chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had the Moderna uh needle and my arm is still sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had the Moderna uh needle and my arm is still sore) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (I had the Moderna uh needle and my arm is still sore). At the time of the report, PAIN IN EXTREMITY (I had the Moderna uh needle and my arm is still sore) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.; This spontaneous case was reported by a patient and describes the occurrence of HEAVY MENSTRUAL BLEEDING (She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: moderna (dose 1, batch-07469) on 06-May-2021, moderna (dose 2 and batch-07469) on 03-Jun-2021; for Product used for unknown indication: pfizer (dose 3) in December 2021, pfizer (dose 4) on 28-Jun-2022 and pfizer (dose 5) on 03-Feb-2023. Past adverse reactions to the above products included No adverse event with moderna, moderna, pfizer, pfizer and pfizer. Concurrent medical conditions included Menopause since January 2023.    On 04-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEAVY MENSTRUAL BLEEDING (She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.). At the time of the report, HEAVY MENSTRUAL BLEEDING (She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.
Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Headache
Clinical narrative: Daily/Nightly headaches began 15Oct and have continued. Waking up most mornings with pounding pain on one side of my temple or the other; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 12:30 as dose 1, single (Lot number: HG4665) at the age of 44 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 07Oct2023 as dose 1, single (Lot number: u8200da), in left arm for immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: until 24. Concomitant medication(s) included: AMITRIPTYLINE. Past drug history included: Augmentin, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset 15Oct2023, outcome "not recovered", described as "Daily/Nightly headaches began 15Oct and have continued. Waking up most mornings with pounding pain on one side of my temple or the other". Therapeutic measures were not taken as a result of headache. Additional information: The patient did not have covid prior to the vaccination. The patient has not been tested post vaccination for covid.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain lower, Arthralgia, Periarthritis
Clinical narrative: frozen shoulder/Freezing of his Shoulder; joint pain; lower back pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 76-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Oct2023 as dose number unknown, 0.5 ml single (Lot number: HF5023, Expiration Date: Feb2025) at the age of 76 years intramuscular, in right arm and as dose number unknown, single (Lot number: HA3217, Expiration Date: Mar2025) for respiratory syncytial virus immunisation; for respiratory syncytial virus immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MEDROL DOSEPAK. The following information was reported: PERIARTHRITIS (non-serious) with onset 2023, outcome "unknown", described as "frozen shoulder/Freezing of his Shoulder"; ARTHRALGIA (non-serious) with onset 2023, outcome "unknown", described as "joint pain"; BACK PAIN (non-serious) with onset 2023, outcome "unknown", described as "lower back pain". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: The patient was symptomatic 19Oct and tested positive 20Oct2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 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 to the reported events Drug ineffective and COVID-19 cannot be ruled out
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 09:00 as dose 1, single (Lot number: HH7595) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulenmia" (unspecified if ongoing); "severe scoliosis kyphosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ciprofloxazosin, reaction(s): "known allergies: Ciprofloxazosin", notes: known allergies: Ciprofloxazosin all osteoporosis meds. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: 6j2524, Location of injection: Arm Left), administration date: 13Sep2022, when the patient was 54-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 4, Batch/Lot No: FR9894, Location of injection: Arm Left), administration date: 29Mar2022, when the patient was 53-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: FL3181, Location of injection: Arm Left), administration date: 17Aug2021, when the patient was 53-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 52-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 05Feb2021, when the patient was 52-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: made patient blind in one eye; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 immunisation. The following information was reported: BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "made patient blind in one eye". Clinical details: patient received a Pfizer booster and it made patient blind in one eye.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A-fib; 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 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. Vaccination history included: Flu shot (DOSE NUMBER UNKNOWN, SINGLE, Clarifies he got his Flu shot 7 weeks ago.), administration date: Sep2023. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A-fib". The event "a-fib" required physician office visit. The patient had all the vaccines, he's always gotten Pfizer. His only question is, because of his age and he has A-fib, which is under control. He's being seen by a Cardiologist, stating everything is fine. Confirmed he has not received the COVID-19 Vaccine for 2023-2024 yet. Caller provided that he had no problems with the COVID-19 Vaccines he has taken. However, when mentioning he has A-fib, caller did not state if the A-fib was diagnosed prior to or after the COVID-19 Vaccines he received.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: breakthrough infection/infection 6-12 months post-D3; breakthrough infection/infection 6-12 months post-D3; This is a literature report for the following literature source(s):  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (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 "breakthrough infection/infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown result; Positive.  Follow-up attempts are not needed. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.   ,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: breakthrough infection/infection 6-12 months post-D3; breakthrough infection/infection 6-12 months post-D3; This is a literature report for the following literature source(s):  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (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 "breakthrough infection/infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown result; Positive.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Return COVID symptoms 96 hours after completion of Paxlovid treatment in Oct2023; Return COVID symptoms 96 hours after completion of Paxlovid treatment in Oct2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial tachycardia" (unspecified if ongoing); "afib" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2019, stop date: 21Oct2023; METOPROLOL, start date: Aug2017; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Oct2023 at 13:00, outcome "recovering" and all described as "Return COVID symptoms 96 hours after completion of Paxlovid treatment in Oct2023". Therapeutic measures were not taken as a result of drug ineffective, covid-19. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), 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.  Clinical course: The patient had no known allergies and had received other vaccination in 2 weeks. The patient did not receive other medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 24Oct2023 to 29Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract, Retinal detachment
Clinical narrative: retine detachment on both eyes; cataracts on both eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), on 06May2021 at 12:00 as dose 2, single (Lot number: EW0168) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8735, Location of injection: Arm Right, At 12:00 AM), administration date: 15Apr2021, for COVID-19 immunisation. The following information was reported: CATARACT (hospitalization, disability) with onset 25Feb2023 at 22:00, outcome "recovered with sequelae", described as "cataracts on both eyes"; RETINAL DETACHMENT (hospitalization, disability) with onset 25Feb2023 at 22:00, outcome "recovered with sequelae", described as "retine detachment on both eyes". The patient was hospitalized for retinal detachment, cataract (hospitalization duration: 2 day(s)). The events "retine detachment on both eyes" and "cataracts on both eyes" required emergency room visit. Therapeutic measures were taken as a result of retinal detachment, cataract. Clinical course: Patient did not had covid before the vaccination, not tested positive for covid post vaccination. Patient did not had known allergies, no medical history. No other vaccine was received in four weeks. No other medications were received in two weeks. Patient stated he had retine detachment on both eyes, one first and 15 days later the other eye, 5 months at home recovering and then had cataracts on both eyes. He stated that he must go back to the hospital to make, possibly, another surgery in both eyes.
Age: 54.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: COVID-19, Drug ineffective
Clinical narrative: suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset; suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 12:00 as dose 1, single (Lot number: HF9275) at the age of 54 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 26Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Dermatitis atopic" (unspecified if ongoing); "Exposed to Covid-19 via domestic partner" (ongoing). There were no concomitant medications. Vaccination history included: pfizer covid 19 vaccine (DOSE 4 (BOOSTER), SINGLE, bivalent), administration date: 06Dec2022, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 05Apr2022, when the patient was 53-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE), administration date: 27Mar2022 (as reported), for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE), administration date: 17Apr2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Nov2023, outcome "not recovered" and all described as "suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset". Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Exposed to Covid-19 via domestic partner (no recent Covid vaccinations, only 2 primary series received 2021), who tested Covid positive in nasal swab test on 04Nov2023. My symptoms started the same day. Highly suspected signs and symptoms of COVID-19 as follows: mild shortness of breath with moderate walking, dizziness, mild headache, mild GI upset, eye light sensitivity, mild dry cough, mild rhinorrhea, joint/muscle aches, fatigue, somnolence, hypersomnia (slept 18 hours during a 24 hr period), mild temperature and occasional shivers. Still ongoing symptoms. Have had COVID-19 three times before over past 3 years. Did not do COVID test at this time.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Lip swelling
Clinical narrative: Anaphylactic reaction to the shot; Lips swelled up double in size; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction to the shot"; LIP SWELLING (medically significant), outcome "unknown", described as "Lips swelled up double in size". Clinical course: His lips swelled up double in size and they happened like 3 or 4 days after the shot was taken. He didn't take anything this time, he didn't take anything since the first two. His doctor forbid for taking any more Covid shot.  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-202300356951 same reporter/product, different patient/event;US-PFIZER INC-202300357098 same reporter/product, different patient/event;
Age: 71.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 14Oct2021 at 11:30 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 20Apr2022 at 01:00 as dose 4 (booster), single (Lot number: FJ4989), 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: "Asthma" (unspecified if ongoing); "sulfa drugs allergy" (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 Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 19Oct2023 to 25Oct2023.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300356713 Same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had Covid twice, once in 2019 and one last year; had Covid twice, once in 2019 and one last year; 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 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "had Covid twice, once in 2019 and one last year". Clinical course: Consumer stated, "she took the original 2 Pfizer shot when it first came out, took two of the boosters back about a year and a half ago. The every shot (Pfizer COVID-19 Vaccine) she had taken and she had Covid twice, once in 2019 and one last year.  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-202300356951 Same patient/product, different dose/events;US-PFIZER INC-202300356952 different patient;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand other: Novavax; Vaccine brand: Pfizer/BioNTech; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 14Oct2023 at 12:00 as dose number unknown, single (Lot number: 5683MF012), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "Vaccine brand other: Novavax; Vaccine brand: Pfizer/BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 27Oct2023 to 31Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357527 same patient, different drug and event;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand other= Moderna, Vaccine administration date= 04Oct2023,; 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 75-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: tylenol, acedemetaphen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2023, outcome "unknown", described as "Vaccine brand other= Moderna, Vaccine administration date= 04Oct2023,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 29Oct2023 to 03Nov2023.  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: Linked Report(s) : US-PFIZER INC-202300357541 same patient, different drug and event;
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Palpitations
Clinical narrative: shortness of breath; palpitation; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 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: FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "extreme fatigue"; PALPITATIONS (non-serious) with onset 2023, outcome "unknown", described as "palpitation"; DYSPNOEA (non-serious) with onset 2023, outcome "unknown", described as "shortness of breath". Additional information: Caller said that he got his COVID 19 vaccine last week since reporting day (02Nov2023) and asking if it's normal to have shortness of breath, palpitation and extreme fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Near death experience, Schizophreniform disorder
Clinical narrative: schizophrenic brain; nearly died/close to a code blue; allergic reaction; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001330.  A 72-year-old female patient received bnt162b2 (BNT162B2), on 05Feb2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing); "migraine" (unspecified if ongoing); "headaches" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obsessive-compulsive disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: Mar2022, when the patient was 70 years old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 2023, outcome "recovered", described as "allergic reaction"; NEAR DEATH EXPERIENCE (medically significant) with onset 2023, outcome "recovered", described as "nearly died/close to a code blue"; SCHIZOPHRENIFORM DISORDER (non-serious), outcome "unknown", described as "schizophrenic brain". The events "nearly died/close to a code blue" and "allergic reaction" required emergency room visit. Therapeutic measures were taken as a result of near death experience, hypersensitivity. Clinical courses: On 19Oc2023 and 25Oct2023, it was reported that a  woman patient started treatment on 05Feb2023 with Pfizer BioNTech COVID-19 vaccine dose 1 for COVID-19 vaccination. It was reported the patient did not get the 2nd dose because she had an allergic reaction so bad she had to go to the ER, and was "close to a code blue" and "nearly died." It was reported an EpiPen was used to bring her back. It was reported the patient was allergic to eggs, and had migraine, headaches, asthma, and obsessive-compulsive disorder. The patient jokingly stated: "I think have a schizophrenic brain." She had the Janssen COVID-19 vaccine in Mar2022.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect vaccine bnt162b2 to the reported events Hypersensitivity and Near death experience cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral palsy, Immune system disorder, Trisomy 21
Clinical narrative: Immune issues; Cerebral palsy; Down syndrome; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. 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: IMMUNE SYSTEM DISORDER (disability), outcome "unknown", described as "Immune issues"; CEREBRAL PALSY (medically significant), outcome "unknown"; TRISOMY 21 (disability), outcome "unknown", described as "Down syndrome". Therapeutic measures were taken as a result of cerebral palsy, trisomy 21. Additional information: the patient's mother called in on behalf of the patient seeking assistance with the Pfizer-BioNTech COVID-19 Vaccine. During the call caller stated." He's disabled and has a bunch of immune issues.. He's 28 he has down syndrome and cerebral palsy.. He's in a wheel chair.. and he has a bunch of different health conditions."  The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided,a causal association between reported events and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial tachycardia, Blood pressure measurement
Clinical narrative: atrial tachycardia/heart irregularities/extra beats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 70's received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: ATRIAL TACHYCARDIA (medically significant) with onset Apr2023, outcome "unknown", described as "atrial tachycardia/heart irregularities/extra beats". The event "atrial tachycardia/heart irregularities/extra beats" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2023) unknown results. Clinical course: The patient reported: "I received two of your COVID-19 vaccinations. I was 73 at the time. In Apr of this year (2023), I was in the ER at withheld for what turned out to be atrial tachycardia. I have since visited the ER a total of four times this year, all related to tachycardia. I have long since felt that this medical condition is related to the COVID vaccinations, as I have never had heart issues before and this came on with a bang in Apr. Finally, I was able to get a medical professional to admit that there is evidence that the vaccine has caused heart issues in many people, especially older people. I also read an 18 page report on the web by a panel of medical people who said they are seeing an alarming number of heart-related issues directly related to the COVID vaccine. I want you to know that my life is pretty much ruined. Prior to Apr, I was a fairly vibrant, very active "senior", who traveled the world and hiked and biked. Now I sit, take my blood pressure twice a day, and try to be comfortable with my heart irregularities and such hard extra beats that sometimes I swear it will either burst or bump me off a chair or out of bed. This is truly awful Someday, some dever attorney will file a class action lawsuit and, assuming I'm still alive, I will join.".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Chills, Flushing, Headache, Heart rate increased
Clinical narrative: tingling; numbness starting from her left chest up to the sides of her left fingertips; rapid heart rate; pain in her left arm where she received the flu shot; experienced chest pain; headaches; flushing; chills; Initial information received on 26-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Patient).  This case involves a 46 years old female patient who experienced tingling, numbness starting from her left chest up to the sides of her left fingertips, rapid heart rate, pain in her left arm where she received the flu shot, experienced chest pain, headaches, flushing and chills after receiving Influenza Quadrival A-B Vaccine [Fluzone Qiv].  The patient's past medical history, Concomitant medications, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rubber sensitivity and Drug hypersensitivity.  On 02-Sep-2023, the patient received a unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (Strength: standard, frequency: once, expiry date: 30-Jun-2024 and lot URV8200DA via intramuscular route in the left deltoid as immunization.  On 03-Sep-2023, the patient developed tingling (paraesthesia), numbness starting from her left chest up to the sides of her left fingertips (hypoaesthesia), rapid heart rate (heart rate increased), pain in her left arm where she received the flu shot (vaccination site pain), experienced chest pain (chest pain), headaches (headache), flushing and chills (latency: 1 day).  Action taken: not applicable.  The patient was treated with Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]); And Prednisone for all events (Vaccination site pain, Paraesthesia, Hypoaesthesia, Chest pain, Headache, Flushing, Chills and Heart rate increased ).  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2023 for all events.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: tingling; numbness starting from her left chest up to the sides of her left fingertips; rapid heart rate; pain in her left arm where she received the flu shot; experienced chest pain; headaches; flushing; chills; Initial information received on 26-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Patient).  This case involves a 46 years old female patient who experienced tingling, numbness starting from her left chest up to the sides of her left fingertips, rapid heart rate, pain in her left arm where she received the flu shot, experienced chest pain, headaches, flushing and chills after receiving Influenza Quadrival A-B Vaccine [Fluzone Qiv].  The patient's past medical history, Concomitant medications, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rubber sensitivity and Drug hypersensitivity.  On 02-Sep-2023, the patient received a unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (Strength: standard, frequency: once, expiry date: 30-Jun-2024 and lot URV8200DA via intramuscular route in the left deltoid as immunization.  On 03-Sep-2023, the patient developed tingling (paraesthesia), numbness starting from her left chest up to the sides of her left fingertips (hypoaesthesia), rapid heart rate (heart rate increased), pain in her left arm where she received the flu shot (vaccination site pain), experienced chest pain (chest pain), headaches (headache), flushing and chills (latency: 1 day).  Action taken: not applicable.  The patient was treated with Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]); And Prednisone for all events (Vaccination site pain, Paraesthesia, Hypoaesthesia, Chest pain, Headache, Flushing, Chills and Heart rate increased ).  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2023 for all events.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administration error
Clinical narrative: pharmacist did not visually inspect the syringe prior to administration; she did not realize the syringe was empty until she had stuck the patient with the needle with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves a 47 years old female patient and reporter reported pharmacist did not visually inspect the syringe prior to administration; she did not realize the syringe was empty until she had stuck the patient with the needle with no reported adverse event after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for Immunization and pharmacist did not visually inspect the syringe prior to administration; she did not realize the syringe was empty until she had stuck the patient with the needle with no reported adverse event (product administration error) (latency: same day).  It was reported, The pharmacist had already stuck the patient with the needle, when they noticed that there was no solution inside of the syringe. The patient notes that the syringe looked intact, and there was no leaking during administration; the syringe was already empty at the time of administration. The patient reports that the pharmacist had to get out a different FLUZONE QIV NP pre-filled syringe to complete the dose. The patient notes that she is fine, but wanted to report the even    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Headache
Clinical narrative: received an expired dose of FLUZONE; headache; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 29 years old female patient who experienced headache and received an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (Menactra) for Prophylactic vaccination.  On 24-Oct-2023, the patient received a dose of suspect influenza quadrival a-b multidose vaccine preserved [fluzone] suspension for injection (lot- U8096AA and expiration date- 30-Jun-2023) via intramuscular route in the left arm (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day)  On an unknown date in Oct- 2023 the patient developed headache (unknown latency) following the administration of   Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events (headache).  At time of reporting, the outcome was Recovered / Resolved in 2023 for the event headache and was Unknown for the event received an expired dose of fluzone.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.