chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTPPVHBHPB, VARCEL
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: mom states she is doing well, but has a rash; The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX; This non-serious spontaneous safety report, with Agency Case ID number: 02509272, was received by a partner on 27-NOV-2023 and forwarded to Agency on 30-NOV-2023, from a HCP.   This case was considered as non-valid (No clarification about administration of Vaxelis).   Due to the nature of the event, the causality between the event " The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX" and Vaxelis was assessed as not applicable.   Further information is expected.  Follow-up information was received by Agency on 05-DEC-2023, from a HCP. The case is maintained as non-serious and no longer non-valid (as vaxelis was administered)  Due to the nature of the event, the causality between the event " The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX" and Vaxelis was assessed as not applicable.   Further information is expected.  Follow-up information was received by Agency on 19-DEC-2023, from a HCP. The case is maintained as non-serious and Valid.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event 'mom states she is doing well but has a rash' and the casual relationship between Vaxelis and event ' The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX' was assessed as not applicable due to the nature of these reported event.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP calling to report the administration of a ROTATEQ and VAXELIS to the same patient following a temperature excursion. No symptoms or additional details reported; This spontaneous safety report, with reference number 02516459 (Interaction# 02516441), was received by the partner on 04-DEC-2023 and forwarded on 04-DEC-2023, from a non- health professional.   Due to the nature of the event, the causality between the event "calling to report the administration of a ROTATEQ and VAXELIS to the same patient following a temperature excursion. No symptoms or additional details reported" and Vaxelis was not applicable.  Further information is expected
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: accidentally administered VAXELIS twice to the same patient on 11/30/2023.; accidentally administered two doses of VAXELIS instead of one dose of VAXELIS and one dose of PREVNAR 15.; This spontaneous safety report with case ID reference number: #02517052 (inquiry number:#02517050) was received by the partner on 04-DEC-2023 and forwarded on 05-DEC-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events of  "accidentally administered VAXELIS twice to the same patient on 11/30/2023." and "accidentally administered two doses of VAXELIS instead of one dose of VAXELIS and one dose of PREVNAR 15."  Due to the nature of the events, the causality between the events;  "accidentally administered VAXELIS twice to the same patient on 11/30/2023." and "accidentally administered two doses of VAXELIS instead of one dose of VAXELIS and one dose of PREVNAR 15."  and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLUX
Symptoms: Injection site nodule
Clinical narrative: Nodules at the injection site; This non-serious spontaneous safety report with reference number: 2023SA382032 (inquiry#: 01870351) was received by a partner on 07-DEC-2023 and forwarded to UBC on 08-DEC-2023, from a HCP in the (Privacy).   Due to the nature of the event, the causality between the events; "Nodules at the injection site" and Vaxelis was assessed as Related.   NoFurther information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, PNC20
Symptoms: Injection site nodule
Clinical narrative: Pharmacy administrator called in to inform that they have 3 patients that was administered with VAXELIS and that they observed nodules at the injection site of these three patients.; This spontaneous safety report, with reference number 2023SA382063 (Inquiry number 01870351), was received by the partner on 07-DEC-2023 and forwarded to Agency on 08-DEC-2023, from a health professional.  The reporter assessed the causality between the event "Pharmacy administrator called in to inform that they have 3 patients that was administered with VAXELIS and that they observed nodules at the injection site of these three patients." and Vaxelis as related.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site nodule
Clinical narrative: Pharmacy administrator called in to inform that they have 3 patients that was administered with VAXELIS and that they observed nodules at the injection site of these three patients.; This spontaneous non-serious safety report, with reference number 2023SA381972 (Inquiry number 01870416), was received by the partner on 07-DEC-2023 and forwarded on 08-DEC-2023, from a health professional.  The reporter assessed the causality between the event "Pharmacy administrator called in to inform that they have 3 patients that was administered with VAXELIS and that they observed nodules at the injection site of these three patients" and Vaxelis as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called and reported that 1 dose of VAXELIS (pre-filled syringe) had been administered after the product was involved in TE. Caller stated the patient has not had any symptoms. No additional AE/no PQC reported. Temp:48F, Time frame:15min; This spontaneous non-serious safety report, with reference number 02522462, was received by a partner on 14-DEC-2023 and forwarded to Agency on the same day, from a HCP.   Due to the nature of the event, the causality between the event "Nurse called and reported that 1 dose of VAXELIS (pre-filled syringe) had been administered after the product was involved in TE. Caller stated the patient has not had any symptoms. No additional AE/no PQC reported. Temp:48F, Time frame:15min" and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Wrong product administered
Clinical narrative: Patient is an 11-year-old patient who received VAXELIS but patient was supposed to received TDAP.; Patient is an 11-year-old patient who received VAXELIS but patient was supposed to received TDAP.; This non-serious spontaneous safety report with reference number 2023SA394450 (Inquiry number: 01883052) was received by a partner on 19-DEC-2023 and forwarded to UBC on 20-DEC-2023, from a HCP.  This case was considered off-label use as Vaxelis was administered by mistake to an 11-year-old patient.  Due to the nature of the event, the causality between the events; "Patient is an 11-year-old patient who received VAXELIS but patient was supposed to received TDAP." and Vaxelis was assessed as not applicable.  Further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Headache, Wrong product administered
Clinical narrative: erroneously administered first Prevnar 20 dose; headaches; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 10-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "erroneously administered first Prevnar 20 dose"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter reported that her daughters, ages 10 was erroneously administered first Prevnar 20 dose. The reporter was interested in knowing if there is information available regarding vaccination in this age group. The reporter did mention that daughter had experienced headaches after vaccination, and she also mentioned that she was not concerned with expected side effects such as pain at the injection site.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300447110 same reporter/drug/event, different patient;
Age: 64.0
Sex: F
Vaccine: FLUX, RSV
Symptoms: Limb injury, Skin discolouration, Skin exfoliation, Wound
Clinical narrative: arm turned black and blue; her arm turned black and blue/The black and blue peeled off; holes in her arm/open wounds underneath; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 14Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for immunisation; influenza vaccine (FLU VACCINE VII), on 14Nov2023 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE EXFOLIATION (medically significant) with onset 2023, outcome "unknown", described as "her arm turned black and blue/The black and blue peeled off"; WOUND (medically significant) with onset 2023, outcome "unknown", described as "holes in her arm/open wounds underneath"; VACCINATION SITE DISCOLOURATION (medically significant) with onset 17Nov2023, outcome "unknown", described as "arm turned black and blue". The events "arm turned black and blue", "her arm turned black and blue/the black and blue peeled off" and "holes in her arm/open wounds underneath" required emergency room visit. Therapeutic measures were taken as a result of vaccination site discolouration, vaccination site exfoliation, wound. Additional information: Patient received RSV shot and Flu shot on 14Nov2023. About 3 days later was when her arm turned black and blue and then it got more black and blue. The black and blue peeled off and has open wounds underneath. Today is last day of antibiotic so she started antibiotic 7 days ago. It was her left arm. The black and blue went crossways across her arm. Then the black and blue peeled and underneath it was holes and open wounds. The physician saw it when it was just black and blue, but not since open wounds. She went to Urgent Care. She was not provided a vaccination card so she was not able to provide the name of the RSV shot or the Flu shot. She was put on an antibiotic. She has physical next month on the 19th.   Causality for "arm turned black and blue", "her arm turned black and blue/the black and blue peeled off" and "holes in her arm/open wounds underneath" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Dysstasia, Muscular weakness, Musculoskeletal disorder
Clinical narrative: My legs stopped working/my legs just collapse; I cannot stand up; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 04Dec2023 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "My legs stopped working/my legs just collapse"; DYSSTASIA (non-serious), outcome "unknown", described as "I cannot stand up". Therapeutic measures were not taken as a result of muscular weakness, dysstasia. Additional information: Patient received the rsv vaccine prot.subunit pref 2v vaccine on 04Dec2023 and reported that her legs stopped working, she cannot stand up. It is becoming worse. She has been in touch with her doctor but they are not sure what to do. She was wondering if we had any reports of anything like that and agent addressed her inquiry.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Respiratory symptom
Clinical narrative: 60+ yr old Pt had RSV symptoms for 2 weeks after vaccination.; This is a spontaneous report received from a Pharmacist from a sales representative.  A female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: Name of Drug as Reported: Unknown. The patient's concomitant medications were not reported. The following information was reported: SYMPTOM RECURRENCE (non-serious), outcome "unknown", described as "60+ yr old Pt had RSV symptoms for 2 weeks after vaccination.". It was unknown if therapeutic measures were taken as a result of symptom recurrence. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Headache, Wrong product administered
Clinical narrative: erroneously administered first Prevnar 20 dose; headaches; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 12-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "erroneously administered first Prevnar 20 dose"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter reported for her daughters, one of age 12 years old was erroneously administered first Prevnar 20 dose. The reporter was interested in knowing if there is information available regarding vaccination in this age group. The reporter did mention that daughter had experienced headaches after vaccination, and she also mentioned that she was not concerned with expected side effects such as pain at the injection site.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300446708 same reporter/drug/event, different patient;
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue; chills; This is a spontaneous report received from a Physician from a sales representative.  A 63-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset Sep2023, outcome "recovered" (Sep2023); CHILLS (non-serious) with onset Sep2023, outcome "recovered" (Sep2023). Therapeutic measures were taken as a result of fatigue, chills. Additional information: No other vaccine administered. Other medications 2 weeks includes depression meds and statin. No known allergies. In Sep2023, the patient had fatigue and chills, needed prednisone as treatment.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG4659) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 omi ba.4-5 (Done number unknown, single, Lot number: GJ3270, Location: Left arm), administration date: 23Jun2023, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. The patient received PAXLOVID as a treatment for the events from 09Dec2023 to 13Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 61 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: doxycycline"; Rhondomycin, reaction(s): "Known allergies: Rondomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid (Lot Number: GJ7330) from 12Dec2023 to 17Dec2023, for the treatment of COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; I got Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 27Sep2023 as dose number unknown, single), in right arm for influenza immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FAMOTIDINE; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: COVID-19 (medically significant) with onset 18Dec2023, outcome "recovering", described as "I got Covid"; VACCINATION FAILURE (medically significant) with onset 18Dec2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient did not had COVID prior vaccination. She had no known allergies. Facility type vaccine was PRIVACY.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 61.0
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 Nurse.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesteremia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies"; Keflex, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 08Dec2023 to 13Dec2023 for the COVID-19 treatment. The patient felt well after 3 days of Paxlovid treatment.      The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: In Oct I was vaccinated with Comirnaty.  This is to report despite vaccinated I contracted COVID. On 18Dec I started feeling ill. My husband was ill having tested positive for COVID several; In Oct I was vaccinated with Comirnaty.  This is to report despite vaccinated I contracted COVID. On 18Dec I started feeling ill. My husband was ill having tested positive for COVID several; This is a spontaneous report received from a Pharmacist.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, single. manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (dose 2, single. manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (dose 3 (BOOSTER), single. manufacturer unknown), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Dec2023, outcome "recovering" and all described as "In Oct I was vaccinated with Comirnaty.  This is to report despite vaccinated I contracted COVID. On 18Dec I started feeling ill. My husband was ill having tested positive for COVID several". The event "in oct i was vaccinated with comirnaty.  this is to report despite vaccinated i contracted covid. on 18dec i started feeling ill. my husband was ill having tested positive for covid several" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Positive; (21Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : Reporter stated that in Oct I was vaccinated with Comirnaty. This is to report despite vaccinated I contracted COVID. On 18Dec I started feeling ill. My husband was ill having tested positive for COVID several days earlier. He had not been vaccinated. On 19Dec I tested positive for COVID. I was prescribed Paxlovid and started therapy the same day. On 21Dec I felt much better and retested and was negative for COVID. I plan on continuing to finish Paxlovid, although I do have a very strong metallic taste after every dose lingering for a couple of hours. No other vaccine in four weeks. Other medications in two weeks was none. No covid tested post vaccination. No Known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Vaccination Failure and COVID-19 cannot be ruled out.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "stent", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, stop date: 07Dec2023; ASPIRIN [ACETYLSALICYLIC ACID], stop date: 07Dec2023; ROSUVASTATIN, stop date: 07Dec2023. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster), Single; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 08Dec2023 to 12Dec2023 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: tested for COVID and I tested positive; tested for COVID and I tested positive; Running nose; Light grade fever; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) and on 19Dec2023 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; EZETIMIBE; CIALIS; METOPROLOL; LOSARTAN; ELIQUIS. Vaccination history included: moderna (DOSE 3 (BOOSTER), SINGLE), administration date: 01Nov2022, when the patient was 77-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE), administration date: 04Nov2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 1, SINGLE), administration date: 25Feb2021, when the patient was 75-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 20Dec2023, outcome "recovering", described as "Light grade fever"; RHINORRHOEA (non-serious) with onset 20Dec2023, outcome "recovering", described as "Running nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "recovering" and all described as "tested for COVID and I tested positive". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Light grade; SARS-CoV-2 test: (23Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, pyrexia.  Clinical course: The consumer reported "I had a COVID Vaccine (Later clarified as Pfizer COVID-19 Vaccine) on last Tuesday afternoon along with a RSV vaccine (Later clarified as RSV Abrysvo) like the 2 shots. And Wednesday evening I started having some symptoms you know kind of like running nose and light grade fever and they were kind of like COVID symptoms and, so they continued the next day a little bit and yesterday I went ahead and tested for COVID and I tested positive and I had your COVID shots all along the way I mean from the very beginning every time available for a booster I had one and I had one in even last October and then this most recent one again on Tuesday and I did not know if it was my testing positive was a possible response to the vaccine or if I actually have the COVID virus."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested for COVID and I tested positive; tested for COVID and I tested positive; Running nose; Light grade fever; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) and on 19Dec2023 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; EZETIMIBE; CIALIS; METOPROLOL; LOSARTAN; ELIQUIS. Vaccination history included: moderna (DOSE 3 (BOOSTER), SINGLE), administration date: 01Nov2022, when the patient was 77-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE), administration date: 04Nov2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 1, SINGLE), administration date: 25Feb2021, when the patient was 75-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 20Dec2023, outcome "recovering", described as "Light grade fever"; RHINORRHOEA (non-serious) with onset 20Dec2023, outcome "recovering", described as "Running nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2023, outcome "recovering" and all described as "tested for COVID and I tested positive". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Light grade; SARS-CoV-2 test: (23Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, rhinorrhoea, pyrexia.  Clinical course: The consumer reported "I had a COVID Vaccine (Later clarified as Pfizer COVID-19 Vaccine) on last Tuesday afternoon along with a RSV vaccine (Later clarified as RSV Abrysvo) like the 2 shots. And Wednesday evening I started having some symptoms you know kind of like running nose and light grade fever and they were kind of like COVID symptoms and, so they continued the next day a little bit and yesterday I went ahead and tested for COVID and I tested positive and I had your COVID shots all along the way I mean from the very beginning every time available for a booster I had one and I had one in even last October and then this most recent one again on Tuesday and I did not know if it was my testing positive was a possible response to the vaccine or if I actually have the COVID virus."  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Lot number: Ho983) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CML (Chronic myeloid leukemia)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imatinib for Daily chemo; Sulfa, reaction(s): "Allergy". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot No: GH9694 , Anatomical Location: Arm Left), administration date: 29Sep2022, when the patient was 83-year-old, for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: 2 negative tests the previous week; (Dec2023) Negative, notes: 2 negative tests the previous week. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 07Dec2023 to 12Dec2023.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Rash, Suspected COVID-19
Clinical narrative: get Covid in Oct; get Covid in Oct; had kind of reactive skin, something felt like little raised places in skin; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "get Covid in Oct"; RASH (non-serious), outcome "unknown", described as "had kind of reactive skin, something felt like little raised places in skin". Clinical course: Finally did get Covid in Oct. Was a piece of cake, never had to take medicine, or do anything. Just took hot showers, coughing so much, felt like she was on vacation. Clearly, couldn't go anywhere or do anything much. Just saying, was 72 years old, just saw doctor yesterday, was in great shape. Was not on medication, was not bad risk or anything. Does not have diabetes or blood pressure issues, or trouble like that. Does not know, whether this was even a symptom but, with the earlier vaccines, had kind of reactive skin, something felt like little raised places in skin. Wasn't even near vaccination site, was probably not relevant. This was from previous Pfizer vaccinations, what she has always gotten. Wondered if that was related to the vaccination. It wasn't any problem, didn't itch or burn, didn't bother her. Clarified, the little raised pieces, occurred with precious Pfizer Covid vaccinations and not most recent Pfizer Covid vaccination. Does not feel this was related to vaccine, was just wondering, in her head. That was why she was asking, if it had anything to do with the vaccine. Was sometimes a little scared, never got scared during Covid, thought this was worse.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300452834 same patient, same product, different events and dose;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Full blood count, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive; He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single) and as dose 2, single) 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 09Dec2023, outcome "unknown" and all described as "He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Chest X-ray: (08Dec2023) Unknown results; Full blood count: (08Dec2023) Unknown results; Metabolic function test: (08Dec2023) Unknown results; SARS-CoV-2 test: (08Dec2023) Negative; (09Dec2023) Positive, notes: They retake his COVID test and it's been positive.". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment. Clinical Course: Reporter stated she is patients spouse and nurse but not working for the facility and she was a care giver.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, SARS-CoV-2 test
Clinical narrative: interchange of vaccine products; He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive; He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single) and as dose 2, single) 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 09Dec2023, outcome "unknown" and all described as "He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Chest X-ray: (08Dec2023) Unknown results; Full blood count: (08Dec2023) Unknown results; Metabolic function test: (08Dec2023) Unknown results; SARS-CoV-2 test: (08Dec2023) Negative; (09Dec2023) Positive, notes: They retake his COVID test and it's been positive.". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment. Clinical Course: Reporter stated she is patients spouse and nurse but not working for the facility and she was a care giver.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Interchange of vaccine products, Metabolic function test, Skin discolouration
Clinical narrative: interchange of vaccine products; He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive; He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single) and as dose 2, single) 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 09Dec2023, outcome "unknown" and all described as "He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer/They retake his COVID test and it's been positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Chest X-ray: (08Dec2023) Unknown results; Full blood count: (08Dec2023) Unknown results; Metabolic function test: (08Dec2023) Unknown results; SARS-CoV-2 test: (08Dec2023) Negative; (09Dec2023) Positive, notes: They retake his COVID test and it's been positive.". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid treatment. Clinical Course: Reporter stated she is patients spouse and nurse but not working for the facility and she was a care giver.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Pharmacist.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 15Dec2023 to 20Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Vaccination Failure and COVID-19 cannot be ruled out.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "bad cholesterol" (unspecified if ongoing), notes: on medicine for bad cholesterol; "Sulfa allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; ATORVASTATIN. Past drug history included: Niacin, reaction(s): "Niacin allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures (Paxlovid treatment start date: 11Dec2023, stop date: 15Dec2023) were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 10Dec2023 to 14Dec2023. Clinical Course: On 08Dec patient had fever, sore throat, cough, sneezing, fatigue, dizziness. 10Dec: Covid was diagnosed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing); "LBBB" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 12Dec2023 to 16Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.