chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis with full colectomy and ileoanal pouch" (unspecified if ongoing); "full colectomy" (not ongoing); "ileoanal pouch" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. 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: Linked Report(s) : US-PFIZER INC-202300263290 same patient, different drug/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative after taking Paxlovid; Positive, notes: tested positive for Covid about a week after last dose of Paxlovid. 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 5 (booster), single (Lot number: CTJ3277) at the age of 56 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 30Dec2021 as dose 3 (booster), single (Lot number: FE3594), in left arm and on 01Aug2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN, start date: 22Sep2022, stop date: 21Jul2023; TAMSULOSIN, start date: 22Sep2022, stop date: 21Jul2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jul2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2023) Positive; (28Jul2023) Negative; (30Jul2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not have known allergies. Patient received other medication in 2 weeks included Rosuvastatin (brand: Aurobindo) and Tamsulosin (brand: Citron). On 22Jul2023, patient tested positive for Covid-19. Symptoms included sore throat, congestion, low grade fever, chills. Patient received COVID-19 treatment with Paxlovid form 22Jul2023 to 26Jul2023. Took a five day regimen of Paxlovid, as prescribed. On 27Jul2023, symptoms nonexistent except for sudden onset of fatigue and nausea. Lasted 3 hours, then no symptoms. On 28Jul2023, tested negative for Covid-19. No symptoms. On 30Jul2023, tested positive for Covid-19. No symptoms.
Age: 75.0
Sex: F
Vaccine: 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 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25Apr2023 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received COVID 19 treatment with Paxlovid form 21Jul2023 to 26Jul2023 and patient did not receive other medication in 2weeks. No Known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single at the age of 40 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 18Jul2023 to 22Jul2023 for the COVID-19 treatment.   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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 21Jan2021 as dose 2, single (Lot number: EL3249), in right arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 48 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 31Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "insomnia" (unspecified if ongoing); "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrum, reaction(s): "Known allergies: Bactrum". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2022, outcome "not recovered", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jul2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2023) Positive, notes: I tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Pavlovid for 5 days starting on the evening of the day she tested positive for COVID. The patient took Paxlovid from 21Jul2023 to 26Jul2023 for the treatment of COVID-19.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the events drug ineffective , Covid -19 and interchange of vaccine products cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: having heart problems from the COVID-19 Shot; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: CARDIAC DISORDER (non-serious), outcome "not recovered", described as "having heart problems from the COVID-19 Shot". The event "having heart problems from the covid-19 shot" required physician office visit.  Additional information: Question: Caller wanted to contact the CICP after he reported with Pfizer on 12Jul2023, reportum, that he's been having heart problems from the COVID-19 Shot. Caller only added that his doctor hasn't been able to do anything for him and can't find the problem. No further details were shared as caller wanted to be transferred to the department.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunization; 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. 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) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. The patient received treatment with Paxlovid from 12Jul2023 to 16Jul2023. Patient experienced return of Covid symptoms and positive test result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Discomfort, Headache, Injection site hypersensitivity, Pyrexia, Vaccination site discomfort
Clinical narrative: Huge headache Friday afternoon; high fever; sensitive injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2023 at 08:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "migraines" (unspecified if ongoing); "GERD" (unspecified if ongoing); "sulfur allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Iodine, reaction(s): "Allergies: Iodine"; Codeine, reaction(s): "Allergies: Codeine". The following information was reported: HEADACHE (non-serious) with onset 28Jul2023 at 13:30, outcome "recovering", described as "Huge headache Friday afternoon"; PYREXIA (non-serious) with onset 28Jul2023 at 13:30, outcome "recovering", described as "high fever"; VACCINATION SITE DISCOMFORT (non-serious) with onset 28Jul2023 at 13:30, outcome "recovering", described as "sensitive injection site". Therapeutic measures were not taken as a result of headache, pyrexia, vaccination site discomfort. Additional information: The patient experienced high fever on (also reported at Friday night). No other vaccine received at same date, or within four weeks. No other medications in two weeks. Adverse events did not result in any serious criteria.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). 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), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not have any known allergies. Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date-19Jul2023, Treatment stop date-23Jul2023, Indication-Treatment of COVID-19, Administrator Route-Oral.   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: Based on the information provided, a causal relationship between BNT162b2, BNT162b2 omi ba.4-5 and the reported events Covid-19, drug ineffective cannot be excluded.
Sex: F
Vaccine: PNC20
Symptoms: Muscle swelling, Pain, Pain in extremity, Urticaria
Clinical narrative: rash like hives on the whole deltoid; little bit of deltoid swelling; a lot of pain when raising the hand; a lot of pain when raising the hand; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Jul2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Poor kidney function" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset Jul2023, outcome "not recovered" and all described as "a lot of pain when raising the hand"; MUSCLE SWELLING (non-serious) with onset Jul2023, outcome "not recovered", described as "little bit of deltoid swelling"; URTICARIA (non-serious) with onset Jul2023, outcome "not recovered", described as "rash like hives on the whole deltoid". Therapeutic measures were taken as a result of urticaria, muscle swelling, pain in extremity, pain.  Additional information: The patient was experiencing a rash like hives on the whole deltoid but there is no itching, a little bit of deltoid swelling and also a lot of pain when raising the hand. The rash like hives on the whole deltoid, little bit of deltoid swelling, and pain when raising the hand are still continuing. The patient was taking Tylenol as treatment.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
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; Moderna, Dose: 1, 2, 3, 4 / Pfizer, Dose: 5, 6; This is a spontaneous report received from a contactable reporter(s) (Other 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 16Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm and on 07Jun2023 as dose 6 (booster), single (Lot number: Bl2042) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 16Feb2021 as dose 2, single (Lot number: 029L20A), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: r014F21A), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Moderna, Dose: 1, 2, 3, 4 / Pfizer, Dose: 5, 6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the events drug ineffective, covid-19, Interchange of vaccine products cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Patient reported getting COVID after completion of 2 shots of Pfizer Covid vaccine; Patient reported getting COVID after completion of 2 shots of Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Patient reported getting COVID after completion of 2 shots of Pfizer Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Platelet count Result: 147 (Norm Low: 150, Norm High: 400); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24May2023 at 14:00 as dose 5 (booster), single (Lot number: GL2042) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 09Mar2021, for Covid-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Time: 15:00, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EW0158), administration date: 12Apr2021, for Covid-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Time: 10:00, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EW0187), administration date: 05Nov2021, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Time: 13:00, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: FK9893), administration date: 12Apr2022, for COVID-19 immunisation, reaction(s): "Total knee replacement". The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 12Jun2023, outcome "unknown", described as "Platelet count Result: 147 (Norm Low: 150, Norm High: 400)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Anatomical site of injection was Shoulder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300111188 same patient/ product, different dose/event (LOE);
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: girlfriend's dad arm was injured; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: LIMB INJURY (non-serious), outcome "unknown", described as "girlfriend's dad arm was injured".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb injury, Tremor
Clinical narrative: his sister's arm was injured; His sister's arms are shaking like crazy; she can't sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: LIMB INJURY (non-serious), outcome "unknown", described as "his sister's arm was injured"; TREMOR (non-serious), outcome "unknown", described as "His sister's arms are shaking like crazy"; INSOMNIA (non-serious), outcome "unknown", described as "she can't sleep at night".  Additional information: The reporter mentioned that he'd seen the Pfizer CEO talk about on a podcast that he wasn't vaccinated yet because he wouldn't endanger himself and they're plan was to reduce the population by 50 percent. Also, he stated that his sister's arm was injured because of the Pfizer vaccine. His sister's arms were shaking like crazy, and she couldn't sleep at night. It kind of scared them off. He also mentioned that Pfizer keeps getting sued for malpractice for Doller 3.5 billion or lying stuff in this and he's not happy about that. He would like to know how we can kill a person.  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: U
Vaccine: FLUX
Symptoms: Swelling, Swelling face
Clinical narrative: facial swelling; Neck swelling; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional. This was a courtesy case received from Pfizer, Pharmaceuticals.  This case involves an unknown age and unknown gender patient who experienced facial swelling and neck swelling after receiving vaccine influenza vaccine.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Adhesive tape allergy with Reaction: Rash Severity: Moderate and Drug allergy with Reaction: Anaphylaxis, Drug Allergy Cortisone Reaction: Anaphylaxis Severity: Severe Sensitivity: Allergy Type: Drug Allergy Eliquis Reaction: Tongue swelling Severity: Severe Sensitivity: Allergy Type: Drug Allergy Vicodin Reaction: Nausea Severity: Mild Sensitivity: Intolerance Type: Drug Allergy OxyContin Reaction: Hallucinations Severity: Severe Sensitivity: Adverse Reaction Type: Drug Allergy Kenalog.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via subcutaneous route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient developed facial swelling (swelling face) and neck swelling (swelling) (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 events.  At time of reporting, the outcome was Unknown for both the events.
Age: 60.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of expired TENIVAC with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 60 years old and unknown gender patient who had administration of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-JUN-2023, the patient received a standard expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 ml  once (lot U7092AA, expiry date- 24-JUN-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered)(latency- same day).  Reportedly, A nurse manager reported that they have administered an expired TENIVAC to a patient. caller asks if the administered dose is still valid and if not, should they be administering another dose to the patient.  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.; Sender's Comments:  US-SA-2023SA228035:
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: ipol vaccine was administered to a patient after the excursion with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4-year-old male patient, IPV (VERO) [IPOL] vaccine was administered to a patient after the excursion 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, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On 24-Jul-2023, the patient received 0.5 ml total dose of suspect IPV (VERO) Suspension for injection (strength, expiry date: unknown) (lot: V1B901M) via intramuscular route in the right deltoid for Immunization.  On 24-Jul-2023 the patient had an event of ipol vaccine was administered to a patient after the excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: 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 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.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administration of the vaccine which was more SubQ than going into the muscle, with no reported adverse event; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient who had administration of the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] which was more subq (subcutaneously) than going into the muscle, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength, expiry date, administration site- not reported) for Prophylactic vaccination, which was more subcutaneous than going into the muscle, with no reported adverse event (incorrect route of product administration) (latency- same day). Information on the batch number was requested.  Reportedly, Caller stated that they administered the vaccine to a patient, and it was more SubQ than going into the muscle. Caller wanted to know if the vaccine should be given again since it did not go into the muscle.  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 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: 0.33
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered half the dose of Pentacel only the diluent was administered, with no reported adverse event; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 4 months old female patient who was administered half the dose of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] only the diluent was administered, 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and rotavirus vaccine live reassort ORAL 5V (Rotateq) for Prophylactic vaccination.  On 26-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB (PRP/T) vaccine, Suspension for injection (batch number: UJ877AA) (expiry date unknown) via intramuscular route in the right vastus lateralis for Immunization, half the dose of pentacel only the diluent was administered, with no reported adverse event (product preparation error) (same day latency).  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event administered half the dose of pentacel only the diluent was administered, with no reported adverse 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: 11.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: administered daptacel instead of the intended adacel with no reported adverse event; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient for whom Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] was administered instead of the intended Diphtheria, Tetanus And Acellular Pertussis Vaccine [Adacel] 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 HPV vaccine VLP RL1 9V (YEAST) (Gardasil 9) and Meningococcal Vaccine B (MENB) for Prophylactic vaccination.  On 13-Jun-2023, the patient received a dose of 0.5 ml 1x (frequency: once) of suspect Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (lot: DR2GR, Expiry date: 29-Nov-2024) with unknown strength via unknown route in unknown administration site for Immunization instead of the intended Diphtheria, Tetanus And Acellular Pertussis Vaccine [Adacel]suspension for injection with unknown strength, batch number & expiry date with no reported adverse event (wrong product administered) (latency: same day).  Information on batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was 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: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received adacel a couple of weeks after the vaccine expired with no reported adverse event; Initial information received on 28-Jul-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 53 years old male patient who experienced received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] a couple of weeks after the vaccine expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2023, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5882AA, Expiry date: 10-May-2023) (Strength: Standard, Frequency: Once) via unknown route in unknown administration site for immunization.  On 07-Jul-2023, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] a couple of weeks after the vaccine expired with no reported adverse event (expired product administered) (Latency: same day).  It was reported, Physician states that a patient received ADACEL a couple of weeks after the vaccine expired. The vaccine was given on 07Jul2023, and the expiration date of the vaccine was on 10May2023. Physician mentioned that the patient is good fine and does not have any adverse event. Physician did not want to provide information about the patient due to HIPAA. Physician mentioned that he will be seeing the patient on Saturday (28Jul2023) and will talk to patient about redoing the ADACEL vaccine. The physician mentioned that he will make a clinical decision about if the consumer should be taking the ADACEL again or not and mentioned that the patient will be traveling. Physician. This situation is reported as a medication error due to expired vaccine administered.  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 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: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired July 2023, I administered the vaccine on 8/01/23. I forgot today's date, resulting in the error. No adverse reactions known at this time.
Age: 14.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was administered to a patient outside of the age range.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 76.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Pt reports since she got vaccine 5 days ago, her L hand has a constant burning and tingling.  LUE is weak, she is unable to hold a magazine, type or do dishes. L5 finger not moving like it should.  Denies any arm pain, swelling or redness.   On exam over video visit she is able to wiggle all fingers but there is decreased movement of L5 finger esp with abduction, adduction. She is RHD.  Reports symptoms are stable to worsening.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus (severe) in right ear.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site indentation, Rash
Clinical narrative: patient reported having rash on  left arm and indent due to vaccine needle
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEVIED VACCINE AFTER BUD
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 7/28/2023 Vaccine Event    Pfizer 5-11 COVID vaccine bivalent dose was ordered for child (8yM) by MD. Past immunizations, history, and COVID-19 vaccine history was reviewed prior to meeting patient to confirm appropriateness of order. Plan, COVID questionnaire, and double identifications were confirmed with MoC using video interpreter. After obtaining informed consent, the immunization was prepared by myself.    MoC also requested that sibling, who accompanied child during this visit, receive COVID vaccine as well. Sibling is due for Moderna 6m-5 year bivalent dose or Pfizer 5-11 bivalent dose per CDC guidelines for age 5. Both sibs have completed their monovalent series. Records, CDC advice, and immunization history confirmed this plan. Sibling was added to nurse only IZ schedule.    Preparation - Each syringe was correctly labeled and vaccines/identifiers (I.e. vaccine cards, and immunization records), were separated, and 1 pink cap Moderna 6m-5yr dose and 1 orange cap Pfizer 5-11yr dose was brought to the room. Double verifiers again were performed with MoC and children in the room. MoC agreed to verifiers prior to immunization - however, when I confirmed sibling's name and birthdate and gestured to patient, MoC stated that this was correct. However, patient's identifiers were confirmed incorrectly to patient. Due to this confusion, patient (8yM) received pink cap Moderna bivalent for ages 6 months through 5 years, and sibling (5yM) received orange cap Pfizer bivalent for ages 5-11.    After this incident, I reviewed findings with vaccine RN coordinator and supervising MD Dr. Per CDC guidelines, sibling (5yM) received appropriate dose for age. However, patient (8yM received the younger age range for Moderna bivalent). Children have already left home in stable condition. However, I personally called MOC and notified her of error on my behalf. Relayed advice from vaccine supervising RN and MD that no adverse reactions are to be expected, reviewed again expected side effect from COVID vaccine (fever, soreness) versus s/s allergic reactions. MoC was understanding to explanation and verbalized understanding. Instructed MoC to call back should there be any new symptoms or concerns.  7/31/2023 follow up:   F/U with MoC over telephone using interpreter regarding child receiving incorrect COVID vaccine on Friday 7/28/2023. MoC reported that no adverse s/s were noted, and that children are their regular playful selves today. Both child and sibling reported sore arm and fever which resolved in first 1-2 days. Also spoke to CDC and Moderna manufacturing team over telephone, who provided information regarding next steps via online CDC resource for errors. Spoke with MD Medical Director Dr. regarding situation who advised that there are no dangerous consequences for the child, but child may not be fully protected and that another/repeat dose is not recommended at this time. Follow up instructions provided to MoC, who appreciated call.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: Baby experienced moderate to severe stomach pain with diarrhea for the following 2 days post vaccination (May 24th) . The stomach discomfort continued and then gassiness increased on day three and continued until day 10 after the vaccine. Out of all the vaccines she was given only 1 had stomach pain linked as a potential side effect, and this was the rotavirus oral vaccine. I opted NOT to continue with the second dose at month 4 vaccinations. She received Pedairix, pcv and HIB dose number 2 and has no discomfort in the stomach, no gas, and is happy. I am convinced the oral rotavirus vaccine is the cause of the stomach pain and diarrhea that my daughter experienced.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEVIED VACCINE AFTER BUD
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEVIED VACCINE AFTER BUD
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Tachycardia, Vomiting
Clinical narrative: THE PATIENT HAD A SYMPTOMS OF NASUEA, VOMITING, TACHYCARDIA, DIZZINESS, AND SWEATING
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given a varivax 7/14/23 and an M-M-R on 7/31/23. Patient got the second live vaccine  within 14 days instead of 28 days.  Patient had no adverse reaction, however the third dose must be repeated on 8/28/23.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient's parents requesting booster vaccine. Electronic chart record prompting for patient to receive booster vaccine. In chart review, patient had received higher dose for age on 11/11/2022 and the electronic chart system message stating that dose invalid and did not count. Per chart review and Covid-19 Vaccine Interim Immunization Schedule for 5 years and older, patient showing due for vaccine. Covid-19 vaccine appropriate for age adminstered and patient tolerated shot well. Post adminstration facility quality check reviewed and found booster administration not indicated according to the updated CDC guidelines of May 2023 in Interim Clinical Considerations for Use of Covid 19Vaccines- Table C due to previous dose received in 11/2022 though electronic chart indicating previous vaccine dose did not count as booster in series. VAERS completed today per CDC guidelines when patient receiving a dose not due.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.