chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 3(booster), single (Batch/Lot number: unknown), in right arm, as dose 4(booster), single (Batch/Lot number: unknown), in right arm and in Jul2022 as dose 5(booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Many including autoimmune disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given on 09Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "DVT" (unspecified if ongoing), notes: being treated for DVT using Eloquis; "Some fresh fruit" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11Nov2022 to 16Nov2022.  Clinical course: No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0196) and on 02Jul2021 as dose 2, single (Lot number: EW0198) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Got covid twice after getting Covid Vaccine. Clinical course: She later added, she got Covid a year after the inoculation and she had been fully vaccinated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318929 same patient/drug, different dose/event;US-PFIZER INC-202201318928 same patient/drug, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bladder disorder, Micturition disorder
Clinical narrative: Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0196) and on 02Jul2021 as dose 2, single (Lot number: EW0198) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Got covid twice after getting Covid Vaccine. Clinical course: She later added, she got Covid a year after the inoculation and she had been fully vaccinated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318929 same patient/drug, different dose/event;US-PFIZER INC-202201318928 same patient/drug, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She currently has extreme urinary problems due to the vaccines, later said due to second vaccine; She currently has extreme bladder problems due to the vaccines, later said due to second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Jul2021 as dose 2, single (Lot number: EW0198) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Injection was given on 11Jun2021, Sometime in early afternoon, Batch/lot number: EW0196, Dosage text: administered in right upper arm, unknown dose), administration date: 11Jun2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "After the initial vaccination she could not walk"; BNT162b2 (First Injection was given on 11Jun2021, Sometime in early afternoon, Batch/lot number: EW0196, Dosage text: administered in right upper arm, unknown dose), administration date: 11Jun2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "She had extreme inflammation/she blew up from the knee down to her ankles". The following information was reported: MICTURITION DISORDER (non-serious), outcome "not recovered", described as "She currently has extreme urinary problems due to the vaccines, later said due to second vaccine"; BLADDER DISORDER (non-serious), outcome "not recovered", described as "She currently has extreme bladder problems due to the vaccines, later said due to second vaccine".  Additional information: Patient second vaccine sometime in early afternoon in in right upper arm. Vaccination Facility Type was Pharmacy or Drug Store, prior vaccinations (within 4 weeks) were none. No other conditions and no other products. Reporter was calling about the second inoculation of the Pfizer. She is an unhappy patient.  She clarified she is calling about the Pfizer Vaccine, the second injection of the Covid Vaccine. After the second vaccination she had a bad reaction. Before getting the vaccine, she was healthy with no issues and takes no medicines at all. She had several doctors. She currently had extreme urinary and bladder problems due to the vaccines, later said due to second vaccine. Initially said, it started to get worse six months ago. Attempted to clarify start date, but reporter would only it got worse six months ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318928 same patient/drug, different dose/event;US-PFIZER INC-202201318002 same patient/drug, different dose/event.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bladder disorder, Micturition disorder
Clinical narrative: She currently has extreme urinary problems due to the vaccines, later said due to second vaccine; She currently has extreme bladder problems due to the vaccines, later said due to second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Jul2021 as dose 2, single (Lot number: EW0198) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Injection was given on 11Jun2021, Sometime in early afternoon, Batch/lot number: EW0196, Dosage text: administered in right upper arm, unknown dose), administration date: 11Jun2021, when the patient was 68-year-old, for Covid-19 Immunization, reaction(s): "After the initial vaccination she could not walk"; BNT162b2 (First Injection was given on 11Jun2021, Sometime in early afternoon, Batch/lot number: EW0196, Dosage text: administered in right upper arm, unknown dose), administration date: 11Jun2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "She had extreme inflammation/she blew up from the knee down to her ankles". The following information was reported: MICTURITION DISORDER (non-serious), outcome "not recovered", described as "She currently has extreme urinary problems due to the vaccines, later said due to second vaccine"; BLADDER DISORDER (non-serious), outcome "not recovered", described as "She currently has extreme bladder problems due to the vaccines, later said due to second vaccine".  Additional information: Patient second vaccine sometime in early afternoon in in right upper arm. Vaccination Facility Type was Pharmacy or Drug Store, prior vaccinations (within 4 weeks) were none. No other conditions and no other products. Reporter was calling about the second inoculation of the Pfizer. She is an unhappy patient.  She clarified she is calling about the Pfizer Vaccine, the second injection of the Covid Vaccine. After the second vaccination she had a bad reaction. Before getting the vaccine, she was healthy with no issues and takes no medicines at all. She had several doctors. She currently had extreme urinary and bladder problems due to the vaccines, later said due to second vaccine. Initially said, it started to get worse six months ago. Attempted to clarify start date, but reporter would only it got worse six months ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318928 same patient/drug, different dose/event;US-PFIZER INC-202201318002 same patient/drug, different dose/event.
Age: 30.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Headache, Interchange of vaccine products, Myalgia, Nausea
Clinical narrative: Headache; joint pain; intense muscle aches; very sore injection site; sinus pressure; nausea; vaccine received same date: Influenza Quadrivalent; vaccine received same date: Influenza Quadrivalent; Pfizer Bivalent - Dose Number: 3 / Moderna - Dose Number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 15:00 as dose 3 (booster), single (Lot number: 6H9097) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 20Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "transgender" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: elasomeran (dose 1, lot number: 025B21A, vaccine location: Left arm), administration date: 07Apr2021, for covid-19 immunisation; elasomeran (dose 2, lot number: 039B21A, vaccine location: Left arm), administration date: 07May2021, for covid-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Nov2022, outcome "unknown", described as "Pfizer Bivalent - Dose Number: 3 / Moderna - Dose Number: 2"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Nov2022, outcome "unknown" and all described as "vaccine received same date: Influenza Quadrivalent"; HEADACHE (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered"; MYALGIA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "intense muscle aches"; ARTHRALGIA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "joint pain"; NAUSEA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "sinus pressure"; VACCINATION SITE PAIN (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "very sore injection site". The events "headache", "joint pain", "intense muscle aches", "very sore injection site", "sinus pressure" and "nausea" required emergency room visit. Therapeutic measures were not taken as a result of headache, arthralgia, myalgia, vaccination site pain, paranasal sinus discomfort, nausea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Paranasal sinus discomfort, Product use issue, Vaccination site pain
Clinical narrative: Headache; joint pain; intense muscle aches; very sore injection site; sinus pressure; nausea; vaccine received same date: Influenza Quadrivalent; vaccine received same date: Influenza Quadrivalent; Pfizer Bivalent - Dose Number: 3 / Moderna - Dose Number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 15:00 as dose 3 (booster), single (Lot number: 6H9097) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 20Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "transgender" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: elasomeran (dose 1, lot number: 025B21A, vaccine location: Left arm), administration date: 07Apr2021, for covid-19 immunisation; elasomeran (dose 2, lot number: 039B21A, vaccine location: Left arm), administration date: 07May2021, for covid-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Nov2022, outcome "unknown", described as "Pfizer Bivalent - Dose Number: 3 / Moderna - Dose Number: 2"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Nov2022, outcome "unknown" and all described as "vaccine received same date: Influenza Quadrivalent"; HEADACHE (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered"; MYALGIA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "intense muscle aches"; ARTHRALGIA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "joint pain"; NAUSEA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "sinus pressure"; VACCINATION SITE PAIN (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "very sore injection site". The events "headache", "joint pain", "intense muscle aches", "very sore injection site", "sinus pressure" and "nausea" required emergency room visit. Therapeutic measures were not taken as a result of headache, arthralgia, myalgia, vaccination site pain, paranasal sinus discomfort, nausea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 49 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: "GERD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: 03Oct2022; PANTOPRAZOLE; MONTELUKAST.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine within 2 weeks and received other medication within 2 weeks with Doxycycline and Pantoprazole, Montelucast, Flovent from 03Nov2022 to 12Nov2022. Patient received treatment for COVID-19 with Paxlovid from 03Nov2022 to 07Nov2022.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 17:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 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), 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) all with onset 21Nov2022 at 03:00, outcome "recovering" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: Body temperature: (21Nov2022) 102; SARS-CoV-2 test: (unspecified date) Negative, notes: Tests for 2 days were negative; (unspecified date) Negative, notes: has been negative all this time, over 3 years; (21Nov2022) Positive, notes: she tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received Pfizer Covid-19 Booster, Friday around 5:15 PM. Tests for 2 days were negative then, became sick last night, had fever 102 and general malaise, 3am, going into today, 21Nov2022. This morning, tested positive for Covid-19. It was today, this morning, that she tested positive for Covid-19. General malaise went away, took the Tylenol and it went away. Patient had been negative all this time, over 3 years.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Vaccination site pain
Clinical narrative: my arm is still very swollen; had a rash most of last night; it still hurts like hell where the shot was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Nov2022 as dose number unknown (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: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH (non-serious) with onset Nov2022, outcome "recovering", described as "had a rash most of last night"; VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "not recovered", described as "it still hurts like hell where the shot was given"; PERIPHERAL SWELLING (non-serious) with onset Nov2022, outcome "not recovered", described as "my arm is still very swollen".  Additional information: the patient got the latest COVID-19 vaccine mRNA. The patient's arm was still very swollen and had a rash most on the night. Most of the rash has went away but the swelling was still there. The patient wanted to know if it was dangerous and will the patient will get hurt, if the swollen arm and rash was not going to kill the patient, or the patient's arm wont fall off and the if the patient will not have any real damage to the body just from having the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Aug2022, stop date: 21Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had Paxlovid for covid-19 treatment started on 05Nov2022 and stopped on 09Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 31Jul2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient had no other medication in 2 weeks. Patient received treatment for covid-19 with anti-viral product brand was Paxlovid.  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: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose number unknown (orange cap; 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Sore arm"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "mild fever".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318850 same product, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: inadvertent administration of a Bivalent orange cap vaccine to a vaccine-naive patient; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "inadvertent administration of a Bivalent orange cap vaccine to a vaccine-naive patient". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955) at the age of 57 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ORAL HERPES (non-serious) with onset 17Mar2021, outcome "recovered" (19Mar2021), described as "Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: Facility type vaccine. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. Known allergies was reported as No.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Dizziness, Electroencephalogram, Electromyogram, Magnetic resonance imaging
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year; 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 72-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EN6201) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9263; Route of Administration: intramuscular; Anatomical location: Left Arm), administration date: 25Jan2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm a little sore". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "not recovered", described as "She has had dizzy spells for over a year". The event "she has had dizzy spells for over a year" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: All her vaccine doses would be given on left side because she is right handed and it made her arm a little sore, so she thought they were all given in left arm. When she first had dizziness, it would last 30 seconds and then it will be gone. The dizzy spells did not go away.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318465 Same patient/vaccine, different dose;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year; 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 72-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EN6201) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9263; Route of Administration: intramuscular; Anatomical location: Left Arm), administration date: 25Jan2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm a little sore". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "not recovered", described as "She has had dizzy spells for over a year". The event "she has had dizzy spells for over a year" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: All her vaccine doses would be given on left side because she is right handed and it made her arm a little sore, so she thought they were all given in left arm. When she first had dizziness, it would last 30 seconds and then it will be gone. The dizzy spells did not go away.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318465 Same patient/vaccine, different dose;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Dizziness, Electroencephalogram, Magnetic resonance imaging, Magnetic resonance imaging head
Clinical narrative: All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm.; She has had dizzy spells for over a year; 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 72-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose: Date: 25Jan2021. Time: not probed. Route of Administration: intramuscular. Batch/Lot number: EL9263.), administration date: 25Jan2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm  a little sore"; BNT162b2 (2nd dose: Date: 15Feb2021. Time: not probed. Anatomical Site of injection: left arm. Route of Administration: intramuscular. Batch/Lot number: EN6201.), administration date: 15Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm a little sore", "She has had dizzy spells for over a year". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm."; DIZZINESS (non-serious), outcome "not recovered", described as "She has had dizzy spells for over a year". The event "she has had dizzy spells for over a year" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm. She had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. She saw a heart doctor who had her wear a thing on her chest, she had been to two neurosurgeons and two neurologists and has had brain MRI and MRA, and she was getting ready to do an EMG and has done an EEG, and been to the breathing doctor. All of her tests have been negative, nothing comes back positive, and every single doctor asked if she has had COVID, but she did not have COVID.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm.; She has had dizzy spells for over a year; 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 72-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose: Date: 25Jan2021. Time: not probed. Route of Administration: intramuscular. Batch/Lot number: EL9263.), administration date: 25Jan2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm  a little sore"; BNT162b2 (2nd dose: Date: 15Feb2021. Time: not probed. Anatomical Site of injection: left arm. Route of Administration: intramuscular. Batch/Lot number: EN6201.), administration date: 15Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm a little sore", "She has had dizzy spells for over a year". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm."; DIZZINESS (non-serious), outcome "not recovered", described as "She has had dizzy spells for over a year". The event "she has had dizzy spells for over a year" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm. She had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. She saw a heart doctor who had her wear a thing on her chest, she had been to two neurosurgeons and two neurologists and has had brain MRI and MRA, and she was getting ready to do an EMG and has done an EEG, and been to the breathing doctor. All of her tests have been negative, nothing comes back positive, and every single doctor asked if she has had COVID, but she did not have COVID.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: A patch of skin redness and warmth 1 inch below injection site; A patch of skin redness and warmth 1 inch below injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: Gj3377), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ewo172, Location of injection: Arm Left), administration date: 23Apr2022, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Ewo177, Location of injection: Arm Left), administration date: 19May2022, for COVID-19 Immunization; Bnt162b2 (Dose Number: 3, Batch/Lot No: Fd7218, Location of injection: Arm Left), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 21Nov2022, outcome "unknown" and all described as "A patch of skin redness and warmth 1 inch below injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. A patch of skin redness and warmth 1 inch below injection site, developed on day 3 after getting bi-valent booster. Prior to vaccination, The patient not diagnosed with COVID-19. Since the vaccination, The patient has not been tested for COVID-19. Device Date: 21Nov2022.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Feeling paralyzed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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: PARALYSIS (medically significant), outcome "recovered", described as "Feeling paralyzed". Clinical course: While talking to (pharmacy name withheld) about Paxlovid a pharmacy technician said a patient had reported feeling paralyzed after taking a vaccine. Pharmacy technician directed patient to report the incident to Pfizer. Patient only reported during a flu shot appointment that after getting a Pfizer Vaccine he felt paralyzed and then recovered. Product confirmed as Pfizer COVID-19 Vaccine. Patient reported the event to the reporter during a different appointment for a flu shot. Confirmed the flu shot was not the vaccine that caused the patient to feel paralyzed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EP6955) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". The following information was reported: ORAL HERPES (non-serious) with onset 07Apr2021, outcome "recovered" (09Apr2021), described as "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: It was reported that herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose in upper lip. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient had no known allergies and none other medical history.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Nov2021 at 15:30 as dose 3 (booster), single (Lot number: FE3592) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: EP6955,), administration date: 17Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip"; BNT162b2 (DOSE 2, SINGLE, lot number: EP6955), administration date: 07Apr2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". The following information was reported: ORAL HERPES (non-serious) with onset 30Nov2021, outcome "recovered" (02Dec2021), described as "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip. Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies. Patient received DOSE 4 on 06Aug2022 (Batch/Lot: FJ6369) in Left arm and DOSE 5 on 17Nov2022 at 14:30 (Batch/Lot: GH9693) in the right arm both for COVID-19 immunization.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes simplex virus reactivation with every dose.Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FJ6369, Location of injection: Arm Left), administration date: 06Aug2022, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Oral herpes"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FE3592, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 30Nov2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Oral herpes"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 07Apr2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Oral herpes"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Oral herpes". The following information was reported: ORAL HERPES (non-serious) with onset 17Nov2022, outcome "recovered", described as "Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "BP" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal, start date: 05Sep2018, stop date: 21Nov2022. Past drug history included: Minacycline, reaction(s): "Known allergies: Minacycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events and the suspect drug BNT162B2 cannot be excluded.