chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 at 14:00 as dose 1, single (Lot number: EN5319), on 20Feb2021 at 14:45 as dose 2, single (Lot number: EN6198), in left arm, on 12Nov2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 08May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing); "known allergies;Gluten due to celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (23Jun2022) Positive, notes: Rebound Covid infection. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid Treatment start date: 12Jun2022; Treatment stop date=18Jun2022, Indication=Treatment of COVID-19
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccine brand=Pfizer / BioNTech, product=COVID 19 Treatment; Vaccine brand=Pfizer/BioNTech, product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 07Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovering", described as "Vaccine brand=Pfizer / BioNTech, product=COVID 19 Treatment"; COVID-19 (medically significant), outcome "recovering", described as "Vaccine brand=Pfizer/BioNTech, product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 100.1 Centigrade, notes: began running a fever 100.1; SARS-CoV-2 test: positive, notes: Tested positive for COVID-19 after having been negative for 5 days. 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Indication for use in the case: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid from 17Jun2022 to 21Jun2022 for treatment of COVID-19. The patient had rebound covid symptoms after 4 days of finishing Paxlovid and positive rapid test after 5 days from 25Jun2022.  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 limited information in the case narrative, a causal association between reported events and suspect cannot be excluded. case will be reassessed upon receipt of further information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), on 06Apr2021 as dose 2, single (Lot number: ER8737), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 06May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Congenital Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Influenza like illness, Pain in extremity
Clinical narrative: sore arm; slight flu like symptoms; 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 female patient received BNT162b2 (BNT162B2), on 06Apr2021 at 10:00 as dose 2, single (Lot number: EW0151) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 1978 (unspecified if ongoing); "illness" (unspecified if ongoing); "B/P" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Hormone" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE ACCORD oral taken for blood pressure measurement, start date: 2012 (ongoing); CITALOPRAM oral taken for depression, start date: 2019 (ongoing); ESTRADIOL [ESTRADIOL BENZOATE] oral taken for hormone therapy, start date: 1999 (ongoing); WELLBUTRIN oral taken for depression, start date: 2012 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2020 (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 9:30, Anatomical Site of injection: Upper arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EN6208), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "Sore arm", "Slight flu like symptoms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "slight flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: I had just sore arm and slight flu like symptoms with first immunizations. Lasted 2 days- 4rth (2nd booster) on my 14May2022 reaction was horrible but nothing needing hospital, (husband through I should) Injection site was hot and red for about 2 weeks whole arm ached and today that muscle is still sore.  Had temp around 100 degree for about a week. Extremely tired and achy and brain fog. Every joint ached and had headache off and on. I looked pale and felt like warm than cold-This basically went for 2 weeks. The muscle in my arm still aches when I use left arm. I still do not have my energy back all the way. So the worst is over but not truly recovered 100 (percent).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: sore arm; slight flu like symptoms; 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 female patient received BNT162b2 (BNT162B2), on 15Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 1978 (unspecified if ongoing); "Illness" (unspecified if ongoing); "B/P" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Hormone" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE oral taken for blood pressure abnormal, start date: 2012 (ongoing); CITALOPRAM oral taken for depression, start date: 2019 (ongoing); ESTRADIOL oral taken for hormone therapy, start date: 1999 (ongoing); WELLBUTRIN oral taken for depression, start date: 2012 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2020 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Route of administration: Intramuscular; Anatomical site: upper arm; Vaccine administration time: 9:30), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "slight flu like symptoms"; BNT162b2 (DOSE 2, SINGLE; Lot number: EW0151; Route of administration: Intramuscular; Anatomical site: upper arm; Vaccine administration time: 10:00), administration date: 06Apr2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "slight flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "slight flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The patient had just sore arm and slight flu like symptoms with first 3 immunizations. Lasted 2 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No specific relevant test for thromboembolic events with thrombocytopenia.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 15Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "metabolic syndrome" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "known allergies: all penicillin based meds" (unspecified if ongoing), notes: known allergies: all penicillin based meds. Concomitant medication(s) included: FLUOXETINE; PHENTERMINE; VITAMIN D3; EXCEDRIN MIGRAINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". It was reported that patient has taken Multivitamin as other medications within 2 weeks of vaccination. 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 with Paxlovid start date of the treatment as 16Jun2022 and stop date of the treatment as 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: 301358A) 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), 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: COVID 19 Treatment; Positive, notes: positive PCR test 1.5 days after recurrence of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 74.0
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 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6207), in right arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN, start date: 30Jun2014, stop date: 12Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received vaccine and other medication in two weeks. The patient received COVID 19 Treatment from 12Jun2022 to 17Jun2022. Covid-19 recurred a week after testing negative after the previous infection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vitamin B12 deficiency
Clinical narrative: Vitamin B12 deficiency; 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 received BNT162b2 (BNT162B2), on 11Apr2021 as dose 2, single (Lot number: EW0153) at the age of 49 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "choroidal melanoma", start date: Oct2012 (ongoing), notes: Pertinent details: plaque therapy (radioactive) left eye; "Dad allergic to penicillin." (unspecified if ongoing), notes: Dad allergic to penicillin. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Date: 21Mar2021, Time: ?, Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot Number: ER2613), administration date: 21Mar2021, when the patient was 49-year-old, for Covid-19 immunization. The following information was reported: VITAMIN B12 DEFICIENCY (non-serious) with onset 16Apr2022, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took dose 3 on 30Dec2021 on right arm intramuscular (Batch/Lot Number: Moderna 069F21A .25 mcg).
Age: 35.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Nov2021 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: my first positive test; Negative, notes: tested negative six days later. I subsequently remained negative for two more days; Positive, notes: On the third day my symptoms returned and I again tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After the onset of symptoms and first positive test, took the full course of Paxlovid and tested negative six days later subsequently remained negative for two more days. On the third day  symptoms returned and again tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
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 60-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 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: "CTEPH" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. Concomitant medication(s) included: OPSUMIT, start date: 14Apr2021; ORENITRAM, start date: 06Sep2015; ADEMPAS, start date: 16Jan2014; JANTOVEN, start date: 04May2008; SYMBICORT; SPIRONOLACTONE, start date: 10Jan2016. Past drug history included: Platelets, reaction(s): "known allergies Platelets", notes: known allergies Penicillin, Platelets. 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 information: The patient had other medication in 2 weeks.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Took paxlovid with diagnosis of covid; Took paxlovid with diagnosis of covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "varicose veins" (unspecified if ongoing); "mucocele of maxillary sinus" (unspecified if ongoing), notes: mucocele of maxillary sinus; "vit d deficiency" (unspecified if ongoing); "recurrent UTI's wtih voiding dysfunction" (unspecified if ongoing), notes: recurrent UTI's; "recurrent UTI's wtih voiding dysfunction" (unspecified if ongoing), notes: voiding dysfunction; "s/p mastectomy" (unspecified if ongoing), notes: s/p mastectomy. The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: ciprofloxacin", notes: Known allergies: ciprofloxacin.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Took paxlovid with diagnosis of covid". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Adverse event: Took paxlovid with diagnosis of covid and 3 days after completion of paxlovid, became very ill with cold symptoms, severe fatigue, "feeling feverish", head congestion. Never did testing in between to determine if she was negative following treatment but felt much better at that time. now with pounding heartbeat feeling,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 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. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. Patient was not taking other medication in past 2 weeks. patient was taking treatment of Paxlvoid for covid 19, Treatment start date: 20Jun2022, Treatment stop date: 23Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years, 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: At Day 10, Covid symptoms recurred indication=Treatment of COVID-19. Therapeutic measures (Paxlovid) taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid taken from 17Jun2022 to 21Jun2022 for treatment of COVID-19. At Day 10, Covid symptoms recurred. Adverse event start date: 26Jun2022 (as reported). Known allergies: Not that patient known of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment/ positive rapid test; COVID-19 Treatment/ positive rapid test; 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 male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: ER8727) at the age of 40 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; PSEUDOEPHEDRINE; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROBIOTICS daily. Past drug history included: Meloxicam, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment/ positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: tested positive for covid-19 in early June; (Jun2022) Negative, notes: On days 9 and 11 tested negative on rapid tests; (Jun2022) Negative, notes: On days 9 and 11 tested negative on rapid tests; (Jun2022) Positive, notes: tested positive on two rapid tests; (Jun2022) Positive, notes: tested positive on two rapid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was tested positive for covid-19 in early June. The patient have asthma and his doctor prescribed paxlovid, which he began taking on Day 3 of symptoms (day following positive rapid test). At the time patient had a high fever for two days, but showed steady improvement after starting paxlovid (days 3-7). On days 9 and 11 tested negative on rapid tests, and most of symptoms had improved other than an occasional cough and fatigue. On day 14, the patient began experiencing some a sore throat and mild acheyness. On day 15 my symptoms were more severe including acheyness, mild chills and mild fever, and tested positive on two rapid tests.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer/BioNTech/Treatment of COVID-19; Pfizer/BioNTech/Treatment of COVID-19/ Had COVID symptoms sore throat, stuffed-up head, fever, dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster) single (Lot number: FH8030), in left arm and on 23Feb2022 as dose 4 (booster), single (Lot number: ik9893) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 26Jan2021 as dose 1, single (Lot number: 012M20A), in left arm and on 25Feb2021 as dose 2, single (Lot number: 014M20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan2000; SIMVASTATIN, start date: Dec1989, stop date: 17Jun2022. Past drug history included: Amoxycillin, reaction(s): "Allergy". The patient received past medications (unspecified) in Dec1989 and Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Jun2022, outcome "not recovered", described as "Pfizer/BioNTech/Treatment of COVID-19"; COVID-19 (medically significant) with onset 18Jun2022, outcome "not recovered", described as "Pfizer/BioNTech/Treatment of COVID-19/ Had COVID symptoms sore throat, stuffed-up head, fever, dry cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive; (24Jun2022) Negative; (25Jun2022) Negative; (28Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Had COVID symptoms 16Jun2022 sore throat, stuffed-up head, fever, dry cough. The patient had been tested positive for Covid-19 on 18Jun2022. Symptoms abated starting 19Jun. The patient's PCR test was negative on 24Jun and 25Jun. Symptoms returned 27Jun - sore throat, stuffed up head. The patient's PCR test was positive on 28Jun. The patient was prescribed with Paxlovid on 18Jun2022. Took according to directions for 5 days. The patient received Paxlovid as treatment for Covid-19 from 17Jun2022 to 21Jun2022.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had a headache, pretty severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 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 included: "ulcerative colitis" (not ongoing), notes: had ulcerative colitis prior to getting any of the vaccines. There were no concomitant medications. Past drug history included: Levofloxacin, reaction(s): "Drug allergy", notes: Brand name Levaquin; allergic to whatever is active in both the generic and brand name of the medication. Vaccination history included: BNT162b2 (Dose 1, single, Only says Pfizer COVID-19 vaccine purple cap., NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 23Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Only says Pfizer COVID-19 vaccine purple cap., NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 13Apr2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Had a headache, pretty severe headache". Therapeutic measures were taken as a result of headache.  Additional information: Other conditions was noted as no. For the first and second boosters patient received, the reason for those doses was because patient had ulcerative colitis, which is an autoimmune condition. It was confirmed that patient had ulcerative colitis prior to getting any of the vaccines. Family medical history relevant to adverse event was noted as no. Patient only had one known drug allergy, that was to an antibiotic with the generic name levofloxacin, brand name Levaquin, patient was allergic to whatever was active in both the generic and brand name of the medication. Anatomical location of suspect dose was noted as upper left arm. Vaccination facility type was noted as other (medical facility). Vaccine administered at military facility was noted as no. Other products was noted as no. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was noted as no. List all vaccines administered on same date with the Pfizer vaccine considered as suspect noted as no. It was reported that patient had a headache, pretty severe headache, after the first booster but that was really it and the headache only lasted on and off for a day, took an Excedrin or caffeine acetaminophen aspirin combination drug for his headache. The event did not required emergency room or physician office visit. Investigations was noted as no. Relevant tests was noted as none.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 59.0
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 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 28Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: asthma; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, latex; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: penicillin, latex. Concomitant medication(s) included: SYMBICORT. The following information was reported: VACCINATION FAILURE (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. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment/Vaccination failure; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EM9810), on 25Apr2021 as dose 2, single (Lot number: EW0175), on 17Aug2021 as dose 3 (booster), single (Lot number: FC3182) and on 16Jan2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "History of cancer (AML) treatment (Vidaza, Venetoclax) ongoig." (ongoing); "Chronic GVHD" (unspecified if ongoing); "CKD" (unspecified if ongoing); "lymphedema (lower legs and feet)" (unspecified if ongoing). Concomitant medication(s) included: ISAVUCONAZONIUM; SODIUM FLUORIDE 5000 PLUS; CALCIUM 500+D; ATOVAQUONE; ATORVASTIN; SIROLIMUS; PENTOXIFYLLINE; VENETOCLAX; AMLODIPINE; GRANISETRON; DOCUSATE; PANTOPRAZOLE; VALACYCLOVIR [VALACICLOVIR]; CYANOCOBALAMIN. Past drug history included: Cytarabine, reaction(s): "allergies", notes: Known allergies: Yes. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 Treatment"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 Treatment/Vaccination failure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical Course: Patient received anti-viral treatment, started from 16jun2022 to 21 jun2022 for covid-19 with lot number GC4718 and treatment of COVID-19. also, patient received other medication in 2weeks which includes Multivitamin-min-folic-vit K lycopodium 400-20-370 mcg tablet. Mild symptoms of covid was reported as (sore throat, nasal congestion, runny nose, dry cough). The vaccine received reported as yes. Other medication in 2weeks reported as yes.
Age: 30.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral treatment start date was 12Jun2022 to 17Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had covid, took Paxlovid, 07Jun -11Jun.  Tested antigen and PCR sputum negative 11Jun & 17Jun; Had covid, took Paxlovid, 07Jun -11Jun.  Tested antigen and PCR sputum negative 11Jun & 17Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 at 13:00 as dose 4 (booster), single (Lot number: FJ49E9) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 at 01:00 as dose 1, single (Lot number: 032L20A), in right arm, on 02Mar2021 at 13:00 as dose 2, single (Lot number: 032L20A), in left arm and on 26Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 071F214), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", described as "Had covid, took Paxlovid, 07Jun -11Jun. Tested antigen and PCR sputum negative 11Jun & 17Jun. Husband became covid positive with symptoms 17Jun. I tested positive home test and PCR sputum test on 19Jun"; COVID-19 (medically significant), outcome "recovered", described as "Had covid, took Paxlovid, 07Jun -11Jun. Tested antigen and PCR sputum negative 11Jun & 17Jun. Husband became covid positive with symptoms 17Jun. I tested positive home test and PCR sputum test on 19Jun." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) UNKNOWN RESULTS, notes: Had covid,took Paxlovid, 07Jun -11Jun; (19Jun2022) positive, notes: I tested positive home test and PCR sputum test on 19Jun; (23Jun2022) negative, notes: I tested negative home test on 23Jun; (11Jun2022) negative, notes: Tested antigen and PCR sputum negative 11Jun & 17Jun; (17Jun2022) negative, notes: Tested antigen and PCR sputum negative 11Jun & 17Jun; (19Jun2022) positive, notes: I tested positive home test and PCR sputum test on 19Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient dad covid, took Paxlovid from 07Jun to 11Jun. Tested antigen and PCR sputum negative 11Jun & 17Jun. Her husband became covid positive with symptoms on 17Jun. She tested positive home test and PCR sputum test on 19Jun. No symptoms. She tested negative home test on 23Jun. Her husband was still positive and became symptom free on 25Jun.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 10:00 as dose 1, single (Lot number: FG3527) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "colon cancer" (unspecified if ongoing), notes: 10+years ago. The patient took concomitant medications. The following information was reported: VERTIGO (non-serious) with onset Nov2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient was tested for COVID post vaccination. Patient used Birth control medications in two weeks and Vertigo sudden onset 2 days later. Now common and happening more frequently.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Product administered at inappropriate site, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever and chills 72 hours after vaccine given; fever and chills 72 hours after vaccine given; age: 2 Years; vaccine location: Left leg; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 2-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 24Jun2022, outcome "unknown", described as "age: 2 Years"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Jun2022, outcome "unknown", described as "vaccine location: Left leg"; CHILLS (non-serious), PYREXIA (non-serious) all with onset 27Jun2022, outcome "recovering" and all described as "fever and chills 72 hours after vaccine given". Therapeutic measures were not taken as a result of chills, pyrexia.  Clinical information: Vaccine facility type was other. No other vaccine in four weeks and no other medications in two weeks. The patient has no known allergies and no other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 Batch/Lot No: FL8095; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: FP6955), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145417), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FL8095) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; CITRACAL + D3; BIOTIN; PROBIOTIC 10; LEVOTHYROXINE; VALACYCLOVIR HCL; TRAZODONE; ONE-A-DAY ACTIVE. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 21Apr2022, outcome "unknown", described as "Dose Number: 4 Batch/Lot No: FL8095"; 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=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Adverse event- After sixth dose of medication -Profuse sweating, nausea, vomiting, increased blood pressure, reduced heart rate - 60 BPM. Allergies with Codeine.Other medical history- Hyperthyroidism, depression, obesity, insomnia.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Language disorder, Movement disorder, SARS-CoV-2 test
Clinical narrative: received three Pfizer BioNTech Covid 19 vaccines but now has COVID; received three Pfizer BioNTech Covid 19 vaccines but now has COVID; he can barely move; has been sick for two days; he can barely talk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: FR6955), on 16Apr2021 as dose 2, single (Lot number: ER8720) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 51 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Jun2022, outcome "recovered" (Jun2022), described as "has been sick for two days"; MOVEMENT DISORDER (non-serious) with onset Jun2022, outcome "unknown", described as "he can barely move"; LANGUAGE DISORDER (non-serious) with onset Jun2022, outcome "unknown", described as "he can barely talk"; VACCINATION FAILURE (medically significant) with onset 27Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 27Jun2022, outcome "not recovered" and all described as "received three Pfizer BioNTech Covid 19 vaccines but now has COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive, notes: has tested positive for COVID.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: received three Pfizer BioNTech Covid 19 vaccines but now has COVID; received three Pfizer BioNTech Covid 19 vaccines but now has COVID; he can barely move; has been sick for two days; he can barely talk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: FR6955), on 16Apr2021 as dose 2, single (Lot number: ER8720) and on 28Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 51 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Jun2022, outcome "recovered" (Jun2022), described as "has been sick for two days"; MOVEMENT DISORDER (non-serious) with onset Jun2022, outcome "unknown", described as "he can barely move"; LANGUAGE DISORDER (non-serious) with onset Jun2022, outcome "unknown", described as "he can barely talk"; VACCINATION FAILURE (medically significant) with onset 27Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 27Jun2022, outcome "not recovered" and all described as "received three Pfizer BioNTech Covid 19 vaccines but now has COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive, notes: has tested positive for COVID.