chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Autonomic neuropathy, Illness
Clinical narrative: I was not aware I had COVID until I was tested on 20Sep2021 / had tested positive for COVID in Sep2021; I was not aware I had COVID until I was tested on 20Sep2021 / had tested positive for COVID in Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer) from product quality group, Program ID:  The reporter is the patient. A 57-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9265), in arm and on 23Feb2021 as dose 2, single (Lot number: EL9267) at the age of 57 years, in arm for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "I was not aware I had COVID until I was tested on 20Sep2021 / had tested positive for COVID in Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2021) Positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Clinical information: It was stated that on received the first Pfizer vaccine on 02Feb2021. It was stated that no negative side effects. Then, the received the 2nd dose on 23Feb2021.  On 18Aug2021, the patient had swallowing issue and pain. A scope was put down the patient throat and had right side vocal cord paralysis. It was mentioned that it was not normal and explained regarding the issues with swallowing and pain. He needed to schedule surgery to inject the vocal cord and look to see if there were abnormal cells for biopsy (computed tomography of the thorax with Contract material). During the procedure, she contracted COVID 19 for the first time. Her symptom was raid heart rate when  walking. She was not aware that she had COVID until she was tested on 20Sep2021. She was given Monoclonal Antibodies. She could not tell that it did any good or not since she had the virus probably since surgery on 09Sep2021. It took about 6 weeks for her heart rate to regulate. Also mentioned that during the procedure, that her vocal cord moved which was good news. The injection helped but it took time to start functioning again. There was no sign of cancer. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300002692 same patient/drug, different dose number and event;
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I was not aware I had COVID until I was tested on 20Sep2021 / had tested positive for COVID in Sep2021; I was not aware I had COVID until I was tested on 20Sep2021 / had tested positive for COVID in Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer) from product quality group, Program ID:  The reporter is the patient. A 57-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9265), in arm and on 23Feb2021 as dose 2, single (Lot number: EL9267) at the age of 57 years, in arm for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "I was not aware I had COVID until I was tested on 20Sep2021 / had tested positive for COVID in Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2021) Positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Clinical information: It was stated that on received the first Pfizer vaccine on 02Feb2021. It was stated that no negative side effects. Then, the received the 2nd dose on 23Feb2021.  On 18Aug2021, the patient had swallowing issue and pain. A scope was put down the patient throat and had right side vocal cord paralysis. It was mentioned that it was not normal and explained regarding the issues with swallowing and pain. He needed to schedule surgery to inject the vocal cord and look to see if there were abnormal cells for biopsy (computed tomography of the thorax with Contract material). During the procedure, she contracted COVID 19 for the first time. Her symptom was raid heart rate when  walking. She was not aware that she had COVID until she was tested on 20Sep2021. She was given Monoclonal Antibodies. She could not tell that it did any good or not since she had the virus probably since surgery on 09Sep2021. It took about 6 weeks for her heart rate to regulate. Also mentioned that during the procedure, that her vocal cord moved which was good news. The injection helped but it took time to start functioning again. There was no sign of cancer. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300002692 same patient/drug, different dose number and event;
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: I got an Apple watch for my birthday; it told me that I was in A-fib. I made an appointment with my doctor who ordered an EKG that said everything looked fine. He also ordered, a Body Guardian mini monitor for me to wear for two weeks. When I went in for the results it did show that I was in A-fib.  am now taking Eliquis and Metoprolol Succinate to help with the A-fib. Currently my blood pressure is normal, and my heart is not showing any signs of A-fib. I was referred to a cardiologist by my family physician to confirm the results and medications. She changed my Metoprolol to twice a day. I do not feel like I am getting better, I have no energy and I am tired all the time.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Asthenia, Atrial fibrillation, Cardiac monitoring normal, Electrocardiogram normal
Clinical narrative: I got an Apple watch for my birthday; it told me that I was in A-fib. I made an appointment with my doctor who ordered an EKG that said everything looked fine. He also ordered, a Body Guardian mini monitor for me to wear for two weeks. When I went in for the results it did show that I was in A-fib.  am now taking Eliquis and Metoprolol Succinate to help with the A-fib. Currently my blood pressure is normal, and my heart is not showing any signs of A-fib. I was referred to a cardiologist by my family physician to confirm the results and medications. She changed my Metoprolol to twice a day. I do not feel like I am getting better, I have no energy and I am tired all the time.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4
Symptoms: Fatigue
Clinical narrative: I got an Apple watch for my birthday; it told me that I was in A-fib. I made an appointment with my doctor who ordered an EKG that said everything looked fine. He also ordered, a Body Guardian mini monitor for me to wear for two weeks. When I went in for the results it did show that I was in A-fib.  am now taking Eliquis and Metoprolol Succinate to help with the A-fib. Currently my blood pressure is normal, and my heart is not showing any signs of A-fib. I was referred to a cardiologist by my family physician to confirm the results and medications. She changed my Metoprolol to twice a day. I do not feel like I am getting better, I have no energy and I am tired all the time.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No other adverse events; a 12 year old received an adult dose of VAQTA in error on 28Feb2023.; a 12 year old received an adult dose of VAQTA in error on 28Feb2023.; This spontaneous report was received from a registered nurse concerning a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-FEB-2023, the patient was vaccinated in error with and adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, adult dose/formulation, lot# NZ7GR, expiration date: 17-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate age at vaccine administration) (Incorrect dose administered). No additional adverse events were reported.   The reporter inquired whether the dose of hepatitis a vaccine, inactivated (VAQTA) could be considered a valid dose.   This is one of two reports received from the same reporter.  Lot Number NZ7GR was confirmed to be not valid for hepatitis a vaccine, inactivated (VAQTA) by the lot validation team.; Sender's Comments:  US-009507513-2303USA001716:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse events; Vaccine administered from expired lot; This spontaneous report was received from an unspecified health professional and refers to a 17-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated from an expired lot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, once, lot #T028583, expiration date: 04-MAR-2023, administered intramuscularly for prophylaxis (strength was not provided) (expired product administered), and requested guidance for revaccination. No further information provided, no additional adverse event (AE).
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: After receiving a covid-10 vaccine, they suffered heart palpitations that required going to the hospital.; On 02-MAR-2023, this serious initial non-interventional study safety report was received from a consumer and was received by Novavax on 02-MAR-2023.   A female of an unspecified age was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on an unspecified date.  The following medical history was reported: Palpitations.  No concomitant medications were reported.  On an unspecified date, after second vaccination, the individual suffered heart palpitations that required going to the hospital (PT: Palpitations) (Serious: Hospitalization).  At the time of reporting, the event outcome of Palpitations was recovered/resolved.  Lot number was requested but was unknown to the reporter.; Sender's Comments: This female of an unspecified age experienced: Palpitations after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Palpitations was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Palpitations was assessed as unknown.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 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 had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative multiple times; (02Mar2023) Positive, notes: Began experiencing symptoms again and tested positive on 02Mar2023. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Feb2023 to 22Feb2023. The patient recovered from Covid after taking Paxlovid. The patient tested negative multiple times and all symptoms were gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; 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 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GS3227) at the age of 42 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FH8018), 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: "Non alcoholic fatty liver disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin"; Sulfa, reaction(s): "known allergies: sulfa". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received no other medication in 2 weeks. The patient received anti-viral treatment with Paxlovid from 23Feb2023 to 27Feb2023. The patient experienced adverse event of mild symptoms (congestion) and just tested positive on antigen 7 days after end of Paxlovid treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096893 same reporter/patient, different product/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 43-year-old female patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". 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. COVID 19 Treatment was taken from 24Feb2023 to 01Mar2023.  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-202300096903 Same patient, different product, different event;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Drug as reported; Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 at 12:00 as dose 5 (booster), single (Lot number: gh9703) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 at 15:00 as dose 1, single (Lot number: en9581), in left arm, on 23Feb2021 at 14:00 as dose 2, single (Lot number: en6198), in left arm and on 30Aug2021 at 15:00 as dose 3 (booster), single (Lot number: fd8448), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jul2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "previous lymphoma" (unspecified if ongoing), notes: Other medical history: previous lymphoma. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Jul2022 at 12:00, outcome "unknown", described as "Drug as reported; Moderna"; 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: Positive; positive, notes: rebound test positive; negative, notes: several days after last negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna/ Dose #6: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), on 13Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "chronic cough" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE, start date: 19Mar2020, stop date: 06Mar2023; FLUTICASONE, start date: 19Mar2020, stop date: 25Feb2023. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone", notes: Known allergies: prednisone; Mucinex-d, reaction(s): "Known allergies: Mucinex-d", notes: Known allergies: Mucinex-d. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna/ Dose #6: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Mar2023) Negative, notes: tested negative 1 day after finishing of Paxlovid treatment; (05Mar2023) Positive, notes: On the 4th day after completing treatment mild symptoms re occurred and  tested positive again; (Mar2023) Negative, notes: tested negative the following 2 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Feb2023 to 01Mar2023.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Herpes simplex, Lichen sclerosus, SARS-CoV-2 test, Vaginal infection
Clinical narrative: Herpes Outbreak (hadn't had one in more than 2 years); vaginitis; fibromyalgia symptoms exacerbated; vaginal lichen sclerosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "herpes" (unspecified if ongoing); "MCK" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; LATANOPROST; HYDROCHLOROTH; YUVAFEM. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 13Nov2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: HERPES SIMPLEX (non-serious), outcome "not recovered", described as "Herpes Outbreak (hadn't had one in more than 2 years)"; VAGINAL INFECTION (non-serious), outcome "not recovered", described as "vaginitis"; FIBROMYALGIA (non-serious), outcome "not recovered", described as "fibromyalgia symptoms exacerbated"; LICHEN SCLEROSUS (non-serious), outcome "not recovered", described as "vaginal lichen sclerosis". The events "herpes outbreak (hadn't had one in more than 2 years)", "vaginitis", "fibromyalgia symptoms exacerbated" and "vaginal lichen sclerosis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes simplex, vaginal infection, fibromyalgia, lichen sclerosus (Vagifem; clobetasol; acyclovir; antibiotics).  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, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Lot number: 04l20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: c01az1a), in left arm, on 04Nov2021 as dose 3 (booster), single (Lot number: 014F21A), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: 06911214), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NABUMETONE; SULFASALAZINE; AMLODIPINE; HYZAAR. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", 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: Patient received Paxlovid treatment for Treatment of COVID-19 from 20Feb2023 to 24Feb2023. Patient had 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300097285 Same reporter and patient, different product and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had covid; had covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had covid". Clinical course: Patient just recently got covid virus, and she asked when she could get the fifth shot. Patient also stated that she got the four doses of Pfizer covid 19 vaccine. Patient stated she had 2 covid vaccines and 2 boosters. She recently had covid and wanted to know when she could get the fifth dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: Had four trips at a hospital and they keep working on his lungs and draining fluid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 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 and concomitant medications were not reported. The following information was reported: LUNG DISORDER (hospitalization), outcome "unknown", described as "Had four trips at a hospital and they keep working on his lungs and draining fluid". Therapeutic measures were taken as a result of lung disorder.  Clinical course: Reporter states, ah, yes, my son had a Pfizer rejection the 07Dec. And before the end of the month, he was at a hospital with life problems, and he had four trips at a hospital, and they keep working on his lungs and draining fluid.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Had COVID 3 weeks ago; Had COVID 3 weeks ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID 3 weeks ago". Clinical course: Caller stated she has taken 3 Pfizer COVID-19 vaccines, the primary series and a booster. She wanted to know if she can get the bivalent booster even if she had COVID 3 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: The patient, asking if he requires any additional booster doses at this time of the Pfizer COVID-19 vaccine. The patient having the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. The caller reports also having had COVID exactly a year ago yesterday. The patient said this occurred after his third and then his fourth dose. All of the doses have been the Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Product use issue
Clinical narrative: The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: The patient, asking if he requires any additional booster doses at this time of the Pfizer COVID-19 vaccine. The patient having the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. The caller reports also having had COVID exactly a year ago yesterday. The patient said this occurred after his third and then his fourth dose. All of the doses have been the Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller reports also having had covid exactly a year ago yesterday. The caller said this occurred after his third". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: The patient, asking if he requires any additional booster doses at this time of the Pfizer COVID-19 vaccine. The patient having the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. The caller reports also having had COVID exactly a year ago yesterday. The patient said this occurred after his third and then his fourth dose. All of the doses have been the Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Knee hurting; could be arthritis; Knee hurting; could be arthritis; 3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 65 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Grave's Disease", start date: Oct2009 (ongoing), notes: Grave's Disease , Takes: Methimazole for condition. Concomitant medication(s) included: METHIMAZOLE taken for basedow's disease, start date: Oct2009 (ongoing). Vaccination history included: BNT162b2 (dose 1, single, lot number: EN6202, intramuscular in the left arm), administration date: 27Feb2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, lot number: ER2613, intramuscular in the left arm), administration date: 22Mar2021, when the patient was 65-year-old, for COVID-19 immunization; Shingles vaccine (prior to the first COVID vaccine; did not get at the same time as the COVID vaccine), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day"; ARTHRITIS (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Knee hurting; could be arthritis".
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Product use issue
Clinical narrative: Knee hurting; could be arthritis; Knee hurting; could be arthritis; 3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 65 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Grave's Disease", start date: Oct2009 (ongoing), notes: Grave's Disease , Takes: Methimazole for condition. Concomitant medication(s) included: METHIMAZOLE taken for basedow's disease, start date: Oct2009 (ongoing). Vaccination history included: BNT162b2 (dose 1, single, lot number: EN6202, intramuscular in the left arm), administration date: 27Feb2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, lot number: ER2613, intramuscular in the left arm), administration date: 22Mar2021, when the patient was 65-year-old, for COVID-19 immunization; Shingles vaccine (prior to the first COVID vaccine; did not get at the same time as the COVID vaccine), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day"; ARTHRITIS (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Knee hurting; could be arthritis".
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Knee hurting; could be arthritis; Knee hurting; could be arthritis; 3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 65 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 24Sep2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Grave's Disease", start date: Oct2009 (ongoing), notes: Grave's Disease , Takes: Methimazole for condition. Concomitant medication(s) included: METHIMAZOLE taken for basedow's disease, start date: Oct2009 (ongoing). Vaccination history included: BNT162b2 (dose 1, single, lot number: EN6202, intramuscular in the left arm), administration date: 27Feb2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single, lot number: ER2613, intramuscular in the left arm), administration date: 22Mar2021, when the patient was 65-year-old, for COVID-19 immunization; Shingles vaccine (prior to the first COVID vaccine; did not get at the same time as the COVID vaccine), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "3rd dose: Pfizer first monovalent booster / Given a Flu Shot on the same day"; ARTHRITIS (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Knee hurting; could be arthritis".
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.; The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.; 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 patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Mar2022, outcome "unknown" and all described as "The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.". The patient had the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. Patient reported having had COVID exactly a year ago yesterday (05Mar2022). This was after his third and then his fourth dose. All of the patient's doses have been the Pfizer COVID-19 vaccine.   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-202300097593 same patient/reporter/drug/events, different dose number;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Product use issue
Clinical narrative: The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.; The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.; 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 patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Mar2022, outcome "unknown" and all described as "The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.". The patient had the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. Patient reported having had COVID exactly a year ago yesterday (05Mar2022). This was after his third and then his fourth dose. All of the patient's doses have been the Pfizer COVID-19 vaccine.   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-202300097593 same patient/reporter/drug/events, different dose number;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.; The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.; 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 patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Mar2022, outcome "unknown" and all described as "The caller reports also having had COVID exactly a year ago yesterday. The caller said this occurred after his third and then his fourth dose.". The patient had the two primary series vaccines, 2 more vaccines, and one "bivariant" vaccine on 20Sep2022. Patient reported having had COVID exactly a year ago yesterday (05Mar2022). This was after his third and then his fourth dose. All of the patient's doses have been the Pfizer COVID-19 vaccine.   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-202300097593 same patient/reporter/drug/events, different dose number;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID; COVID; Moderna dose 4 and 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6201), on 24Mar2021 as dose 2, single (Lot number: ER8727) and on 06Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 50 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 016J212A) and on 17Oct2022 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown", described as "Moderna dose 4 and 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Feb2023, outcome "unknown" and all described as "Diagnosed with COVID 23Feb2023". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 24Feb2023.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 11:00 as dose 5 (booster), single (Lot number: Fk9893) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 at 10:00 as dose 4 (booster), single (Lot number: Fk9893), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 10Feb2021 as dose 2, single (Lot number: Em9810), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: Ff2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, some antibiotics; "Known allergies: some antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 23Feb2023 to 28Feb2023.