chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Return of covid symptoms; Return of covid symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 at 12:30 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: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Jan2022. Past drug history included: Ibuprofen, reaction(s): "Drug allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Return of covid symptoms". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment; Paxlovid, start date: 29Jun2022, Stop date: 04Jul2022, for treatment of COVID-19). Return of covid symptoms began 2 days ago (6 days after finishing Paxlovid) with pain in the lower left abdomen (did not occur prior to first infection); yesterday followed by fatigue, congestion, and sneezing; today followed by sore throat, coughing, loss of taste (did not lose taste during original infection), malaise, body aches, chills, clamminess, and 100.8 fever (his first infection prior to Paxlovid treatment saw his fever spike at 103).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID rebound; COVID rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. 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 rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of Drug ineffective, covid-19. Patient received COVID 19 treatment with Paxlovid from 23Jun2022 to 28Jun2022. Patient experienced Covid rebound from 02Jul2022 to 09Jul2022 (Recovered) and no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: Fm7753) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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. It was reported that the patient had No Known allergies.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Plaxovid on 08Jl2022.
Age: 63.0
Sex: U
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 64-year-old patient received BNT162b2 (BNT162B2), on 12Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "Psoriasis" (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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
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 55-year-old patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. 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: Negative, notes: tested negative; Unknown results, notes: I had tested negative after the 5th day of initial testing. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course received on 12Jul2022: stopped taking the meds on the third day because patient kept gagging at night from the metallic after taste and had tested negative after the 5th day of initial testing. 3 days after stopped taking the meds and relapsed with different symptoms (congestion, sneezing) and wondering if it is because patient did not finish the whole treatment or because that is one of the side effects. Patient was fully vaccinated and double boosted. Adverse event started on 11Jul2022, patient was not recovered. Its unknown that any treatment for adverse event was received. Patient is allergic to Penicillin and other medical history includes asthma. Anti viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 05Jul2022, Treatment stop date: 07Jul2022, Lot number: 609422, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
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) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EN7533), in left arm and on 22Apr2021 as dose 2, single (Lot number: ER8736) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; FLONASE [FLUTICASONE PROPIONATE]; FLOVENT. Past drug history included: Known allergies: cephalexin, reaction(s): "Drug Allergy", notes: known allergies: Cephalexin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) positive, notes: I tested positive for Covid-19 on 02Jul2022; (10Jul2022) negative, notes: I finished the 5 day course, and tested negative 10Jul2022; (13Jul2022) positive, notes: I began to feel minor symptoms 13Jul2022, and again tested positive on that date. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 02Jul2022 to 07Jul2022.  Clinical Course: Reported as, patient tested positive for Covid-19 on 02Jul2022. patient began treatment with Paxlovid on that date. She finished the 5 day course, and tested negative 10Jul2022. She began to feel minor symptoms 13Jul2022, and again tested positive on that date. It was her belief that it was Covid rebound.
Age: 66.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "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 "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Positive COVID test after 2 negatives, 7 days after finishing Paxlovid; Also TERRIBLE burnt metal bitter taste in mouth the entire 5 days taking Paxlovid.  No follow-up attempts are possible. No further information is expected.
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 23-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), 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: negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral treatment received as paxlovid started on 28Jun2022 and stop date was 02Jul2022. Covid rebound symptoms and positive test days after paxlovid treatment. Tested negative last week and now symptoms are back with positive test. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
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) (Physician).  A 60-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE oral, start date: Jan2022; SIMVASTATIN oral, start date: Jan2022, stop date: 11Jul2022; LISINOPRIL oral, start date: Jan2022; LEVOTHYROXINE oral, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Jul2022 till Jul2022.  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 information currently available, a possible contributory role of the suspect drug to all the reported events Drug ineffective,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction to the COVID Vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had an allergic reaction to the COVID Vaccine".  Additional information: Reporter wanted to know if a patient was eligible to take PAXLOVID if they had an allergic reaction to the COVID Vaccine. Patient took the Pfizer COVID-19 Vaccine. When asked if patient had more information about the patient, reporter stated that they will let the provider know that Pfizer wanted more information about the patient.  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: Abnormal dreams
Clinical narrative: I started having very vivid good dreams the 2nd day after the 2nd shot; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: ABNORMAL DREAMS (non-serious), outcome "unknown", described as "I started having very vivid good dreams the 2nd day after the 2nd shot".  Additional information: It was reported that patient had a weird experience with her 2nd dose of the Pfizer Covid19 primary series. She started having very vivid good dreams, with the 2nd day after the 2nd shot was administered and it lasted approximately 6 weeks and happened almost every night. Caller stated that she did not experience this with the booster doses. She also stated that she don't normally have dreams that she remembered and these dreams were very vivid and specific, but not scary. Nobody she talked to had that side effect but she did not have the headaches. She didn't know, it was approximately six weeks, it was a long time and almost every single night. 6 out of 7 nights every week. She never had dreams that she could remember that specific but nothing was getting her upset and it wasn't scary stuff. Nobody else she talked to had this particular experience. It was also reported that maybe its a coincidence, maybe its connected, she didn't know. The only difference was the shot. She didn't take other medicine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: recently got covid; recently got covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID: (004756).  A 13-month-old 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), COVID-19 (medically significant), outcome "unknown" and all described as "recently got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Pain, Pyrexia
Clinical narrative: Patient tested positive for COVID-19 on 13-Jul-2022.; Patient tested positive for COVID-19 on 13-Jul-2022.; fever; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Hyperthyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "Patient tested positive for COVID-19 on 13-Jul-2022."; PAIN (non-serious) with onset 13Jul2022, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 13Jul2022, outcome "not recovered"; PYREXIA (non-serious) with onset 13Jul2022, outcome "not recovered", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Flowflex COVID test Lab Notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia, chills, pain.  Clinical Information: Patient tested positive for COVID-19 on 13Jul2022. Symptoms include fever, chills, body aches. No other vaccine in four weeks. AE treatment: Tylenol. No covid prior vaccination and tested covid post vaccination. Other medical history: Graves Disease, Hyperthyroidism.  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: SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 on 13-Jul-2022.; Patient tested positive for COVID-19 on 13-Jul-2022.; fever; chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves Disease" (unspecified if ongoing); "Hyperthyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "not recovered" and all described as "Patient tested positive for COVID-19 on 13-Jul-2022."; PAIN (non-serious) with onset 13Jul2022, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 13Jul2022, outcome "not recovered"; PYREXIA (non-serious) with onset 13Jul2022, outcome "not recovered", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Flowflex COVID test Lab Notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia, chills, pain.  Clinical Information: Patient tested positive for COVID-19 on 13Jul2022. Symptoms include fever, chills, body aches. No other vaccine in four weeks. AE treatment: Tylenol. No covid prior vaccination and tested covid post vaccination. Other medical history: Graves Disease, Hyperthyroidism.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6203), in right arm, on 15Nov2021 as dose 3 (booster), single (Lot number: 30135BA), in right arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 65 years, in right arm, all intramuscular for covid-19 immunisation; glucosamine (GLUCOSAMINE), (Batch/Lot number: unknown). The patient's relevant medical history included: "Elevated cholesterol (under control)" (unspecified if ongoing); "vasomotor rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ALFUZOSIN; CALCIUM D [CALCIUM;COLECALCIFEROL]; COQ10 [UBIDECARENONE]; LORATADINE; CETRIZINE; FAMOTIDINE; PRESERVISION AREDS 2; CHONDROITIN; RESTASIS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "not recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. The action taken for glucosamine was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. Cold symptoms (head, nasal and chest congestion, productive cough with excessive mucus) beginning 10Jul2022. Subsequently tested positive for COVID-19 on 12Jul2022. Ae treatment Mucinex, saline nasal spray, Ponaris nose drops. No COVID prior vaccination. Patient was tested for COVID post vaccination. No known allergies.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller states her son had all of the Pfizer Covid vaccines, 2 series, and 2 boosters, and subsequently tested positive for Covid; Caller states her son had all of the Pfizer Covid vaccines, 2 series, and 2 boosters, and subsequently tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the parent.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 30Mar2021 as dose 2, single (Lot number: EP6955), in right arm, on 12Jan2022 as dose 3 (booster), single (Lot number: FJ5683, Expiration Date: 31Jan2022), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9896, Expiration Date: 30Jun2022) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizures" (ongoing), notes: From: 6 months old.seizures happened after a Pertussis vaccine. , . There were no concomitant medications. Vaccination history included: Pertussis vaccine (AE(s) following prior vaccinations: Seizure: Caller probed : Pertussis vaccine: Caller cannot provide an NDC, Lot number, expiration date, when probed, as it was years ago.), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Caller states her son had all of the Pfizer Covid vaccines, 2 series, and 2 boosters, and subsequently tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Patient had all of the Pfizer COVID vaccines, 2 series, and 2 boosters, and subsequently tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:Patient had no prior vaccinations(within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 58.0
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) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3302), in right arm, on 19Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 04Nov2021 as dose 3 (booster), single (Lot number: FG3527), in right arm and on 06May2022 as dose 4 (booster), single (Lot number: EL9992) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; BUPROPION; FISH OIL; MAGNESIUM; ESTER C [ASCORBIC ACID]; TURMERIC [CURCUMA LONGA RHIZOME]; VITAMIN B-12; VITAMIN B3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive; (13Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient tested positive on 29Jun2022, mild symptoms, started PAXLOVID on 30Jun2022 (in the evening) and ended Paxlovid on Monday, 04Jul2022. Tested negative on 05Jul2022 (Tuesday). Symptoms were gone. Symptoms returned on 12Jul2022, 12:00 (event start date), tested positive on 13Jul2022 with mild symptoms at this time. Known allergies were none.   No follow-up attempts are required. No further information is expected
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got covid; Got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3247), on 08Feb2021 as dose 2, single (Lot number: EL9269) and on 03Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol; COQ10 [UBIDECARENONE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) 150, notes: blood count it was over 150 his cholesterol and it worked so now it's down to 100; (unspecified date) 100, notes: blood count it was over 150 his cholesterol and it worked so now it's down to 100; SARS-CoV-2 test: (10Jul2022) Positive, notes: At home covid test, it showed up quick, it says in 15 minutes but it was not 15 minutes, the line started forming quick. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no Allergies. Patient had been on a statin for 30 years, it was called atorvastatin. It was just a cat. Patient started the treatment on 02July2022 and finished it on 06July2022. Patient felt great, tested negative on 07July2022 and within two days, on Sunday patient started with symptoms again. They are mild, I'm treating them like a cold. Patient have a running nose, sore throat, some drainage. Patient think it is foggy; it is starting to fade now. Additional Context: Incoming transfer from (Name withheld): INT-00708268. Patient was treating this like a cold, this was really mild, he had a runny nose, and a sore throat, but it was already now starting to fade again. Caller clarified that it was actually Saturday night 09JUL2022 when he started to feel a little wonky, so then on Sunday morning 10Jul2022, he took the covid test and it was positive. The Paxlovid itself made all symptoms go away within 2 days of starting it. He started Paxlovid on Saturday morning 02JU2022 and by start Sunday he was good, and by Monday he was symptom free. At this moment, his ongoing symptoms are his mild sore throat, slight runny nose, slight stuffiness, drainage, his symptoms are almost identical to prior Paxlovid but he has no fever, this morning it was a turn around, despite his voice being froggy, he is now taking less cold remedy this morning, he took a decongestant, but all his symptoms are improved.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3246), in right arm, on 02Feb2021 as dose 2, single (Lot number: EL9263), in right arm, on 28Aug2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 23Feb2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Essential hypertension" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing); "HCC Prostate Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "known allergies Cephalexin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with antiviral drug (Paxlovid) from 25Jun2022 to 29Jun2022 with lot number (FY9918). The patient previously received a COVID-19 Vaccine.  No follow-up attempts are required. No further information is expected
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: my breathing  started in February/March of 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 2, single (Lot number: EL9266) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Batch/Lot No: El9262, Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 21Jan2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: RESPIRATION ABNORMAL (non-serious) with onset 15Feb2021 at 12:00, outcome "not recovered", described as "my breathing  started in February/March of 2021". Therapeutic measures were not taken as a result of respiration abnormal.  Additional information: He had copd and was managing it with the copd medicine But his breathing started in February/March of 2021 after the booster the breathing became very bad. there was no other medicine or treatments during this time.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Lot number: 3303fb) 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 was not reported. Concomitant medication(s) included: INSULIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 10 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks (Insulin). Patient received Anti-viral treatment for COVID-19 with Paxlovid from 29Jun2022 to 03Jul2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Smear test
Clinical narrative: Breakthrough COVID infection after 3 Pfizer doses.; Breakthrough COVID infection after 3 Pfizer doses.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), 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. Past drug history included: Name of drug as reported: unknown, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Breakthrough COVID infection after 3 Pfizer doses.". The patient underwent the following laboratory tests and procedures: Smear test: (Jul2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not diagnosed with COVID-19, prior to vaccination. Patient been tested for COVID-19, since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paralysis
Clinical narrative: I was paralyzed and went into the hospital; I need to sleep with Oxygen with my head halfway up on a easy rest bed that just puts the head up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: DYSPNOEA (medically significant) with onset Feb2021, outcome "unknown", described as "I need to sleep with Oxygen with my head halfway up on a easy rest bed that just puts the head up"; PARALYSIS (hospitalization, medically significant) with onset Feb2021, outcome "unknown", described as "I was paralyzed and went into the hospital". Therapeutic measures were taken as a result of dyspnoea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 20Mar2021 as dose 2, single (Lot number: ER2613), in right arm and on 13Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "chronic bronchitis" (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 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Paxlovid rebound; (12Jul2022) Positive, notes: Return of symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received no other medication in 2 weeks.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 09:00 as dose 1, single (Lot number: EN6257), in left arm, on 10Apr2021 at 10:00 as dose 2, single (Lot number: EW0153), in left arm and on 21Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 331308A) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergy: Peanuts" (unspecified if ongoing). Concomitant medication(s) included: VASCEPA; MICARDIS; HYDROXYZINE; VERAPAMIL; FLOVENT HFA.  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: Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Your vaccine & 2 boosters made me very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Covid", "Drug ineffective", "Your vaccine & 2 boosters made me very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Your vaccine & 2 boosters made me very sick".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Your vaccine and 2 boosters made me very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 Immunization, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Your vaccine and 2 boosters made me very sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "sick"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "sick"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "vaccine & 2 boosters made me very sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "sick"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "sick"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "vaccine & 2 boosters made me very sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: after catching Covid; after catching Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "after catching Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient reported that vaccine and 2 boosters made patient very sick. The patient was taking Paxlovid at the moment after catching covid. The taste in patient's mouth was disgusting but it beats being hospitalized. The patient was asking if there was any research that shows people with antibodies don't get as sick with booster shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: after catching Covid; after catching Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "after catching Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient reported that vaccine and 2 boosters made patient very sick. The patient was taking Paxlovid at the moment after catching covid. The taste in patient's mouth was disgusting but it beats being hospitalized. The patient was asking if there was any research that shows people with antibodies don't get as sick with booster shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.