chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; 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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 64 years, in right arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Feb2021 at 15:00 as dose 1, single (Lot number: 006M20A), in left arm, on 19Mar2021 as dose 2, single (Lot number: 003AZIA), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: Other medical history: no. Concomitant medication(s) included: CITALOPRAM; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was yes. Patient received other medication in 2weeks. anti viral details as product: COVID 19 Treatment, brand: PAXLOVID, treatment start date: 01Sep2022, treatment stop date: 06Sep2022, indication: Treatment of COVID-19. No Known allergies. No Other medical history.
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) (Pharmacist).  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL; AMLODIPINE; ATORVASTATIN; LOSARTAN; HYDROCHLOROTHIAZIDE; SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 reported information ,a causal relationship between the event COVID19 and suspected drug cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, 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) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 31Mar2021 as dose 2, single (Lot number: ER8732), on 29Sep2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Valley fever w/pneumonia", start date: Apr2021 (unspecified if ongoing); "Valley fever w/pneumonia", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Aug2022, outcome "recovered" (11Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (11Sep2022) Low grade fever; SARS-CoV-2 test: (01Sep2022) Positive; (02Sep2022) Negative; (05Sep2022) Positive; (11Sep2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient did not received any other medication within 2 weeks of vaccination. On 03Sep to 04Sep still had runny nose headache sore throat and tested on 05Sep2022 Positive. Patient had increased symptoms until tested Negative n 11Sep2022 and symptoms included low grade fever, headache, sore throat runny nose, sore heavy chest, sneezing, coughing, sore runny eyes, hot and cold flashes, tired. Treatment received for the adverse events include administration of drug Paxlovid on 26Aug2022 which is stopped on 30Aug2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Biopsy, Condition aggravated, Insomnia, Pruritus
Clinical narrative: hives; itching; progressively worse and worse; I can't sleep; itch to the point of swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREDNISONE. Vaccination history included: BNT162b2 (DOSE:3, lot 301308A), administration date: 08Sep2021, for Covid-19 immunization; BNT162b2 (DOSE:2), administration date: 09Feb2021, for Covid-19 immunization; BNT162b2 (DOSE:1, lot EL3247), administration date: 25Jan2021, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset Apr2022, outcome "unknown", described as "itch to the point of swollen"; URTICARIA (non-serious), outcome "not recovered", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "itching"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "progressively worse and worse"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that after all the tests and everything, it was found that this is from a reaction from a booster shot. Caller was on prednisone for months, I had 150 allergy tests, the dermatologist did biopsies and came back that it is drug related". "Before and after my booster shot, any medicine that was on, was on years and nothing changed at all. Nothing changed with the allergy test as well and Caller concluded that it is Pfizer-related. reported her condition getting "progressively worse and worse and that the "itching is all over and is starting to affect her sleep. I can't sleep, the itching goes from here to there. "I itch to the point of swollen; they come and go to a different area". It is so bad on the outside, they start to itch and it is affecting my life. reporter added that nobody knows what to do" and asked what kind of doctor would help? My internist said that this is nothing except Pfizer booster-related. added that she read on internet people had this reaction but mine is not going away.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: hives; itching; progressively worse and worse; I can't sleep; itch to the point of swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREDNISONE. Vaccination history included: BNT162b2 (DOSE:3, lot 301308A), administration date: 08Sep2021, for Covid-19 immunization; BNT162b2 (DOSE:2), administration date: 09Feb2021, for Covid-19 immunization; BNT162b2 (DOSE:1, lot EL3247), administration date: 25Jan2021, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset Apr2022, outcome "unknown", described as "itch to the point of swollen"; URTICARIA (non-serious), outcome "not recovered", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "itching"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "progressively worse and worse"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that after all the tests and everything, it was found that this is from a reaction from a booster shot. Caller was on prednisone for months, I had 150 allergy tests, the dermatologist did biopsies and came back that it is drug related". "Before and after my booster shot, any medicine that was on, was on years and nothing changed at all. Nothing changed with the allergy test as well and Caller concluded that it is Pfizer-related. reported her condition getting "progressively worse and worse and that the "itching is all over and is starting to affect her sleep. I can't sleep, the itching goes from here to there. "I itch to the point of swollen; they come and go to a different area". It is so bad on the outside, they start to itch and it is affecting my life. reporter added that nobody knows what to do" and asked what kind of doctor would help? My internist said that this is nothing except Pfizer booster-related. added that she read on internet people had this reaction but mine is not going away.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypoacusis, Nervous system disorder, SARS-CoV-2 test
Clinical narrative: Violent nervous system reaction; lingering fatigue; joint pain; vision and hearing impairment; vision and hearing impairment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing), notes: other medical history: Gout. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19 , Prev dose brand unknown: True , Prev dose brand name unknown: COVID19 Vaccine , Prev dose lot unknown: True, Prev dose lot unknown reason: Unable to locate or read the details, Prev dose administration date: 16Mar2021 , Prev dose administration time: 07:00 PM , Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 16Mar2021, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "Violent nervous system reaction"; ARTHRALGIA (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "joint pain"; FATIGUE (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "lingering fatigue"; VISUAL IMPAIRMENT (disability), HYPOACUSIS (disability) all with onset 07Apr2021 at 21:00, outcome "not recovered" and all described as "vision and hearing impairment". The events "violent nervous system reaction", "lingering fatigue", "joint pain" and "vision and hearing impairment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nervous system disorder, fatigue, arthralgia, visual impairment, hypoacusis.  Clinical information: Facility type vaccine was other. No other vaccine in four weeks. None other medications in two weeks. Medical episode 24 hours after second dose. Violent nervous system reaction with lingering fatigue, joint pain, vision and hearing impairment Symptoms continue to this day. Patient received treatment for adverse event. Adverse event treatment included Saw 3 MD's and 5 specialists and no relief. No covid prior vaccination. He had no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Violent nervous system reaction; lingering fatigue; joint pain; vision and hearing impairment; vision and hearing impairment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 19:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing), notes: other medical history: Gout. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19 , Prev dose brand unknown: True , Prev dose brand name unknown: COVID19 Vaccine , Prev dose lot unknown: True, Prev dose lot unknown reason: Unable to locate or read the details, Prev dose administration date: 16Mar2021 , Prev dose administration time: 07:00 PM , Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 16Mar2021, when the patient was 62-year-old, for Covid-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "Violent nervous system reaction"; ARTHRALGIA (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "joint pain"; FATIGUE (disability) with onset 07Apr2021 at 21:00, outcome "not recovered", described as "lingering fatigue"; VISUAL IMPAIRMENT (disability), HYPOACUSIS (disability) all with onset 07Apr2021 at 21:00, outcome "not recovered" and all described as "vision and hearing impairment". The events "violent nervous system reaction", "lingering fatigue", "joint pain" and "vision and hearing impairment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nervous system disorder, fatigue, arthralgia, visual impairment, hypoacusis.  Clinical information: Facility type vaccine was other. No other vaccine in four weeks. None other medications in two weeks. Medical episode 24 hours after second dose. Violent nervous system reaction with lingering fatigue, joint pain, vision and hearing impairment Symptoms continue to this day. Patient received treatment for adverse event. Adverse event treatment included Saw 3 MD's and 5 specialists and no relief. No covid prior vaccination. He had no Known allergies.  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: Two weeks ago she tested positive for COVID; Two weeks ago she tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Two weeks ago she tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Two weeks ago she tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller was a retired Physician Assistant and was calling because she had the Pfizer BioNTech COVID-19 vaccine for all four of her doses, two primary doses and two boosters. Two weeks ago she tested positive for COVID and would like the Pfizer bivalent booster vaccine and would like to know how long it is recommended to wait to get that after an active COVID-19 infection. She stated all of her shots were Pfizer, she and her husband had the same scenario. They were sick but not as sick as she thinks they would have been so they are thankful for Pfizer. She was not sure if she should wait 3 months after their natural immunity because they were both pretty sick, but were not hospitalized. She had monoclonal antibody treatment and her husband had treatment with Paxlovid. Caller on the line who mentioned that her and her husband had two primary doses and two booster COVID-19 shots and tested positive for COVID. Mentioned they were going to get the new bivalent vaccine on 23Sep2022. Asking if they can get the bivalent vaccine on 23Sep2022. Provided the number to company already. product complaint to report.  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 LOE events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201161119 same reporter/drug/event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Two weeks ago she tested positive for covid/she and her husband had the same scenario; Two weeks ago she tested positive for covid/she and her husband had the same scenario; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Two weeks ago she tested positive for covid/she and her husband had the same scenario". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: She is not sure if she should wait 3 months after their natural immunity because they were both pretty sick,but were not hospitalized. She had monoclonal antibody treatment and her husband had treatment with Paxlovid. She stated they are back to normal now, or as normal as 77 year olds can be.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201160950 same reporter/drug/event, different patients;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: already positive for COVID.; already positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "already positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: already had the 4 shots (Unspecified Shot); he recently took the bivalent booster but he was already positive for COVID. I have a caller on the other line, She is calling because her dad is taking Paxlovid and he is going to be taking his last dose tonight. He is feeling a lot better, he is not coughing that much and they just want to know how do you know if her dad needs to take more of it? She has mentioned that her dad already had the 4 shots (Unspecified Shot), he is fully boostered and he recently took the bivalent booster but he was already positive for COVID."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; off label use; Interchange of vaccine products; 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 as dose 5 (booster), single (Lot number: FJ6369) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: O25A27A), in left arm, on 30Mar2021 as dose 2, single (Lot number: O17B21A), in left arm, on 14Aug2021 as dose 3 (booster), single (Lot number: O40C21A), in left arm and on 07Jan2022 as dose 4 (booster), single (Lot number: D84J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Known allergies: Sulfa medications" (unspecified if ongoing), notes: Known allergies: Sulfa medications. Concomitant medication(s) included: WELCHOL; REMICADE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jul2022, outcome "unknown"; OFF LABEL USE (medically significant) with onset 07Jul2022, outcome "unknown"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Sep2022, 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; (Sep2022) Negative, notes: three days of negative tests; (Sep2022) Negative, notes: three days of negative tests; (Sep2022) Negative, notes: three days of negative tests; (Sep2022) Positive, notes: still testing positive; (12Sep2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03Sep2022, Treatment stop date: 08Sep2022, Lot number: 2815238, Indication: Treatment of COVID-19. Covid symptoms returned and tested positive on lateral flow antigen test on 12Sep2022 after three days of negative tests and no symptoms. Still testing positive with symptoms and other medication in 2weeks brand Janssen.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine product; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8730), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0167) and on 23Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: CVX207) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "unknown", described as "Interchange of vaccine product"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: known allergies: No; other medication in 2weeks: Yes; Patient was received paxlovid treatment from 30Aug2022 to 03Sep2022 for treatment of covid-19. Adverse event: I am Reporting rebound COVID symptoms after showing significant improvement from Paxlovid treatment. Four days After completing the 5 day regimen, I began experiencing new/worsening symptoms such as new sinus congestion, aggravated asthma and worsening cough with wheezing and continued fatigue. Required a trip to the ER for assessment of possible pulmonary embolism (ruled out with testing). Prescribed course of prednisone and released. Husband who also took Paxlovid fully recovered.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tired; Ache all over body; 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 male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Ache all over body".  Additional information: Reporter stated, so, I got the new booster what is it called, the Pfizer (Clarified as Pfizer COVID-19 vaccine). I got the new one and I was just wondering, so my son's been so tired. Was that normal. It says on there tiredness. When probed to clarify the concern: Reporter stated, we both get the same one (Pfizer COVID-19 Vaccine), I am having different symptoms than him. Just want to make sure we are okay with this. Reporter was informed about the role of Pfizer Drug Safety and Medical Information Department for the concern.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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 was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID] oral; VITAMIN D [VITAMIN D NOS] oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: Pt (patient) admits to testing positive for covid 01Sep2022 with an at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient admits to testing positive for covid 01Sep2022 with an at home test. Patient states she was seen virtually and treated with Paxlovid from 01Sep2022 to 05Sep2022. Patient states her symptoms resolved and she tested negative for covid on 07Sep2022 with an at home covid test. She developed symptoms of sinus infection that started again 10Sep2022. She took an at home covid test and states it was positive. Patient developed rebound covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Hepatocellular carcinoma
Clinical narrative: hepatocellular carcinoma; hepatic cirrhosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 17:30 as dose 2, 0.3 ml single (Lot number: FF8839, Expiration Date: 31Dec2021) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (ongoing); "Chronic hepatitis C" (ongoing). Concomitant medication(s) included: HYDROXYZINE oral; ONDANSETRON oral; FAMOTIDINE oral; TRAZODONE oral; LIDOCAINE oral; FUROSEMIDE oral; KCL oral; SPIRONOLACTONE oral; ALBUTEROL [SALBUTAMOL]; BACLOFEN oral. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE;  Lot number: FA6780), administration date: 02Sep2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: HEPATIC CIRRHOSIS (medically significant) with onset 26Jan2022, outcome "not recovered"; HEPATOCELLULAR CARCINOMA (medically significant) with onset 26Jan2022, outcome "not recovered". Therapeutic measures were not taken as a result of hepatocellular carcinoma, hepatic cirrhosis.  Clinical information: It was reported that family history of cancer, diabetes and heart disease. The patient received third vaccine on 14Mar2022 (Lot: FF8839) and fourth dose booster on 11Aug2022 (Batch/Lot no.: FK9894). He received third booster subsequent dose. Booster dose due to a weakened immune system: checked. If the reason was a weakened immune system, the conditions below: Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas): Checked Booster dose (other). He received concomitant trazodone 50 and baclofen 10 (unit not reported).; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Feb2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 at 02:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 27Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2weeks.No known allergies reported for the patient. Other medical history mentioned as Allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore in her arm; 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 91-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL9262) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore in her arm".  Additional information: Serious: No and NDC number of covid vaccine was unknown
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore in her arm; 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 91-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Lot number: FM9810) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9262, She read from the vaccine card: MSB1-NZ), administration date: 23Jan2021, when the patient was 89-year-old, for COVID-19 Immunization, reaction(s): "sore in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a sore in her arm".  Additional Information: PQC Details: Request Name: REQ, Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than =12 years - 15/15 mcg per dos. Question: Transfer in from DSU: (Name withheld): Report: E-transmit, possible duplicate/additional information gathered. Per DSU, caller "had her 5th dose of the Pfizer Covid vaccine, and called it the 'new updated one'". Caller is a consumer (91-year-old female) who confirms that she's had "diarrhea since that 5th dose" and that it started "within 2 hours" of having that dose and was "severe the 4th day and getting less severe, still a watery stool." Caller states her pharmacist told her to take imodium to treat this side effect and wants to know if that's correct. She'd like to know how long to expect diarrhea to last, and if having a side effect will affect the efficacy of the vaccine. Caller also expressed concern regarding the handling of the vaccine prior to administration stating, "the person giving it was carrying it around in a jug. I was a little surprised." Please see REQ for handling. Per attached Cons doc, no information about duration of diarrhea, many side effects only lasted 1-2 days on average. Directed back to HCP for treatment recommendations.She brought up concerns about the handling of the vaccination, stating, "the vaccination was given to me in the whole general area, the person giving it was carrying it ar ound in a jug. I was little surprised." She asked, isn't it supposed to be refrigerated.Caller is a consumer reporting an AE to the Bivalent PFizer-Covid19 vaccine. She asks, "could I be allergic to something in this new formulation".She is calling to report about a negative effect when she got new Pfizer covid vaccine from (Name withheld). Asks if she really needs to go through this, she just wants to report the effect.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262), administration date: 23Jan2021, when the patient was 89-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: FM9810), administration date: 13Feb2021, when the patient was 89-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A sore in her arm".
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore in her arm; 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 91-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Pfizer Covid vaccine: 23Jan2021, Lot: EL9262, She read from the vaccine card: , administration date: 23Jan2021, when the patient was 89-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm"; BNT162b2 (Dose 2, Pfizer Covid vaccine: 13Feb2021, Lot: FM9810, She read from the vaccine card:  then something after it but cannot make out what it is, might be a O or Q after MSBI.), administration date: 13Feb2021, when the patient was 89-year-old, for Covid-19 immunization, reaction(s): "A sore in her arm"; BNT162b2 (Dose 3, Pfizer covid vaccine: 25Aug2021, Lot: FA7485), administration date: 25Aug2021, when the patient was 90-year-old, for COVID-19 immunization, reaction(s): "A sore in her arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "a sore in her arm".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 32  for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE, start date: 25May2018. The following information was reported: DRUG INEFFECTIVE (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: Positive, 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: 82.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: Feeling lousy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  An 83-year-old male patient received tofacitinib citrate (XELJANZ XR), (ongoing) (Lot number: FA0918, Expiration Date: 31Aug2023) at 11 mg 1x/day for rheumatoid arthritis; BNT162b2 (BNT162B2), on 23Aug2021 as dose 3 (booster), single (Lot number: FC183, Expiration Date: 31Oct2021) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "compromised immunity" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: FC183), administration date: 23Aug2021, when the patient was 84-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "Feeling lousy". The action taken for tofacitinib citrate was dosage not changed. Additional information: When he got his first booster he didn't stop his Xeljanz XR because it wasn't recommended. He was feeling lousy a couple of days after it, but he was sure it was the booster and then he was okay.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia oral, Illness, Pain, Pain in extremity
Clinical narrative: ache all over body; tiredness; arm pain; she is getting sick; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; her lips and tongue are a little numb and tingly; 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 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Comments: Blood pressure high; "Panic attacks" (unspecified if ongoing), notes: Comments: Panic attacks. The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series completed), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Sep2022, outcome "unknown", described as "ache all over body"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2022, outcome "unknown", described as "arm pain"; PARAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "her lips and tongue are a little numb and tingly"; ILLNESS (non-serious) with onset 13Sep2022, outcome "unknown", described as "she is getting sick"; FATIGUE (non-serious) with onset 13Sep2022, outcome "unknown", described as "tiredness". Therapeutic measures were taken as a result of pain, fatigue, pain in extremity, illness, paraesthesia oral, hypoaesthesia oral, hypoaesthesia oral, paraesthesia oral.  Additional information: She states she received the Pfizer Covid-19 Bivalent booster vaccine yesterday and she has had body ache, arm pain, overall achy feeling like she is getting sick, her lips and tongue are a little numb and tingly. She states that her son also got the vaccine yesterday and he came home and went to sleep and has a headache. So, she is calling today give her experiences and her son's experiences were normal with the vaccines. She did also state that she had recieved the primary Covid series with Moderna vaccine'. Treatment, consumer stated, He didn't took no medicine. I took some Advil today. Reporter stated, I do take high blood pressure pills and also for panic attack, that's it'.  No follow-up attempts are possible. No further information is expected.