chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Magnetic resonance imaging
Clinical narrative: I was diagnosed with COVID; three (Pfizer COVID-19 Vaccine) that I have taken; I was diagnosed with COVID; three (Pfizer COVID-19 Vaccine) that I have taken; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203, Expiration Date: 30Jun2021), on 15Mar2021 as dose 2, single (Lot number: EN6207, Expiration Date: 31Jul2021) and on 01Dec2021 as dose 3 (booster), single (Lot number: 32030DD, Expiration Date: 28Feb2022) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Pulmonary embolism" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Cancer" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Sep2022, outcome "unknown" and all described as "I was diagnosed with COVID; three (Pfizer COVID-19 Vaccine) that I have taken". The event "i was diagnosed with covid; three (pfizer covid-19 vaccine) that i have taken" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) Result: unknown, notes: I just went for MRI because I had cancer; SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: The patient was diagnosed with COVID, Monday and symptoms started Sunday so, doctor gave Paxlovid, and on Tuesday patient started the dosage. Patient had pulmonary embolism and had several blood clots so; patient was on blood thinners.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Depression" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril", notes: Known allergies: Lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Home test with an extremely, barely visible, faint positive line that only showed 10 mins; (29Aug2022) Positive, notes: Line appeared immediately as it had when I tested positive on my first bout on 29Aug2022; (Sep2022) Positive, notes: a clear positive retest 7 days after competition of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks: unknown. I had a reoccurrence of COVID symptoms and a clear positive retest 7 days after competition of Paxlovid and feeling fully recovered and having had a home test with an extremely, barely visible, faint positive line that only showed 10 mins into waiting (also on day 7 post Paxlovid). At this testing the line appeared immediately as it had when I tested positive on my first bout on 29Aug2022.  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, 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 female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2019 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. The patient received treatment as Product: COVID 19, treatment Brand: paxlovid, treatment start date/ stop date: 01Sep2022/05Sep2022. The known allergies was all type meds and other medical history was narcolepsy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: a high level of inflammation; 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 received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "pulmonary embolism" (unspecified if ongoing); "blood clots" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "a high level of inflammation".  Additional information: I had reaction with every shot yes, with the vaccine and everything, I had a high level of inflammation from it, from COVID."
Age: 58.0
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) (Physician). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Htn; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LOSARTAN, start date: 01Jun2020; METHIMAZOLE, start date: 01Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID rebound day 10 testing positive; (2022) Negative, notes: day 11 was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment started from 27Aug2022 to 30Aug2022. COVID rebound day 10 testing positive day 11 was negative days 5-10) with worse rebound symptoms than with initial infection. The reporter reporting this because it was believed rebound is much higher, 25-50%, than reported in current literature and clearly needs more study. The reporter will not personally be prescribing paxlovid except in limited circumstances. The patient did not receive any treatment for adverse event but recovering from the symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: extreme fatigue; fever; headache; severe body aches; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 17:45 as dose 3 (booster), single (Lot number: FJ1620) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 ({vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=23Apr2021,, vaccine_administration_time=01:15 PM,, vaccine_lot_number=EW0170,, vaccine_lot_unknown=False,, vaccine_dose_number=2,, vaccine_dose_number_unknown=False,, vaccine_location=Left arm},), administration date: 23Apr2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 ({vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=02Apr2021,, vaccine_administration_time=01:15 PM,, vaccine_lot_number=ER8737,, vaccine_lot_unknown=False,, vaccine_dose_number=1,, vaccine_dose_number_unknown=False,, vaccine_location=Left arm}]), administration date: 02Apr2021, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021), described as "extreme fatigue"; PYREXIA (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021), described as "fever"; HEADACHE (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021); PAIN (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021), described as "severe body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, headache, pain.  Additional information: vaccine received, Unknown other medication in 2weeks, After the third shot (Booster), she experienced extreme fatigue, fever, headache and severe body aches for one week and moderate for the second week. she took a Covid antibody test at (withheld) on 02Jun2022 to see how much antibody load she still had to determine if she should get another booster. she had approximately 23,600 which is very high. she tested again on 07Sep2022 and it came back at 17,800. she donot want to be sick for two weeks from another booster. Do you recommend her get the combined booster or should her continue to monitor my antibody levels?
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness near injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Slight soreness near injection site".  Additional information: The patient received Pfizer/BioNTech COVID-19 vaccine on 27Feb2021 as dose 1, single (Lot number: EN6200) intramuscular, in upper left arm. On 21Mar2021, patient received Pfizer/BioNTech COVID-19 vaccine as dose 2, single (Lot number: EN6208) intramuscular, in upper left arm and on 27Sep2021, patient received Pfizer/BioNTech COVID-19 vaccine as dose 3 (booster), single (Lot number: FF2589). On 27Apr2022, the patient received second booster Moderna (Lot number: 065K21A). There was no negative reaction to any of the shots. Slight soreness near injection site resolved in as few hours. No relevant or specific relevant tests for thromboembolic events with thrombocytopenia were done. None of the vaccinations involved family doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm the first and second time/she had a sore right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 79-year-old female patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EP6955) at the age of 79 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Right arm the first and second time/she had a sore right arm".  Additional information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm the first and second time, and then wanted to remember not to do that again because she had a sore right arm, may have gotten the booster in her left arm as well as the second he was not sure which one she got it in.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152145 same patient, same event, different dose;
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: right arm the first and second time/she had a sore right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0151) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: COVID, start date: 2020 (unspecified if ongoing); trolley horses, start date: 2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955, anatomical location: right arm), administration date: 07Mar2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): right arm the first and second time/she had a sore right arm. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome unknown, described as right arm the first and second time/she had a sore right arm.  Additional information: The patient had COVID in early 2020 and developed more trolley horses than usual after that. The patient received first and second dose in right arm and then wanted to remember not to do that again because she had a sore right arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152144 same patient, same event, different dose;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: Er8737) and on 21Apr2021 as dose 2, single (Lot number: Ew0171) at the age of 38 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 034f21a), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITINE, start date: 01Jan2020; FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2020; CALCIUM GUMMY, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
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) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "G6PD" (unspecified if ongoing); "Known allergies: Faba beans" (unspecified if ongoing), notes: Known allergies: Faba beans; "Known allergies: iodine contrast, iodine" (unspecified if ongoing), notes: Known allergies: iodine contrast, iodine; "Known allergies: iodine contrast, iodine" (unspecified if ongoing), notes: Known allergies: iodine contrast, iodine; "Known allergies: nitro gas" (unspecified if ongoing), notes: Known allergies: nitro gas; "Known allergies: adhesive tape" (unspecified if ongoing), notes: Known allergies: adhesive tape. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". 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: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks. Patient received anti-viral COVID-19 treatment with Paxlovid from 08Sep2022 (lot: GE9805). Headache other than a migraine. Disorientation. Felt completely different, pressure on the temporal part of the left side of brain. Insomnia, could not sleep even if it was 3 in the morning, felt like it was daytime. Completely stunned.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "allergies Prednisone", notes: Known allergies Prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details for COVID-19 Treatment included Paxlovid, Treatment start date: 08Sep2022, Lot number: Geo809. The patient did not receive other medication in 2 weeks.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: Rebound after 2 negative tests; (Sep2022) Negative, notes: Rebound after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound after 2 negative tests. Fever, stuffiness, earache, body aches. COVID-19 Treatment: Paxlovid treatment start date :31Aug2022 and treatment stop date :05Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lamotrigine (LAMOTRIGINE), (Batch/Lot number: unknown) at 125 mg for migraine. The patient's relevant medical history included: "terrible migraine " (ongoing), notes: Intent: Medical History. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 Immunisation.  The following information was reported: RASH (non-serious), outcome "unknown". The action taken for lamotrigine was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 45-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8729), in right arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in right arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 44 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Aug2022 as dose 4 (boster), single (Lot number: 053B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, stop date: 03Sep2022; AMBIEN, start date: 03Sep2022, stop date: 08Sep2022.  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". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, COVID-19, 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) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0165), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Occasionally allergic reactions to metals" (unspecified if ongoing), notes: Known allergies: Occasionally allergic reactions to metals; "Other medical history: Good condition. Slightly high cholesterol" (unspecified if ongoing), notes: Other medical history: Good condition. Slightly high cholesterol. The patient's concomitant medications were not reported. 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: Blood cholesterol: high cholesterol, notes: Other medical history: Good condition. Slightly high cholesterol. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid for COVID-19 treatment with start date 06Sep2022 and stop date 09Sep2022. Patient took Nyquil Liqui Caps cold & Flu Night-time relief (only 1 night), Vicks with start date 04sep2022 and stop date was 05sep2022, Tylenol 8hr (only 1 night), with start date 05sep2022 and stop date was 06sep2022. On 07Sep2022 patient experienced skin rash on her breast, abdomen, back, arms, legs. For the treatment of adverse event patient received prednisone 20MG tablet and diphenhydramine 25 mg cap.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, the patient did not receive any other medication in two weeks. The patient received Paxlovid from 28Aug2022 to 01Sep2022 for the treatment of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 14Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2022) Negative, notes: Tested negative on Wednesday, 07Sep; (09Sep2022) Positive, notes: tested positive on Friday, 09Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Patient was not taken any Other medication in 2weeks. No known allergies and Other medical history reported as None. Patient had rebound COVID-19 infection after taking Plaxovid. Day 0 was Thursday, 01Sep. Tested negative on Wednesday, 07Sep and tested positive on Friday, 09Sep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: En6205), in left arm, on 30Mar2021 as dose 2, single (Lot number: Er8733), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: Fj8762), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: Fm0173) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Bactria" (unspecified if ongoing), notes: Known allergies: Bactria. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin; Clindamycin, reaction(s): "Known allergies: Clindamycin.", notes: Known allergies: Clindamycin.  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: (unspecified date) Positive, notes: COVID 19 Treatment; (Sep2022) Positive, notes: Testing positive again and bad symptoms 4 days after finishing initial treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication was received in 2weeks.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Investigation, Palpitations, Tachycardia
Clinical narrative: Palpitations; Tachycardia; Increased heart rate; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EL3247), in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Increased heart rate"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown". The events "palpitations", "tachycardia" and "increased heart rate" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for BNT162b2 was unknown. Therapeutic measures were not taken as a result of palpitations, tachycardia, heart rate increased.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heart rate, Heart rate increased, Palpitations, Tachycardia
Clinical narrative: Palpitations; Tachycardia; Increased heart rate; the side effects was worst with the booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 52 years, in left deltoid for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (the second shot I got on 29Jan2021,Single, Lot: EL3247), administration date: 29Jan2021, for Covid-19 Immunization, reaction(s): "Palpitations", "Tachycardia", "Increased heart rate"; Covid-19 vaccine (Dose 1, Single, manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown"; TACHYCARDIA (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Increased heart rate"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "the side effects was worst with the booster". The events "palpitations", "tachycardia", "increased heart rate" and "the side effects was worst with the booster" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, tachycardia, heart rate increased, condition aggravated.  Additional information: It was reported that Tachycardia; Increased heart rate, lasted for a month after the vaccine and the side effects was worst with the booster then with the second shot. Doctor stated that No treatment was taken because nothing was diagnosed. So he did go to the doctor and did not go through testing but this was not in the past two weeks." Age at time of vaccination was reported as 52 and she was 53 and by the time of vaccination I was 52." Lot#: Doctor stated the lot number one given on 29Jan was EL3247 and the one given in Nov was FH8020."  No follow-up attempts are required. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing), notes: Other medical history: Hyperthyroid.; "AORTIC ROOT ENLARGEMENT" (unspecified if ongoing), notes: Other medical history: Enlarged aortic root valve in heart. Concomitant medication(s) included: SYNTHYROID. Past drug history included: Neosporen, reaction(s): "Known allergies: Neosporen", notes: Known allergies: Neosporen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: tested negative for two days; Negative, notes: tested negative for two days; Positive, notes: woke up the third day felt more congested and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product=COVID 19 Treatment, Treatment start date=02Aug2022, Treatment stop date=08Sep2022, 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), on 17Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 25Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: fp4554) at the age of 70 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (01Sep2022) Negative, notes: Covid symptoms resolved after finishing Paxlovid on day 5. Negative antigen test day after finishing Paxlovid; (04Sep2022) Negative, notes: negative antigen test 3 days after finishing Paxlovid; (07Sep2022) Positive, notes: Covid symptoms returned (nasal congestion) and positive antigen test on 6th day after finishing Paxlovid; (09Sep2022) Positive, notes: Positive antigen test on 8th day after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2weeks was Yes. Anti-Viral Details: Product: Covid 19 Treatment. Brand: Paxlovid. Treatment start date: 28Aug2022. Treatment stop date: 01Sep2022. Lot number: 2692129. Indication: Treatment of Covid-19. Known allergies was No.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8787), in left arm and on 23Apr2021 as dose 2, single (Lot number: EW0172) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Known allergies: several, too numerous to mention" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Sep2022) Negative, notes: tested negative; (05Sep2022) Negative, notes: tested negative again; (09Sep2022) Positive, notes: postive COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient was treated with Paxlovid from 29Aug2022 to 03Sep2022 for Covid-19.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2020 at 14:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Apr2021 at 12:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunization. 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient did not received any Other medication in 2weeks. treatment start date: 05Sep2022. treatment stop date: 09Sep2022  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Known allergies: Yes, penicillin" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 including PF-07321332 (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6200), in left arm, as dose 2, single (Lot number: EN6207), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 08Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 66 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 "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Positive, notes: positive home test; (31Aug2022) Negative, notes: Tested negative on 31Aug and 01Sep; (01Sep2022) Negative, notes: Tested negative on 31Aug and 01Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient didn't receive other medication in 2 weeks. Patient received treatment for COVID 19 from 01Sep2022 to 05Sep2022.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 08May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022 at 15:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Sep2022) Negative, notes: On Thursday I tested negative; (11Sep2022) Positive, notes: Today 11Sep2022 I woke up feeling as sick as I was before taking the paxlovid. I retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient had completed the course on Tuesday and she was feeling much better. On Thursday she tested negative. Yesterday 10Sep2022, she started to feel sick again. Today 11Sep2022, she woke up feeling as sick as she was before taking the paxlovid. She retested and it was positive. Patient was treated with Paxlovid from 02Sep2022 to 06Sep2022 for 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received anti-viral medication Paxlovid (Lot number: GD7763) via oral route from 07Sep2022 for the treatment of COVID-19. Known allergies was reported as yes.  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 available information in the case the reported events DRUG INEFFECTIVE and Covid 19 are assessed as related to suspect drug .