chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6203), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: ER8729), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reporte d. Past drug history included: Neosporin, reaction(s): "Allergic to Neosporin". 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. Paxlovid Treatment start date 13May2022. While taking this medication the patient reported a metallic taste in their mouth all day. Therapeutic measures were taken as a result of covid-19.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/He has had all four doses of the Pfizer COVID vaccine; COVID 19 Treatment/He has had all four doses of the Pfizer COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 at 13:00 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 at 13:00 as dose 2, single (Lot number: ER6213), in left arm, on 19Aug2021 at 14:00 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 11Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FC9943) at the age of 60 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: Other medical history: Psoriatic arthritis. Concomitant medication(s) included: COSENTYX, start date: 02May2022; VALTREX, start date: 03Jan2022; LINZESS, start date: 03Jan2022; ROSUVASTATIN, start date: 06Dec2021; ENSTILAR, start date: 07Feb2022; MOMETASONE, start date: 06Dec2021; BABY ASPIRIN, start date: 03Jan2022; MUCINEX D, start date: 03Jan2022; VITAMIN D [VITAMIN D NOS], start date: 03Jan2022; FLORASTOR [SACCHAROMYCES BOULARDII], start date: 03Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/He has had all four doses of the Pfizer COVID vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I tested positive five days after the last dose of Paxlovid; (unspecified date) Positive, notes: I tested positive five days after the last dose of Paxlovid; (unspecified date) Positive, notes: I tested positive five days after the last dose of Paxlovid; (unspecified date) Positive, notes: I tested positive five days after the last dose of Paxlovid; (unspecified date) Positive, notes: I tested positive five days after the last dose of Paxlovid; (unspecified date) Positive, notes: Treatment of COVID-19; (09May2022) Negative, notes: He said that he felt fine, and tested negative 09May2022 and 10May2022; (10May2022) Negative, notes: He said that he felt fine, and tested negative 09May2022 and 10May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient just recently finished taking Paxlovid last Sunday morning and experiencing Paxlovid rebound. Patient just started testing positive Covid again last night. He just wanted to make sure it was reported. He started Tuesday 10th finished 5th dose on Sunday. Patient felt fine and tested negative on the 9th and 10th and all of a sudden he got a runny nose and the cough seems to be gone and he testing positive again. Patient have read about it being isolated but he don't think it is so isolated.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1 , single (Lot number: EL9267), in right arm, on 10Oct2021 as dose 2 , single (Lot number: EN6207), in right arm and on 20Feb2022 as dose 3 (booster) , single (Lot number: FF2590) at the age of 66 years, in right arm 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), SUSPECTED COVID-19 (medically significant) all with onset May2022, latency 7 months 3 days after the suspect product(s) administration, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No known allergies. Covid symptoms returned 4 days after my last dose of Paxlovid. Stuffy head, headache and fatigue. All symptoms were worse than I had prior to taking Paxlovid.
Age: 76.0
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 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Lot number: EP6955), in left arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 76 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. No known allergies. No other medical history. The patient had no relevant medical history. Received other medication in 2 weeks. Concomitant medication(s) included: NOREL AD, start date: 28Apr2022; BENZONATATE, start date: 28Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: I tested positive on 28Apr2022; (05May2022) Positive, notes: Another positive test on 05May; (09May2022) Negative, notes: On 09May, a home test in the a.m, Another in the p.m. was negative; (11May2022) Positive, notes: On 11May, after feeling ill again, I tested positive at home, then positive at the doctors office; (14May2022) Positive, notes: An at home test today, on 14May, is positive. Therapeutic measures were taken as a result of covid-19. As reported, product: COVID 19 Treatment. Brand: Pfizer. Treatment start date: 28Apr2022. Treatment stop date: 03May2022. Lot number: FY6859. Indication: Treatment of COVID-19. Patient was tested positive on 28Apr2022, with another positive test on 05May. On 09May, a home test in the a.m. was negative, and another in the p.m. was negative. On 11May, after feeling ill again, patient was tested positive at home, then positive at the doctors office. An at home test today, on 14May, is positive.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12May2022) Negative, notes: Tested negative on Thursday 12May2022; (13May2022) Positive, notes: On Saturday 13May2022 I tested positive again via home test. I took 2 different tests to confirm. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that completed the treatment on 08May2022. Patient tested negative on Thursday 12May2022, and most symptoms went away. On Friday 13May2022 started feeling very congested and had a headache. On Saturday 13May2022, tested positive again via home test. Patient took 2 different tests to confirm. He still feel very congested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Suspected Covid-19; Suspected 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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: Fe3592) at the age of 46 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 was not reported. Concomitant medication(s) included: SERTRALINE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Suspected Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Patient received COVID 19 Treatment, brand: Pfizer, Treatment start date: 06May2022, Treatment stop date: 11May2022.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "dose 1, 2 - Pfizer/ dose 3 - moderna" (unspecified if ongoing), notes: dose 1, 2 - Pfizer/ dose 3 - moderna. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Patient had a horrendous taste in her mouth throughout treatment, some combo of citric acid and metallic that made it hard to sleep it was so awful. About 4 days after treatment stopped some of her symptoms were returned. About 4 days after treatment stopped some of my symptoms returned. She had a fever again, a cough, a stuffy nose, fatigue, muscle aches, and her tests were coming back strongly positive. Frankly had she known about either of these things she never would have taken Paxlovid. Treatment of COVID-19 started on 04May2022 and date of last administration: 09May2022 (Paxlovid).  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
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: ESTRADIOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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.
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) (Physician).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ROSUVASTATIN. The patient had no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive, notes: Positive COVID-19 antigen test; (10May2022) Negative, notes: Negative COVID-19 antigen test; (16May2022) Positive, notes: Positive COVID-19 antigen test. 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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events drug ineffective and covid19 cannot be totally excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster) single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Yes, reaction(s): "Allergy", notes: Known allergies: Yes.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "product=COVID 19 Treatment"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19.The patient received Paxlovid as other medication in 2weeks for treatment of COVID-19, the treatment start date was reported as 12May2022, treatment stop date was 16May2022 with lot number Ga3567. The patient received Levothyroxine as other medication in 2 weeks products. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 08Dec2021 as dose 3, (booster), single (Lot number: FJ8726) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "chronic gut issues" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: Jun2021; TRAZODONE, start date: Sep2021; PROGESTERONE, start date: Jan2018; LIOTHYRONINE, start date: Jan2020; PSEUDOEPHEDRINE, start date: 01May2022; OLIVE LEAF EXTRACT, start date: 29Apr2022, stop date: 16May2022; N ACETYL CYSTEINE, start date: 25Apr2022; VITAMIN D3 K2, start date: Jan2001; LIPOSOMAL VITAMIN C, start date: Jan2020; B COMPLEX SUPREME, start date: Mar2022; CULTURELLE, start date: Jan2020; MUCOSA, start date: Dec2021; CETRIZINE, start date: Jun2020; ADVIL [IBUPROFEN], start date: Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received COVID 19 treatment antiviral started on 03May2022, and treatment stopped on 07May2022. Patient had received vaccine and other medication in 2 weeks. The patient had other medication in 2 weeks Zoloft, trazadone, progesterone, liothyronine, advil (ibuprofen), pseudoephedrine (sudafed), olive leaf extract d-lenolate, nac, vitamin D3 K2, reacted multimin, liposomal vitamin c, SBI protect, B suprem culturelle probiotics (culturelle), mega mucosa and cetrizine hydrochloride. Adverse event Relapse of COVID symptoms beginning 2 days after completing Paxlovid treatment. Tested positive for COVID again 3 days after completing Paxlovid treatment', start date on 09May2022 08:00, event outcome was recovering and no received AE treatment. Patient had known allergies with gluten and casein intolerance. Relevant med history reported as anxiety, depression, hypothyroid and chronic gut issues.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: IBUPROFEN. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". 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. Paxlovid was given as a treatment for COVID-19 on 12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pruritus, SARS-CoV-2 test, Sneezing, Vaccination failure
Clinical narrative: son with COVID visited him and then he had sx sneezing ST itchy nose and fatigue, fever on 5/13 and + Ag 5/15; son with COVID visited him and then he had sx sneezing ST itchy nose and fatigue, fever on 5/13 and + Ag 5/15; sneezing; itchy nose; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious) with onset 13May2022, outcome "unknown", described as "itchy nose"; SNEEZING (non-serious) with onset 13May2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "unknown" and all described as "son with COVID visited him and then he had sx sneezing ST itchy nose and fatigue, fever on 5/13 and + Ag 5/15". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive, notes: unknown suspect home Ag. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, sneezing, pruritus. Clinical course: It was unknown if patient had covid prior vaccination or not.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Vaccination failure, COVID-19 and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test, Throat irritation
Clinical narrative: Caller reports that she went to have a COVID-19 test on 13May2022 and received positive test results on Saturday 14May2022.; Caller reports that she went to have a COVID-19 test on 13May2022 and received positive test results on Saturday 14May2022.; Sore throat; Tickling in her throat; 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 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: Heart disease. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 12May2022, outcome "unknown", described as "Sore throat"; THROAT IRRITATION (non-serious) with onset 12May2022, outcome "unknown", described as "Tickling in her throat"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Caller reports that she went to have a COVID-19 test on 13May2022 and received positive test results on Saturday 14May2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: Caller also reports that she performed an at home COVID-19 test; (14May2022) Positive, notes: positive test results on Saturday 14May2022.  Additional information: She said that she does have a medical history of heart disease (Intent: Medical history). So, on 12May she started having complaint of the sore throat and it was tickling, her throat was tickling that's what she said. She got a, she want to had on Friday on 13May, she went ahead and had a COVID 19 test. On Saturday she got the results and she was positive. She also did a home test on Friday 13May2022 she said that was positive as well. she also said she has received a primary series of Pfizer COVID 19 vaccine as well as the booster dose of the COVID 19 vaccine. That is all the information I have."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
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) (Nurse) from product quality group. The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL0142), on 28Jan2021 as dose 2, single (Lot number: EL9261) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Menorrhagia" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "headaches" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI FE 1/20, start date: Jan2016; WELLBUTRIN XL, start date: Feb2018; MELATONIN GUMMIES, start date: May2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Apr2022; FLONASE [FLUTICASONE PROPIONATE], start date: Apr2022; ASTELIN [AZELASTINE HYDROCHLORIDE], start date: Apr2022. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: VACCINATION FAILURE (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: On 17May, had a positive home rapid test, with sore and swollen throat, runny nose, headache and fatigue; (17May2022) Positive, notes: had a positive home rapid test. Therapeutic measures were taken as a result of covid-19.  Clinical Information: On 17May, had a positive home rapid test, with sore and swollen throat, runny nose, headache and fatigue. For a couple days prior had runny nose, but thought it was allergies given history of allergies and local weather reports. Adverse event start date provided as 17May2022. Outcome provided as Unknown.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Suspected COVID-19
Clinical narrative: Got sick of COVID-19 (omicron variant) after he had 3 doses of the Pfizer COVID-19 Vaccine; Got sick of COVID-19 (omicron variant) after he had 3 doses of the Pfizer COVID-19 Vaccine; Chronic fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Got sick of COVID-19 (omicron variant) after he had 3 doses of the Pfizer COVID-19 Vaccine"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue".  Clinical Course: Reporter was a consumer. She explained that she has 3 doses of Pfizer-BioNTech COVID-19 Vaccine so far. Her physician recommended her to get the second booster dose (or fourth dose) of the vaccine, since she was a diabetic patient. Reporter said she knew that Pfizer might be working on a new formulation for the booster doses, which would be more effective against the omicron variant. Reporter wanted to know if she should get the second booster now or wait until the new formulation or she can receive the second booster dose now and then a possible third booster dose (fifth dose) when this new formulation was available. Reporter stated that she knows the immunity wanes after several months and she was thinking to get another dose of the vaccine by Fall instead of this time. He did not need to be hospitalized, he had chronic fatigue but overcame the infection with home cares.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Drug ineffective; 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 42-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single at the age of 42 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID 19 Treatment/Drug ineffective"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19. Anti-viral details was product-COVID 19 Treatment was Paxlovid, treatment start date-07May2022, treatment stop date-12May2022 for Treatment of COVID-19. 4 days after completing patient 5 days of Paxlovid, my Covid symptoms returned. Headache, congestion, sore throat, fatigue. They had gone away completely within 36 hours of the first dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200725686 Same patient, different product and event
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: left ankle and foot was swollen; left ankle and foot was swollen; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 09:00 as dose 4 (booster), single (Lot number: FK9894) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "chronic illness" (unspecified if ongoing), notes: 1x chronic illness; "known allergies pollen" (unspecified if ongoing), notes: Allergy: Mesquite, pollen; "known allergies Mesquite" (unspecified if ongoing), notes: Allergy: Mesquite, pollen. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization.  The following information was reported: JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 10May2022 at 12:00, outcome "recovered" and all described as "left ankle and foot was swollen". The events "left ankle and foot was swollen" required emergency room visit. Therapeutic measures were taken as a result of joint swelling, peripheral swelling.  Additional information: patient did not take any vaccine in four weeks and was not wish to answer regarding other medications in two weeks. Patient did not had covid prior vaccination nor tested covid post vaccination. Patient received Tylenol, Ibuprofen, Acewrap as therapy for the events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: We both got the Pfizer vaccines and now we are both taking Paxlovid; We both got the Pfizer vaccines and now we are both taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "We both got the Pfizer vaccines and now we are both taking Paxlovid". Therapeutic measures were taken as a result of covid-19.  Clinical course included Reporter states that he is on his 2nd day of taking Paxlovid. Reporter states that his doctor told him to stop taking Lipitor while taking Paxlovid. Reporter states that his doctor told him to continue taking his blood pressure medicine Lisinopril and Hydrochlorathiazide. it was reported that Referred Reporter to follow up with his doctor for clarification and informed Reporter not to stop taking any medications before first consulting with his doctor.Reporter is a male consumer who is calling on behalf of his wife, withheld (female), who was prescribed Paxlovid today and just picked up her prescription from the pharmacy. Reporter states that both he and his wife have both been vaccinated with Pfizer Covid19 vaccines. Reporter states "it is 3pm here now and my wife would like to know if she should take her 1st dose of Paxlovid now or wait until this evening" Reporter also states "I started my Paxlovid yesterday at 9:00 and then took my evening dose at 9pm and then my morning dose this morning at 9:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200727764 same reporter/drug/event, diff patients
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Lot number: 029L20A) and on 17Feb2021 as dose 2, single (Lot number: 022M20A) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "interchange of vaccine products" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got the Pfizer vaccine and no reactions but I still got covid; I got the Pfizer vaccine and no reactions but I still got 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 59-year-old 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I got the Pfizer vaccine and no reactions but I still got covid". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Therapeutic measures included Paxlovid. It was reported that patient was on Plaxovid and was very tired. She was in bed a lot of course with covid. She had that horrible taste. She felt good for a couple days then 3 days after sheI got off it she had debilitating fatigue all of a sudden.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Feeling abnormal
Clinical narrative: Lost my sense of smell and taste.; Lost my sense of smell and taste.; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 05:00 as dose 2, single (Lot number: RA6503) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: RA6503, Location of injection: Arm Left, Vaccine Administration Time: 17:45), administration date: 13Sep2021, when the patient was 60-year-old, for Covid-19 immunization.  The following information was reported: ANOSMIA (disability), AGEUSIA (disability) all with onset 25Nov2021 at 17:30, outcome "not recovered" and all described as "Lost my sense of smell and taste."; FEELING ABNORMAL (disability) with onset 25Nov2021 at 17:30, outcome "not recovered", described as "brain fog". The events "lost my sense of smell and taste." and "brain fog" required physician office visit. Therapeutic measures were taken as a result of anosmia, ageusia, feeling abnormal.
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood alkaline phosphatase increased, Rash, SARS-CoV-2 test
Clinical narrative: showed an alk phos of 2199 (41-133) from bone which fell to 1100 last week; rash on her legs in early Oct2021; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A 77-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY, solution for injection), on 19Aug2021 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: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Comirnaty (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset 01Oct2021, outcome "recovered" (Feb2022), described as "rash on her legs in early Oct2021"; BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious) with onset 2022, outcome "unknown", described as "showed an alk phos of 2199 (41-133) from bone which fell to 1100 last week". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. It was unknown if therapeutic measures were taken as a result of blood alkaline phosphatase increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Has the patient received a COVID-19 vaccination: Yes. Pfizer#123 in 2021; Has the patient received a COVID-19 vaccination: Yes. Pfizer#123 in 2021; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 85-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 85 years, in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Cancer", start date: 2019 (unspecified if ongoing), notes: Stage IV small cell lymphoma in 2019; "Prostate cancer", start date: 2013 (unspecified if ongoing), notes: Prostate cancer 2013. Concomitant medication(s) included: ACALABRUTINIB taken for lymphoma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has the patient received a COVID-19 vaccination: Yes. Pfizer#123 in 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive; (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient was administered paxlovid (PF07321332/ Ritonavir) at a dose of Routine 300 mg/100 mg dose BID/ 5days.Dates of administration of paxlovid were 11Apr2022- 16Apr2022 and repeated for second injection 27Apr2022.On 16Apr2022 patient symptoms improved while taking paxlovid. It was also reported that after full recovery he worsened again on 20Apr2022 and was retreated on 27Apr2022 after positive test.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the event drug ineffective and covid19 cannot be totally excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: daughter with covid at home last week and then she had sx 16May and Ag positive 17May; daughter with covid at home last week and then she had sx 16May and Ag positive 17May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. The reporter is the parent.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 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) with onset 16May2022, outcome "unknown", COVID-19 (medically significant) with onset 16May2022, outcome "recovering" and all described as "daughter with covid at home last week and then she had sx 16May and Ag positive 17May". The events "daughter with covid at home last week and then she had sx 16may and ag positive 17may" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical information: Other vaccine in four weeks was unknown. COVID prior vaccination was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID - 19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 51.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0170) and on 13Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 51 years 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: "Hypertension" (unspecified if ongoing); "Mild intolerance to cucumbers and squash" (unspecified if ongoing), notes: Mild intolerance to cucumbers and squash; "Mild intolerance to cucumbers and squash" (unspecified if ongoing), notes: Mild intolerance to cucumbers and squash. Concomitant medication(s) included: LOSARTAN, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Symptoms flared up 4-5 days after Paxlovid treatment ended. Tested consistently positive for Covid (different brands of rapid tests on consecutive days) and had to enter isolation again.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
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 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: EW0178) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pots" (unspecified if ongoing), notes: POTS; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: It was reported that no other medication were received in 2 weeks.  Follow-up attempts are completed. No further information is expected.