chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: broke out in hives all over my back; have a painful knot in my left armpit that's swollen and hard for me to move my arm; have a painful knot in my left armpit that's swollen and hard for me to move my arm; have a painful knot in my left armpit that's swollen and hard for me to move my arm; This is a spontaneous report received from a non-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 02Aug2022 at 15:15 as dose 3 (booster), single (Lot number: FJ4991) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; CELEBREX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; VITAMIN D [VITAMIN D NOS]. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline". Vaccination history included: BNT162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Obscured by other product labelling, Prev dose administration date=15Sep2021,, Prev dose dose number=2,, Prev dose vaccine location=Left arm,), administration date: 15Sep2021, when the patient was 33-year-old, for COVID-19 Immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EW0175,, prev dose lot unknown=False,, prev dose administration date=14Aug2021,, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 14Aug2021, when the patient was 33-year-old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 03Aug2022, outcome "recovering", described as "broke out in hives all over my back"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset 03Aug2022, outcome "recovering" and all described as "have a painful knot in my left armpit that's swollen and hard for me to move my arm". Therapeutic measures were not taken as a result of urticaria, vaccination site pain, vaccination site swelling, vaccination site movement impairment.  Additional information: patient did not received other vaccine in four weeks. No treatment received for ae. Patient did not had covid prior vaccination and covid was not tested post vaccination patient has Known allergies with Amitriptyline Other medications in two weeks reported as Trazodone. Flexeril. Celebrex. Protonic. Vitamin D and Other medical history is reported as Osteoarthritis. Fibromyalgia. IBS.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years 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: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; UCERIS rectal. 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: (unspecified date) positive, notes: Treatment of COVID-19; (02Aug2022) negative, notes: tested negative 02Aug; (04Aug2022) positive, notes: Tested positive with minor new symptoms (runny nose, sore throat) 04Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2 weeks: Yes. Anti viral details: Product: COVID 19 Treatment. Brand: Paxlovid Treatment start date: 26Jul2022. Treatment stop date: 31Jul2022. Indication: Treatment of COVID-19.  Adverse event: Covid rebound, tested negative 02Aug. Tested positive with minor new symptoms (runny nose, sore throat) 04Aug. Adverse event start date: 04Aug2022. Ae resulted in: [None of the above]. If patient recovered: Recovering. If treatment ae: No. Other medical history: Crohn's disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, 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 43-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 had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE; LEVOTHYROXINE; FLUOXETINE. 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 treatment with Paxlovid for COVID-19 from 26Jul2022 to 30Jul2022. Patient had no known allergies or any other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cerebrovascular disorder, Head discomfort, Headache, Migraine
Clinical narrative: 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 06Apr2021 as dose 1, single (Lot number: ER8734) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zoaforte, reaction(s): "Known allergies: Zoaforte", notes: Known allergies: Zoaforte. The following information was reported: CEREBROVASCULAR DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "blood vessels in the brain are resonating"; TINNITUS (non-serious) with onset Jul2021, outcome "unknown", described as "buzzing sounds"; HEAD DISCOMFORT (non-serious) with onset Jul2021, outcome "not recovered", described as "feels as if I am being punched/assaulted at the base of my skull"; HEADACHE (non-serious) with onset Jul2021, outcome "not recovered", described as "headaches are intense/pounding headaches"; MIGRAINE (non-serious) with onset Jul2021, outcome "not recovered", described as "intense migraine attacks"; PALPITATIONS (non-serious) with onset Jul2021, outcome "not recovered", described as "pounding heartbeat"; ANXIETY (non-serious) with onset Jul2021, outcome "not recovered", described as "worried". The events "feels as if i am being punched/assaulted at the base of my skull", "worried", "pounding heartbeat", "intense migraine attacks", "buzzing sounds", "headaches are intense/pounding headaches" and "blood vessels in the brain are resonating" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, anxiety, palpitations, migraine, tinnitus, headache, cerebrovascular disorder. Additional information: COVID tested post vaccination. No other vaccine in four weeks. No other medication with in two weeks. Sender's Comments: Linked Report(s) : PFIZER INC-202201038243 Same reporter/Patient/AE, different Dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test, Tinnitus
Clinical narrative: 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 06Apr2021 as dose 1, single (Lot number: ER8734) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zoaforte, reaction(s): "Known allergies: Zoaforte", notes: Known allergies: Zoaforte. The following information was reported: CEREBROVASCULAR DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "blood vessels in the brain are resonating"; TINNITUS (non-serious) with onset Jul2021, outcome "unknown", described as "buzzing sounds"; HEAD DISCOMFORT (non-serious) with onset Jul2021, outcome "not recovered", described as "feels as if I am being punched/assaulted at the base of my skull"; HEADACHE (non-serious) with onset Jul2021, outcome "not recovered", described as "headaches are intense/pounding headaches"; MIGRAINE (non-serious) with onset Jul2021, outcome "not recovered", described as "intense migraine attacks"; PALPITATIONS (non-serious) with onset Jul2021, outcome "not recovered", described as "pounding heartbeat"; ANXIETY (non-serious) with onset Jul2021, outcome "not recovered", described as "worried". The events "feels as if i am being punched/assaulted at the base of my skull", "worried", "pounding heartbeat", "intense migraine attacks", "buzzing sounds", "headaches are intense/pounding headaches" and "blood vessels in the brain are resonating" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, anxiety, palpitations, migraine, tinnitus, headache, cerebrovascular disorder. Additional information: COVID tested post vaccination. No other vaccine in four weeks. No other medication with in two weeks. Sender's Comments: Linked Report(s) : PFIZER INC-202201038243 Same reporter/Patient/AE, different Dose.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 21Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 09Feb2022 as dose 4 (booster), single (Lot number: FK9729), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "osteosrthritis" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, stop date: 05Jul2022; TENORMIN; ENALAPRIL; ZOLOFT; TRAMADOL; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]; TYLENOL; XANAX; MUCINEX; SUDAFED 12 HOUR; FLONASE [FLUTICASONE PROPIONATE]. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:The patient received COVID -19 treatment with Paxlovid from 05Jul2022 to 10Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Alpha tumour necrosis factor, Antinuclear antibody, Blood pressure diastolic, Blood pressure systolic, Blood thyroid stimulating hormone
Clinical narrative: Postural orthostatic tachycardia syndrome; This is a literature report.  A 19-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 18 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor (normal high range 7.2): 12.8 pg/mL, notes: elevated; Antinuclear antibody: 1:80, notes: elevated; Blood pressure diastolic: 10 mmHg; Blood pressure systolic: 16 mmHg; Blood thyroid stimulating hormone: Normal; Echocardiogram: normal; Electrocardiogram: normal; Electrocardiogram ambulatory: normal; Full blood count: Normal; Heart rate: 62, notes: BPM; 130, notes: BPM; Heart rate variability test: showed a significant, notes: increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol; Interleukin level (normal high range 2.8): 6.2 pg/mL; Tilt table test: orthostatic tachycardia, notes: without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. A 19-year-old female-developed dizziness, headache, nausea, bloating, excessive sweating, and fatigue after 18 days of receiving a second dose of BioNTech-Pfizer COVID vaccine. She has no significant PMH and takes no medication. Her echocardiogram, EKG, and Holter were within normal. Autoimmune panel showed elevated ANA 1:80, elevated tumor necrosis factor-a 12.8 pg/ml (normal < 7.2 pg/mL), and interleukin 10 6.2 pg/mL (normal < 2.8 pg/mL). HUTT showed orthostatic tachycardia without OH, consistent with a diagnosis of POTS. HRV spectral Fourier analysis showed a significant increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol.; Sender's Comments: Based on available information, the causal association between the event postural orthostatic tachycardia syndrome and the suspect drug bnt162b2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Full blood count, Heart rate
Clinical narrative: Postural orthostatic tachycardia syndrome; This is a literature report.  A 19-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 18 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor (normal high range 7.2): 12.8 pg/mL, notes: elevated; Antinuclear antibody: 1:80, notes: elevated; Blood pressure diastolic: 10 mmHg; Blood pressure systolic: 16 mmHg; Blood thyroid stimulating hormone: Normal; Echocardiogram: normal; Electrocardiogram: normal; Electrocardiogram ambulatory: normal; Full blood count: Normal; Heart rate: 62, notes: BPM; 130, notes: BPM; Heart rate variability test: showed a significant, notes: increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol; Interleukin level (normal high range 2.8): 6.2 pg/mL; Tilt table test: orthostatic tachycardia, notes: without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. A 19-year-old female-developed dizziness, headache, nausea, bloating, excessive sweating, and fatigue after 18 days of receiving a second dose of BioNTech-Pfizer COVID vaccine. She has no significant PMH and takes no medication. Her echocardiogram, EKG, and Holter were within normal. Autoimmune panel showed elevated ANA 1:80, elevated tumor necrosis factor-a 12.8 pg/ml (normal < 7.2 pg/mL), and interleukin 10 6.2 pg/mL (normal < 2.8 pg/mL). HUTT showed orthostatic tachycardia without OH, consistent with a diagnosis of POTS. HRV spectral Fourier analysis showed a significant increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol.; Sender's Comments: Based on available information, the causal association between the event postural orthostatic tachycardia syndrome and the suspect drug bnt162b2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Heart rate variability test, Interleukin level, Postural orthostatic tachycardia syndrome, Tilt table test
Clinical narrative: Postural orthostatic tachycardia syndrome; This is a literature report.  A 19-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 18 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Alpha tumour necrosis factor (normal high range 7.2): 12.8 pg/mL, notes: elevated; Antinuclear antibody: 1:80, notes: elevated; Blood pressure diastolic: 10 mmHg; Blood pressure systolic: 16 mmHg; Blood thyroid stimulating hormone: Normal; Echocardiogram: normal; Electrocardiogram: normal; Electrocardiogram ambulatory: normal; Full blood count: Normal; Heart rate: 62, notes: BPM; 130, notes: BPM; Heart rate variability test: showed a significant, notes: increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol; Interleukin level (normal high range 2.8): 6.2 pg/mL; Tilt table test: orthostatic tachycardia, notes: without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome. A 19-year-old female-developed dizziness, headache, nausea, bloating, excessive sweating, and fatigue after 18 days of receiving a second dose of BioNTech-Pfizer COVID vaccine. She has no significant PMH and takes no medication. Her echocardiogram, EKG, and Holter were within normal. Autoimmune panel showed elevated ANA 1:80, elevated tumor necrosis factor-a 12.8 pg/ml (normal < 7.2 pg/mL), and interleukin 10 6.2 pg/mL (normal < 2.8 pg/mL). HUTT showed orthostatic tachycardia without OH, consistent with a diagnosis of POTS. HRV spectral Fourier analysis showed a significant increase in sympathetic tone after the head-up position. She responded fairly to salt tablets and propranolol.; Sender's Comments: Based on available information, the causal association between the event postural orthostatic tachycardia syndrome and the suspect drug bnt162b2 cannot be totally excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Blood pressure systolic, Blood thyroid stimulating hormone, Echocardiogram, Electrocardiogram
Clinical narrative: Postural orthostatic tachycardia syndrome; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Blood pressure diastolic: 18; Blood pressure systolic: 30; Blood thyroid stimulating hormone: normal; Echocardiogram: normal; Electrocardiogram: normal; Full blood count: normal; Heart rate: 53; 123; Heart rate variability test: showed an increased sympathetic activity with, notes: occasional spikes of vagal tone after the head-up position; Interleukin level (normal high range 2.8): 5.6 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.3): 10.4 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.1): 9.4 pg/mL, notes: showed increased titer levels; head-up tilt table (HUTT): showed orthostatic, notes: tachycardia without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heart rate, Heart rate variability test, Interleukin level, Investigation
Clinical narrative: Postural orthostatic tachycardia syndrome; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Blood pressure diastolic: 18; Blood pressure systolic: 30; Blood thyroid stimulating hormone: normal; Echocardiogram: normal; Electrocardiogram: normal; Full blood count: normal; Heart rate: 53; 123; Heart rate variability test: showed an increased sympathetic activity with, notes: occasional spikes of vagal tone after the head-up position; Interleukin level (normal high range 2.8): 5.6 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.3): 10.4 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.1): 9.4 pg/mL, notes: showed increased titer levels; head-up tilt table (HUTT): showed orthostatic, notes: tachycardia without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome; This is a literature report.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Blood pressure diastolic: 18; Blood pressure systolic: 30; Blood thyroid stimulating hormone: normal; Echocardiogram: normal; Electrocardiogram: normal; Full blood count: normal; Heart rate: 53; 123; Heart rate variability test: showed an increased sympathetic activity with, notes: occasional spikes of vagal tone after the head-up position; Interleukin level (normal high range 2.8): 5.6 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.3): 10.4 pg/mL, notes: showed increased titer levels; Interleukin level (normal high range 2.1): 9.4 pg/mL, notes: showed increased titer levels; head-up tilt table (HUTT): showed orthostatic, notes: tachycardia without OH, consistent with a diagnosis of POTS. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200033614 Same article/ drug/event and different patient.;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Investigation, Myasthenia gravis
Clinical narrative: diagnosed with myasthenia gravis/trouble with her vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2021 at 01:15 as dose 2, single (Lot number: EP6955) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREVACID. Vaccination history included: BNT162b2 (DOSE 1, lot number EP7533, at 09Apr2021 12:00 PM, vaccine location Left arm), administration date: 09Apr2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: MYASTHENIA GRAVIS (caused and prolonged hospitalization, disability, life threatening) with onset 07May2021 at 13:15, outcome "recovering", described as "diagnosed with myasthenia gravis/trouble with her vision". The patient was hospitalized and prolonged hospitalization for myasthenia gravis (hospitalization duration: 25 day(s)). The event "diagnosed with myasthenia gravis/trouble with her vision" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (2021) myasthenia gravis; Lab tests: (2021) Nothing wrong. Therapeutic measures were taken as a result of myasthenia gravis. Clinical course: No other vaccine in four weeks. No covid tested prior and post vaccination. No Known allergies. Within a week of receiving the second dose, patient had trouble with her vision. She saw her eye doctor, nothing wrong, she saw her general practitioner, bunch of test, nothing wrong, saw a neurologist many many tests including a blood test where she was diagnosed with myasthenia gravis. AE treatment included Thyectomy, 17 plasmapheresis treatments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID Rebound; COVID Rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Aug2022 at 12:00, outcome "not recovered" and all described as "COVID Rebound". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was not received other medication in two weeks. Antiviral details reported as Paxlovid for COVID-19 treatment start date: 27Jul2022 and stop date 01Aug2022. All vaccine lot number reason was reported as not available/provided to reporter at the time of report completion. Adverse event was not resulted in physician office or emergency room visit. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Covid after getting 3 doses of Pfizer Covid vaccine; got Covid after getting 3 doses of Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), on 09Apr2021 as dose 2, single (Lot number: EN6206) and on 12Oct2021 as dose 3 (booster ), single (Lot number: FE3590) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 14Jul2021, outcome "unknown", VACCINATION FAILURE (medically significant) with onset 14Jul2022, outcome "unknown" and all described as "got Covid after getting 3 doses of Pfizer Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that the patient had a rebound case after treatment of Paxlovid. On 14Jul2022, first tested positive for Paxlovid. Started Paxlovid on 15Jul2022, finished the treatment on 20Jul2022. Tested positive again for COVID last night 03Aug2022. She stated that she did receive the Pfizer Covid vaccines. She also stated that she had the metallic taste in her mouth and felt like she was sweating out a fever while on the medication, clammy and sweating, exact dates unknown.
Age: 44.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 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. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Tested positive for Covid about one week after completing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient received no other medication in 2 weeks. The patient received anti-viral Paxlovid (lot number:1918528A) from 27Jul2022 to 31Jul2022 for Covid 19 Treatment. No known allergies were reported. The other medical history 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: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: droopy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Lot number: FL8094) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "droopy".  Additional information: The report was not related to study or programme. The reporter stated that her daughter got Pfizer vaccine, clarifying that it was the Pfizer covid vaccine. She was not a doctor obviously, her daughter did not have a crazy reaction with the covid vaccine, she was just droopy but no reaction. She did completely different day, she was 10 years old, she was 9 at the time, but this has nothing to do with her, it was a different time when she got it, she did it in Mar2022 or Apr2022, whenever they authorized vaccines for kids. When probed for her daughter Lot and Expiry of the Covid vaccine, reporter declined as she does not feel it was relevant to provide.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0162), on 04May2021 as dose 2, single (Lot number: EW0171) and on 13Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "carrier for hemophilia A" (unspecified if ongoing), notes: other medical history: carrier for hemophilia A; "high cholesterol" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing); "Known allergies: medical tape/adhesive" (unspecified if ongoing); "known allergies: mushrooms" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; LISINOPRIL.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive; (30Jul2022) Negative, notes: On 30Jul I tested negative and was feeling mostly better; (05Aug2022) Positive, notes: Had a positive test on 05Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound case of covid. Tested positive on 21Jul2022. Started 5 day course of Paxlovid which was completed. On 30July, She was tested negative and was felt mostly better. She Started exhibiting new symptoms on 03Aug and Had a positive test on 05Aug. Other medications which were administered in 2 weeks were Pristiq, Lisinopril and Birth control. Patient received treatment for covid-19 include antiviral vaccine of Paxlovid on :21Jul2022 and was stopped on 25Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Caller states that her Booster shot was Pfizer; she tested positive for covid; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FJ4489) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 04Feb2021 as dose 1, single (Lot number: 007M20A), on 04Mar2021 as dose 2, single (Lot number: 036A21A) and on 24Oct2021 as dose 3 (booster),single (Lot number: 014F21A) for covid-19 immunisation. The patient's relevant medical history included: "Allergy NOS" (unspecified if ongoing), notes: She is allergic to so many things. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 31Jul2022, outcome "unknown", described as "Caller states that her Booster shot was Pfizer"; COVID-19 (medically significant) with onset 31Jul2022, outcome "unknown", described as "she tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jul2022) Positive, notes: tested positive for covid on Sunday 31JUL2022. Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products. Clinical Course: Reporter stated that she was taking the Paxlovid. She had a question about it, she tested positive for covid on Sunday 31Jul2022. She started taking Paxlovid on Tuesday and has been taking it for 3 days. She had also had the covid vaccines, all 4 of them. The doctor suggested that since she would had mild case of covid that she might want to try the Paxlovid. reporter stated that she had been taking it, and she was not known, she  she was getting better, she was no congested, she had a little cough and nose running, but with the Paxlovid she was noticing that she feels agitated. reporter asks is it okay to stop taking the paxlovid. Reporter clarified that she had 4 doses in total, the first 3 were from Moderna, the last shot she got was from Pfizer.
Sex: M
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 70-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EL3249), in right arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: ff2588), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Plaque Psoriasis" (unspecified if ongoing), notes: other medical: history Plaque Psoriasis; "known allergies: bee stings" (unspecified if ongoing), notes: known allergies: bee stings. There were no concomitant medications. The patient did not receive any other medication in 2 weeks. 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, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 03Jul2022 to 08Jul2022.  Clinical course: He started feeling bad on Saturday 02Jul. After taking Paxlovid starting on 03Jul for 5 days his symptoms seem to go away. Then around 4 to 5 days later his symptoms returned. The symptoms were just about the same as the initial symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "allergic to: Augmentin", notes: specifically the clavulanic acid part; Codeine, reaction(s): "allergic to: Codeine"; Protonix, reaction(s): "allergic to: Protonix"; Cymbalta, reaction(s): "allergic to: Cymbalta", notes: this is a major reaction; Neurontin, reaction(s): "allergic to: Neurontin"; Oxycodone with percocet, reaction(s): "allergic to: Oxycodone with Percocet"; Tramadol, reaction(s): "allergic to: Tramadol"; Toradol, reaction(s): "allergic to: Toradol".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Tested positive for COVID-19 on Saturday.  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, 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 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 included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Non-steroidal anti-inflammatory drugs (NSAIDS)" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: Other medical history: (Hypertension) HTN, reflux, high cholesterol; "reflux" (unspecified if ongoing), notes: Other medical history: (Hypertension) HTN, reflux, high cholesterol; "high cholesterol" (unspecified if ongoing), notes: Other medical history: (Hypertension) HTN, reflux, high cholesterol. Concomitant medication(s) included: LOSARTAN; PROGESTERONE; HYDROCHLOROTHIAZID; ESTROGEN; PRAVASTATIN; PROTONIX [OMEPRAZOLE]. 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: (unspecified date) Negative, notes: I previously tested negative on day 6 of the first bout of covid; (05Aug2022) Positive, notes: I did a home rapid test today, on day 11 after contracting covid, before babysitting my grandchildren and it is positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I did a home rapid test today, on day 11 after contracting covid, before babysitting my grandchildren and it is positive. I previously tested negative on day 6 of the first bout of covid. I took a course of paxlovid from 26Jul to 30Jul. I have no symptoms. Anti-viral details : paxlovid, COVID 19 Treatment, Treatment start date=26Jul2022 Treatment stop date=30Jul2022, Lot number=2692129, Indication=Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.