chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 2 days later it came back and we are again positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day and as dose 4 (booster), single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "unknown", described as "2 days later it came back and we are again positive"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Both me and my wife had Paxlovid. After taken course we were negative; Positive, notes: however 2 days later it came back and we are again positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 19Aug2022 to 23Aug2022. Therapeutic measures were not taken as a result of disease recurrence. Reported as no other medication within 2 weeks. Reporter and his wife had Paxlovid. After taken course, they were negative however 2 days later it came back and they were again positive.   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-202201114827 Same reporter/vaccine/event, different patient;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive test; positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: En6208), in left arm, on 07Apr2021 as dose 2, single (Lot number: Er8737), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: Fd0809), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer surgery", start date: Dec2019, stop date: Dec2019, notes: Dec2019 breast cancer surgery; "Known allergies: Xray contrast dye", start date: 1992 (unspecified if ongoing), notes: known allergies Xray contrast dye (1992). Concomitant medication(s) included: ANASTROZOLE, start date: Dec2021; HYDROCHLOROTHIAZIDE, start date: Aug2021; ATORVASTATIN, start date: May2018. Past drug history included: Gabapentin, reaction(s): "Known allergies: gabapentin", notes: Known allergies: Erythromycin; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2021) Negative, notes: starting two days after a negative test; (19Aug2021) Positive, notes: following a positive test two days prior, and two days .after finishing a course of Paxlovid; (23Aug2022) Positive, notes: following a positive test two days prior, and two days. after finishing a course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courser. Rebound case of COVID, starting two days after a negative test (following a positive test two days prior, and two days after finishing a course of Paxlovid). patient is not recovered and no treatment for a received, Known allergies: Xray contrast dye (1992), gabapentin, Euthromycin. Patient received other medication in 2weeks, Anastrozole, Hydrochlorothiazide, Atorvastatin.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; Rebound COVID 3 days after completion of Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: ER8732), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 27Jan2022 at 09:45 as dose 4 (booster), single (Lot number: FK9729) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Generalized anxiety" (unspecified if ongoing); "AIHA" (unspecified if ongoing); "GVHD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "MDS" (unspecified if ongoing). Concomitant medication(s) included: HAILEY 1.5/30 oral, start date: 25Aug2020; PENICILLIN V POTASSIUM oral, start date: 12Sep2017; HYDROXYZINE oral, start date: 03Nov2020; CYANOCOBALAMIN oral; CALCIUM oral; CHOLECALCIFEROL oral. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin".  The following information was reported: DISEASE RECURRENCE (medically significant) with onset 18Aug2022, outcome "recovered" (01Sep2022), described as "Rebound COVID 3 days after completion of Paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment; Negative, notes: a negative test; Negative, notes: Rebound COVID lasted 7-8 days; then again tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient was treated with Paxlovid from 10Aug2022 to 15Aug2022 orally. Rebound COVID 3 days after completion of Paxlovid and a negative test. Rebound COVID lasted 7-8 days; then again tested negative. Mild cold-like symptoms and sore throat.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Adverse event: Rebound; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have any known allergies. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "Adverse event: Rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Aug2022 to 22Aug2022. Therapeutic measures were not taken as a result of disease recurrence. The device date was reported as 01Sep2022.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 37.0
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 a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in right arm, on 11Jan2021 at 13:00 as dose 2, single (Lot number: EL0140), in left arm, on 14Aug2021 at 15:00 as dose 3 (booster), single (Lot number: EW0198), in right arm and on 16Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not received any other medication within 2 weeks. The patient received antiviral Covid-19 treatment with Paxlovid form 23Aug2022 to 27Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is : expected. The case will be reassessed further upon receipt of additional information.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Started to take Paxlovid, recurrence in symptoms 11 days later; 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 11Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Started to take Paxlovid, recurrence in symptoms 11 days later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Any other medication in 2 weeks was not reported. Patient started to take Paxlovid, recurrence in symptoms 11 days later. Patient was taking anti viral drug from 23Aug2022 till 27Aug2022 for treatment of Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Paxlovid rebound (but worse symptoms than with covid 1st time round); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "recovering", described as "Paxlovid rebound (but worse symptoms than with covid 1st time round)"; 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. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: No other medication in 2 weeks. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 15Aug2022 to 20Aug2022.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Has patient ever had COVID positive test or diagnosis. If yes, provide date. Jan2022; Has patient ever had COVID positive test or diagnosis. If yes, provide date. Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208) intramuscular, on 31Mar2021 as dose 2, single (Lot number: ER8737) and on 20Nov2021 as dose 3 (booster), single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Past drug history included: Cortisone, reaction(s): "Allergies (medications, food and other products) Cortisone", notes: Allergies (medications, food and other products) Cortisone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Has patient ever had COVID positive test or diagnosis. If yes, provide date. Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: Has patient ever had COVID positive test or diagnosis. If yes, provided date on Jan2022. Patient stated got first dose of Pfizer vaccine on 10Mar2021, second dose of Pfizer on 31Mar2021, first booster of Pfizer on 20Nov2021, and second booster of Moderna COVID-19 Vaccine on 08Aug2022. Patient was allergic to cortisone. Patient had COVID-19 Positive test or diagnosis on an unspecified date in Jan2022. Patient was not hospitalized due to COVID-19. Patient did not have a history of Myocarditis/Pericarditis. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and 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) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing). Concomitant medication(s) in 2 weeks included: METOPROLOL. The patient had no known allergies. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "recovering", described as "Recurrence of Covid symptoms and recurrence of positive Covid test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrence of Covid symptoms and recurrence of positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Treatment included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Lymph node pain, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: lymph nodes under left arm was very painful. Although pain subsided, area still tender when touched.; fullness in my abdomen, from hip to hip.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jun2022 as dose 3 (booster), single (Lot number: FP7135) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "Known allergies: some preservatives" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulphur, reaction(s): "known allergies: Sulphur". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: 33130BA; Anatomical location: Arm Left), administration date: 07Jan2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FT1614; Anatomical location: Arm Left), administration date: 28Jan2022, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "What hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip". The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset Jun2022, outcome "not recovered", described as "fullness in my abdomen, from hip to hip."; LYMPH NODE PAIN (non-serious) with onset Jun2022, outcome "not recovered", described as "lymph nodes under left arm was very painful. Although pain subsided, area still tender when touched.". The events "lymph nodes under left arm was very painful. although pain subsided, area still tender when touched." and "fullness in my abdomen, from hip to hip." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymph node pain, abdominal distension.  Additional information: The patient did not receive other vaccine in four weeks. The other medication in two weeks included over the counter (OTC) Supplements, DK which ones, not taken daily. It was unknown whether the patient had covid prior to vaccination. The patient had been tested for covid post vaccination. AE treatment was also reported as to receive diagnostic detailed ultrasound imaging.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: What hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 as dose 2, single (Lot number: FT1614) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Known allergies: some preservatives" (unspecified if ongoing), notes: known allergies:some preservatives; "Known allergies: latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulphur, reaction(s): "Known allergies: Sulphur". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot No: 33130BA; Anatomical location: Arm Left), administration date: 07Jan2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset Jun2022, outcome "not recovered", described as "What hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip". The event "what hasn't gone away since the 2nd shot leading to the 3rd one -is the fullness in my abdomen, from hip to hip" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal distension.  Additional information: The patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 3 (booster), single (Lot number: FP7135) in left arm for covid-19 immunisation. The patient did not received other vaccine in four weeks. The other medication in two weeks included OTC Supplements, Don't Know which ones, not taken daily. It was unknown whether the patient had covid prior to vaccination. The patient had been tested negative for covid post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201117095 same reporter/patient/product, different dose/events;
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Two days later (02Sep) I rebounded and tested positive for covid even after having completed my Paxlovid meds (20Aug).; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EN8730), in left arm, on 01May2021 as dose 2, single (Lot number: EW0176), in left arm and on 30Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "not recovered", described as "Two days later (02Sep) I rebounded and tested positive for covid even after having completed my Paxlovid meds (20Aug).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: I rebounded; (16Aug2022) Positive; (02Sep2022) Positive, notes: tested positive for covid even after having completed my Paxlovid meds. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid (Antiviral, Lot number: unknown) from 16Aug2022 to 21Aug2022 for COVID-19 treatment. Patient received other medication in 2 weeks was Coldeeze (Mylan consumer healthcare) from 14Aug2022 to 15Aug2022, Vitamin C from 11Aug2022 to 15Aug2022 and Vitamin D from 11Aug2022 to 15Aug2022. Patient had a lingering cough since testing positive initially on 16Aug2022. Patient was started getting intermittent headaches again on 30Aug2022 after almost two weeks of being okay. Two days later (02Sep2022) patient rebounded and tested positive for covid even after having completed my Paxlovid meds (20Aug2022).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left 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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 including PF-07321332/ritonavir (PAXLOVID). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 18:30 as dose 1, single (Lot number: EN6202), in left arm, on 23Mar2021 at 16:00 as dose 2, single (Lot number: EP6955), in left arm, on 13Dec2021 as dose 3 (booster), single (Lot number: FE3594), in left arm and on 09Jun2022 at 11:00 as dose 4 (booster), single (Lot number: Fch0173) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "narcolepsy type 2" (unspecified if ongoing); "nerve damage on left side of torso from car accident" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE, start date: Oct2021; MODAFINIL, start date: Oct2021; GABAPENTIN, start date: Feb2020; TOPIRAMATE, start date: Apr2005. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 23Aug2022, Treatment stop date: 28Aug2022, Lot number: GD9454, Indication: Treatment of COVID-19. The patient had no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 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 "testing positive for COVID-19/she got COVID now and mentioned 2 or 3 months ago, she also got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Caller was prescribed Paxlovid after testing positive; (2022) 2 of 3 months ago had COVID, notes: Caller has COVID now and mentioned 2 of 3 months ago had COVID as well. Therapeutic measures were taken as a result of drug ineffective, covid-19. Per clinical course, patient online reporting adverse events for Paxlovid and Pfizer COVID-19 Vaccine. Patient was prescribed Paxlovid after testing positive for COVID-19 and also taking Amlodipine. She has not taken Paxlovid and was contraindicated to take with Amlodipine. She was also taking Losartan and Raloxifene. She is fully vaccinated with 4 doses and with Pfizer. While she got COVID now and mentioned 2 or 3 months ago, she also got COVID. During 2nd booster dose she mentioned that she had arm pain and felt weak for 2 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201117729 same reporter/patient/product, different dose/AE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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), 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 "testing positive for COVID-19/she got COVID now and mentioned 2 or 3 months ago, she also got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Caller was prescribed Paxlovid after testing positive; (2022) 2 of 3 months ago had COVID, notes: Caller has COVID now and mentioned 2 of 3 months ago had COVID as well. Therapeutic measures were taken as a result of drug ineffective, covid-19. Per clinical course, patient online reporting adverse events for Paxlovid and Pfizer COVID-19 Vaccine. Patient was prescribed Paxlovid after testing positive for COVID-19 and also taking Amlodipine. She has not taken Paxlovid and was contraindicated to take with Amlodipine. She was also taking Losartan and Raloxifene. She is fully vaccinated with 4 doses and with Pfizer. While she got COVID now and mentioned 2 or 3 months ago, she also got COVID. During 2nd booster dose she mentioned that she had arm pain and felt weak for 2 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201117729 same reporter/patient/product, different dose/AE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: arm pain; felt weak for 2 days; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; ASTHENIA (non-serious), outcome "recovered", described as "felt weak for 2 days".  Additional Information: She was fully vaccinated with four doses and with Pfizer. During second booster dose patient had arm pain and felt weak for two days.   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: Asthenia, Pain in extremity
Clinical narrative: arm pain; felt weak for 2 days; 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 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; ASTHENIA (non-serious), outcome "recovered", described as "felt weak for 2 days".  Additional Information: She was fully vaccinated with four doses and with Pfizer. During second booster dose patient had arm pain and felt weak for two days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "known allergies Contrast Dye" (unspecified if ongoing), notes: Known allergies: Ibuprofen and Iodine Contrast Dye. Concomitant medication(s) included: LEXAPRO; ATORVASTATIN, stop date: 22Aug2022; TYLENOL; RITALIN [METHYLPHENIDATE]. Past drug history included: Ibuprofen, reaction(s): "known allergies Ibuprofen", notes: Known allergies: Ibuprofen and Iodine Contrast Dye. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 01Sep2022, outcome "recovering"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative; Positive, notes: I am testing positive again; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient received other medication in 2weeks. Birth Control medication took in 2weeks stop date was 22Aug2022. Treatment for Covid 19 included Paxlovid started on 23Aug2022 and stop date was 28Aug2022. Patient finished taking Paxlovid, symptoms improved and she tested negative. 5 days later, mild symptoms have returned and She was testing positive again. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; WELLBUTRIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine intolerance". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 2022, outcome "not recovered", described as "Testing positive for Covid now for two weeks straight"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Testing positive for Covid now for two weeks straight. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Contracted Covid; lethargy and body aches, not much coughing. Began Paxlovid and felt immediate Improvement but a few days after the end of Paxlovid lethargy, congestion, and decreased lung capacity began. Testing positive for Covid now for two weeks straight. Patient is not recovered and Paxlovid received as treatment for AE from 19Aug2022 to 24Aug2022. Patient has known allergy to Codeine intolerance. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:15 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 at 13:15 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Oct2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 15Jul2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Apr2022, stop date: Sep2022; LISINOPRIL, start date: Apr2022, stop date: Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "After finishing treatment for Covid about a week later tested positive for Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After finishing my treatment for Covid about a week later tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: The patient was treated for covid-19 with Paxlovid from 23Aug2022 to 28Aug2022. After finishing treatment for Covid about a week later tested positive for Covid again. She had a runny nose, cough, and sore throat with a slight fever. She had no allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin"; Diclofenac sodium, reaction(s): "Known allergies: Diclofenac sodium". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received treatment for covid-19 as Paxlovid from 25Aug2022 to 29Aug2022, administrator through oral. 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 available information in the case, the causal association between the event Vaccination failure, COVID-19, disease recurrence and the suspect drug BNT162B2 cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, SARS-CoV-2 test, Seizure
Clinical narrative: seizure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: FJ1611) and on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, LOT: EW0150 , NDC/EXPIRY: Unknown, reading information from Vaccine Card, not on Vaccine Card for any of the doses.), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "booster hurt way more than any of the shots she had previously". The following information was reported: SEIZURE (hospitalization, medically significant), outcome "recovered with sequelae". The patient was hospitalized for seizure (start date: 30May2022, discharge date: 30Jun2022, hospitalization duration: 31 day(s)). The patient underwent the following laboratory tests and procedures: Testing: Unknown, notes: Had major testing done for seizure; SARS-CoV-2 test: Unknown results, notes: Checked for her COVID.  Clinical information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original (Monovalent), greater than or equal to 12 years, minus 30 mcg/dose, Do not dilute. Reporter reported that 63-year-old female patient and states that she had a seizure after receiving the Pfizer COVID-19 booster vaccine. The patient was in hospital for Severe Seizure from 30May2022 to 30Jun2022. The patient had the booster on 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. The patient was so upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. The patient clarified she thought she had 4 doses total, but she only had three doses. Confirmed seizure was caused by second dose and third booster. Had major testing done for seizure. HCPs don't know what caused it. Checked her for COVID, relevant injuries, checked for a lot of things. Unknown test names or test results. Declined vaccine supplemental form.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient, different dose/events;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Gait disturbance, Ill-defined disorder, Laboratory test, Language disorder
Clinical narrative: seizure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: FJ1611) and on 15May2022 as dose 3 (booster), single (Lot number: EM9222) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, LOT: EW0150 , NDC/EXPIRY: Unknown, reading information from Vaccine Card, not on Vaccine Card for any of the doses.), administration date: 30Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "booster hurt way more than any of the shots she had previously". The following information was reported: SEIZURE (hospitalization, medically significant), outcome "recovered with sequelae". The patient was hospitalized for seizure (start date: 30May2022, discharge date: 30Jun2022, hospitalization duration: 31 day(s)). The patient underwent the following laboratory tests and procedures: Testing: Unknown, notes: Had major testing done for seizure; SARS-CoV-2 test: Unknown results, notes: Checked for her COVID.  Clinical information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original (Monovalent), greater than or equal to 12 years, minus 30 mcg/dose, Do not dilute. Reporter reported that 63-year-old female patient and states that she had a seizure after receiving the Pfizer COVID-19 booster vaccine. The patient was in hospital for Severe Seizure from 30May2022 to 30Jun2022. The patient had the booster on 15May2022 and two weeks later on 30May2022 she had a very, very severe seizure that she believes was directly related to the booster shot. Put her out for two weeks, has no memory of those two weeks. Was out in the hospital. Had another two weeks in hospital for rehab. Took her shot and her boosters regularly. The fact that this seizure was so close to the booster she doesn't believe it was caused by anything other than the booster shot. The patient was so upset that she can't express herself, has almost has no walking ability, problems with speaking ability, and other problems as well as a result from the seizure. The patient clarified she thought she had 4 doses total, but she only had three doses. Confirmed seizure was caused by second dose and third booster. Had major testing done for seizure. HCPs don't know what caused it. Checked her for COVID, relevant injuries, checked for a lot of things. Unknown test names or test results. Declined vaccine supplemental form.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118303 same reporter/patient, different dose/events;