chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Hearing aid therapy, Hypoaesthesia, Magnetic resonance imaging, Motion sickness
Clinical narrative: Lots of middle ear pain; balance issues; was completely deaf in my left ear; 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 NOS), on 19Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 21Dec2022, outcome "not recovered", described as "was completely deaf in my left ear"; EAR PAIN (medically significant), outcome "not recovered", described as "Lots of middle ear pain"; BALANCE DISORDER (medically significant), outcome "not recovered", described as "balance issues". The events "was completely deaf in my left ear", "lots of middle ear pain" and "balance issues" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, ear pain. Clinical course: Almost 6 months and patient had not regained any hearing after treatment from ENT's, Neurologists, and a Pain management doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sudden hearing loss, Vertigo
Clinical narrative: Lots of middle ear pain; balance issues; was completely deaf in my left ear; 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 NOS), on 19Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 21Dec2022, outcome "not recovered", described as "was completely deaf in my left ear"; EAR PAIN (medically significant), outcome "not recovered", described as "Lots of middle ear pain"; BALANCE DISORDER (medically significant), outcome "not recovered", described as "balance issues". The events "was completely deaf in my left ear", "lots of middle ear pain" and "balance issues" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, ear pain. Clinical course: Almost 6 months and patient had not regained any hearing after treatment from ENT's, Neurologists, and a Pain management doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Deafness unilateral, Ear pain
Clinical narrative: Lots of middle ear pain; balance issues; was completely deaf in my left ear; 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 NOS), on 19Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 21Dec2022, outcome "not recovered", described as "was completely deaf in my left ear"; EAR PAIN (medically significant), outcome "not recovered", described as "Lots of middle ear pain"; BALANCE DISORDER (medically significant), outcome "not recovered", described as "balance issues". The events "was completely deaf in my left ear", "lots of middle ear pain" and "balance issues" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, ear pain. Clinical course: Almost 6 months and patient had not regained any hearing after treatment from ENT's, Neurologists, and a Pain management doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Inbound call from office manager calling to report administration of VARIVAX that experienced a temperature excursion.  Confirmed with reporter that no symptomatic adverse effects were reported.   Affected product was administered to one additional p; No symptomatic adverse effects reported; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 21-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection at a dose of 0.5 milliliter once, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number W025274 with an expiration date of 10-AUG-2024). The administered dose of the vaccine experienced a temperature excursion of -13.2 degrees Celsius (C) for 58 minutes. No data logger was implied. There was no adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported. No additional AE; HCP calling to report AE for VARIVAX. Patient received administration of improperly stored VARIVAX. See case 02413182. No patient demographic information provided. HCP gave permission to contact. No side effects reported. No additional AE/PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 19-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not provided; valid lot number W012163 with an expiry date of 12-APR-2024). The administered dose of the vaccine experienced a temperature excursion 45 degrees Fahrenhei (F)t for 84 hours. It was not reported if the information was recorded or not by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vaccination site redness; vaccination site swelling; vaccination site itching; vaccination site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), 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: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "vaccination site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "vaccination site itching"; VACCINATION SITE PAIN (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229741 Same reporter, same drug, same event, different patient;US-PFIZER INC-202300229692 Same reporter, same drug, same event, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vaccination site redness; vaccination site swelling; vaccination site itching; vaccination site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), 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: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "vaccination site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "vaccination site itching"; VACCINATION SITE PAIN (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229675 Same reporter, same drug, same event, different patient;
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vaccination site redness; vaccination site swelling; vaccination site itching; vaccination site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), 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: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "vaccination site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "vaccination site itching"; VACCINATION SITE PAIN (non-serious), outcome "unknown".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: 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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 13Jun2023 to 17Jun2023. Patient's Known allergy: Not applicable.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300230771 Same reporter/patient, different product/AE;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Hyperhidrosis, Palpitations, Renal cell carcinoma
Clinical narrative: A mass was found on the right kidney. Currently thought to be RCC; Lower ventricular tachycardia; Heart palpations; Sweats; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tylox, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (AT 09:00 AM, DOSE 1, SINGLE, Batch/lot no: EN6202, Anatomical location: Right arm), administration date: 09Mar2021, for COVID-19 immunization; BNT162b2 (AT 11:00 AM, DOSE 2, SINGLE, Batch/lot no: ER8733, Anatomical location: Right arm), administration date: 30Mar2021, for COVID-19 immunization; BNT162b2 (AT 10:00 AM, DOSE 3 (BOOSTER), SINGLE, Batch/lot no: FE3592, Anatomical location: Left arm), administration date: 06Oct2021, for COVID-19 immunization. The following information was reported: RENAL CELL CARCINOMA (medically significant) with onset May2022, outcome "recovering", described as "A mass was found on the right kidney. Currently thought to be RCC"; FATIGUE (non-serious) with onset May2022, outcome "recovering"; PALPITATIONS (medically significant) with onset May2022, outcome "recovering", described as "Heart palpations"; VENTRICULAR TACHYCARDIA (medically significant) with onset May2022, outcome "recovering", described as "Lower ventricular tachycardia"; HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovering", described as "Sweats". The events "a mass was found on the right kidney. currently thought to be rcc", "lower ventricular tachycardia", "heart palpations", "sweats" and "fatigue" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: mass was found on the right kidney. Therapeutic measures were taken as a result of ventricular tachycardia, palpitations. Clinical Course: Patient also received BNT162b2, BNT162b2 omi ba.4-5 on 09Nov2022 at 10:00 as dose 5 (booster), single (Lot number: CH6738), in right arm for covid-19 immunisation. Began in May2022, sweats, heart palpations, fatigue. It continued to worsen finally went to see a cardiologist to find lower ventricular tachycardia. No previous heart problem up to that time and no heart familiar heart problems. Heart ablation was done but on the CT scan before the procedure a mass was found on the right kidney. Currently thought to be RCC (Renal Cell Carcinoma). No previous prior kidney problems. Patient had no other vaccine in four weeks nor had any Other medications in two weeks.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: A mass was found on the right kidney. Currently thought to be RCC; Lower ventricular tachycardia; Heart palpations; Sweats; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tylox, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (AT 09:00 AM, DOSE 1, SINGLE, Batch/lot no: EN6202, Anatomical location: Right arm), administration date: 09Mar2021, for COVID-19 immunization; BNT162b2 (AT 11:00 AM, DOSE 2, SINGLE, Batch/lot no: ER8733, Anatomical location: Right arm), administration date: 30Mar2021, for COVID-19 immunization; BNT162b2 (AT 10:00 AM, DOSE 3 (BOOSTER), SINGLE, Batch/lot no: FE3592, Anatomical location: Left arm), administration date: 06Oct2021, for COVID-19 immunization. The following information was reported: RENAL CELL CARCINOMA (medically significant) with onset May2022, outcome "recovering", described as "A mass was found on the right kidney. Currently thought to be RCC"; FATIGUE (non-serious) with onset May2022, outcome "recovering"; PALPITATIONS (medically significant) with onset May2022, outcome "recovering", described as "Heart palpations"; VENTRICULAR TACHYCARDIA (medically significant) with onset May2022, outcome "recovering", described as "Lower ventricular tachycardia"; HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovering", described as "Sweats". The events "a mass was found on the right kidney. currently thought to be rcc", "lower ventricular tachycardia", "heart palpations", "sweats" and "fatigue" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: mass was found on the right kidney. Therapeutic measures were taken as a result of ventricular tachycardia, palpitations. Clinical Course: Patient also received BNT162b2, BNT162b2 omi ba.4-5 on 09Nov2022 at 10:00 as dose 5 (booster), single (Lot number: CH6738), in right arm for covid-19 immunisation. Began in May2022, sweats, heart palpations, fatigue. It continued to worsen finally went to see a cardiologist to find lower ventricular tachycardia. No previous heart problem up to that time and no heart familiar heart problems. Heart ablation was done but on the CT scan before the procedure a mass was found on the right kidney. Currently thought to be RCC (Renal Cell Carcinoma). No previous prior kidney problems. Patient had no other vaccine in four weeks nor had any Other medications in two weeks.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 57 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: "Previous Stroke" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 21Jun2023 to 24Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231399 same patient/drug, different dose/events;
Sex: U
Vaccine: MENB
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Both kids had significant swelling at site of injection and fever; Both kids had significant swelling at site of injection and fever; redness/swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), 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: VACCINATION SITE SWELLING (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Both kids had significant swelling at site of injection and fever"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness/swelling".  Additional information: The office has a photo of the redness/swelling.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300111732 same reporter/drug/AE, different patient;
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 13Jun2023, stop date: 17Jun2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231714 Same patient, different drug and different AE.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events drug ineffective, COVID-19 and BNT162B2, BNT162B2 OMI BA.4-5 is considered possible.,Linked Report(s) : US-PFIZER INC-PV202300112100 different patient, same drug/ event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 21Apr2023 at 10:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression type 2 diabetes" (unspecified if ongoing); "Clinical depression type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known Allergies: Compazine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had Paxlovid treatment from 15Jun2023 to 19Jun2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231366 same patient, different drug/events;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232002 same patient, different vaccine dose/event;US-PFIZER INC-202300232003 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;US-PFIZER INC-202300232005 same patient, different vaccine dose/event;US-PFIZER INC-202300232006 same patient, different vaccine dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 21Apr2023 at 10:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression type 2 diabetes" (unspecified if ongoing); "Clinical depression type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known Allergies: Compazine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had Paxlovid treatment from 15Jun2023 to 19Jun2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231366 same patient, different drug/events;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232002 same patient, different vaccine dose/event;US-PFIZER INC-202300232003 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;US-PFIZER INC-202300232005 same patient, different vaccine dose/event;US-PFIZER INC-202300232006 same patient, different vaccine dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 10:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Clinical depression " (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bnt162b2, start date: 01Apr2022, stop date: 01Apr2022, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 4 (BOOSTER), SINGLE , Batch/Lot No: FK9895, Location of injection: Arm Left; Bnt162b2, start date: 27Sep2021, stop date: 27Sep2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left; Bnt162b2, start date: 02Mar2021, stop date: 02Mar2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 2, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left; Bnt162b2, start date: 02Feb2021, stop date: 02Feb2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left; Compazine, reaction(s): "Allergy: Compazine". Vaccination history included: BNT162b2, BNT162b2 omi ba 4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left), administration date: 09Sep2022, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same reporter/patient/product, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 10:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Clinical depression " (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bnt162b2, start date: 01Apr2022, stop date: 01Apr2022, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 4 (BOOSTER), SINGLE , Batch/Lot No: FK9895, Location of injection: Arm Left; Bnt162b2, start date: 27Sep2021, stop date: 27Sep2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left; Bnt162b2, start date: 02Mar2021, stop date: 02Mar2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 2, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left; Bnt162b2, start date: 02Feb2021, stop date: 02Feb2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left; Compazine, reaction(s): "Allergy: Compazine". Vaccination history included: BNT162b2, BNT162b2 omi ba 4-5 (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GH9694, Location of injection: Arm Left), administration date: 09Sep2022, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same reporter/patient/product, different dose/event;
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jun2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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. Past drug history included: Amoxi, reaction(s): "known allergies: Amoxi". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovered" (Jun2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2023) Positive, notes: I took Paxlovid immediately symptom onset and positive test; (Jun2023) Negative, notes: on day 6 I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Jun2023 to 17Jun2023. On day four and five, patient felt great and on day 6, she tested negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231702 Same patient, different drug and different AE;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Mar2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Jul2022 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate-to-severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, 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, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231719 same patient, different drug/ event;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 13Jun2023 to 17Jun2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232265 Same patient, different drug and different AE.;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL9263), in left arm, on 25Mar2021 as dose 2, single (Lot number: EL9263), in right arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: FM0173), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pernicious Anemia" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "known allergies: Macadamia nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment for COVID-19 with Paxlovid (Batch/lot no: GJ6048) from 18Jun2023 to 22Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232210 Same patient, different drug/ AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-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 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had COVID 19 Treatment from 15Jun2023 to 19Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232346 Same patient, different drug and different AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-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) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was administered with Paxlovid from 22Jun2023. 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: PNC20
Symptoms: Device breakage
Clinical narrative: dropped and the whole thing shattered; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT0538, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "dropped and the whole thing shattered".  Additional information: Caller is a registered nurse that reported that they had a Prevnar 20 that dropped and the whole thing shattered. There was no patient involvement. No nurse involvement. She clarified that there were no needle sticks or anything like that.
Sex: U
Vaccine: MENB
Symptoms: Injection site swelling, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Both kids had significant swelling at site of  injection and fever; Both kids had significant swelling at site of  injection and fever; redness/swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An adolescent patient received meningococcal group b Rlp2086 (TRUMENBA), 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: VACCINATION SITE SWELLING (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "Both kids had significant swelling at site of  injection and fever"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness/swelling".  Additional information: The office has a photo of the redness/swelling.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231496 same reporter/drug/AE, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Have four vaccines and shocked that contracted COVID; Have four vaccines and shocked that contracted COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Have four vaccines and shocked that contracted COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300231829 different patient, same drug and event.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had my two initial [Pfizer] vaccines and three boosters/ I did get Covid; I had my two initial [Pfizer] vaccines and three boosters/ I did get Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient 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; BNT162b2 (BNT162B2 NOS), 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), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "recovered" and all described as "I had my two initial [Pfizer] vaccines and three boosters/ I did get Covid". Clinical course: Patient felt that it was important to be vaccinated against Covid so had two initial Pfizer vaccines and three boosters. Patient got Covid in February and because she was fully vaccinated, she only dealt with Covid for two days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error, Product preparation issue
Clinical narrative: medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event; Initial information received on 08-Dec-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2022SA489108, 2022SA502558 and 2022SA503839.  This case involves a 14-year-old male patient who had medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event with yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine (Typhoid) and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) both for Prophylactic vaccination.  On 20-Oct-2022, the patient received suspect yellow fever vaccine at a dose of 0.5 ml total (lot UJ412AB, expiry date: 22-Nov-2025) via subcutaneous route in the left arm for immunization.  On 20-Oct-2022 the patient had a non-serious medication error due to administration of vaccine that was reconstituted with wrong diluent with no reported adverse event (product preparation error, latency: same day).  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.