chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: mild hives on the arms and trunk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Soma, reaction(s): "Known allergies: soma". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "recovered", described as "mild hives on the arms and trunk". Therapeutic measures were taken as a result of urticaria.  Additional information: Within 10 days of the first booster, the patient developed mild hives on the arms and trunk which resolved after a month. The patient was treated with steroid cream and antihistamines. The patient did not received any other vaccine in four weeks. The patient did not had COVID-19 prior vaccination and not tested for COVID -19 post vaccination.  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: Pain in extremity
Clinical narrative: my arm is still in a lot of pain; 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 36-year-old female patient received BNT162b2 (BNT162B2), on 22Jul2022 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: PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "not recovered", described as "my arm is still in a lot of pain". Additional information: Patient got the Pfizer Biontech COVID-19 vaccine last Friday. She stated that where can I go to get a sick leave because my arm is still in a lot of pain.  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-202201008173 same  drug/reporter, different patient/AE;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: The first time you know typical soreness; 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 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The first time you know typical soreness".  Additional information: caller was experiencing side effects from the COVID vaccine and she wants to know if she should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04Apr, the second time it was a full blown feeling like she have the flu with a full grade fever, then the third time she had her ears swell up to the point she cannot hear in any ears now. Caller mentioned that now it was time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she thinks she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that she seek medical advise from her doctor and they don't know what to do as well and referred her to Pfizer MI. The first time typical soreness, the second time was actually Flu like symptoms and then the third was the bad reaction. Proprietary medicinal product name was Covid-19 vaccine. Batch or lot number was FH8028, Unspecified medication manufacturer was Moderna. Can someone tell her should she continue with Pfizer or should she switch to different like Moderna (Unspecified medication) because each time it got worse. Patient have Pre diabetes, Blood pressure and Cholesterol medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Ear swelling, Hypoacusis
Clinical narrative: The first time you know typical soreness; 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 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The first time you know typical soreness".  Additional information: caller was experiencing side effects from the COVID vaccine and she wants to know if she should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04Apr, the second time it was a full blown feeling like she have the flu with a full grade fever, then the third time she had her ears swell up to the point she cannot hear in any ears now. Caller mentioned that now it was time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she thinks she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that she seek medical advise from her doctor and they don't know what to do as well and referred her to Pfizer MI. The first time typical soreness, the second time was actually Flu like symptoms and then the third was the bad reaction. Proprietary medicinal product name was Covid-19 vaccine. Batch or lot number was FH8028, Unspecified medication manufacturer was Moderna. Can someone tell her should she continue with Pfizer or should she switch to different like Moderna (Unspecified medication) because each time it got worse. Patient have Pre diabetes, Blood pressure and Cholesterol medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The first time you know typical soreness; 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 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "The first time you know typical soreness".  Additional information: caller was experiencing side effects from the COVID vaccine and she wants to know if she should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04Apr, the second time it was a full blown feeling like she have the flu with a full grade fever, then the third time she had her ears swell up to the point she cannot hear in any ears now. Caller mentioned that now it was time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she thinks she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that she seek medical advise from her doctor and they don't know what to do as well and referred her to Pfizer MI. The first time typical soreness, the second time was actually Flu like symptoms and then the third was the bad reaction. Proprietary medicinal product name was Covid-19 vaccine. Batch or lot number was FH8028, Unspecified medication manufacturer was Moderna. Can someone tell her should she continue with Pfizer or should she switch to different like Moderna (Unspecified medication) because each time it got worse. Patient have Pre diabetes, Blood pressure and Cholesterol medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cyclic vomiting syndrome
Clinical narrative: CVS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 1, single (Lot number: F13198) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYCLIC VOMITING SYNDROME (non-serious) with onset 2022, outcome "unknown", described as "CVS".  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo spread exponentially and still spreading; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6206) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Vitiligo" (unspecified if ongoing); "sjogrens possible RA" (unspecified if ongoing); "Possible RA" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: CYMBALTA; RAMIPRIL; AMBIEN; LEVOXYL; LEVOTHYROXINE. The following information was reported: VITILIGO (non-serious), outcome "not recovered", described as "vitiligo spread exponentially and still spreading".  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient had no known allergies. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: allergy; itching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 32-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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy"; PRURITUS (non-serious), outcome "unknown", described as "itching".  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: BNT162B2: Treatment of COVID-19; BNT162B2: 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "BNT162B2: 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 40-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Positive, notes: covid test type post vaccination: Nasal Swab. Clinical information: Patient experienced moderate fever and sinus congestion. Prior to vaccination patient was not diagnosed with COVID-19.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Vaccination Failure and COVID 19 and the suspect drug BNT162b2 .
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 07Feb2021 as dose 2, single (Lot number: EL9269), in left arm and on 26Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: All she had was swollen lymph nodes under the arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (COVID-19 Vaccine: Dose 1, Manufacturer: Moderna, Date: 04Mar2021, LOT: 026A21A, NDC/EXP: unknown, All were done at Withheld.), administration date: 04Mar2021, when the patient was 64-year-old, for COVID-19 Immunization; moderna (COVID-19 Vaccine: Dose 2, Manufacturer: Moderna, Date: 06Apr2021, NDC/EXP: unknown, LOT: 028A21A, All were done at Withheld.), administration date: 06Apr2021, when the patient was 64-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered", described as "All she had was swollen lymph nodes under the arm.".  Additional information: She had two Moderna COVID-19 Vaccines since last Mar and then two Pfizer COVI-19 Vaccines. All were done at withheld Her most recent Pfizer COVID-19 Vaccine has sent her reeling. She called on Saturday, spoke with a representative who took down a lot of information and was then advised to call this number today. Caller doesn't know what's going to come of this today. Had first Pfizer COVID-19 Vaccine in Dec, doesn't specify year. All she had was swollen lymph nodes under the arm. For dose 3 vaccine, she only had swollen lymph nodes that resolved. It was under the left arm, not both arms, only the left arm. She had the shot on the left arm.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022, outcome "unknown" and all described as "Tested positive for Covid". The event "tested positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive; (23Jul2022) Positive, notes: Patient now testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Antiviral details included product for COVID-19 Treatment. Patient had taken both doses of Pfizer Covid vaccine. Yet, patient got tested positive for Covid at the ER on 14Jul2022. They prescribed PAXLOVID. After 3-4 days, patient was feeling ok. Patient completed the five doses. Patient now tested positive for Covid with mild fever, cough, and little runny nose. Patient questioned about , "What next step should patient have to take. Some new medication, quarantining for many more days or something else. Patient has his wife with him and she was okay". Adverse event start date/time reported as 23Jul2022 at 12:00 AM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medications included: WARFARIN; SERTRALINE; SUMATRIPTAN. Past drug history included: Percocet, reaction: "Known allergies: Percocet"; Anticoagulation, notes: long-term anticoagulation treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid. Clinical course: After completion of full 5 day Paxlovid regimen and symptoms mostly resolved/neg test, symptoms reemerged 4 days later and tested positive.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 18-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Jul2022, outcome "recovering", described as "This person had huge lymph nodes around her arm pit and upper breast tissue for 2 -3 days post 3rd dose". It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient did not diagnose with COVID-19 Prior to vaccination and Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been not tested for COVID. Device timestamp 25Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-year-old 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: 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 covid-19. Additional information: It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient was diagnosed with COVID-19 and prescribed Paxlovid. Took full course of Paxlovid and experienced viral rebound.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Injection site pruritus, Vaccination site pruritus
Clinical narrative: Unknown if any patient experienced itching at the site of injection after administration of Prevnar 20; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Unknown if any patient experienced itching at the site of injection after administration of Prevnar 20". Additional information: Concern: Reporter stated, "I have a question about the Prevnar 20, a pneumonia shot vaccine, Is that common to have an itching in the site of the injection? (Further clarifications Unknown if any patient experienced itching at the site of injection after administration of Prevnar 20) Is that normal ?" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "tension HA" (unspecified if ongoing), notes: tension HA; "plantar fasciitis" (unspecified if ongoing); "varicose veins" (unspecified if ongoing); "hx elevated BP reading" (unspecified if ongoing), notes: hx elevated BP reading. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive; (22Jul2022) Negative; (23Jul2022) Negative; (24Jul2022) Negative; (25Jul2022) Positive, notes: awoke symptomatic today 25Jul2022 and was positive on recheck. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks was reported as no. Known allergies was reported as NKDA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  l the reported events vaccination failure , covid 19   cannot be completely excluded based on temporal association and known drug safety profile
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Taking Paxlovid; Taking Paxlovid; 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 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 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 "Taking Paxlovid". 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: BNT162B2: COVID-19 Treatment; BNT162B2: 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 36-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 was not reported. Concomitant medication(s) included: BUSPIRONE taken in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "BNT162B2: COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 17Jul2022 to 21Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Recurrance of symptoms and positive test on the home test; Recurrance of symptoms and positive test on the home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 1, single (Lot number: FH8027) and on 06May2022 as dose 2, single (Lot number: FJ49489), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Recurrance of symptoms and positive test on the home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrance of symptoms and positive test on the home test; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti-viral medication which included Paxlovid (Lot number: 1910754A) for COVID-19 Treatment. Treatment started on 13Jul2022 and stopped on 18Jul2022.  Follow-up attempts are completed. No further information is expected.
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) (Other HCP). The reporter is the patient. A 51-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 51 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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Jun2022 as dose 4 (booster), single (Lot number: 060A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Asa, reaction(s): "Known allergies"; Compozine, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "recovering" and all described as "Treatment of COVID-19". Adverse events resulted in none of the above. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Lot number: GC9431) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Jul2022, outcome "unknown" and all described as "got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: her husbands was positive for covid also. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Reporter states that she got covid from her husband. Reporter states that she herself did not have any vaccine, but her husband had the vaccines. Reporter again repeats that she herself did not have any vaccines. Reporter states that she wanted something added to this. Her husband went to a family gathering before 04Jul2022, and then he came home coughing and sneezing, coughing and sneezing just everywhere, and after 2 days or 3 she found out that she has fever. She did a test at urgent care with her husband, the doctor said to do a PCR test, and when they did PCR in which she would told the result would come the following day and be ready by 05Jul2022 so she did the test. She also did a rapid test which tells the result after 15 minutes. After 15 minute the rapid antigen test was positive for and then her husbands was positive for covid also. Reporter states that she did have a fever prior to Paxlovid. Reporter clarified that before the covid test, her husband, 1 weeks before 04Jul2022 Monday, her husband was coughing and stuff. Reporter states that she had a fever on 03Jul2022 but because of the holiday her husband told her not to bother with testing since everything will be closed, that's why she checked on 05Jul2022. Reporter was probed if she had her husbands covid vaccine Lot number or Dates they were administerd, call responded stating that she does not have any of her husbands information, and she knows is that his first 2 shot were Pfizer, and he had 2 booster so all together that's 4 vaccines. He is very careful he is 68. Reporter states that whatever he took for his symptoms the doctor gave him an antibiotic and cough syrup and he was okay, he's coughing a little bit.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19 on 09Jul2022; began treatment with Paxlovid that afternoon; Tested positive for Covid-19 on 09Jul2022; began treatment with Paxlovid that afternoon; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 09Jul2022, outcome "not recovered" and all described as "Tested positive for Covid-19 on 09Jul2022; began treatment with Paxlovid that afternoon". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive; (18Jul2022) Positive; (17Jul2022) Negative; (25Jul2022) Positive, notes: As of today 25Jul2022 I have intermittent cough, fatigue, stuffy runny nose and still testing positive on a home Covid test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was received covid vaccine treatment. She was no pregnant and occupation None of the above. The patient was no Other medication in 2weeks.The vaccine lot unknown reason other Can't find vax card. The patient was not recovered. The patient was no received other medication treatment and unknown allergies was reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment of COVID-19 from 10Jul2022 to 15Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: Unknown), in right arm for covid-19 immunisation, Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "CLL stage 1" (unspecified if ongoing), notes: No treatment. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received Paxlovid from 13Jul2022 to 18Jul2022 for treatment of COVID-19. The patient 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: developed severe erythema multiforme over trunk which has not resolved in 7 weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 at 10:45 as dose 4 (booster), single (Lot number: fk9893) at the age of 70 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "depression" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CELECOXIB]; SYNTHROID; CRESTOR. Past drug history included: Soma, reaction(s): "Known allergies: soma". Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown; Within 10 days of the first booster developed mild hives on the arms and trunk which resolved after a month.), for Covid-19 Immunization, reaction(s): "Mild hives"; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: ERYTHEMA MULTIFORME (medically significant) with onset 25May2022, outcome "not recovered", described as "developed severe erythema multiforme over trunk which has not resolved in 7 weeks". Therapeutic measures were taken as a result of erythema multiforme, reported that the patient was treated with steroid cream and antihistamines. Clinical course: The patient did not received any other vaccine in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Stated that, Within 1 week of the second booster developed severe erythema multiforme over trunk which has not resolved in 7 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 53-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies- Tree nuts" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.   Clinical information: Patient had no other medication in 2 weeks.The patient received treatment with Paxlovid from 06Jul2022 to 10Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hashimotos" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: bell peppers" (unspecified if ongoing); "Known allergies: hayfever" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; SYNTHROID; HYZAAR; SINGULAIR, all received in 2 weeks around vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: 4 days after negative test after Paxlovid; (24Jul2022) Positive, notes: Paxlovid rebound. 4 days after negative test after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received Paxlovid as treatment from 15Jul2022 to 20Jul2022. The patient had paxlovid rebound 4 days after negative test after paxlovid, the symptoms worsened and with positive testing.    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: tested positive after getting the Pfizer COVID-19 vaccine; tested positive after getting the Pfizer COVID-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive after getting the Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I believe they tested positive after getting the Pfizer COVID-19 vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received treatment for covid. No known allergies. He was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. He was previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.