chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: None Just a little sore arm or achy with the previous Pfizer COVID vaccines; None Just a little sore arm or achy with the previous Pfizer COVID vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in right arm and on 25Mar2021 as dose 2, single (Lot number: ER8733) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese and has type 2 diabetes diagnosed 2 years ago.; "Type 2 diabetes" (unspecified if ongoing), notes: Obese and has type 2 diabetes diagnosed 2 years ago.; "Hayfever" (unspecified if ongoing), notes: Hayfever and Seasonal allergies diagnosed years ago.; "Seasonal allergies" (unspecified if ongoing), notes: Hayfever and Seasonal allergies diagnosed years ago.; "Compromised immune status" (unspecified if ongoing), notes: Compromised immune status-10 years ago. There were no concomitant medications. Past drug history included: Prednisone, notes: She is immunosuppressed because she is on daily doses of Prednisone. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "None Just a little sore arm or achy with the previous Pfizer COVID vaccines".  Additional information: Obese and has type 2 diabetes diagnosed 2 years ago. Hayfever and Seasonal allergies diagnosed years ago. Compromised immune status-10 years ago. She is immunosuppressed because she is on daily doses of Prednisone. This was before taking the Pfizer COVID vaccines.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 03Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 59 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 24Apr2022, stop date: 01May2022. Past drug history included: Ibuprofen, reaction(s): "known allergies ibuprofen", notes: known allergies sulfa and ibuprofen; Sulfonamide, reaction(s): "known allergies sulfa", notes: known allergies sulfa and ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Apr2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: On 07May tested positive via antigen and PCR tests; (24Apr2022) Positive, notes: First positive COVID test: 24Apr; (30Apr2022) Negative, notes: Improved and tested negative 30Apr- 04May; (04May2022) Negative, notes: Improved and tested negative 30Apr- 04May; (07May2022) Positive, notes: On 07May tested positive via antigen and PCR tests. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: the patient received other medication in 2weeks product=Tylenol, other medication in 2weeks brand=Johnson & Johnson, other medication in 2weeks start date 24Apr2022, other medication in 2weeks stop date 01May2022.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 52-year-old male patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FS4991), at the age of 52, in left arm, on Apr 6, 2022, single dose, for COVID-19 immunization. Vaccination history included the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EE3590), left arm, on Oct 11, 2021, the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0151), on Apr 8, 2021, left arm, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), left arm, on Mar 18, 2021; all single dose, for COVID-19 immunization. Medical history included multiple sclerosis (unspecified if ongoing). Concomitant medications not reported. The patient experienced ineffective drug (medically significant) and COVID-19 (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19; negative, notes: COVID-19 symptoms during treatment with negative test two days after completion of treatment; negative, notes: COVID-19 symptoms during treatment with negative test two days after completion of treatment. Therapeutic measures were taken as a result of COVID-19. Clinical course: No other medication in 2 weeks. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 53-year-old female patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Vaccination history included the 3rd (booster) dose of COVID-19 vaccine, (batch/lot# unknown), the 2nd dose of COVID-19 vaccine (batch/lot# unknown), and the 1st of COVID-19 vaccine, (batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history included penicillin (unspecified if ongoing); sulfonamide(unspecified if ongoing); connective tissue disorder NOS (unspecified if ongoing); gastroparesis (unspecified if ongoing) and GERD (unspecified if ongoing). Concomitant medication not reported. The patient experienced COVID-19/COVID-19 treatment (medically significant) and ineffective drug (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of COVID-19 and ineffective drug. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected Covid-19. The information on the batch/lot on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8731), on 04May2021 as dose 2, single (Lot number: EW0167) and on 11Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 80 years for Covid-19 immunisation. The patient's relevant medical history included: "Back problems has had for years" (ongoing), notes: Caller states she has issues with her back, has had them for years; "Fibromyalgia" (ongoing), notes: Fibromyalgia has had for years. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "tested positive"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "symptoms were worse"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: she tested and tested positive. Therapeutic measures were taken as a result of sars-cov-2 test positive.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8731), on 04May2021 as dose 2, single (Lot number: EW0167) and on 11Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 80 years for Covid-19 immunisation. The patient's relevant medical history included: "Back problems has had for years" (ongoing), notes: Caller states she has issues with her back, has had them for years; "Fibromyalgia" (ongoing), notes: Fibromyalgia has had for years. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "tested positive"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "symptoms were worse"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: she tested and tested positive. Therapeutic measures were taken as a result of sars-cov-2 test positive.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a noncontactable (nurse). A 32-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 31, on Nov 19, 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 23, 2021, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 2, 2021; both single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced influenza-like illness, onset May 7, 2022, with outcome of unknown, vaccination failure (medically significant) and COVID-19/flu-like symptoms May 7; positive Ag test May 9 (medically significant), onset May 9, 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May 9, 2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of COVID-19/influenza-like illness. Clinical course: Unknown if patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, unknown if patient diagnosed with COVID-19. Since the vaccination, patient tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Based on the information available a possible contributory role of the suspect cannot be excluded for the reported events of COVID-19 and ineffective drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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. There was no other medication in 2weeks. Symptoms rebound/return to positive covid test after stopping Paxlovid. There was no known allergies. There was no other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
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) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7533) and on 25Apr2021 as dose 2, single (Lot number: EW0172) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3(booster) , single (Lot number: 065F21A). The patient's relevant medical history included: "Tuburculosis 1995.", start date: 1995 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Neg, notes: Neg Antigen Test.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 26Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypocomplementemia urticarial vasculitis treated with Rituximab" (unspecified if ongoing), notes: Hypocomplementemia urticarial vasculitis treated with Rituximab. There were no concomitant medications. Past drug history included: Rituximab, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient received no other medication in 2 weeks. After testing positive for COVID 19, I began taking Paxlovid. I almost immediately began to get better, and at the conclusion of the Paxlovid was symptom free and testing negative on rapid antigen test. Originally I was symptomatic mostly in my throat. Approximately 4 days after I finished the Paxlovid, I began to be moderately Ill, with symptoms mostly in my sinuses and lungs. I began testing positive again on rapid antigen and had a temp max 102.6 F. I tested positive on rapid antigen test on day 9 after initial illness, 4 days after testing negative. I was symptomatic and ill for approximately 5 days, and continued testing positive on rapid antigen until day 20 from initial symptom onset. 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: Deafness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A 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: DEAFNESS (medically significant), outcome "unknown", described as "lost all hearing in his right ear". Additional information: Forwarded as an Adverse Event by the Escalation team on 09May2022. Reporter provided verification of contact address on 08May022. Customer Verbatim: Hey my dad got your corona vaccine as per (name withheld). He lost all hearing in his right ear immediately after the vaccine. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. 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: This is a spontaneous report received from a contactable other HCP (patient). A 41-year-old female patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient also received the COVID-19 vaccine, as dose 1, single (batch/lot# unknown); as dose 2, single (batch/lot number: unknown); and as dose 3 (booster), single (batch/lot# unknown) for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing). Concomitant medication(s) included: Advair. Past drug history included known allergies: Cephalexin, notes: known allergies Cephalexin. The patient experienced ineffective drug (medically significant) and COVID-19/tested positive for COVID-19 (medically significant), onset Apr 2022, with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On day 10 after tested positive for COVID-19 and after taking Paxlovid. Therapeutic measures were taken as a result of ineffective drug; COVID-19 with Paxlovid (Pfizer) from Apr 29, 2022 to May 4, 2022. Clinical course: Experienced rebound of COVID-19 symptoms (profuse runny nose & cough) on day 10 after testing positive for COVID-19 and after taking Paxlovid. Tested positive for COVID-19 on an antigen test on day 11. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received. Sender's comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: Penicillin" (unspecified if ongoing). Patient received any other medications within two weeks of vaccination was reported as no. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "recovered" (20Apr2022) and all described as "COVID-19 treatment". Therapeutic measures were not taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022 at 08:00, 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) Positive; (unspecified date) Positive, notes: Tested positive twice on lateral flow and now feel sick and testing positive again; (unspecified date) Positive, notes: Tested positive twice on lateral flow and now feel sick and testing positive again; (09May2022) Positive, notes: Tested positive twice on lateral flow and now feel sick and testing positive, again. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti virals for Covid 19 Treatment, Treatment duration from 02May2022 to 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test positive
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 62-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3(booster) , single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2 (Batch/Lot number: unknown) and as dose 1 (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "EGPA" (unspecified if ongoing). Concomitant medication(s) included: NUCALA, start date: 04Sep2018. The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test positive: positive. Therapeutic measures were taken as a result of covid-19. Clinical course : Primary Immunization series completed from an UNKNOWN MANUFACTURER. Anti viral details, Product: COVID 19 treatment, Treatment start date: 26Apr2022, Treatment stop date: 01May2022, Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Myalgia, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 50-year-old female patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 3rd (booster) dose of the COVID-19 vaccine (manufacturer unknown), the 2nd dose of the COVID-19 vaccine (manufacturer unknown), and 1st of the COVID-19 vaccine (manufacturer unknown), immunization. The patient experienced peripheral swelling, axillary pain (swelling and pain in under arm area), myalgia and arthralgia/muscle aches in shoulder and arm, with outcome of unknown. Additional information: Swelling and pain in under arm area and muscle aches in shoulder and arm after 2nd booster of Comirnaty vaccine. Symptoms only appear on side of injection. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: REMIFEMIN. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she has been diagnosed with Covid-19; she has been diagnosed with Covid-19; 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 71-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Statin allergy" (unspecified if ongoing); "hair loss" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], stop date: 07May2022; PITAVASTATIN, stop date: 09May2022; FISH OIL; CINNAMON; TURMERIC [CURCUMA LONGA]; COQ-10; SPIRONOLACTONE taken for alopecia; OLMESARTAN MEDOXOMIL; EZETIMIBE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has been diagnosed with Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Diagnosed with Covid-19. Therapeutic measures were taken as a result of covid-19. Additional information: caller reports that she has a medical history of pre-diabetes, hypertension, and statin allergy. Caller reports that she takes Flonase, Pitavastatin, Fish Oil, Cinnamon, Turmeric, Coq-10, Spironolactone (takes for hair loss per Caller), Olmesartan Medoxomil 40 mg, and Ezetimibe 10 mg. Caller reports that she has also had the primary series of the Pfizer Covid-19 vaccine as well as one booster dose and usually takes Advil but has switched to Tylenol. Caller reports that she has complaints of brain fog, headache and backache. Caller reports that her last dose of Flonase was on 07May2022 and was prescribed Paxlovid on 07May2022. Caller was advised by HCP to start taking the dose of Paxlovid on the evening of 07May2022 and to stop taking her Flonase. Caller reports that she stopped taking her Pitavastatin today 09May2022. Caller reports that she has also stopped taking her Fish Oil, Cinnamon, Turmeric, and Coq-10. Caller reports that her HCP told her she can continue to take her Pitavastatin. Caller reports that she has taken 2.5 days worth of doses for Paxlovid. Caller was asking if she has to wait 90 days to get the fourth booster dose since she has been diagnosed with 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
Symptoms: Blindness, Endocrine ophthalmopathy, Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. 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: BLINDNESS (medically significant), outcome "unknown", described as "I am blind now, blindness"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "Thyroid eye disease"; ILLNESS (non-serious), outcome "unknown", described as "being sick after this vaccination". Consumer stated that he/she was blind now. Consumer handed over the phone to the reporter. Reporter added to the concern, "Thyroid eye disease. Is the patient also the reporter: No. Reporter type could not be probed over the call hence captured as Consumer or other non health professional by default. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infertility, Menstruation irregular
Clinical narrative: unable to get pregnant; Having irregular periods; This is a spontaneous report received from non-contactable reporter (other non HCP). The reporter is the patient.  A female patient received BNT162b2 (Pfizer-BioNTech COVID-19), 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: INFERTILITY (medically significant), outcome "unknown", described as "unable to get pregnant"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Having irregular periods". Caller states that the patient in the doctor's office told the caller that she has been having irregular periods and is unable to get pregnant. The patient believed this was from the Pfizer Covid Vaccine. History and Investigations: Caller is not aware of any other medications, medical conditions, labs, testing, or treatments related to these events for the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: tested COVID positive with at home test on 09-May-2022; tested COVID positive with at home test on 09-May-2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm at workplace clinic for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Patient do not have any known allergy. Concomitant medication(s) included: ATORVASTATIN; VENLAFAXINE HYDROCHLORIDE. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left), administration date: 18Nov2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 51-year-old, for COVID-19 immunization. There were no other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "tested COVID positive with at home test on 09-May-2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (09May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms; he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms; 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 50-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms". 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, suspected covid-19. Clinical course: The patient started taking Paxlovid on 07May2022 for Covid infection. The patient stated that he has received 3 Pfizer Covid19 vaccines in the past and has had mild Covid symptoms. Caller states that he tried exercising yesterday and had to stop after 10 minutes due to his heart racing. Caller stated that his heart was racing also when sitting still, patient stated that he took his Paxlovid dose last night, but had not taken it yet this morning. Patient was wondering if he should stop taking Paxlovid due to his heart racing. Patient stated that he was not sure if he wanted to get Paxlovid, but read that it can stop long Covid, so he asked his doctor for it. Patient was asking if heart racing is a normal side effect 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, Polymerase chain reaction
Clinical narrative: Tested positive on an antigen test 5 days later; Tested positive on an antigen test 5 days later; This is a literature report for the following literature source(s).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cough", start date: 2022 (unspecified if ongoing); "pharyngitis", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive on an antigen test 5 days later". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug Ineffective and COVID-19 cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 74-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9261), at the age of 72, left arm, on Jan 26, 2021, single dose, for COVID-19 immunization. Medical history included blood pressure (unspecified if ongoing) and allergy (unspecified if ongoing). Concomitant medication included hydrochlorothiazide taken for blood pressure measurement. The patient experienced flushing/she had minor face flushing, with outcome of unknown. No therapeutic measures taken as a result of flushing. Additional information: Patient said her age was 73 and 74 when events occurred. Patient received other medication included Wixela for allergy. She had minor face flushing like an allergy, but it was not significant and not reportable. Patient received dose 2 on Feb 16, 2021 and dose 3 on Nov 19, 2021. The rest of her symptoms occurred immediately after booster and persisted for 6-7 weeks. She would like to know if she risks getting another booster or not. Caller declined to provide batch/lot numbers for her first, second and third doses of the vaccine. She said she has heart damage and is exhausted. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: 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 60-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for Covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 29Apr2022 (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: COVID-19 (medically significant) with onset 09May2022, outcome "unknown", described as "COVID- 19"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "positive to COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (09May2022) Positive. 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: Chest X-ray, Chills, Cough, Drug ineffective, Gait inability
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19 / did not test positive for COVID-19"; THROMBOSIS (medically significant), outcome "unknown", described as "Clot in my leg"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Leg swollen up"; MALAISE (non-serious), outcome "unknown", described as "Fell ill"; CHILLS (non-serious), outcome "recovered"; COUGH (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "Soreness on the right side"; GAIT INABILITY (non-serious), outcome "unknown", described as "Could not walk". The events "positive for Covid-19 / did not test positive for Covid-19", "clot in my leg", "leg swollen up" and "could not walk" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown; SARS-CoV-2 test: Negative, notes: Around the holidays the family gathered after being tested and we all tested negative; Scan: clot, notes: The doctor came and did a scan and they found a clot in my leg. Therapeutic measures were taken as a result of thrombosis. Clinical information: Patient was fully vaccinated. 2 doses and then one booster. Everything was fine after the booster. Just a little sore. Around the holidays the family gathered after being tested and they all tested negative. However, her grandson fell sick. He had a fever, cough, congestion. He was taken to the doctor and the fever went down. A day after fell ill. By the third day, at home, felt chills, cough, fever, soreness on the right side. The next day it was gone. The next 3 or 4 days it was fine. Then, on 18Jan to 19Jan2022 ended up in the ER with leg swollen up. The doctor came and did a scan and they found a clot in leg. Patient was administered heparin and all that kind of stuff. He was sent to be taken an X-ray and the hematologist put on blood thinners for a minimum of three months. For 2 weeks straight patient couldn't walk. The doctor said that, according to the timeframe, most probably patient got the clot from a mild case of COVID-19. So now patient on a blood thinner. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19 / did not test positive for COVID-19"; THROMBOSIS (medically significant), outcome "unknown", described as "Clot in my leg"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Leg swollen up"; MALAISE (non-serious), outcome "unknown", described as "Fell ill"; CHILLS (non-serious), outcome "recovered"; COUGH (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "Soreness on the right side"; GAIT INABILITY (non-serious), outcome "unknown", described as "Could not walk". The events "positive for Covid-19 / did not test positive for Covid-19", "clot in my leg", "leg swollen up" and "could not walk" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown; SARS-CoV-2 test: Negative, notes: Around the holidays the family gathered after being tested and we all tested negative; Scan: clot, notes: The doctor came and did a scan and they found a clot in my leg. Therapeutic measures were taken as a result of thrombosis. Clinical information: Patient was fully vaccinated. 2 doses and then one booster. Everything was fine after the booster. Just a little sore. Around the holidays the family gathered after being tested and they all tested negative. However, her grandson fell sick. He had a fever, cough, congestion. He was taken to the doctor and the fever went down. A day after fell ill. By the third day, at home, felt chills, cough, fever, soreness on the right side. The next day it was gone. The next 3 or 4 days it was fine. Then, on 18Jan to 19Jan2022 ended up in the ER with leg swollen up. The doctor came and did a scan and they found a clot in leg. Patient was administered heparin and all that kind of stuff. He was sent to be taken an X-ray and the hematologist put on blood thinners for a minimum of three months. For 2 weeks straight patient couldn't walk. The doctor said that, according to the timeframe, most probably patient got the clot from a mild case of COVID-19. So now patient on a blood thinner. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.