chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Interchange of vaccine products, Muscle spasms
Clinical narrative: blood pressure at 170/104...my normal high is 135/85; Extreme leg cramping in left leg; Headache; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 at 15:15 as dose 3 (booster), single (Lot number: Gj6742 RA4063) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure controlled" (unspecified if ongoing), notes: High blood pressure controlled. Concomitant medication(s) included: LISINOPRIL; EFFEXOR; STATIN [NYSTATIN]. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 01Oct2021, when the patient was 61-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 29Apr2022, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Jan2023, outcome "unknown"; MUSCLE SPASMS (non-serious) with onset 13Jan2023 at 01:00, outcome "recovered" (Jan2023), described as "Extreme leg cramping in left leg"; HEADACHE (non-serious) with onset 13Jan2023 at 01:00, outcome "recovered" (Jan2023); HYPERTENSION (medically significant) with onset 13Jan2023 at 01:00, outcome "recovered" (Jan2023), described as "blood pressure at 170/104...my normal high is 135/85". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 135/85; (unspecified date) 120/72; (13Jan2023) 170/104. Therapeutic measures were not taken as a result of hypertension, muscle spasms, headache.  Clinical course: Extreme leg cramping in left leg which woke me. Headache next morning and blood pressure at 170/10. My normal high is 135/85. And normally 120/72. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. Patient had no known allergies.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive; (11Jan2023) Negative; (15Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Had a dizzy reaction to the Pfizer Covid 19 Vaccine; Has had a very bad time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION, reaction(s): "Had a dizzy reaction to the Pfizer Covid 19 Vaccine", "Has had a very bad time.". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Had a dizzy reaction to the Pfizer Covid 19 Vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Has had a very bad time".  Additional information: Two years ago caller received three doses of the Pfizer Covid-19 Vaccine. Had a dizzy reaction to the Pfizer Covid 19 Vaccine. Ever since, has had a very bad time.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018904 same reporter/patient/AE, different dose;US-PFIZER INC-202300018910 same reporter/patient/AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Had a dizzy reaction to the Pfizer Covid 19 Vaccine; Has had a very bad time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Had a dizzy reaction to the Pfizer Covid 19 Vaccine", "Has had a very bad time"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "Had a dizzy reaction to the Pfizer Covid 19 Vaccine", "Has had a very bad time". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Had a dizzy reaction to the Pfizer Covid 19 Vaccine"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Has had a very bad time.". Clinical course details: Two years ago, patient received three doses of the Pfizer Covid 19 Vaccine. Had a dizzy reaction to the Pfizer Covid 19 Vaccine. Ever since, has had a very bad time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018909 same reporter/patient/AE, different dose;US-PFIZER INC-202300018904 same reporter/patient/AE, different dose;
Age: 58.0
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) (Physician). 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 15Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "obesity" (unspecified if ongoing); "migraines" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine; Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Vicodin, reaction(s): "Known allergies: vicodin", notes: Known allergies: vicodin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2023) Negative, notes: after taking Paxlovid with multiple negative Covid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took other medication in 2weeks.   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 product bnt162b2 , BNT162b2 omi ba.4-5 to the reported Drug ineffective and COVID-19 cannot be ruled out.
Age: 54.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 12:00 as dose 4 (booster), single (Lot number: G13275) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies", notes: Known allergies: doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12Jan2023) Positive, notes: Returned to testing positive for COVID four days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Received anti-viral treatment for COVID 19 from 03Jan2023 to 08Jan2023. Returned to testing positive for COVID four days after completing Paxlovid treatment.
Age: 77.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2 NOS), on 14Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: Unknown. Paxlovid, treatment start date: 03Jan2023, treatment stop date: 08Jan2023, indication: treatment of covid-19. Known allergies: None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
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). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound of Covid symptoms two days after negative test; Negative, notes: Rebound of Covid symptoms two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Anti-viral Product Paxlovid for COVID 19 Treatment started on  29Dec2022 and stopped on 03Jan2023. No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Jan2023.  Additional information: Known allergies reported as NA and Other medical history was NA.  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.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Eye inflammation, Inflammation
Clinical narrative: stress out the autoimmune system; inflammation in my eyes; inflammation; 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 61-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208) for covid-19 immunisation. The patient's relevant medical history included: "auto immune disorder" (unspecified if ongoing), notes: I do have an auto immune disorder already I'm celiac person.; "celiac person" (unspecified if ongoing), notes: I do have an auto immune disorder already I'm celiac person. The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "stress out the autoimmune system"; EYE INFLAMMATION (non-serious), outcome "not recovered", described as "inflammation in my eyes"; INFLAMMATION (non-serious), outcome "not recovered".  Clinical course: Caller was a patient that states the following: "I've reached out to Pfizer before, and you guys have sent me some forms to fill out because of the COVID vaccine and some of the terminology I just don't know what it was. I really need to sit down to review it again. The reason I was reaching out this time was that I want to know if you guys have learned any more about how the COVID vaccine could stress out the autoimmune system and we can have some inflammation as a result of that.  I have some inflammation in my eyes to come down. I'm seeing a specialist." I need information for both [Pfizer monovalent and bivalent vaccines] because my first reaction was from the initial vaccine and then I had reactions to the booster also. I do have an auto immune disorder already I'm celiac person so you know I had other things go on but mainly the thing I can't seem to, I guess I'm having a hard time figuring out was this inflammation and the only thing that can come down to is that it might be a reaction to the COVID vaccine. I was just curious about what you guys are finding out about that and if other people are having the same reaction and if they are going down and see if they can get it resolved, you know what I'm saying, I'm not upset about it, I'm just trying to figure it out. You know what you might already have my information because I called in before I don't know if I can pull it up because I'm in my car and I don't have the vaccine information with me to give you exact dates, I did give it before.
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 contactable reporter(s) (Consumer or other non HCP). 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 09Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "colon removed" (unspecified if ongoing), notes: I have had most of my colon removed; "Bee Venom" (unspecified if ongoing), notes: Known allergies: Bee venom. The patient's concomitant medications were not reported. Past drug history included: Macrodantin (nitrofurantoin);, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: product=COVID 19 Treatment, brand=Pfizer, Treatment start date: 02Jan2023, Treatment stop date: 03Jan2023, Lot number: GF4000, Indication: Treatment of COVID-19. Did you/the patient previously receive a COVID-19 Vaccine: Yes. At 5:15 pm on Monday, 02Jan2023, I took the first dose (3 pills) of Paxlovid.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Serious criteria reported as no any results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. COVID 19 Treatment received from 03Jan2023 to 08Jan2023, lot number was not sure. Other medication details: other medication in 2weeks product=Zoloft, Sulfazalasine, Atorvastatin, Prednisone. Adverse event: I tested negative on day 7 of the original covid infection after taking Paxlovid. 2 days later I felt weak and woke up with a cold, had some chills and took 2 tests and tested positive again. Patient was recovering. No treatment for adverse event. No known allergies.   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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke of unknown origin on 02May2021, that caused Permanent disability; 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 male patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: Ew0169) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol at that time only, minor other unrelated health concerns" (unspecified if ongoing), notes: High cholesterol at that time only, minor other unrelated health concerns; "known allergies: New stings" (unspecified if ongoing), notes: known allergies: New stings; "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 02May2021 at 08:00, outcome "not recovered", described as "Stroke of unknown origin on 02May2021, that caused Permanent disability". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 30 day(s)). The event "stroke of unknown origin on 02may2021, that caused permanent disability" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: If COVID tested post vaccination: Yes. COVID test type post vaccination was Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: It was reported that Serious: patient received more than 3 doses. No other vaccine informers. Stroke of unknown origin on 02May2021 that caused Permanent disability. Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma. AE resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment AE with Stroke rehab.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder, Vaccination site erythema, Vaccination site warmth
Clinical narrative: feels like a bubble under my skin and like the size of the may be a golf ball; not hard like golf ball but the little bubble is that that big around; place where I got the shot is pink and very warm; place where I got the shot is pink and very warm; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 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: SKIN DISORDER (non-serious) with onset Jan2023, outcome "unknown", described as "feels like a bubble under my skin and like the size of the may be a golf ball; not hard like golf ball but the little bubble is that that big around"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Jan2023, outcome "unknown" and all described as "place where I got the shot is pink and very warm".  Additional information: Concern: Consumer stated, "I got a Booster shot (Pfizer COVID-19 Vaccine) on Thursday this week and the place where I got the shot is pink and very warm and feels like a bubble under my skin and like the size of the may be a golf ball." Consumer stated, "Yes, it is not hard like golf ball but the little bubble is that that big around."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Inappropriate schedule of product administration, Plasma cell myeloma
Clinical narrative: Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma; Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma; prev dose administration date=18Jun2021, prev dose dose number=2/prev dose administration date=19Apr2021, dose 1; 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 male patient received BNT162b2 (BNT162B2), on 18Jun2021 as dose 2, single (Lot number: EW0187) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol at that time only, minor other unrelated health concerns; "known allergies: New stings" (unspecified if ongoing), notes: known allergies: New stings; "COVID" (unspecified if ongoing), notes: COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0169, Stroke of unknown origin on 02May2021 that caused Permanent disability.), administration date: 19Apr2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Stroke of unknown origin", "COVID-19". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Jun2021, outcome "unknown", described as "prev dose administration date=18Jun2021, prev dose dose number=2/prev dose administration date=19Apr2021, dose 1"; ACUTE KIDNEY INJURY (hospitalization, disability, medically significant, life threatening) with onset 19Aug2021, outcome "not recovered", PLASMA CELL MYELOMA (hospitalization, disability, medically significant, life threatening), outcome "not recovered" and all described as "Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma". The patient was hospitalized for acute kidney injury, plasma cell myeloma (hospitalization duration: 30 day(s)). The event "then on 19aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma" required emergency room visit. Therapeutic measures were taken as a result of acute kidney injury, plasma cell myeloma.  Clinical course: It was reported that the report was about COVID vaccine. Dose received More than 3.The patient had no other vaccine in four weeks.In Doctor's office/urgent care facility the most recent COVID-19 vaccine was administered. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received treatment for AE. AE treatment: Stroke rehab. Patient had COVID tested post vaccination. COVID test type post vaccination was Nasal Swab.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was hospitalized for having a stroke; Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:00 as dose number unknown (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 28Sep2022 at 17:00, outcome "recovering", described as "I was hospitalized for having a stroke"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2023, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident included anti-coagulant Aspirin.  Clinical information: Patient had no known allergies. No covid prior vaccination. No other vaccine in four weeks.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if other medication received in 2 weeks. Paxlovid started on 03Jan2023 and stopped on 07Jan2023 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment for event included Paxlovid, treatment started on 03Jan2023 and stopped on 08Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken with ritonavir (PAXLOVID), from 04Jan2023 to 08Jan2023 for covid-19 treatment as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 14Oct2022 at 18:30 as dose number unknown, single (Lot number: GH6665) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulpha" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Hashimotos Thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Jan2023 to 09Jan2023.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood testosterone, Blood testosterone decreased, Headache, Influenza like illness
Clinical narrative: 1st dose: Headache, flu like symptoms and cramps; 1st dose: Headache, flu like symptoms and cramps; 1st dose: Headache, flu like symptoms and cramps; 10-15 days before 2nd shot, which was around 30Apr2021. The only thing that came back a little low was Testosterone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: EW0161) at the age of 44 years, in left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Other Conditions: No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: BLOOD TESTOSTERONE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "10-15 days before 2nd shot, which was around 30Apr2021. The only thing that came back a little low was Testosterone"; HEADACHE (non-serious), INFLUENZA LIKE ILLNESS (non-serious), MUSCLE SPASMS (non-serious), outcome "recovering" and all described as "1st dose: Headache, flu like symptoms and cramps". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received dose 1 in left shoulder. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events (AEs) was none. There were no any other products.The day of the 1st one. He got headache, flu and all that stuff and the cramps and that went away. He had a blood panel done and they said everything on blood panel, that was normal what they tested for. Drew 17 vials of blood drawn. 10-15 days before 2nd shot, which was around 30Apr2021. The only thing that came back a little low was Testosterone and they said really not even low. The normal was 100 and his was like on a scale of 90-120, he was like 95 or 90. He got the blood draw because he had been sick and never was sick before this and turned his life upside down with work and life.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: 1st dose: Headache, flu like symptoms and cramps; 1st dose: Headache, flu like symptoms and cramps; 1st dose: Headache, flu like symptoms and cramps; 10-15 days before 2nd shot, which was around 30Apr2021. The only thing that came back a little low was Testosterone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: EW0161) at the age of 44 years, in left deltoid for COVID-19 immunization. The patient's relevant medical history included: "Other Conditions: No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: BLOOD TESTOSTERONE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "10-15 days before 2nd shot, which was around 30Apr2021. The only thing that came back a little low was Testosterone"; HEADACHE (non-serious), INFLUENZA LIKE ILLNESS (non-serious), MUSCLE SPASMS (non-serious), outcome "recovering" and all described as "1st dose: Headache, flu like symptoms and cramps". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received dose 1 in left shoulder. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events (AEs) was none. There were no any other products.The day of the 1st one. He got headache, flu and all that stuff and the cramps and that went away. He had a blood panel done and they said everything on blood panel, that was normal what they tested for. Drew 17 vials of blood drawn. 10-15 days before 2nd shot, which was around 30Apr2021. The only thing that came back a little low was Testosterone and they said really not even low. The normal was 100 and his was like on a scale of 90-120, he was like 95 or 90. He got the blood draw because he had been sick and never was sick before this and turned his life upside down with work and life.
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillan" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective and COVID-19 cannot be ruled out.
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) (Physician). The reporter is the patient.  A 65-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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 included: "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "Hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2023) Positive, notes: I tested positive for COVID again-6 days after finishing the course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 11Jan2023 to unknown date.   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: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid as COVID-19 Treatment; Paxlovid as COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid as COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: After taking Paxlovid; Positive again after negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid given on an unspecified date..  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.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) and covid 19  cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Wrong product administered
Clinical narrative: bruising in chest; arm soreness; is bivalent False/administration date 11Jan2023 /dose number 3; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received BNT162b2 (BNT162B2), on 11Jan2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single, Manufacturer unknown), for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Jan2023, outcome "unknown", described as "is bivalent False/administration date 11Jan2023 /dose number 3"; CONTUSION (non-serious), outcome "unknown", described as "bruising in chest"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". It was unknown if therapeutic measures were taken as a result of contusion, pain in extremity.  Additional Information: Events were reported non-serious, did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating nor resulted to congenital anomaly/birth defect. It was unknown if patient had COVID prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 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 a contactable reporter(s) (Other HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "OSA" (unspecified if ongoing), notes: OSA; "GERD" (unspecified if ongoing), notes: GERD; "ED" (unspecified if ongoing), notes: ED; "Insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (10Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Dec2022 to 05Jan2023 to treat COVID-19. The patient completed Paxlovid, had improvement of symptoms and tested negative and was fine for several days but got symptoms again on 09Jan2023 and tested positive for COVID on 10Jan2023. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the available information the causality of the events drug ineffective,and covid-19 with the suspect can not be ruled out completely.