chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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) (Physician).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2021 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: ATORVASTATIN, start date: 16Jun2022; ASPIRIN 81, start date: 16Jun2022. 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: Unknown result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 06May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment of covid-19 was by paxlovid, taken orally with start and stop date on May 2022. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech and Moderna; Pfizer / BioNTech and Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6206), in left arm and on 03Apr2021 as dose 2, single (Lot number: EP7533) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Oct2021 as dose 3 (booster), single (Lot number: 037F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. 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"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Pfizer / BioNTech and Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. 3 days after stopping taking paxlovid, symptoms were better and antigen test came out negative. Two days after this symptoms were back and antigen test was positive. Runny nose and loss of taste and smell during the rebound symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), on 24Oct2021 as dose 3 (booster), single (Lot number: Ff2590) at the age of 68 years, in left arm for Covid-19 immunisation; coviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 31Jan2021 as dose 1, single (Lot number: 007M20A), in left arm, on 28Feb2021 as dose 2, single (Lot number: 025A21A), in left arm and on 28Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional Information: Covid infection and severe symptoms returned three days after completing Paxlovid. Patient was not recovered. No treatment received for AE. No other medical history was reported. Vaccine received was yes. No other medication in 2 weeks. No follow up attempts are needed. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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: "Graves' disease" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Effexor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Additional information: Possible rebound. Only took 3 of 5 days. Pt reported helped reduce fever and symptoms significantly. Then tested neg. Then left for vacation 2 weeks later and had similar symptoms for 10 days while there.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech, Moderna; testing positive for covid; Pfizer / BioNTech, Moderna; testing positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 19Jun2022. Past drug history included: No for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech, Moderna; testing positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: testing positive for covid on 6/20. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 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: "LBBB" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "asthma" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "anxiety" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "orthostatic hypotension" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension. Concomitant medication(s) included: PROGESTERONE, start date: May2015; VIVELLE DOT, start date: May2015; SYMBICORT, start date: Dec2014; SODIUM CHLORIDE, start date: Jan2010; MONTELUKAST SODIUM, start date: Jan2010; PROZAC, start date: May2015, stop date: 08Jun2022; B100, start date: May2015; AZELASTINE HYDROCHLORIDE, start date: May2015; LEVOCETIRIZINE, start date: May2020. Past drug history included: Doxicyclin, reaction(s): "Known allergies: Doxicyclin", notes: Known allergies: Doxicyclin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks product: Multivitamin. Other medication in 2weeks brand: Solo. Other medication in 2weeks start date: 04Jun2015.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Burning sensation, COVID-19, Cough, Ear pain
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 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: "LBBB" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "asthma" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "anxiety" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "orthostatic hypotension" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension. Concomitant medication(s) included: PROGESTERONE, start date: May2015; VIVELLE DOT, start date: May2015; SYMBICORT, start date: Dec2014; SODIUM CHLORIDE, start date: Jan2010; MONTELUKAST SODIUM, start date: Jan2010; PROZAC, start date: May2015, stop date: 08Jun2022; B100, start date: May2015; AZELASTINE HYDROCHLORIDE, start date: May2015; LEVOCETIRIZINE, start date: May2020. Past drug history included: Doxicyclin, reaction(s): "Known allergies: Doxicyclin", notes: Known allergies: Doxicyclin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks product: Multivitamin. Other medication in 2weeks brand: Solo. Other medication in 2weeks start date: 04Jun2015.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 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: "LBBB" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "asthma" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "anxiety" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "orthostatic hypotension" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension. Concomitant medication(s) included: PROGESTERONE, start date: May2015; VIVELLE DOT, start date: May2015; SYMBICORT, start date: Dec2014; SODIUM CHLORIDE, start date: Jan2010; MONTELUKAST SODIUM, start date: Jan2010; PROZAC, start date: May2015, stop date: 08Jun2022; B100, start date: May2015; AZELASTINE HYDROCHLORIDE, start date: May2015; LEVOCETIRIZINE, start date: May2020. Past drug history included: Doxicyclin, reaction(s): "Known allergies: Doxicyclin", notes: Known allergies: Doxicyclin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks product: Multivitamin. Other medication in 2weeks brand: Solo. Other medication in 2weeks start date: 04Jun2015.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test positive, Upper-airway cough syndrome
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 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: "LBBB" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "asthma" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "anxiety" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "orthostatic hypotension" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension. Concomitant medication(s) included: PROGESTERONE, start date: May2015; VIVELLE DOT, start date: May2015; SYMBICORT, start date: Dec2014; SODIUM CHLORIDE, start date: Jan2010; MONTELUKAST SODIUM, start date: Jan2010; PROZAC, start date: May2015, stop date: 08Jun2022; B100, start date: May2015; AZELASTINE HYDROCHLORIDE, start date: May2015; LEVOCETIRIZINE, start date: May2020. Past drug history included: Doxicyclin, reaction(s): "Known allergies: Doxicyclin", notes: Known allergies: Doxicyclin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks product: Multivitamin. Other medication in 2weeks brand: Solo. Other medication in 2weeks start date: 04Jun2015.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 19Jun2022, Treatment stop date: 23Jun2022, lot number: Unknown, Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 14:00 as dose 1, single (Lot number: EP7533), in right arm, on 13Apr2021 at 14:00 as dose 2, single (Lot number: EW0161), in left arm, on 03Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ8757), in right arm and on 27May2022 at 11:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 18Jun2022, treatment stop date: 22Jun2022, lot number: FY6826, Indication: treatment of COVID-19, developed change in taste (metallic) almost right away 9 days after completing treatment, woke up with small, round bumps on shoulders, which later turned into full-blown hives everywhere. Also had (apparently) a rash inside my mouth, and any food caused a stinging pain, lasted a few days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Verbatim: other medical history: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: anti viral details. product: COVID 19 Treatment, brand: Paxlovid. Treatment start date: 12Jun2022,; treatment stop date: 19Jun2022, indication: Treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Recurrent cancer
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: cancer came back over different spots. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: RECURRENT CANCER (medically significant) with onset 28Jun2022, outcome "unknown", described as "He said he got his booster and his cancer came back over different spots.". Clinical course: It was reported that the patient was fine prior to vaccination and his cancer is all over after he received his booster shot. 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, COVID19
Symptoms: Body temperature, 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) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 48 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: "Pulmonary emboli" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "chronic urticaria" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; CRESTOR; TRULICITY; OMEPRAZOLE; JARDIANCE; METFORMIN; SPIRONOLACTONE; VITAMIN D 3; FISH OIL; BASAGLAR; XOLAIR; VITAMIN B NOS. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (30Jun2022) 98.7; (01Jul2022) 97; SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) Positive; (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Concomitants administered within 2 weeks of vaccine. On 22Jun2022, she started Paxlovid for treatment of COVID-19. Patient took her last treatment of Paxlovid on Sunday, 26Jun2022. She tested negative for COVID-19 on Monday, 27Jun (Day 9 after onset of symptoms). She had adverse event on 29Jun2022 at 06:15 am and given unknown treatment. Had a follow-up with her primary care on Wednesday, 29Jun and was given a clean bill of health. Thursday night (30Jun), she felt a bit warm, but temperature was 98.7. On 01Jul2022 (Friday), she woke up still feeling a bit warm, but temperature was only 97. Her throat feels a bit scratchy and so she decided to take a COVID-19 test and tested positive again.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 19Jun2022 to 23Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID on 02Apr2022; positive for COVID on 02Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Apr2022, outcome "unknown" and all described as "positive for COVID on 02Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2022) Positive, notes: she was positive for COVID on 02Apr2022.  Clinical Course: The reporter is a 56 year old female patient. She refers having her first series of the Pfizer Biontech COVID 19 vaccine last year and then her first booster on 18Oct2021. After that, she was positive for COVID on 02Apr2022. She was asymptomatic, not even had low energy according to her. She asks if she should get her second booster now or wait some months before getting it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic type 1" (unspecified if ongoing), notes: Other medical history: Diabetic type 1. Concomitant medication(s) included: LISINOPRIL.  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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (24Jun2022) Positive, notes: Tested slightly positive on 24Jun and 25Jun; (25Jun2022) Positive, notes: Tested slightly positive on 24Jun and 25Jun; (26Jun2022) Negative, notes: negative on 26Jun and 27Jun; (27Jun2022) Negative, notes: negative on 26Jun and 27Jun; (28Jun2022) Positive, notes: positive on 28Jun, 29Jun and 30Jun; (29Jun2022) Positive, notes: positive on 28Jun, 29Jun and 30Jun; (30Jun2022) Positive, notes: positive on 28Jun, 29Jun and 30Jun. Therapeutic measures were taken as a result of covid-19.  Additional clinical information: Anti-viral details, Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=19Jun2022,Treatment Stop date=23Jun2022. Adverse event: Rebounded after treatment. Tested slightly positive on 24Jun and 25Jun, negative on 26Jun and 27Jun and positive on 28Jun, 29Jun and 30Jun. Other medication in 2weeks product=Lisinopril. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "got 2 shots and the booster/just recovered from Covid omicron". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: I just recovered from Covid omicron. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient was prescribed Paxlovid. Active Drug substance names were Nirmatrelvir tablets and Ritonavir tablets. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 08:00 as dose 1, single (Lot number: EN6207), in right arm, on 02Apr2021 at 08:00 as dose 2, single (Lot number: ER8732), in right arm, on 08Oct2021 at 08:00 as dose 3 (booster), single (Lot number: EW0217), in right arm and on 07Apr2022 at 16:00 as dose 4 (booster), single (Lot number: Fk9894) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension;; "metastatic breast cancer survivor" (unspecified if ongoing), notes: other medical history: metastatic breast cancer survivor; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti viral details: COVID 19 treatment start date was 17Jun2022 and stop date was 21Jun2022. Rebound COVID on 30Jun. Report about covid treatment: Yes.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 75-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 at 14:15 as dose 4 (booster), single (Lot number: Fj4991) at the age of 75 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: "Atrial fibrillation" (unspecified if ongoing), notes: Other medical history: Afib; "Hay fever" (unspecified if ongoing), notes: Known allergies: Hay fever. I use Flonase daily. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: COVID 19 Treatment, Brand was Paxlavoid, Treatment start date was 09Jun2022 to 14Jun2022. other medication in 2weeks product: Xarelto, Atorvastatin and Flonase. Adverse event was Sluggish for a few days. Nose runny. Post nasal drip with throat clearing cough. Known allergies was Hay fever. patient use Flonase daily. Other medical history was Afib.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment / Rebound covid; COVID 19 Treatment / Rebound covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 12:00 as dose number unknown, single (Lot number: Eng202) at the age of 47 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment / Rebound covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment of Paxlovid for covid-19 from 8Jun2022 to 12Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
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 65-year-old male patient received BNT162b2 (BNT162B2, Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 03Apr2022 at 19:00 as dose 3 (booster), single (Lot number: FM0698) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 27Oct2021 at 13:00 as dose 2, single (Lot number: 058E21A), in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE, Vaccine brand unknown, Vaccine lot unknown and Vaccine dose number unknown: False), on 01Apr2021 at 10:00 as dose 1, single (Lot number: 1805031), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen", notes: known allergies: Naproxen. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Jun2022 at 07:00, outcome "unknown", COVID-19 (medically significant) with onset 29Jun2022 at 07:00, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: COVID 19 Treatment; (29Jun2022) Positive, notes: positive antigen test within 5 days of completing Paxlovid medication. Anti viral details: Product: COVID 19 Treatment. Brand: Paxlovid, Treatment start date: 18Jun2022, Treatment stop date: 23Jun2022. Adverse event: COVID rebound (positive antigen test within 5 days of completing Paxlovid medication). Report about covid treatment: Yes. If vaccine received: Yes. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech start date: 26May2022/ Treatment of COVID-19 start date: 20Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Report about COVID treatment was yes. The patient did not receive other medication in 2weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 51 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (29Jun2022) positive, notes: positive test, four days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: No Other medication in 2weeks.
Age: 55.0
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "eosinophilic esophagitis" (unspecified if ongoing); "elevated BP" (unspecified if ongoing); "dermatitis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FLUTICASONE PROPIONATE; CETRIZINE; MONTELUKAST SODIUM; SPIRONOLACTONE; PSEUDOEPHEDRINE HYDROCHLORIDE, start date: 13Jun2022, stop date: 21Jun2022; GUAIFENESIN, start date: 15Jun2022, stop date: 23Jun2022. Past drug history included: Biaxin, reaction(s): "Allergy: Biaxin", notes: digestive issues; Doxycycline, reaction(s): "Allergy: doxycycline", notes: digestive issues. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022 at 01:30, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: Finished Paxlovid on evening of 20Jun2022. Began home testing on 20Jun2022 and continued to test positive; (24Jun2022) Negative, notes: Finished Paxlovid on evening of 20Jun2022. Began home testing on 20Jun2022 and continued to test positive (results grew progressively more faint) until 24Jun2022, when I had a negative result; (25Jun2022) Positive, notes: On the following day (25Jun2022), I again tested positive (very faint); (30Jun2022) Positive, notes: have continued to test positive through yesterday (30Jun2022). Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 41 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Lot number: 027L20A) and on 11Feb2021 as dose 2, single (Lot number: 013M20A) for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medications within 2 weeks of Covid vaccine included: METFORMIN; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Negative, notes: tested negative on 28Jun2022; (01Jul2022) Positive, notes: tested positive for Covid on 01Jul2022. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 19Jun2022 to 24Jun2022.  Additional information: The patient had covid-19 rebound and was administered with Paxlovid from 19Jun2022. The patient was tested negative on 28Jun2022, noted nasal congestion on 30Jun2022 and later tested positive for Covid on 01Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 19Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "RA" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Prediabetic" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 31Jan2003; METFORMIN, start date: 31Dec2017; HYDROXYCHLOROQUINE SULFATE, start date: 31Dec2017; PANTOPRAZOLE SODIUM, start date: 31Dec2013; EVENING PRIMROSE, start date: 31Dec2001; CHROMIUM PICOLINATE, start date: 31Dec2015; ALLER-ITIN, start date: 30Apr2017; TURMERIC CURCUMIN, start date: 01May2018; PROBIOTICS, start date: 30Apr2018; OMEGA-3 NOS, start date: 31Dec2016; SAMBUCUS [SAMBUCUS NIGRA], start date: 30Apr2021; AIRBORNE, start date: 30Apr2020; ZINC, start date: 28Feb2022. Past drug history included: Codine for Known allergies: Codine; Wellbutrin for known allergies: Wellbutrin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Return of Covid Symptoms 3 days after finishing doses. Symptoms were worse then before medication. Symptoms lasted 10 days. with the cough continuing now. day 23. The patient treatment received Albuteral Inhaler. Antiviral details product COVID 19 Treatment, Paxlovid, treatment start date 07Jun2022, treatment stop date=11Jun2022,  lot number=FY7026, indication=Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.