chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer BioNTech Covid 19 vaccine- got Covid; Pfizer BioNTech Covid 19 vaccine- got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years 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 2022, outcome "unknown" and all described as "Pfizer BioNTech Covid 19 vaccine- got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Caller took Paxlovid and finished it a month ago. Still having a very pronounced loss of taste and cotton mouth, mouth is totally dry all the time and is somewhat hoarse from it. Has shortness of breath but he has breathing problems anyway. Wondering if these are made worse by Paxlovid. Also has swallowing problems. Read about skin rash and hoarseness too but the hoarseness could be related to his vocal cord and is something he had beforehand. Swelling of mouth and lips, cotton mouth and loss of taste are all related. It's strange as he finished it a month ago and within a week taste was better but the last few days his taste is worse than it ever was. Has that overhand metallic taste. When he took Paxlovid it was pronounced metallic odor in his perspiration, to everything, it was fine at the time as it was for the benefit. Got Covid again half dozen days after he finished Paxlovid and got on an antibiotic and prednisone afterwards Has had a real time of the whole thing. Still feeling effects for sure with breathing problems.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 15:00 as dose 3 (booster), single (Lot number: 33130ba) at the age of 37 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 was not reported. Concomitant medication(s) included: MUCINEX, start date: 12Jul2022, stop date: 21Jul2022; IBUPROFEN, start date: 12Jul2022, stop date: 21Jul2022. Past drug history included: Septra, reaction(s): "Known allergies: Septra". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment given from 14Jul2022 to 18Jul2022 for covid-19.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/ Experiencing COVID rebound; Treatment of COVID-19/ Experiencing COVID rebound; 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 male patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0168) 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: "Hypertension" (unspecified if ongoing); "hypertriglyceremia" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FENOFIBRATE; ASPIRINE; VITAMIN D [ERGOCALCIFEROL]; ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19/ Experiencing COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive, notes: First tested positive for COVID on 07Jul2022 by PCR test; (17Jul2022) Negative, notes: Tested negative by COVID 19 antigen rapid test on 17Jul2022; (20Jul2022) Positive, notes: tested positive with the test on 20Jul and on 21Jul2022; (21Jul2022) Positive, notes: tested positive with the test on 20Jul and on 21Jul2022. Therapeutic measures were taken as a result of drug ineffective and covid-19, included Paxlovid, Treatment start date: 07Jul2022, Treatment stop date: 12Jul2022.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Gastrooesophageal reflux disease" (unspecified if ongoing); "Strawberries" (unspecified if ongoing); "Known allergies : ants" (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 "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested positive after testing negative for 4 days; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, patient received anti-viral product Paxlovid for COVID 19 treatment on 12Jul2022. Treatment with paxlovid was stopped on 17Jul2022 (Indication: Treatment of COVID-19). Patient had rebound Covid. She tested positive after testing negative for 4 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL9265), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 64 years, in right arm for covid-19 immunisation. The patient relevant medical history included: "Inflammatory osteoarthritis" (unspecified if ongoing); "hyperparathyroid" (unspecified if ongoing). The patient concomitant medications were not reported. Past drug history included: Iodine based intravenous test dye, reaction(s): "Allergy: Iodine based intravenous test dye". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Jul2022) Negative. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical information: Rebound Covid infection felt unwell. Took home rapid antigen test it was positive. Last tested on 13Jul was negative.  Follow-Up (26Jul2022): Follow-up attempts are completed. No further information is expected.
Age: 65.0
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) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2578), in right arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "shellfish allergy" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Tested positive again 6 days after finishing Paxlovid prescription. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received anti-viral Paxlovid (Lot number: 1917017A) from 11Jul2022 to 16Jul2022 for COVID 19 treatment. Rebound of virus after Paxlovid. Tested positive again 6 days after finishing Paxlovid prescription.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 73.0
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) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PVCs" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient did not take other medication in 2 weeks. Patient took Paxlovid Antiviral COVID 19 Treatment from 12Jul2022 to 16Jul2022.  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 events drug ineffective and covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient has been treated with Paxlovid from 16Jul2022 to 20Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: a cousin of mine, 79 years old, it didn't protect him; a cousin of mine, 79 years old, it didn't protect him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79-year-old male 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "a cousin of mine, 79 years old, it didn't protect him". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Additional information: It was reported that, reporter's cousin was an ageing person and then they also said that the symptoms of the disease or very mild for everyone. Reporter was unwilling to complete the report. No further probing was done. Hence, limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Salivary hypersecretion, Vomiting
Clinical narrative: weird feeling; slight headache; saliva forms in her mouth; vomits/throws up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 18Jun2021 at 10:00 as dose 2, single (Lot number: EW0173) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: pfizer covid-19 shot (Dose 1, injection to left arm at about 10:00  , Batch/lot number: EW0164), administration date: 21May2021, when the patient was 67-year-old, for COVID-19 Immunization. The following information was reported: SALIVARY HYPERSECRETION (non-serious) with onset Sep2021, outcome "not recovered", described as "saliva forms in her mouth"; HEADACHE (non-serious) with onset Sep2021, outcome "not recovered", described as "slight headache"; VOMITING (non-serious) with onset Sep2021, outcome "not recovered", described as "vomits/throws up"; FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "not recovered", described as "weird feeling ". Additional information: Patient seeking any info on side effects from Pfizer Covid vaccine. Caller states that every three months she has been getting a "weird feeling", slight headache, saliva forms in her mouth, and she vomits.
Age: 73.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 73 years 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: "Known Allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: AVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as covid-19 treatment (start date Apr2022 and stop date Apr2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 17:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Alopecia" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: Jun2018; ATORVASTATIN CALCIUM, start date: Dec2018; CELEBREX, start date: Jun2016; GLIPIZIDE, start date: Jun2020; JANUVIA, start date: Jan2018. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated, began having a slight metallic taste in her mouth on 20Jul, the second day of treatment. On 21Jul the third day, the metallic taste grew much worse & was gagging her. Roof of her mouth swelled, diarrhea began. Stopped doses with 2-1/2 taken & took an antihistamine. Used her Albuterol inhaler. Roof of mouth returned to normal & metallic taste in mouth subsided. Diarrhea stopped later that evening. Total doses taken was 2.5, half of the 5 day prescription. Covid symptoms were much better with 2.5 days of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has had 2 doses of pfizer covid vaccine with the 2nd  one on 21Jul2021. States she tested positive for covid infection on 12Jul2022; she has had 2 doses of pfizer covid vaccine with the 2nd  one on 21Jul2021. States she tested positive for covid infection on 12Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 21Jul2021 as dose 2, 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 12Jul2022, outcome "unknown" and all described as "she has had 2 doses of pfizer covid vaccine with the 2nd  one on 21Jul2021. States she tested positive for covid infection on 12Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive.  Clinical course: The patient was asking that how long does she had to wait after the infection before getting her booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Fever (100.4); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2022 at 19:00 as dose 3, (booster), single (Lot number: FP4554) at the age of 13 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma (Mild intermittent)" (unspecified if ongoing), notes: Other medical history: Asthma (Mild intermittent). There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose dose number: 1, Time: 03:30 Pm, Lot number: EP6955, Route: Intramuscular, vaccine location: Right arm), administration date: 27May2021, when the patient was 12-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose dose number: 2, Time: 03:30 Pm, Lot number: EP6955, Route: Intramuscular, vaccine location: Right arm), administration date: 17Jun2021, when the patient was 12-year-old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 22Jul2022 at 08:00, outcome "recovered" (Jul2022), described as "Fever (100.4)"; HEADACHE (non-serious) with onset 22Jul2022 at 08:00, outcome "recovered" (Jul2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia.  Additional information: Patient has no known allergies. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. the patient was diagnosed with COVID-19 prior to vaccination. the patient has been tested for COVID-19 since the vaccination.
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 20-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: "Mast Cell Activation Syndrome" (unspecified if ongoing); "Known allergies: spinach" (unspecified if ongoing); "Known allergies: goat cheese" (unspecified if ongoing); "Known allergies: sulfonamide derivatives/Known allergies: sulfa" (unspecified if ongoing); "Known allergies: opium alkaloids" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "Known allergies: Yes: oxycodone"; Trimethoprim, reaction(s): "Known allergies: trimethoprim". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional Information: Patient started PAXLOVID on 21Jul2022 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.
Age: 56.0
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 07Jun2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". 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 vaccination failure, covid-19. Clinical course: Patient received antiviral treatment for Covid-19 with Paxlovid from 11Jul2022 to 16Jul2022. Rebound COVID symptoms - bad sore throat. Patient received treatment with Methylprenisolone 4 mg.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329219 same reporter/patient/product, different dose/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; LOSARTAN; VYVANSE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: equally intense Ag results; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient had other medications in 2 weeks were Finasteride, Losartan and Vyvanse. The patient took Paxlovid from 12Jul2022 to 17Jul2022 as a treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Swelling of eyelid
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 23-month-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 23 months intramuscular, in left leg for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: SWELLING OF EYELID (non-serious), ERYTHEMA OF EYELID (non-serious) all with onset 22Jul2022, outcome "unknown" and all described as "unilateral upper eyelid swelling with redness". The event "unilateral upper eyelid swelling with redness" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of swelling of eyelid, erythema of eyelid. Additional information: No other vaccine in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. Unilateral upper eyelid swelling with redness. Received 2nd Pfizer dose in Left leg with development of left upper eyelid swelling and redness Day 2 post vaccination. No involvement of conjunctiva, no style, no changes in vision and no pain with extraocular movement. Treated with cool compress, antihistamine, over-the-counter pain medication as needed. Follow up with pediatrician with strict return precautions. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 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: "Known allergies: 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
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 50-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Diabetes" (unspecified if ongoing), notes: other medical history: Diabetes; "Obesity" (unspecified if ongoing), notes: other medical history: Obesity; "Hypertension" (unspecified if ongoing), notes: other medical history: Hypertension. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication was reported in 2weeks. No Known allergies was reported. Starting on 20Jul, patient began to feel symptoms of COVID again. These included nasal congestion and scratchy throat. Yesterday, a persistent, wet cough started. It seems to be getting worse as of today. No fevers yet.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Penicillins" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Patient took Antiviral drug Paxlovid from 05Jul2022 to 09Jul2022 for treatment of COVID-19. On 20Jul2022 at 07:00 AM, patient experienced rebound symptoms 8 days after testing negative and symptoms was recovering.   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, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective
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 49-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "adhd" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: greater than 25. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No any other medication in 2 weeks of vaccine. Anti viral details included COVID 19 Treatment, brand was Paxlovid, started on 03Jul2022 to 07Jul2022. It was reported as rebound Covid. Positive on 03Jul2022, Continued testing positive 20Jul2022. Till 22Jul2022 testing positive with symptoms (Fever, heavy sinus congestion).  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 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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF8839) 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: "High blood pressure" (unspecified if ongoing); "Allergy: sulfa drugs" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing); "known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; ALLEGRA; OMEPRAZOLE; AMLODIPINE BESYLATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all 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: (2022) Positive, notes: Tested positive for Covid; (2022) negative, notes: after 8-9 days was testing negative; (2022) Positive, notes: started to have covid-like symptoms again and now testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment, treatment start date: 08Jul2022, Treatment stop date: 13Jul2022, indication: Treatment of COVID-19. Tested positive for Covid, took full 5day dose of Paxlovid. Symptoms improved greatly and after 8-9 days was testing negative. other medication in 2weeks product reported as vitamins.
Age: 34.0
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 non-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 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: eggs" (unspecified if ongoing); "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; ZINC; LEVOTHYROXINE. Past drug history included: Known allergies: baccitracin, reaction(s): "Known allergies: Baccitracin".  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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Leukaemia
Clinical narrative: sick; Caller states that she has leukemia and has had a total of 4 Pfizer Covid19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "has had "no problem" with any of the vaccines"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "has had "no problem" with any of the vaccines"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "has had "no problem" with any of the vaccines". The following information was reported: LEUKAEMIA (medically significant) with onset 2022, outcome "unknown", described as "Caller states that she has leukemia and has had a total of 4 Pfizer Covid19 vaccines"; ILLNESS (non-serious), outcome "unknown", described as "sick". Clinical course: Caller is a consumer/patient who is calling for information on the recommended schedule of Pfizer Covid19 vaccine doses for immunocompromised patients. Patient states that she has leukemia and has had a total of 4 Pfizer Covid19 vaccines, including the 1st and 2nd booster dose and has had "no problem" with any of the vaccines. Caller states that she was told by her pharmacy that she is not eligible for any more boosters. Caller states that she is "scared of the Covid variants" and is asking "isn't there another dose of the Pfizer Covid19 vaccine that I can get since I am immunocompromised". Warm transfer from (Name withheld) with Contact Center. He has a patient on the line and she basically stated one or two months she has leukemia and she was doing ok one or two months ago and a person with immunocompromised was not supposed to take more than one shot and she has had 4 shots of the vaccine.  Agent said he referred her to her doctor. She checked with the pharmacy and was told she cannot get any more shots of the Covid-19 vaccine and she wants a 5 shot. She said she has had 4 of the vaccines and she cannot have anymore per CDC.  She was told immunocompromised supposed to get boosters and she told them the booster was not enough and she needed more and the CDC only approved two boosters. She said she is a patient that is very sick and a few weeks ago she was told she has leukemia and she is looking for how many boosters she can have with an immunocompromised system.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19; her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the parent.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "disabled" (unspecified if ongoing), notes: HCP called on behalf of her son who prescribed Paxlovid due to being diagnosed with Covid-19. 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 "her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: prescribed Paxlovid due to being diagnosed with Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: prescribed Paxlovid due to being diagnosed with Covid-19. HCP reports that her son has received the primary series and both booster doses of the Pfizer Covid-19 vaccine but must of got a variant of Covid-19. HCP reports that another HCP would not honor the prescription for Paxlovid due to her son having a G-tube. HCP was asking if the Paxlovid pills can be broken or crushed and administered via a G-tube.  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.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: After the vaccines, a year ago, she suffered a stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "After the vaccines, a year ago, she suffered a stroke".  Clinical course: It was reported that patient was in her early 80's and stated that feeling weary of getting the booster and asked if there were any double blinded studies of people around her age having strokes related to the Pfizer Biontech COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive test for COVID-19 on 22Jul2022; Positive test for COVID-19 on 22Jul2022; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN6199), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6199), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 41 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovering" and all described as "Positive test for COVID-19 on 22Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient did not take other vaccine in four weeks. Patient was not on other medication in 2 weeks. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.