chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Gait inability, Hypoaesthesia, Impaired work ability, Injury
Clinical narrative: my left arm and side of face went numb; my left arm and side of face went numb; felt ill for 2 wks; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 19Apr2021 as dose 1, single (Lot number: Er8731) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks.  Patient has not received other vaccine in four weeks. Patient has no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The following information was reported: MALAISE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "felt ill for 2 wks"; HYPOAESTHESIA (disability) all with onset 19Apr2021 at 16:30, outcome "not recovered" and all described as "my left arm and side of face went numb". Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, malaise. AE treatment (reported as): Doctor, therapy, chiropractor and even heart doctor. Clinical course: On 19Apr2021 patient received my first shot...30mins later his left arm and Side of face went numb...felt ill for 2 wks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200716747 same reporter/patient, different dose/event
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Malaise, Mobility decreased, Movement disorder, Muscle tightness
Clinical narrative: my left arm and side of face went numb; my left arm and side of face went numb; felt ill for 2 wks; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 19Apr2021 as dose 1, single (Lot number: Er8731) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks.  Patient has not received other vaccine in four weeks. Patient has no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The following information was reported: MALAISE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "felt ill for 2 wks"; HYPOAESTHESIA (disability) all with onset 19Apr2021 at 16:30, outcome "not recovered" and all described as "my left arm and side of face went numb". Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, malaise. AE treatment (reported as): Doctor, therapy, chiropractor and even heart doctor. Clinical course: On 19Apr2021 patient received my first shot...30mins later his left arm and Side of face went numb...felt ill for 2 wks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200716747 same reporter/patient, different dose/event
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal disorder, Neck pain, Pyrexia, Shock
Clinical narrative: my left arm and side of face went numb; my left arm and side of face went numb; felt ill for 2 wks; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 19Apr2021 as dose 1, single (Lot number: Er8731) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks.  Patient has not received other vaccine in four weeks. Patient has no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The following information was reported: MALAISE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "felt ill for 2 wks"; HYPOAESTHESIA (disability) all with onset 19Apr2021 at 16:30, outcome "not recovered" and all described as "my left arm and side of face went numb". Therapeutic measures were taken as a result of hypoaesthesia, hypoaesthesia, malaise. AE treatment (reported as): Doctor, therapy, chiropractor and even heart doctor. Clinical course: On 19Apr2021 patient received my first shot...30mins later his left arm and Side of face went numb...felt ill for 2 wks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200716747 same reporter/patient, different dose/event
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Malaise
Clinical narrative: 30 mins after first shot...left side of face and arm went numb...lasted rest of day...for about a week after felt numb come and go on left side face and arm..after getting second shot got only a fever for 2 days and was fine....two weeks after started feeling ill to stomach..then after a tight grip attacked my neck and right side of back and made my right arm go into shock and couldn't control right arm....then body went into shock like I couldn't walk and pain was severely intense in neck and back.....was checked for MS and nerve damage in neck(MRI) all came clear...could not walk up steps or hardly move....doctor more or less blew me off and reported nothing...when finally able to convince to get help went into hospital physical therapy where I was told I had signs of severe trama...at one point could hardly lift right are and carpal tunnel doctor sent me to more therapy where it was found my right side upper chest bone was pushing out of shoulder....after a change of doctors I was sent to chiropractor where I was told my neck, back and right arm shows signs of trauma still...I have done therapy and everything they wanted... I was even having chest pains to wear I failed a stress test and was sent to Medical Center....thankfully all came all clear..IT HAS BEEN ONE YEAR AND STILL I HAVE THIS PROBLEM WITH NO IDEA HOW I AM GOING TO MAKE MYSELF BETTER... I can't keep going on like this...I need help ..I'm trying to go to work but have problems everyday when it starts to cause me tightness...
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Bone disorder, Cardiac stress test abnormal, Chest pain
Clinical narrative: 30 mins after first shot...left side of face and arm went numb...lasted rest of day...for about a week after felt numb come and go on left side face and arm..after getting second shot got only a fever for 2 days and was fine....two weeks after started feeling ill to stomach..then after a tight grip attacked my neck and right side of back and made my right arm go into shock and couldn't control right arm....then body went into shock like I couldn't walk and pain was severely intense in neck and back.....was checked for MS and nerve damage in neck(MRI) all came clear...could not walk up steps or hardly move....doctor more or less blew me off and reported nothing...when finally able to convince to get help went into hospital physical therapy where I was told I had signs of severe trama...at one point could hardly lift right are and carpal tunnel doctor sent me to more therapy where it was found my right side upper chest bone was pushing out of shoulder....after a change of doctors I was sent to chiropractor where I was told my neck, back and right arm shows signs of trauma still...I have done therapy and everything they wanted... I was even having chest pains to wear I failed a stress test and was sent to Medical Center....thankfully all came all clear..IT HAS BEEN ONE YEAR AND STILL I HAVE THIS PROBLEM WITH NO IDEA HOW I AM GOING TO MAKE MYSELF BETTER... I can't keep going on like this...I need help ..I'm trying to go to work but have problems everyday when it starts to cause me tightness...
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Gait inability, Hypoaesthesia, Impaired work ability, Injury
Clinical narrative: 30 mins after first shot...left side of face and arm went numb...lasted rest of day...for about a week after felt numb come and go on left side face and arm..after getting second shot got only a fever for 2 days and was fine....two weeks after started feeling ill to stomach..then after a tight grip attacked my neck and right side of back and made my right arm go into shock and couldn't control right arm....then body went into shock like I couldn't walk and pain was severely intense in neck and back.....was checked for MS and nerve damage in neck(MRI) all came clear...could not walk up steps or hardly move....doctor more or less blew me off and reported nothing...when finally able to convince to get help went into hospital physical therapy where I was told I had signs of severe trama...at one point could hardly lift right are and carpal tunnel doctor sent me to more therapy where it was found my right side upper chest bone was pushing out of shoulder....after a change of doctors I was sent to chiropractor where I was told my neck, back and right arm shows signs of trauma still...I have done therapy and everything they wanted... I was even having chest pains to wear I failed a stress test and was sent to Medical Center....thankfully all came all clear..IT HAS BEEN ONE YEAR AND STILL I HAVE THIS PROBLEM WITH NO IDEA HOW I AM GOING TO MAKE MYSELF BETTER... I can't keep going on like this...I need help ..I'm trying to go to work but have problems everyday when it starts to cause me tightness...
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Malaise, Mobility decreased, Movement disorder, Muscle tightness
Clinical narrative: 30 mins after first shot...left side of face and arm went numb...lasted rest of day...for about a week after felt numb come and go on left side face and arm..after getting second shot got only a fever for 2 days and was fine....two weeks after started feeling ill to stomach..then after a tight grip attacked my neck and right side of back and made my right arm go into shock and couldn't control right arm....then body went into shock like I couldn't walk and pain was severely intense in neck and back.....was checked for MS and nerve damage in neck(MRI) all came clear...could not walk up steps or hardly move....doctor more or less blew me off and reported nothing...when finally able to convince to get help went into hospital physical therapy where I was told I had signs of severe trama...at one point could hardly lift right are and carpal tunnel doctor sent me to more therapy where it was found my right side upper chest bone was pushing out of shoulder....after a change of doctors I was sent to chiropractor where I was told my neck, back and right arm shows signs of trauma still...I have done therapy and everything they wanted... I was even having chest pains to wear I failed a stress test and was sent to Medical Center....thankfully all came all clear..IT HAS BEEN ONE YEAR AND STILL I HAVE THIS PROBLEM WITH NO IDEA HOW I AM GOING TO MAKE MYSELF BETTER... I can't keep going on like this...I need help ..I'm trying to go to work but have problems everyday when it starts to cause me tightness...
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal disorder, Neck pain, Pyrexia, Shock
Clinical narrative: 30 mins after first shot...left side of face and arm went numb...lasted rest of day...for about a week after felt numb come and go on left side face and arm..after getting second shot got only a fever for 2 days and was fine....two weeks after started feeling ill to stomach..then after a tight grip attacked my neck and right side of back and made my right arm go into shock and couldn't control right arm....then body went into shock like I couldn't walk and pain was severely intense in neck and back.....was checked for MS and nerve damage in neck(MRI) all came clear...could not walk up steps or hardly move....doctor more or less blew me off and reported nothing...when finally able to convince to get help went into hospital physical therapy where I was told I had signs of severe trama...at one point could hardly lift right are and carpal tunnel doctor sent me to more therapy where it was found my right side upper chest bone was pushing out of shoulder....after a change of doctors I was sent to chiropractor where I was told my neck, back and right arm shows signs of trauma still...I have done therapy and everything they wanted... I was even having chest pains to wear I failed a stress test and was sent to Medical Center....thankfully all came all clear..IT HAS BEEN ONE YEAR AND STILL I HAVE THIS PROBLEM WITH NO IDEA HOW I AM GOING TO MAKE MYSELF BETTER... I can't keep going on like this...I need help ..I'm trying to go to work but have problems everyday when it starts to cause me tightness...
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; 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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in left arm and on 26Mar2021 as dose 2, single (Lot number: EP6955) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "former smoker" (unspecified if ongoing), notes: former smoker; "Shrimp" (unspecified if ongoing), notes: known allergies: Shrimp. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as no. other medication in 2weeks was reported as no. anti viral details product was used for COVID 19 Treatment, brand: Paxlovid, treatment start date: 05May2022, treatment stop date: 10May2022, indication: Treatment of COVID-19. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: 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 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 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: "Interchange of vaccine" (unspecified if ongoing), notes: Primary series completed (dose 1 and 2) with covid-19 vaccine and manufacturer unknown. Concomitant medication(s) included: ADDERALL; ZOLOFT also which were other medication in 2 weeks product. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
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 contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "factor V Leiden heterozygous" (unspecified if ongoing), notes: factor V Leiden heterozygous. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE(medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound of COVID symptoms with home antigen test becoming positive again; Negative, notes: after being negative; Positive, notes: rebound of COVID symptoms with home antigen test becoming positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid treatment started on 02May2022 and stopped on 06May2022, Lot number=FY8914. Adverse event: After completing course of Paxlovid, rebound of COVID symptoms with home antigen test becoming positive again after being negative two days in a row. Patient was recovering. No treatment for adverse event.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 60.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 at 12:30 as dose 1, single (Lot number: ER8733), in left arm and on 17Apr2021 at 10:00 as dose 2, single (Lot number: ER8735) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 at 09:45 as dose 3 (booster), single (Lot number: 006D21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Moderate Cholesterol" (unspecified if ongoing), notes: Moderate Cholesterol; "Dose 1, 2 - Pfizer/ Dose 3 - Moderna" (unspecified if ongoing), notes: Dose 1, 2 - Pfizer/ Dose 3 - Moderna. Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2018, stop date: 28Apr2022; LANSOPRAZOLE, start date: 01Jan2019, stop date: 28Apr2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive, notes: Tested positive; (13May2022) positive, notes: Tested positive again. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive; COVID positive; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: FE2588) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03May2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 03May2022, outcome "unknown" and all described as "COVID positive"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03May2022, outcome "unknown", described as "flu like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive; (10May2022) Negative; (14May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional Information: Antiviral details: Product: COVID 19 Treatment (Paxlovid) on 03May2022 and stop date=08May2022. Indication is used for treatment of COVID-19. The patient had no Known allergies. The patient received other medication in 2 weeks Bystolic. Adverse event: The patient experienced COVID positive 03May with flu like symptoms. Started on Paxlovid same day. Good response. Completed course on 08May with strong metallic taste and diarrhea and mild muscle aches as side effects. Tested negative 10May. Again became symptomatic on 13May- marked Ronny nose, congestion, mild GI symptoms. tested positive on 14May. Adverse event start date is on 13May2022. If patient was not recovered. The patient did not receive treatment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), 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) 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). The patient's 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 "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 04Apr2022 at 20:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The vaccine received was yes. The patient received other medication in 2 weeks was no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. Antiviral details: product was COVID 19 Treatment, brand-Pfizer, Treatment start date -04May2022, Treatment stop date-09May2022, Indication: Treatment of COVID-19. Adverse event: I had stomach issues with Paxlovid. Adverse events start date: 06May2022. Adverse events start time 12:00 PM. If patient recovered: Recovered. Adverse events stop date: 09May2022. If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: product=COVID 19 Treatment, brand=pavlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=pavlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6207), in left arm and on 08Apr2021 as dose 2, single (Lot number: EP7533) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Dec2021 as dose 3 (booster), single (Lot number: 059H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "DIABETIS" (unspecified if ongoing). There were no concomitant medications. No other medication in 2weeks. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "product:COVID 19 Treatment, brand:paxlovid/vaccine brand:Pfizer / BioNTech". Treatment start date:12May2022..NO known allergies Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: En6203), in right arm, on 26Mar2021 as dose 2, single (Lot number: Er8730), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: Ew0175) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT; OMEPRAZOLE; LOSARTIN. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine? Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional Information: anti-viral details: COVID 19 Treatment (Paxlovid). treatment start date: 04May2022 and 08May2022. Indication is used for treatment of COVID-19. adverse event: Rebound infection following course of paxlovid. Completed course 08May Tested negative 10May. Experienced new symptoms and positive test starting 15May. adverse event start date: 15May2022. if patient not recovered. if the patient was not received treatment. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Reported Event: Rebound infection following course of paxlovid. Completed course 08May. Tested negative May 10th. Experienced new symptoms and positive test starting May 15th.  Amendment: This follow-up report is being submitted to amend previous information: To amend to update Vaccination date for dose 2, event coding for Covid recoded with Suspected COVID-19 and date format in narrative.
Age: 51.0
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) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, 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: "Rheumatoid arthritis" (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 "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product- COVID 19 Treatment, Brand: Pfizer, Treatment start date-29Apr2022, Treatment stop date- 03May2022, Indication- 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: Illness, Pyrexia
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was a senior women age 66 and has received the Covid-19 vaccine. Each time receiving the shot have gotten her very sick. Yesterday at 09:30 am she received her second booster shot. She started getting very sick after 10:00 pm. She had a fever of 101.8 all night with headache like she never had before. She wanted to ask why every time Ishe receive the shot and got extremely sick. She don't think she would get another booster. Her friends got the shot with no problem, and asked what made her get so sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 at 08:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: TEGRETOL; MONTELUKAST; BENICAR HCT.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID positive". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details included Covid-19 treatment with Paxlovid started on 13May2022 and ended on 13May2022. Other medication in 2 weeks product was Plaquinel. Consumer woke up with a facial rash and swelling on 14May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06May2022 at 13:00 as dose 4, (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "DMII" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "palpitations" (unspecified if ongoing). "Known allergies: Aldactone, Wellbutrin, morphine causes vomiting" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATENOLOL; PIOGLITAZONE; FLUOXETINE; JARDIANCE; LOSARTAN POTASSIUM; ATORVASTATIN; LORATADINE; B12 [CYANOCOBALAMIN]; D3; BYDUREON BCISE. Past drug history included: Morphine, reaction(s): "morphine causes vomiting", notes: morphine causes vomiting. The following information was reported: COVID-19 (medically significant) with onset 13May2022 at 12:00, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 13May2022 at 12:00, outcome "unknown". Therapeutic measures were taken as a result of covid-19 with Paxlovid (Lot: FY6859) on 12May2022.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroidectomy" (unspecified if ongoing); "Statin for cholesterol Control" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; SIMVASTATIN taken for blood cholesterol abnormal. The following information was reported: VACCINATION FAILURE (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, notes: Treatment of COVID-19; (14May2022) Positive, notes: I took a home test 6 days after my last dose, and I tested positive again. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METFORMIN. 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. Additional information: other medication in 2weeks: Yes, anti viral details ,product: COVID 19 Treatment, brand: Paxlovid, covid vaccine details ,vaccine brand: Other, vaccine brand other: Moderna, previous 3x were Pfizer, other medication details, other medication in 2weeks product: Metformin. Adverse event: Rebound infection 2plus weeks after taking Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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 had no relevant medical history and did not had any known allergies. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 16Apr2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with inhaler.   Clinical course: It was reported that adverse event 2 to 3 days after finishing treatment, patient got a severe cough. Much worse than before treatment. All other covid symptoms were managed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FR9896) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: well managed with medication; "high cholesterol" (unspecified if ongoing), notes: well managed with medication; "Known allergies: mussels" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2015; XYZAL, start date: Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05May2022 at 12:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive, notes: 12:00 AM, COVID 19 Treatment; (unspecified date) Negative, notes: Tested negative. Clinical course: : A resurgence of Covid symptoms 3 days after completion of Paxlovid 5 day regimen. Tested negative and felt well, Then symptoms returned, including headache, body aches, mild fever, sore throat, cough, runny nose and extreme fatigue. Paxlovid, Treatment start date=26Apr2022, Treatment stop date=01May2022.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; I tested positive on a rapid test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech"; COVID-19 (medically significant), outcome "not recovered", described as "I tested positive on a rapid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: covid-19 treatment; (12May2022) Negative, notes: 4 days after end of treatment I tested negative on a rapid test; (13May2022) Positive, notes: The next day (5days after end of treatment) I tested positive on a rapid test. Therapeutic measures were taken as a result of covid-19.Clinical course: adverse event- Metallic and acidic taste in mouth for entire course of treatment. 4 days after end of treatment patient tested negative on a rapid test. anti viral details: product- COVID 19 Treatment, brand- Paxlovid, treatment start date- 03May2022, treatment stop date- 08May2022, indication-Treatment of COVID-19. known allergies was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 79 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dilantin, reaction(s): "known allergies: Dilantin", notes: known allergies: Dilantin. 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: COVID 19 Treatment; (15May2022) Positive, notes: Positive test at 10 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptoms return and tested positive again 7 days; Symptoms return and tested positive again 7 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (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 "Symptoms return and tested positive again 7 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative for COVID 2 days after finishing treatment; Positive, notes: Symptoms return and tested positive again 7 days after finishing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Adverse event: Tested negative for COVID 2 days after finishing treatment. Symptoms return and tested positive again 7 days after finishing treatment. There was other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: caller had Covid for about 2-3 days; caller had Covid for about 2-3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8732), on 27Apr2021 as dose 2, single (Lot number: EW0158) and on 02Dec2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caller had Covid for about 2-3 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: Positive for Covid after three doses of vaccine. Therapeutic measures were taken as a result of vaccination failure, covid-19. clinical course: Caller states that the bitter taste woke her up around 01:30, 02:00 this morning. States she is not a complainer, but this is gross. Caller states that she drank water, milk, ate, had soda, brushed her teeth; the bitter taste is still there and the taste in her mouth alters the taste of other stuff too. Caller states that she tested positive for Covid yesterday. She started Paxlovid yesterday evening. The doctor and her think that the caller had Covid for about 2-3 days. Caller states she was upset because she has had the Covid Vaccines. Caller states that all three of them for her were the Pfizer Covid Vaccines.  No follow-up attempts are possible. No further information is expected.