate site, Pyrexia, Rash
Clinical narrative: patient received BNT162B2 in left leg; She had a rash over her body; high fever; excessive diarrhea; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 19-month-old female patient received BNT162b2 on 17Jul2022 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142) at the age of 19 months, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), 0.2 ML SINGLE, Lot no: FT9142), administration date: 26Jun2022, when the patient was 18-month-old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset Jul2022, outcome "not recovered", described as "high fever"; RASH (medically significant) with onset Jul2022, outcome "not recovered", described as "She had a rash over her body"; DIARRHOEA (medically significant) with onset Jul2022, outcome "not recovered", described as "excessive diarrhea"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 17Jul2022, outcome "unknown", described as "patient received BNT162B2 in left leg". Therapeutic measures were not taken as a result of rash, pyrexia, diarrhoea. Parents did not know what to give her. Parents were going to take her to the hospital.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 20:00 as dose 1, single (Lot number: ER2613), in left arm, on 12Apr2021 at 01:00 as dose 2, single (Lot number: ER8729), in left arm and on 09Dec2021 at 19:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Known allergies: Mango" (unspecified if ongoing), notes: Known allergies: Mango. Concomitant medication(s) included: TYLENOL, start date: 10Jul2022, stop date: 12Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information:-Patient received paxlovid from 11jul2022 to 15jul2022 for COVID 19 treatment. Completed Paxlovid prescription as directed. No symptoms as of Saturday 16Jul2022. Started having symptoms again Tuesday 19Jul2022.
Age: 46.0
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) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive; (12Jul2022) Negative, notes: tested negative on 12Jul; (19Jul2022) Positive, notes: tested positive again 19Jul and 20; (20Jul2022) Positive, notes: tested positive again 19Jul and 20. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient took paxlovid starting 07Jul after being diagnosed with Covid on 06Jul. Patient quickly felt better and tested negative on 12Jul. Patient finished her course of paxlovid on 13Jul. Patient began having symptoms again on 19Jul. Patient tested positive again 19Jul and 20.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 31Mar2021 as dose 2, single (Lot number: EH9899), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 67 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 2 days post tx - tested negative x2; (Jul2022) Positive, notes: retested 3 days post paxlovid=positive; (19Jul2022) Positive, notes: retested 19Jul still positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with paxlovid started on 08Jul2022 and stop date 13Jul2022.  Clinical course: Patient did received other medications in two weeks. Paxlovid rebound, took 5 days of Paxlovid. (08Jul-13Jul) 2 days post tx-tested negative x2; then increase rhinorrhea, like water dripping; fatigue, cough, headaches; retested 3 days post paxlovid: positive, isolated again, continue to have rhinorrhea and fatigue and watery stools x 1 day; retested 19Jul still positive.  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 events and the suspect drug BNT162B2 cannot be excluded.
Age: 54.0
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 patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Other medication was received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Rebound of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound of symptoms and positive test was experienced on 18Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: within 24 hours experienced paralysis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "within 24 hours experienced paralysis".  Clinical course: The caller received the Pfizer Covid vaccine and within 24 hours experienced paralysis. Her doctor prescribed her a hospital bed and she is wondering if it's possible to get monetary compensation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Heart rate, Oxygen saturation
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Lumbar/cervical stenosis" (unspecified if ongoing); "factor V Leiden" (unspecified if ongoing); "history of DVT/PE" (unspecified if ongoing); "history of DVT/PE" (unspecified if ongoing); "narrowing of spinal cord" (unspecified if ongoing), notes: narrowing of spinal cord. Concomitant medication(s) included: DULOXETINE; WARFARIN. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Rocephin, reaction(s): "KNown allergies: Recephin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Normal; Heart rate: (20Jul2022) 100, notes: going up to 140 simply walking 20 yards; Oxygen saturation: (10Jul2022) 88-89; (20Jul2022) 88-92. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was suddenly exhausted and after about two hours, she began to notice congestion (which she did not have during the time she was taking Paxlovid), muscle aches, and joint pain. The doctor prescribed another round of Paxlovod, but after personal research, she decided against taking it. On July 10th, she went to the emergency room because she had chest pain, tightness, and my oxygen was 88-89. she had a CT scan and crays and both were normal, so she was sent home with instructions to follow up with her doctor. To date, she was still experiencing low 02 (88-92), extreme fatigue, and a resting heart rate over 100, going up to 140 simply walking 20 yards. Patient recovered with lasting effects and the treatment was received such as steroids, antibiotics, albuterol nebulizer and inhaler.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE, start date: 23May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with Paxlovid from 02Jul2022 to 07Jul2022 for the Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ep7533), in left arm, on 28Apr2021 as dose 2, single (Lot number: ew0171), in left arm and as dose 3 (booster), single (Lot number: fj8757), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was not Pregnant. The patient had received the vaccine. No other medication in 2 weeks taken by patient. The patient has no known allergies. No other medical history was there. Took full course of Paxlovid and had a rebound infection 9 days after testing negative and stopping treatment.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Pyrexia, Rash
Clinical narrative: a 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization; a 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization; a limp; a rash on his/her face, chest, and upper back.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 4-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (hospitalization), PYREXIA (hospitalization), outcome "recovered" and all described as "a 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization"; GAIT DISTURBANCE (non-serious), outcome "recovered", described as "a limp"; RASH (non-serious), outcome "recovered", described as "a rash on his/her face, chest, and upper back.". Clinical course: A 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization, a limp, and a rash on his/her face, chest, and upper back. All symptoms resolved by 10th days.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; LEXAPRO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound. Symptoms and positive home test a few days after recovery. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Treatment included Paxlovid, Treatment start date was 12Jul2022, Treatment stop date was 17Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
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 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (not ongoing), notes: but off medication due to pregnancy. Date of last menstrual period: 17Jan2022. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient is expected to deliver a baby(s) on 07Nov2022. Concomitant medication(s) included: NESTLE MATERNA, start date: 01May2022, stop date: 21Jul2022. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Vomiting
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 37-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Feb2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (not ongoing), notes: but off medication due to pregnancy. Date of last menstrual period: 17Jan2022. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient is expected to deliver a baby(s) on 07Nov2022. Concomitant medication(s) included: NESTLE MATERNA, start date: 01May2022, stop date: 21Jul2022. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 09:30 as dose 1, single (Lot number: FE3592), in left arm and on 08Jun2022 at 12:00 as dose 2, single (Lot number: FJ1611) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Prevacid, reaction(s): "Allergy:Prevacid"; Prilosec, reaction(s): "Allergy:Prilosec"; Protonix, reaction(s): "Allergy:Protonix". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medications in two weeks and treatment received from 01Jul2022 to 06Jul2022. Patient took Paxlovid for 5 days and tested negative on 08Jul2022 for Covid, on Sunday woke to have the Covid symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67-year-old male patient received BNT162b2 (BNT162B2), Age at vaccination 67 years old, on 05Feb2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Feb2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Sep2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 16Apr2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing), notes: Other medical history: Sleep apnea. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient not had Known allergies. Patient did not take other medication in 2weeks. Patient took Paxlovid Anti viral Treatment from 05Jul2022 to 10Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history was not reported. There were no concomitant medications (no other medication in 2weeks). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) negative, notes: still negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included paxlovid from 14Jul2022 to 19Jul2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: 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 52-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207) and on 13Apr2021 as dose 2, single (Lot number: ER8729) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 15Dec2021 as dose 3 (booster), single (Lot number: 213D21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol/triglycerides; "Triglycerides" (unspecified if ongoing), notes: High cholesterol/triglycerides. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment; result was fain, notes: Took an antigen test 2 days after finishing treatment and the result was fain compared to the control; result is as strong as the control, notes: Re-took antigen test 4 days after finishing treatment and the result is as strong as the control. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Adverse event: Started symptoms again 4 days after last dose of treatment. Symptoms are mild and include runny nose, sore throat and diarrhea. Took an antigen test 2 days after finishing treatment and the result was fain compared to the control. Re-took antigen test 4 days after finishing treatment and the result is as strong as the control.  No follow-up attempts are possible. No further information is expected.