chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "generalized anxiety" (unspecified if ongoing), notes: other medical history: generalized anxiety; "adrenal fatigue" (unspecified if ongoing), notes: other medical history: adrenal fatigue; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "not immunocompromised but weak immune system historically" (unspecified if ongoing), notes: other medical history: not immunocompromised but weak immune system historically; "overweight" (unspecified if ongoing), notes: other medical history: overweight; "Pfizer BioNTech Dose number:3/Moderna Dose number:2/ Moderna Dose number: 1" (unspecified if ongoing), notes: Pfizer/BioNTech Dose number:3/Moderna Dose number:2/ Moderna Dose number: 1. Concomitant medication(s) included: MICROGESTIN, start date: 06Feb2014; NYQUIL, start date: 05May2022, stop date: 18May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (11May2022) Negative, notes: tested negative day 6-11May-14May; (12May2022) Negative, notes: tested negative day 6-11May-14May; (13May2022) Negative, notes: tested negative day 6-11May-14May; (14May2022) Negative, notes: tested negative day 6-11May-14May; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: Other medical History: Type 2 diabetic. There were no concomitant medications. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. There were no Known allergies reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Positive, notes: Still testing positive and have harsh cough. 2.5 weeks after testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product: COVID 19 Treatment, brand=Paxlovid, Treatment start date=03May2022, Treatment stop date=08May2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: 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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 14:00 as dose 1, single (Lot number: FN2908) at the age of 56 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 27May2021 at 12:00 as dose 1, single (Lot number: 043A21A), in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: testing negative; (18May2022) Positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product=COVID 19 Treatment (Paxlovid). Treatment received on 11May2022 and Stop date 16May2022. Indication is used for treatment of COVID-19. The patient experienced adverse event Symptoms returned 2 days after last dose of Paxlovid. Tested positive again after testing negative.  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: Took Pfizer vaccine hours from being exposed/Tested positive; Took Pfizer vaccine hours from being exposed/Tested positive; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Took Pfizer vaccine hours from being exposed/Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive and took Paxlovid; Positive, notes: Ten days later still testing positive and experiencing mild symptoms. 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.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8735) and on 23Apr2021 as dose 2, single (Lot number: ER8735) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 3 (booster), single (Lot number: 035C21A) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clarithromycin, reaction(s): "Known allergies clarithromycin". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative, notes: tested negative on rapid antigen testing; (13May2022) Negative, notes: Tested negative again on day 11; (17May2022) Positive, notes: new positive antigen test.Brand: Paxlovid ,Treatment start date:02May2022, Treatment Stop date:06May2022,Indication:Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Vaccination failure, COVID-19 cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: the patient experienced COVID; the patient experienced COVID; MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE; MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3950656-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), 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 "the patient experienced COVID"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE".  The reporter's assessment of the causal relationship of "the patient experienced covid" and "moderna covid-19 vaccine (elasomeran) and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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.
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 12:00 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 included: "Migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM, start date: 01Apr2022, stop date: 18May2022; WELLBUTRIN, start date: 01Apr2022, stop date: 18May2022; ADDERALL, start date: 01Apr2022, stop date: 18May2022. Past drug history included: Endomethicin, reaction(s): "Known allergies Endomethicin", notes: Known allergies: Endomethicin; Buspiron for psych effects, reaction(s): "Known allergies buspiron", notes: Known allergies: buspiron for psych effects. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (02May2022) Negative; (03May2022) Negative; (04May2022) Negative; (11May2022) Positive, notes: Tested positive for covid 10 days after finishing Paxlovid round. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that tested positive for covid 10 days after finishing Paxlovid round. Had previously tested negative three days in a row on day 2, 3, 4 after finishing Paxlovid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 2 (booster), single (Lot number: FD0809) at the age of 69 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 1805025), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penecillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (unspecified date) positive; (unspecified date) Negative; (18May2022) positive; (18May2022) positive. Therapeutic measures were taken as a result of covid-19.  Additional information: If vaccine received: Yes; Other medication in 2 weeks: No. Adverse event: 18May2022, 12 days after positive test and 6 days after stopping paxlovid, symptoms returned (drippy eyes and nose, aches, tired) so I home tested and got a positive antigen test. Other medical history: None
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) . The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral product for COVID 19 Treatment with Brand Paxlovid, treatment start date 13May2022, treatment stop date 17May2022. The patient experienced Itchy back and body 1 day after completing Paxlovid, taste is gone and vision is little blurry.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), on 18Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "splenectomy" (unspecified if ongoing); "Adult onset Bethlem myopathy" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE oral, start date: 16Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment with paxlovid . 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 information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8737), in left arm and on 21Apr2021 as dose 2, single (Lot number: ER8736) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos thyroiditis in remission" (unspecified if ongoing); "elevated blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: COQ10 [UBIDECARENONE]; B COMPLEX [VITAMIN B COMPLEX]; D3; L-THEANINE; FISH OIL. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Positive Test Day 7; negative, notes: Negative tests on days 9 and 11; Asymptomatic, notes: through day 12; positive, notes: Mild symptoms beginning day 13 and positive test on day 14; negative, notes: Negative test on day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfites" (unspecified if ongoing), notes: Known allergies: biaxin, sulfites. Concomitant medication(s) included: LEVOTHYROXINE; ESCITALOPRAM. Past drug history included: Biaxin for Known allergies: biaxin, notes: Known allergies: biaxin, sulfites. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient took other medication in 2weeks : Amneal (Levothyroxine), Accord (escitalopram). Took Paxlovid for 5 days because patient tested positive. Tested negative on 7th day. Started feeling sick again in a few days. Tested positive again 6 days after the negative test. Symptoms were worse this time. No treatment and recovering now. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Took Paxlovid for 5 days because I tested positive. Tested positive again 6 days after the negative test; Negative, notes: Tested negative on 7th day. Therapeutic measures were taken as a result of covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years 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: "Overweight" (unspecified if ongoing). Patient did not have any known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 02May2022 to 06May2022, for the treatment of COVID-19. 3 days after completion of paxlovid, on 10May2022 cough and sore throat and antigen positive test despite being negative on day 5.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 42 years 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 and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) negative. Therapeutic measures were taken as a result of suspected covid-19. Clinical course: COVID 19 Treatment: Paxlovid, start date: 07May2022 and stop date: 11May2022. Paxlovid Rebound. Would like guidance on how to proceed. Rebound. Patient put down the wrong date of rebound on previous form. Patient's doctor need guidance on how to treat patient after a rebound from Paxlovid. By day 2 most symptoms gone. By day 6 or so negative antigens until day 10. Now high fever and cough etc. Far worse than original. Patient inquired what to do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid: Treatment of COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 at 04:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 14Oct2021 at 03:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: VIMPAT, start date: 11Aug2021; OXCARBAZEPINE, start date: 17Oct2019; ZONISAMIDE, start date: 15May2019. Past drug history included: Cefaclor, reaction(s): "Known allergy: Cefaclor".  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Paxlovid: Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown". The event "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) positive; (15May2022) negative; (18May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient tested positive for COVID-19 on Sunday, 08May and was treated with Paxlovid on Monday, 09May. Patient tested negative for covid on Sunday, 15May, and then positive on Wednesday 18May.  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 information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from Regulatory Authority. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 23Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 24Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (May2022) Negative, notes: after Paxlovid course was negative; (May2022) Positive, notes: the Ag became positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had return of viral symptoms after complete Paxlovid course about 5 days later. Original course was very mild and return symptoms were also mild. A Treatment of COVID-19 after Paxlovid course was negative, but when symptoms returned, the Ag became positive again. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "prehypertension" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for nasopharyngitis, influenza, start date: 05May2022, stop date: 07May2022.  The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Positive; (12May2022) Negative; (17May2022) Positive, notes: Took home antigen test that was bright positive; (18May2022) Positive, notes: Test was positive but less bright than May 17; Weight: (unspecified date) Overweight. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks are reported as yes. Known allergies was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Hypogeusia, Hyposmia, Parosmia
Clinical narrative: Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: FA6780) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Previous dose details:, Prev dose product=COVID 19,, Prev dose brand=Pfizer , Prev dose brand unknown=False,, Prev dose lot number=FA6780, Prev dose lot unknown=False, Prev dose Administration date=26Jul2021, Prev dose dose number=1), administration date: 26Jul2021, when the patient was 50-year-old, for Covid-19 immunization. The following information was reported: ANOSMIA (non-serious), HYPOSMIA (non-serious), TASTE DISORDER (non-serious), HYPOGEUSIA (non-serious), AGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "Diminished, change, Loss of taste and smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anosmia, hyposmia, taste disorder, hypogeusia, ageusia, parosmia.  Additional information: Prior to vaccination, Patient has no covid
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder
Clinical narrative: Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; Diminished, change, Loss of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 2, single (Lot number: FA6780) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Previous dose details:, Prev dose product=COVID 19,, Prev dose brand=Pfizer , Prev dose brand unknown=False,, Prev dose lot number=FA6780, Prev dose lot unknown=False, Prev dose Administration date=26Jul2021, Prev dose dose number=1), administration date: 26Jul2021, when the patient was 50-year-old, for Covid-19 immunization. The following information was reported: ANOSMIA (non-serious), HYPOSMIA (non-serious), TASTE DISORDER (non-serious), HYPOGEUSIA (non-serious), AGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "Diminished, change, Loss of taste and smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anosmia, hyposmia, taste disorder, hypogeusia, ageusia, parosmia.  Additional information: Prior to vaccination, Patient has no covid
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product: COVID 19 Treatment; product: 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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing), notes: Other medical history: Sarcoidosis. The patient took concomitant medications. Past drug history included: Zpack, reaction(s): "Known allergies: Zpack", notes: Known allergies: Zpack. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. On 17May2022, patient received anti-viral details: product: COVID 19 Treatment, Paxlovid. Other medication in 2weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic cancer, Hepatic cirrhosis, Hepatitis viral test, Liver disorder, Oesophageal varices haemorrhage
Clinical narrative: 1 case study involving another transplant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Leaking blood" (ongoing), notes: P still leaking blood and can't find source.; "diarrhea" (unspecified if ongoing), notes: diarrhea may have been for last 7 years). The patient's concomitant medications were not reported. The following information was reported: TRANSPLANT (medically significant), outcome "unknown", described as "1 case study involving another transplant". The patient underwent the following laboratory tests and procedures: Hepatic cancer: No marker present or tumor found, notes: o marker present or tumor found for liver CA; Hepatic cirrhosis: Confirmed cirrhosis, notes: Confirmed cirrhosis of liver w no cause of onset determined; Hepatitis viral test: No hepatitis, notes: No hepatitis; Liver disorder: No infection, notes: No infection in liver fluid; Oesophageal varices haemorrhage: No bleeding of varicose veins, notes: No bleeding of varicose veins in esophagus; Stool analysis: No detected blood, notes: No detected blood in diarrhea.  Clinical course: Reporter (sister) and Mom (withheld) 54 year old kidney transplant patient's (withheld) (brother's)medical care team at withheld still leaking blood and can't find source. (withheld) has received 2 units of blood, 4/30 & 5/10 and will receive more today. Confirmed cirrhosis of liver w no cause of onset determined. No infection in liver fluid. No bleeding of varicose veins in esophagus as suspected. No marker present or tumor found for liver CA. No hepatitis. No detected blood in diarrhea (diarrhea may have been for last 7 years). Using diuretic to get rid of fluid w/o damaging donated kidney. May have to withdraw fluid via needle again. Sister did internet search of possible liver injury from Covid vaccine. She found 1 case study involving another transplant (withheld) who received Pfizer vaccine. 54 year old kidney transplant patient Name of Product: 3 doses of Comirnaty vaccine. Reporter has dates & lot numbers.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis, Transplant
Clinical narrative: 1 case study involving another transplant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Leaking blood" (ongoing), notes: P still leaking blood and can't find source.; "diarrhea" (unspecified if ongoing), notes: diarrhea may have been for last 7 years). The patient's concomitant medications were not reported. The following information was reported: TRANSPLANT (medically significant), outcome "unknown", described as "1 case study involving another transplant". The patient underwent the following laboratory tests and procedures: Hepatic cancer: No marker present or tumor found, notes: o marker present or tumor found for liver CA; Hepatic cirrhosis: Confirmed cirrhosis, notes: Confirmed cirrhosis of liver w no cause of onset determined; Hepatitis viral test: No hepatitis, notes: No hepatitis; Liver disorder: No infection, notes: No infection in liver fluid; Oesophageal varices haemorrhage: No bleeding of varicose veins, notes: No bleeding of varicose veins in esophagus; Stool analysis: No detected blood, notes: No detected blood in diarrhea.  Clinical course: Reporter (sister) and Mom (withheld) 54 year old kidney transplant patient's (withheld) (brother's)medical care team at withheld still leaking blood and can't find source. (withheld) has received 2 units of blood, 4/30 & 5/10 and will receive more today. Confirmed cirrhosis of liver w no cause of onset determined. No infection in liver fluid. No bleeding of varicose veins in esophagus as suspected. No marker present or tumor found for liver CA. No hepatitis. No detected blood in diarrhea (diarrhea may have been for last 7 years). Using diuretic to get rid of fluid w/o damaging donated kidney. May have to withdraw fluid via needle again. Sister did internet search of possible liver injury from Covid vaccine. She found 1 case study involving another transplant (withheld) who received Pfizer vaccine. 54 year old kidney transplant patient Name of Product: 3 doses of Comirnaty vaccine. Reporter has dates & lot numbers.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: High fever of 102.8 (degree) - fever reducers weren't helping; Cough; Congestion; Achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Extensive medical history due to unbalanced translocation of chromosomes 2 and 10" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: CLONIDINE; PRILOSEC [OMEPRAZOLE]; ERYTHROMYCIN; SINGULAIR; ZYPREXA. The following information was reported: PAIN (non-serious) with onset 18May2022 at 01:00, outcome "recovering", described as "Achy"; NASAL CONGESTION (non-serious) with onset 18May2022 at 01:00, outcome "recovering", described as "Congestion"; COUGH (non-serious) with onset 18May2022 at 01:00, outcome "recovering"; PYREXIA (non-serious) with onset 18May2022 at 01:00, outcome "recovering", described as "High fever of 102.8 (degree) - fever reducers weren't helping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, cough, nasal congestion, pain.  Additional information: The Reporter was reported about covid vaccine and Events .The Reporter was Patient. The patient Age group: Child (2-11 Years) Current age: 5 and Gender was Female at no pregnant. The Patient occupation was None of the above .The patient Dose received: 1 was received. The Most recent dose details product COVID 19. The brand was Pfizer-BioNTech COVID-19 Vaccine. The Lot unknown reason Not available/provided to reporter at the time of report completion .The Administration date 16May2022 time03:45 PM and Dose number 1 at Vaccine location Right leg. The Facility type vaccine: Doctor's office/urgent care in Facility country. The patient no other vaccine in four weeks and Other medications in two weeks: Clonidine, Prilosec, erythromycin, singulair, zypr .The Adverse event at High fever of 102.8 (degree) - fever reducers weren't helping Cough Congestion Achy .The Adverse event start date: 18May2022 time: 01:00 AM. The patient recovered Recovering and no treatment received. The COVID prior vaccination and no covid tested post vaccination. The Known allergies was Unknown and Other medical history was Extensive medical history due to unbalanced translocation of chromosomes 2 and 10.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain, Pain in jaw, Pyrexia
Clinical narrative: Painful injection site; High fever of 101.8 degree; Nauseous; Vomit (1x); Achy; Jaw hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Achy"; PYREXIA (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "High fever of 101.8 degree"; PAIN IN JAW (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Jaw hurt"; NAUSEA (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Nauseous"; VACCINATION SITE PAIN (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Painful injection site"; VOMITING (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Vomit (1x)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, nausea, vomiting, pain, pain in jaw.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Painful injection site; High fever of 101.8 degree; Nauseous; Vomit (1x); Achy; Jaw hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Achy"; PYREXIA (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "High fever of 101.8 degree"; PAIN IN JAW (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Jaw hurt"; NAUSEA (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Nauseous"; VACCINATION SITE PAIN (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Painful injection site"; VOMITING (non-serious) with onset 17May2022 at 01:00, outcome "recovering", described as "Vomit (1x)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, nausea, vomiting, pain, pain in jaw.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product - COVID 19 Treatment; product - COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm 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 "not recovered" and all described as "product - COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (17May2022) Positive, notes: positive antigen tests. 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.