chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 09:00 as dose 1, single (Lot number: HG4677) at the age of 75 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. 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, Single, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Single, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 5, Single, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid from 15Nov2023 to 20Nov2023, Lot number: GX7843.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got the Pfizer shots and one had Covid 3 times; got the Pfizer shots and one had Covid 3 times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "got the Pfizer shots and one had Covid 3 times". Clinical course: The reporter denied getting Pfizer though 2 of her friends got the Pfizer shots and one had Covid 3 times the other had a really bad case of it. The reporter would stuck with Modera.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in right arm 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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 09Nov2023 to 13Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300414002 same patient, different drug and AE;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 27Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 24Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 03Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gluten allergy" (unspecified if ongoing); "Tuberous sclerosis complex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "recovered" (2023); DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Negative test on day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 17Nov2023 to 22Nov2023.  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-202300414532 same patient different drug/event (Paxlovid case);
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Albumin globulin ratio, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HF9275) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Important to know that his last case of COVID was 14Apr2023", start date: 14Apr2023 (unspecified if ongoing), notes: known allergies: Important to know that his last case of COVID was 14Apr2023. The patient took concomitant medications. 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) with onset 18Nov2023, outcome "recovering", COVID-19 (medically significant) with onset 18Nov2023, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: Albumin globulin ratio: (21Nov2023) Unknown results; SARS-CoV-2 test: (21Nov2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: other vaccine 4weeks product was sequiris on 14Sep2023 (lot number: 94447), in left deltoid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy (vaccination failure and Covid-19) with the suspect vaccine bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)) in this patient cannot be completely excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: En6205), in left arm, on 03Apr2021 as dose 2, single (Lot number: Er8737), in left arm and on 26Dec2021 as dose 3 (booster), single (Lot number: 330368D) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "NASH" (unspecified if ongoing); "fatty liver disease" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Aug2020; BUPROPION, start date: 01Aug2020; CYMBALTA; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 17Nov2023 to 21Nov2023. No known allergies.
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: I got really sick; severe diarrhea; threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Oct2023, outcome "unknown", described as "severe diarrhea"; VOMITING (non-serious) with onset Oct2023, outcome "unknown", described as "threw up"; ILLNESS (non-serious) with onset 18Oct2023, 10 hrs after the suspect product(s) administration, outcome "unknown", described as "I got really sick".  Additional information: It was reported that, patient got it at my doctors office, they didn't ask me about any allergies and just stuck me in one arm then the other. Patient got really sick about 10 hours later (after the injection), this was on 18Oct." "Patient threw up and threw up and had severe diarrhea, Patient couldn't get off the stool and had to throw up in a bucket."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Patient reported pain at injection site to HCP following administration of Abrysvo; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Patient reported pain at injection site to HCP following administration of Abrysvo". It was unknown if therapeutic measures were taken as a result of vaccination site pain. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other- Moderna, Vaccine dose number- 4/ Vaccine brand- Pfizer / BioNTech, Vaccine dose number- 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received bnt162b2 (BNT162B2), on 24Oct2022 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jun2022 as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alpha-1 Antitrypsin Deficiency (ZZ)" (unspecified if ongoing), notes: Alpha-1 Antitrypsin Deficiency (ZZ). Concomitant medication(s) included: TRAMADOL HCL, start date: 15Jun2022. Past drug history included: Bacitracin ointment, reaction(s): "Known allergies: Bacitracin ointment". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Jun2022, outcome "unknown", described as "Vaccine brand other- Moderna, Vaccine dose number- 4/ Vaccine brand- Pfizer / BioNTech, Vaccine dose number- 3"; 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: (25Nov2023) Negative, notes: after negative tests on 25Nov; (27Nov2023) Negative, notes: after negative tests on 25Nov and 27Nov; (28Nov2023) Positive, notes: positive home covid test on 28Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EW0169), in left arm and on 08May2021 as dose 2, single (Lot number: ER8736) at the age of 63 years, in left arm 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 Nov2023, outcome "recovered" (Nov2023) and all described as "COVID-19". Therapeutic measures were taken as a result of the events which included nirmatrelvir/ritonavir on 19Nov2023.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Drug ineffective, Meningococcal infection
Clinical narrative: serogroup B meningococcal disease cases in people; serogroup B meningococcal disease cases in people; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 22-year-old patient received meningococcal group b rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation; for meningococcal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), MENINGOCOCCAL INFECTION (medically significant) all with onset 2022, outcome "unknown" and all described as "serogroup B meningococcal disease cases in people".  There were identified a couple of new (since our previous publication on this topic) serogroup B meningococcal disease cases in people who had previously received one or more doses of TRUMENBA. 2022: 22 years old patient received 2 doses of TRUMENBA, timing unknown, survived.   The information on the batch/lot number for meningococcal group b rlp2086, meningococcal group b rlp2086  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300194596 same reporter/product/event, different patient.;
Age: 72.0
Sex: M
Vaccine: COVID19, PPV
Symptoms: Product use issue, Rash macular
Clinical narrative: day after vacine developed blotchy red patches under both arms; Comirnaty (2023-2024 Formula)/PNEUMOVAX 23 taken on the same date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), on 27Nov2023 (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "moderate Mirtral valve prolapse" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 20Nov2023; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; CIALIS; ATORVASTATIN; ASPIRIN 81; VITAMINS NOS. 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 manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 manufacturer unknown), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 27Nov2023, outcome "unknown", described as "Comirnaty (2023-2024 Formula)/PNEUMOVAX 23 taken on the same date"; RASH MACULAR (non-serious) with onset 29Nov2023 at 07:15, outcome "recovering", described as "day after vacine developed blotchy red patches under both arms". Therapeutic measures were not taken as a result of rash macular. Additional information: The after vaccine the patient developed blotchy red patches under both arms. Not itchy or bothersome, just surprized to see them. Prior to vaccination the patient wasn't diagnosed with COVID-19 and since the vaccination, the patient hasn't been tested for COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: How long do I have a bad feeling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "How long do I have a bad feeling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: deep tissue bruising in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "deep tissue bruising in the arm".  Additional information: The patient in question had been experiencing what felt like deep tissue bruising in the arm that received Covid vaccine/boosters. The bruising was not visible to the eye, but the deep tissue remained as if it's badly bruised. No information patient could find matches what arm was feeling. All patient's shots and boosters for Covid were Pfizer. Patient didn't know why the deep tissue bruising wasn't clearing after months.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Nov2023 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. 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, manufacturer unknown), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 28Nov2023, outcome "recovering", described as "Sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain. Additional information: On 27Nov2023 the patient received another vaccine (Oxford). Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other Novavax/vaccine dose number unknown : Vaccine brand Pfizer / BioNTech / vaccine dose number 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Jan2021 at 13:00 as dose 1, single (Lot number: EL1284), in left arm, on 25Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm for covid-19 immunisation; covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 25Aug2023 at 14:00 as dose 5 (booster), single (Lot number: 5433MF001), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "allergies : Gluten" (unspecified if ongoing); "black pepper" (unspecified if ongoing); "pineapple" (unspecified if ongoing); "coffee" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Aug2023, outcome "unknown", described as "Vaccine brand other Novavax/vaccine dose number unknown : Vaccine brand Pfizer / BioNTech / vaccine dose number 1"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive. Therapeutic measures, Paxlovid from 23Nov2023 until 29Nov2023, were taken as a result of vaccination failure, covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Nasopharyngitis, Rash, SARS-CoV-2 test
Clinical narrative: Developed a rash, afraid it was shingles; Developed a rash, afraid it was shingles; cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 16:30 as dose 1, single (Lot number: HG2282) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2023, outcome "unknown", described as "cold"; RASH (non-serious) with onset Nov2023, outcome "recovering", HERPES ZOSTER (non-serious) with onset Nov2023, outcome "unknown" and all described as "Developed a rash, afraid it was shingles". The event "developed a rash, afraid it was shingles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: the patient developed a rash within two weeks. She had a cream that had been using. The patient went back to everything she had done and there was nothing she ate or used or did or whatever that was different. She did not have anything that was major. The only thing she had since then, within the first week after she got it, she had a bit cold so she tested herself at home for covid and also had a PCR done at an urgent care center; they were negative. In addition to urgent care, she went up there for rash, she went to her regular doctor for couple of days. The rash was improving, but it had been over two weeks and it was not gone. She did not take any other Pfizer vaccine on same day or any other vaccine 4 week prior to Pfizer COVID-19 Vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2013 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine product; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER3731) and on 17Nov2021 as dose 2, single (Lot number: EN6199) at the age of 45 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 939909) and on 06Dec2022 as dose 4 (booster), single (Lot number: A57166B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "minor heart attack", start date: Jun2020 (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 05Jun2020; ATORVASTATIN, start date: 05Jun2020, stop date: 15Nov2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine product"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 15Nov2023-20Nov2023).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 3, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "Swelling at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site swelling.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Dry mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY MOUTH (non-serious) with onset 30Nov2023, outcome "unknown".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient presented to clinic for PCV20 vaccine and Tdap. After administration, the medical assistant informed the provider and supervisor that she administered Flu vaccine instead of PCV20. Patient had no symptoms and was informed that he received an additional flu vaccine for 2023 season.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse signs or symptoms, pediatric vaccine given to pt instead of adult dose- error. Reported to manager
Age: 2.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: The pfizer 6months - 4 yeard old 2023-2024 formulation was administered 1 day past expiration date. Vaccine expired on 11/30/2023 and was administered on 12/1/2023
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pharmacy staff gave patient the Adjuvant only, without mixing the Antigen component. Patient was contacted, is aware, and does not report any side effects.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions noted. Patient noted she had already had the flu vaccine on 9.11.2023.
Age: 4.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: The pfizer 6months - 4 yeard old 2023-2024 formulation was administered 1 day past expiration date. Vaccine expired on 11/30/2023 and was administered on 12/1/2023
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Tendonitis
Clinical narrative: Gradual onset of joint pain, tendonitis, and decreased range-of-motion in wrists, rt shoulder, lft hip, lft ankle, fingers/hands. Ongoing to present day.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: patient is complaining of arm pain/ muscle pain in the arm where he says that it is hard to raise arm
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: Hospitalization after emergency room admission
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Wrong product administered
Clinical narrative: Patient presented himself to the pharmacy, filled out an informed consent to receive vaccines form and received a flu shot. His daughter later came in and said he came to the store to go to the walk in clinic to be tested for the flu. She was very upset that he received a flu shot when he might already have the flu.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth at injection site.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Mobility decreased, Muscle contracture, Muscle disorder, Neck pain
Clinical narrative: Initially typical post-injection arm soreness, as well as fever, aches,and fatigue.  Two days later arm soreness was still present.  A week later there appeared to be a deltoid impingement preventing shoulder movement which then resulted in contracted trapezius muscles and neck pain.  Evolved to severe neck and shoulder pain impacting sleep and work and causing jolts of nerve pain radiating across brachial plexus nerves and down arm.  Two months later pain still exists.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuralgia, Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Initially typical post-injection arm soreness, as well as fever, aches,and fatigue.  Two days later arm soreness was still present.  A week later there appeared to be a deltoid impingement preventing shoulder movement which then resulted in contracted trapezius muscles and neck pain.  Evolved to severe neck and shoulder pain impacting sleep and work and causing jolts of nerve pain radiating across brachial plexus nerves and down arm.  Two months later pain still exists.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: X-ray limb
Clinical narrative: Initially typical post-injection arm soreness, as well as fever, aches,and fatigue.  Two days later arm soreness was still present.  A week later there appeared to be a deltoid impingement preventing shoulder movement which then resulted in contracted trapezius muscles and neck pain.  Evolved to severe neck and shoulder pain impacting sleep and work and causing jolts of nerve pain radiating across brachial plexus nerves and down arm.  Two months later pain still exists.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Periorbital swelling
Clinical narrative: 1 hour after vaccine administration, patient called to state she was having chest tightness and puffiness around the eyes. Pharmacist instructed patient to go to ER and take benadryl. Patient agreed to take benadryl but refused additional medical care
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Altered state of consciousness, Respiratory tract congestion, Seizure
Clinical narrative: Seizure that lasted about 45 seconds followed by chest congestion, and suspended awareness for 5 or 6 minutes.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Pt. administered Havrix that was past date by one day (exp. 11/30/23) - given 12/1/23 Pt. tolerated vaccine well.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood thyroid stimulating hormone normal, Dysphagia, Pharyngeal swelling
Clinical narrative: 9 days after immunization had a "swollen" throat (thyroid area) and slight difficulty swallowing. Has improved a bit, but still bothersome. (TSH elevated at this time) Has been of Lyme Disease protocol for about 6 weeks without these symptoms. No difficulty breathing.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC20, RV5
Symptoms: Autopsy, Cardiac arrest, Crying, Death, Fatigue
Clinical narrative: We received a phone call reporting to our office on 11/15/2023 that the child had died in his sleep at home on 11/14/2023.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC20, RV5
Symptoms: Peripheral coldness, Pyrexia, Screaming, Skin discolouration
Clinical narrative: We received a phone call reporting to our office on 11/15/2023 that the child had died in his sleep at home on 11/14/2023.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC20, RV5
Symptoms: Death, Poor feeding infant, Sepsis neonatal
Clinical narrative: We received a phone call reporting to our office on 11/15/2023 that the child had died in his sleep at home on 11/14/2023.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose fluctuation, Burning sensation, Drug ineffective
Clinical narrative: fluctuating sugar; awful leg pain; joint pain; burning of hands and feet; ringing in ears; pain on top of head; Reynaud's; got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), in Jan2021 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "got covid"; REYNOLD'S SYNDROME (medically significant), outcome "unknown", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "awful leg pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning of hands and feet"; TINNITUS (non-serious), outcome "unknown", described as "ringing in ears"; HEADACHE (non-serious), outcome "unknown", described as "pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: fluctuating.  Clinical course included patient had awful side effects from Pfizer Covid vaccine that took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So patient did not get the Covid vaccine boosters because still had problems from side effects. Patient just got covid for the first time on 23Nov2023 and didn't know if it was ok to take Paxlovid or if should take it to stop the viral load and spike proteins that harm.   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: Headache, Pain in extremity, Raynaud's phenomenon, Suspected COVID-19, Tinnitus
Clinical narrative: fluctuating sugar; awful leg pain; joint pain; burning of hands and feet; ringing in ears; pain on top of head; Reynaud's; got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), in Jan2021 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "got covid"; REYNOLD'S SYNDROME (medically significant), outcome "unknown", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "awful leg pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning of hands and feet"; TINNITUS (non-serious), outcome "unknown", described as "ringing in ears"; HEADACHE (non-serious), outcome "unknown", described as "pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: fluctuating.  Clinical course included patient had awful side effects from Pfizer Covid vaccine that took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So patient did not get the Covid vaccine boosters because still had problems from side effects. Patient just got covid for the first time on 23Nov2023 and didn't know if it was ok to take Paxlovid or if should take it to stop the viral load and spike proteins that harm.   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: Arthralgia, Blood glucose, Blood glucose fluctuation, Burning sensation, COVID-19
Clinical narrative: fluctuating sugar; awful leg pain; joint pain; burning of hands and feet; ringing in ears; pain on top of head; Reynaud's; got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), in Jan2021 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "got covid"; REYNOLD'S SYNDROME (medically significant), outcome "unknown", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "awful leg pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning of hands and feet"; TINNITUS (non-serious), outcome "unknown", described as "ringing in ears"; HEADACHE (non-serious), outcome "unknown", described as "pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: fluctuating.  Clinical course included patient had awful side effects from Pfizer Covid vaccine that took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So patient did not get the Covid vaccine boosters because still had problems from side effects. Patient just got covid for the first time on 23Nov2023 and didn't know if it was ok to take Paxlovid or if should take it to stop the viral load and spike proteins that harm.   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: Drug ineffective, Headache, Pain in extremity, Reynold's syndrome, Tinnitus
Clinical narrative: fluctuating sugar; awful leg pain; joint pain; burning of hands and feet; ringing in ears; pain on top of head; Reynaud's; got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), in Jan2021 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "got covid"; REYNOLD'S SYNDROME (medically significant), outcome "unknown", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "awful leg pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning of hands and feet"; TINNITUS (non-serious), outcome "unknown", described as "ringing in ears"; HEADACHE (non-serious), outcome "unknown", described as "pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: fluctuating.  Clinical course included patient had awful side effects from Pfizer Covid vaccine that took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So patient did not get the Covid vaccine boosters because still had problems from side effects. Patient just got covid for the first time on 23Nov2023 and didn't know if it was ok to take Paxlovid or if should take it to stop the viral load and spike proteins that harm.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; The nurse is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-NOV-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, 1 dose, lot #X011982, expiration date: 22-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature excursion occurred at 6.2 F for 5 minutes. No previous temperature excursion occurred. No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: COVID19, FLUX, RSV
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional information: The patient took Tylenol for sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Drug ineffective, Meningococcal infection, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 42 years old patient received 1 dose of Trumenba; serogroup B meningococcal disease cases; serogroup B meningococcal disease cases; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 42-year-old patient received meningococcal group b rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation; for meningococcal immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ECULIZUMAB. The following information was reported: DRUG INEFFECTIVE (medically significant), MENINGOCOCCAL INFECTION (medically significant) all with onset 2021, outcome "unknown" and all described as "serogroup B meningococcal disease cases"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "42 years old patient received 1 dose of Trumenba".  There were identified a couple of new (since our previous publication on this topic) serogroup B meningococcal disease cases in people who had previously received one or more doses of TRUMENBA.  2021: 42 years old patient taking eculizumab, received 1 dose of TRUMENBA 2.7 years prior to disease onset, survived.   The information on the batch/lot number for meningococcal group b rlp2086, meningococcal group b rlp2086  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300418454 same reporter/product/event, different patient.;