chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2022) Negative, notes: Testing positive 9 days after negative test; (01Jan2023) Positive, notes: Testing positive 9 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Dec2022 to 25Dec2022.  Clinical Course: Patient did not received other medication within 2 weeks of COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 11:00 as dose 1, single (Lot number: EN6198), in left arm and on 20Apr2021 at 11:30 as dose 2, single (Lot number: EW0153) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2021) Positive; (20Dec2021) Positive.  Clinical course: No other vaccine in four weeks. Other medication in two weeks was Tylenol. No COVID prior vaccination. COVID tested post vaccination.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Age: 55.0
Sex: F
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 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jun2022 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Buckwheat" (unspecified if ongoing), notes: Known allergies: Buckwheat; "HBP" (unspecified if ongoing), notes: Other medical history: HBP; "pre-diabetes" (unspecified if ongoing), notes: Other medical history: pre-diabetes; "High cholesterol" (unspecified if ongoing), notes: Other medical history: High cholesterol. 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 "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 30Dec2022 to 03Jan2023.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer / BioNTech, vaccine dose number=4/ vaccine brand other=Moderna, vaccine dose number=5,; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Jan2021 as dose 1, single (Batch/Lot number: unknown), on 31Jan2021 as dose 2, single (Batch/Lot number: unknown), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: DESCOVY; TIVICAY; LISINOPRIL; MOBIC; CONTRAVE. Past drug history included: Sustiva for known allergies :Sustiva, notes: known allergies :Sustiva. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Feb2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech, vaccine dose number=4/ vaccine brand other=Moderna, vaccine dose number=5,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) positive, notes: Initial positive test on 26Dec2022; (31Dec2022) Negative, notes: Previously tested negative on 31Dec2022; (Jan2023) Positive, notes: Tested positive on rapid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested positive on rapid. Previously tested negative on 31Dec2022. Initial positive test on 26Dec2022 and started Paxlovid on 26Dec2022. Other medication in 2weeks: Yes. Patient received COVID 19 Treatment with Paxlovid, treatment start date on 26Dec2022, treatment stop date on 30Dec2022.  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 available information in the case, the causal association between the events INTERCHANGE OF VACCINE PRODUCTS, DRUG INEFFECTIVE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment, brand=Paxlovid; COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 78 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bronchiectasis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "PSVT history" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE nasal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: Felt fine but started paxlovid after positive covid test due to her having bronchiectasis.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "drug ineffective", "COVID-19".
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Paoriatic arthritis" (unspecified if ongoing), notes: Paoriatic arthritis; "joint replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin", notes: known allergies: Aspirin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of COVID-19 Paxlovid from 27Dec2022 to 01Jan2023 for 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer / BioNTech,vaccine dose number=2; vaccine brand other=Moderna,vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Lot number: FP7139) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: en6205), in right arm and on 24Mar2021 as dose 2, single (Lot number: ER8732), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose 3 (booster), single (Lot number: 065F4A), in right arm and on 19May2022 as dose 4 (booster), single (Lot number: 038A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional mild asthma" (unspecified if ongoing), notes: Occasional mild asthma; "known allergies: Mild peanut" (unspecified if ongoing), notes: known allergies: Mild peanut. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2021, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech,vaccine dose number=2; vaccine brand other=Moderna,vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received Vitamin C and Solgar medication in two weeks,
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline", notes: known allergies: Tetracycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2023) Positive, notes: Positive COVID 3 days after testing negative,; (Jan2023) Negative, notes: Positive COVID 3 days after testing negative,. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid treatment from 27Dec2022 till 01Jan2023 and got positive COVID 3 days after testing negative, with return of symptoms, took full 5 day course of paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Hyperkalemia" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 11Oct2020; ROSUVASTATIN, start date: 25Aug2022, stop date: 23Dec2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: COVID-19 treatment with Paxlovid from 24Dec2022 to 29Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 16:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: 071F21A, Location of injection: Arm Left), administration date: 22Oct2021, when the patient was 38-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 016M20A), administration date: 10Feb2021, when the patient was 37-year-old, for Covid-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 012L20A), administration date: 13Jan2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 02Oct2022, outcome "recovering", described as "Heart Attack". Therapeutic measures were taken as a result of myocardial infarction.
Sex: F
Vaccine: PNC20
Symptoms: Herpes virus infection
Clinical narrative: Was diagnosed with with herpes, but that was not the right diagnosis.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES VIRUS INFECTION (non-serious), outcome "unknown", described as "Was diagnosed with with herpes, but that was not the right diagnosis.". The event "was diagnosed with with herpes, but that was not the right diagnosis." required emergency room visit.  Additional information: on 12Dec2022, she had the Prevnar 20 vaccine. she has had trouble with other vaccines. So far she has been to the Emergency room three times. She was diagnosed with with herpes, but that was not the right diagnosis.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Palpitations; Rapid heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 completed, Manufacturer: Unknown), for Covid-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: PALPITATIONS (non-serious) with onset 03Jan2023 at 12:15, outcome "recovered with sequelae"; HEART RATE INCREASED (non-serious) with onset 03Jan2023 at 12:15, outcome "recovered with sequelae", described as "Rapid heartbeat". Therapeutic measures were not taken as a result of palpitations, heart rate increased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Arthralgia, Chills, Off label use, Pain, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 at 14:30 as dose 3 (booster), single (Lot number: GJ6743) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 05Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: er8732), administration date: 21Mar2021, when the patient was 28-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: el3302), administration date: 28Feb2021, when the patient was 28-year-old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 05Jan2023, outcome "unknown" and all described as "flu vaccine 5Jan2023/pfizer Bivalent 5Jan2023"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 06Jan2023 at 08:00, outcome "not recovered" and all described as "body/joint aches"; CHILLS (non-serious) with onset 06Jan2023 at 08:00, outcome "not recovered"; PYREXIA (non-serious) with onset 06Jan2023 at 08:00, outcome "not recovered", described as "low grade fever"; VOMITING (non-serious) with onset 06Jan2023 at 08:00, outcome "not recovered", described as "multiple episodes of vomiting". Therapeutic measures were not taken as a result of vomiting, pyrexia, pain, chills, arthralgia. Additional information: The events occurred within 24 hours of booster vaccine. Other vaccine in four weeks was reported as yes. No other medications in two weeks were reported. Patient did have covid prior vaccination and did not test for covid post vaccination. No known allergies were reported. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 at 14:30 as dose 3 (booster), single (Lot number: GJ6743) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 05Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: er8732), administration date: 21Mar2021, when the patient was 28-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: el3302), administration date: 28Feb2021, when the patient was 28-year-old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 05Jan2023, outcome "unknown" and all described as "flu vaccine 5Jan2023/pfizer Bivalent 5Jan2023"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 06Jan2023 at 08:00, outcome "not recovered" and all described as "body/joint aches"; CHILLS (non-serious) with onset 06Jan2023 at 08:00, outcome "not recovered"; PYREXIA (non-serious) with onset 06Jan2023 at 08:00, outcome "not recovered", described as "low grade fever"; VOMITING (non-serious) with onset 06Jan2023 at 08:00, outcome "not recovered", described as "multiple episodes of vomiting". Therapeutic measures were not taken as a result of vomiting, pyrexia, pain, chills, arthralgia. Additional information: The events occurred within 24 hours of booster vaccine. Other vaccine in four weeks was reported as yes. No other medications in two weeks were reported. Patient did have covid prior vaccination and did not test for covid post vaccination. No known allergies were reported. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
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 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen"; Phenothiazine, reaction(s): "Known allergies: phenothiazine"; Torecan, reaction(s): "Known allergies: torecan"; Phenergan, reaction(s): "Known allergies: phenergan"; Keflex, reaction(s): "Known allergies: Keflex". 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE & COVID-19  and The suspected drug cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Lot number: gj5342) for covid-19 immunisation; BNT162b2 (BNT162B2), in May2022 as dose number unknown, single (Lot number: fk9893) for covid-19 immunisation. The patient's relevant medical history included: "hypertension"; "osteoporosis"; "hypothyroid"; "known allergies: SULFA"; "known allergies: cyanoacrylate glue". The patient's 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 "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Severe tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ventricular tachycardia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization, reaction(s): "chest tightness", "tachycardia". The following information was reported: TACHYCARDIA (non-serious), outcome "recovering", described as "Severe tachycardia". Clinical course: After 2nd dose, she experienced severe tachycardia warranting a call to rescue. Patient was not hospitalized and was stabilized by rescue.  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) : PFIZER INC-PV202300003553 Same reporter /patient, different dose/event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; 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 Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were 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: Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen lymph node; injection site pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: submassive saddle pulmonary embolism; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "submassive saddle pulmonary embolism".; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 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: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have had Covid now 3 times since 2020; I have had Covid now 3 times since 2020; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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), COVID-19 (medically significant) all with onset 2020, outcome "not recovered" and all described as "I have had Covid now 3 times since 2020". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2020) Positive, notes: I have had Covid now 3 times since 2020.  Clinical information: it was reported that the patient had COVID then 3 times since 2020. The patient was vaccinated and had boosters. The patient seeks help from Pfizer.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy, Interchange of vaccine products, Off label use
Clinical narrative: then told to get a 2nd shot but they gave her the pfizer vaccine; then told to get a 2nd shot but they gave her the pfizer vaccine; Myocardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (Dose 1, single), administration date: 18Feb2021, for COVID-19 immunization, reaction(s): "brain bleed". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "then told to get a 2nd shot but they gave her the pfizer vaccine"; CARDIOMYOPATHY (medically significant), outcome "unknown", described as "Myocardia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; pretty sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004911, 2022NVX-US-000004910.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID"; ILLNESS (non-serious), outcome "unknown", described as "pretty sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: It was reported that on 19Dec2022, it was reported that a patient stated treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine unspecified dose for Covid-19 immunisation. It was reported the patient tested positive for COVID. The individual was reported to be pretty sick even though they were fully vaccinated with Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Tachycardia
Clinical narrative: chest tightness and tachycardia after first dose; chest tightness and tachycardia after first dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ventricular tachycardia" (unspecified if ongoing), notes: history of ventricular tachycardia. The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious), TACHYCARDIA (non-serious), outcome "unknown" and all described as "chest tightness and tachycardia after first dose". Therapeutic measures were taken as a result of chest discomfort, tachycardia.  Additional information: Middle aged white female experienced chest tightness and tachycardia after first dose of vaccine. After the event shortly following the first dose of vaccine, she took her medicine and stabilized.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 04-Jan-2023 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious flu event of (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported" I got the flu shot and I still got the flu ".  It is unknown if there were lab data/results available  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: just got over the flu too; Initial information was received on 04-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who had just got over the flu too after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (strength, formulation, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient had just got over the flu too (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (just got over the flu too).  At time of reporting, the outcome was Unknown for the event just got over the flu too.
Sex: U
Vaccine: FLUX
Symptoms: Atrial fibrillation, Influenza, Pneumonia
Clinical narrative: pneumonia; afib; Flu; Initial information received on 04-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves patient of an unknown age and gender who experienced pneumonia, afib (atrial fibrillation) and flu after receiving vaccine influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in October, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient experienced a serious event of pneumonia, afib (atrial fibrillation) and flu (influenza) (unknown latency) following the administration of influenza vaccine.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  The events pneumonia, afib were assessed as medically significant while the patient was hospitalized for all the events.; Sender's Comments: Sanofi company comment for information received on 09-Jan-2023: This case involves patient of an unknown age and gender who experienced pneumonia, afib (atrial fibrillation) and flu after receiving vaccine influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Mobility decreased
Clinical narrative: in bed for almost 2 weeks with the flu; Initial information received on 04-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-Health Care Professional.  This case involves Adult and unknown gender patient who experienced flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (with dose, strength, expiry date, lot number not reported) via subcutaneous route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious flu and was in bed for almost 2 weeks (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient received a booster dose of Adacel before the ten years of tenivac with no reported adverse event; Initial information received on 04-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 years old female patient who received a booster dose of diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] before the ten years of tenivac with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, tetanus vaccine toxoid (tenivac) for Prophylactic vaccination.  On 29-Dec-2022, the patient received a 0.5 ml dose once total of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot: U7561AA; expiry date: 09-Nov-2024; strength: standard) via intramuscular route in the right deltoid for Immunization.  On 29-Dec-2022 the patient received a booster dose of adacel before the ten years of tenivac with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 0.83
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 10 month old received a dose of Menquadfi with no reported adverse event; Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 months old patient of unknown gender who received a dose of vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jan-2023, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE(Solution for injection) (unknown route, strength, lot number and expiry date) in unknown administration site for prophylactic vaccination(immunization).  On 06-Jan-2023 the 10 month old received a dose of menquadfi with no reported adverse event (product administered to patient of inappropriate age)(latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported " This morning a 10 month old received a dose of Menquadfi (meant for 2 year old). Can you have someone look into the ramifications of this administration error? We know sometimes that this has an effect on future vaccinations, so we want make sure there's a plan in case the parents calls."  Action taken: not applicable.  Outcome: Unknown  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 guidelines. 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Mumps, Seizure
Clinical narrative: She had a seizure 7 days after shot and then started to break out with the  mumps all ariund her face
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 99.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Noted that patient received 2 doses of annual flu vaccine (different formulations) within a 10 week period. This was due to documentation of first vaccination for annual flu not being placed into medical record nor into Vaccination System.  By the time documentation was verified for receipt of first flu vaccine dose, a second one had already been administered.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-