chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Jul2023 as dose 5 (booster), single (Lot number: Gj3682) at the age of 82 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway" (unspecified if ongoing); "Known allergies: Opiates" (unspecified if ongoing); "Known allergies: tegretol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Sep2023 to 01Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320803 same patient, different drug/event;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Heart rate, Heart rate increased
Clinical narrative: Diarrhea; Heart was beating fast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: NEBIVOLOL HYDROCHLORIDE taken for hypertension; OLMESARTAN MEDOXOMIL taken for hypertension; AMLODIPINE BESYLATE taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: DIARRHOEA (non-serious) with onset 06Oct2023 at 04:00, outcome "unknown", described as "Diarrhea"; HEART RATE INCREASED (non-serious) with onset 06Oct2023 at 04:00, outcome "recovering", described as "Heart was beating fast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, heart rate increased. Additional information: Patient took the new COVID-19 vaccination (Pfizer COVID-19 Vaccine) yesterday (05Oct2023) and at 4 o'clock this morning (06Oct2023), patient had a bad diarrhea and heart was beating fast but since then it has slow down.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling, Wrong product administered
Clinical narrative: Swelling under right arm and in armpit; Swelling under right arm and in armpit; Proprietary medicinal product name: Pfizer Bivalent/ Date of start of drug: 05Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2023 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years intramuscular, in right arm for covid-19 immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5). The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination : Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown (booster), unknown manufacturer (Dose received : More than 3)), for COVID-19 immunisation; Covid-19 vaccine (Dose 1, unknown manufacturer (Dose received : More than 3)), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, unknown manufacturer (Dose received : More than 3)), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, unknown manufacturer (Dose received : More than 3)), for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Oct2023 at 14:45, outcome "unknown", described as "Proprietary medicinal product name: Pfizer Bivalent/ Date of start of drug: 05Oct2023"; PERIPHERAL SWELLING (non-serious), SWELLING (non-serious) all with onset 06Oct2023 at 07:00, outcome "not recovered" and all described as "Swelling under right arm and in armpit". Therapeutic measures were not taken as a result of peripheral swelling, swelling.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Vaccination site pain
Clinical narrative: site of the injection was quite sore and I have had that before but not as bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2 NOS), 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "site of the injection was quite sore and I have had that before but not as bad". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID but I had a very mild case because of the fact that I had been inoculated; COVID but I had a very mild case because of the fact that I had been inoculated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bottom teeth are temporary" (unspecified if ongoing), notes: waiting for recombinant replacement. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID but I had a very mild case because of the fact that I had been inoculated". Clinical course: Consumer stated, "He was just calling to report a side effect because he had never had one and up and till now, he had 4 shots for COVID (suspect captured as Pfizer Covid Shot), the two initials and then two boosters last year". Since, he had, his wife was living in a rehab hospital and nurse that gave her and him COVID but he had a very mild case because of the fact that he had been inoculated and unfortunately his wife passed away on the Mar of this year. He took it because he saw the add suggesting that they got a new one for this year. The last one he got was in 2022.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321269 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321110 same patient/vaccine, different dose number/event;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: HJ5342) at the age of 72 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 19Jul2022 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Lot number: 023M20A), in left arm and on 19Mar2021 as dose 2, single (Lot number: 006B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Environmentally induced asthma" (unspecified if ongoing); "known_allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; 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 69-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: ELO140), in left arm, on 03Feb2021 as dose 2, single (Lot number: ELO/40), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm, on 25May2023 as dose 6 (booster), single (Lot number: AS7180B), in left arm and on 19Sep2023 at 11:00 as dose 7 (booster), single (Lot number: 3030342), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: shrimp" (unspecified if ongoing); "Known allergies: capers" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was administered with Paxlovid from 25Sep2023 to 30Sep2023.  Product Quality Group provided investigational results on 09Oct2023 for a complaint of a BNT162b2 number FK9895. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9895. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (01Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of COVID-19; (01Oct2023) Negative, notes: Tested negative seven days later, on 01Oct; (07Oct2023) Positive, notes: Tested positive from Covid home test on 07Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Sep2023 to 28Sep2023. Clinical course: Initial symptoms were fever, body ache, burning sensation in chest, and fatigue. Symptoms improved after treatment.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320813 same patient, different drug/event;
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 6 (booster), single (Lot number: GH9693) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing), notes: Other medical history: CTCL (Cutaneous T-cell lymphoma); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (DOSE 4, SINGLE, Lot number: 33130BA), administration date: 31Mar2022, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 3, SINGLE, Lot number: FF2590), administration date: 13Oct2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 1, SINGLE, Lot number: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose"; Bnt162b2 (DOSE 5, SINGLE), for COVID-19 immunization, reaction(s): "persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The following information was reported: TINNITUS (non-serious) with onset Oct2022, outcome "not recovered", described as "bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist. MRI ordered, no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/product/event, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: PCN" (unspecified if ongoing); "known allergies: bee venom" (unspecified if ongoing); "CTCL" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 33130BA), administration date: 31Mar2022, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2590), administration date: 13Oct2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. Additional information: The patient experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist. MRI ordered, no causes identified.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug and dose;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: 33130BA) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2590), administration date: 13Oct2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. Clinical course: Evaluated by ENT and audiologist. Event treated with diagnostic MRI, no treatment available (as reported). The patient had no covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug dose;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 2, single, Batch/Lot No: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose."; bnt162b2 (Dose 1, single, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose.". The following information was reported: TINNITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist at (Withheld). MRI ordered, no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient, same event, different drug dose;
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Magnetic resonance imaging, SARS-CoV-2 test, Tinnitus
Clinical narrative: Inappropriate schedule of vaccine administered; Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "CTCL" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing); "known allergies: bee venom" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist. MRI ordered, no causes identified.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug dose;
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: tenderness, mild swelling of injection site; no redness; fatigue, headache, muscle pain, chills, I slept more; took some Tylenol.  32 hours later feel better.  Just wanted you to know since it was listed on the papers received when I got the vaccine.  Thank you.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site swelling, Myalgia
Clinical narrative: tenderness, mild swelling of injection site; no redness; fatigue, headache, muscle pain, chills, I slept more; took some Tylenol.  32 hours later feel better.  Just wanted you to know since it was listed on the papers received when I got the vaccine.  Thank you.
Age: 54.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Extra dose administered
Clinical narrative: PT RECEIVED VACCINE AT ANOTHER CLINIC PRIOR TO THE ADMINISTERED VACCINES IN THIS CLINIC.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Patient got extremely fatigued about 12 hours after the vaccine. She was at another doctor's appointment and they were very concerned for her getting home. She arrived home but her neighbor found her sleeping in her running car. Luckily she was not injured but she slept for the rest of the afternoon and evening. She felt better after sleeping for 12 hours.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was receiving COVID vaccinations with her three children. She received the pediatric 5-11 dose instead of the 12+ dose.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Feeling of body temperature change, Hallucination
Clinical narrative: Symptoms that were present and lasted for 9 hours: Severe chills, severe back pain, bad headache, hot/cold sensations, sweating, hallucinations  Symptoms that were present for lasted for 24 hours: Headache, fatigue
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Symptoms that were present and lasted for 9 hours: Severe chills, severe back pain, bad headache, hot/cold sensations, sweating, hallucinations  Symptoms that were present for lasted for 24 hours: Headache, fatigue
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Local swelling, redness, extreme heat to the touch
Age: 18.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, UNK, VARCEL
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: 18 year old male presented for vaccine follow-up. Pt did not have any records and proceeded with catch-up vaccination for school entry. Parent accompanied the pt. Prior to vaccine administration, Pt was feeling nervous but was comfortable to proceed.  Pt had a vasovagal response after receiving all intramuscular and intradermal injections. Pt was diaphoretic, and was laid down. Initial BP taken of 84/60, Pt was responsive but eyes were closed. Pt opened eyes given an ice pack to neck and juice. Responded well. Pt was laid down for 10 minutes. After sitting, retake BP 110/75. Pt states that he was feeling better and wanted to continue with remaining subcutaneous injections. Pt left clinic stable. Pt was instructed if any other reactions occur to visit emergency care. Pt will follow up in 2 days at the clinic for TB test review and for a general nurse visit to ensure no further reactions occurred to vaccines.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: patient claims all the vaccine did not go in arm, stated some dropped on floor
Age: 81.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was supposed to receive Spikevax and Fluad, but the pharmacy accidentally dispensed Spikevax and Arexvy (RSV). Patient received Arexvy a few weeks ago.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Haematological infection, Laboratory test abnormal, Rash
Clinical narrative: Customer's wife called on 10/11/23 to question if a small rash that developed on patient's leg on 10/03/23 and then developed to a full body rash on 10/07/23 could have been related to Abrysvo vaccination given on 9/27/23.   Customer did report to hospital due to symptoms.  Tests were run during that visit.  Hospital called customer and requested he return to hospital due to a suspected blood infection.  Customer is still currently hospitalized.  No further information is known at this point.  Pharmacy only had one call from family member with no follow up at this point.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose given- Patient is 11 yrs and 12 + dose given in error.
Age: 81.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Condition aggravated, Erythema, Feeling hot, Hypersensitivity, Infected bite
Clinical narrative: Patient came to get vaccines just after getting bit by a cat in the face. She did not report this to us. She got her vaccinations, they went to dinner after. Her arm started to get hot,itchy and red. She went to the ER and they were so busy they were not seen by 4:30am and they left. She saw her regular doctor today.  By then the itching in her left arm went away, but it was still red and the wound from the cat bite on her face was worse. The dr diagnosed her with a allergic reaction, but also with a cat bite infection on her face. She is 81, her immune system is probably overloaded by the two vaccines and the infection from an animal bite. She reported to have not have had any problems with vaccinations before, including being vaccinated with both covid/flu last year together.
Age: 81.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus, Wound
Clinical narrative: Patient came to get vaccines just after getting bit by a cat in the face. She did not report this to us. She got her vaccinations, they went to dinner after. Her arm started to get hot,itchy and red. She went to the ER and they were so busy they were not seen by 4:30am and they left. She saw her regular doctor today.  By then the itching in her left arm went away, but it was still red and the wound from the cat bite on her face was worse. The dr diagnosed her with a allergic reaction, but also with a cat bite infection on her face. She is 81, her immune system is probably overloaded by the two vaccines and the infection from an animal bite. She reported to have not have had any problems with vaccinations before, including being vaccinated with both covid/flu last year together.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUR4, RSV
Symptoms: Headache, Nausea, Throat irritation
Clinical narrative: Patient had received 3 vaccines. patient was sitting in lobby and started feeling dizzy. we took her into the counseling room and gave her some water and some orange juice. she said she had a headache and felt nauseous and had a scratchy throat. we gave her a 25mg benadryl. we took her blood pressure twice and it was high, 205/120. After the second reading we called the paramedics to take her to the hospital.
Age: 68.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Chest discomfort, Electrocardiogram normal, Injection site urticaria, Urticaria
Clinical narrative: patient received vaccine at 6:20 PM then developed hives at site of injection several minutes later, hives then spread to right arm and chest then  patient developed chest tightness 6:28 PM diphenhydramine 25 mg x2 (per pt an MD) 6:30 PM chest tightness  Epipen 1 dose left thigh 6:35 PM hives resolving 6:44 chest tightness returned 2nd dose of epi pen 6:58 PM EMS arrived EKG performed by EMS- normal patient released to family member to go home
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Infant irritability, Wrong product administered
Clinical narrative: Yesterday, 10/11/2023, patient received a vaccine by mistake. Patient was given Pentacel and PedvaxHib, 2 doses of Hib given. Patient was supposed to get Pentacel and Prevnar 13. Occurrence reported yesterday to RN/Practice manager. Occurrence reported today to patient's PCP and provider that saw patient yesterday, and to his nurse, MA who administered the vaccine yesterday. Patient's father was informed of occurrence, he verbalized understanding and accepted an apology. I inquired on patient, asked how she is doing, he verbalized that patient is well, acting her usual, was a little fussy yesterday after vaccines but not fussy today, overall well, eating and sleeping well, no fever. I advised patient's father to call us with any concerns or changes in patient's behavior. He was informed that patient should come in after 4 weeks to have Prevnar 13 administered, an appointment was scheduled.  State notified today of occurrence.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: Second incident after previous Pfizer vaccine a year ago.  Rash or hives beginning on back, progressing to armpits, breasts, and chest on both sides of torso, more heavily at right armpit.
Age: 1.25
Sex: F
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: patient is 15 months old and should not have recieved flumist (given to 2-49 year olds)
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 81.0
Sex: M
Vaccine: FLU4, PNC20, PNC20
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Patient's wife called the next day and said he had been feeling ill and had a fever and bad body aches was concerned. We followed up with him about 4 days later and he said he was feeling much better. He had contacted his doctor who advised him to take otc pain relievers but I'm not sure if he actually visited the office.
Age: 69.0
Sex: M
Vaccine: HEPAB, RSV
Symptoms: Blood creatine phosphokinase normal, Blood lactic acid normal, Blood magnesium normal, Blood phosphorus normal, Blood pressure abnormal
Clinical narrative: Patient started feeling cold and shivering just after 10pm. He checked his temperature and didn't have a fever, didn't have a blood glucose monitor to check blood sugar, but had a blood pressure monitor and checked that. His blood pressure readings were 160-188 systolic and 112-120 diastolic. I advised him to go to the ER. Blood pressure was still 130/95 when he arrived, but went down after about another hour. He still felt cold, but within 2 hours there he started with a fever of 100 degrees. It was treated with acetaminophen and he received 1 liter of IV fluid. After fever started to resolve and blood pressure was normal he was sent home instructed to follow up with primary care if needed.
Age: 69.0
Sex: M
Vaccine: HEPAB, RSV
Symptoms: C-reactive protein normal, Chills, Differential white blood cell count normal, Electrocardiogram normal, Feeling cold
Clinical narrative: Patient started feeling cold and shivering just after 10pm. He checked his temperature and didn't have a fever, didn't have a blood glucose monitor to check blood sugar, but had a blood pressure monitor and checked that. His blood pressure readings were 160-188 systolic and 112-120 diastolic. I advised him to go to the ER. Blood pressure was still 130/95 when he arrived, but went down after about another hour. He still felt cold, but within 2 hours there he started with a fever of 100 degrees. It was treated with acetaminophen and he received 1 liter of IV fluid. After fever started to resolve and blood pressure was normal he was sent home instructed to follow up with primary care if needed.
Age: 69.0
Sex: M
Vaccine: HEPAB, RSV
Symptoms: Full blood count normal, Metabolic function test normal
Clinical narrative: Patient started feeling cold and shivering just after 10pm. He checked his temperature and didn't have a fever, didn't have a blood glucose monitor to check blood sugar, but had a blood pressure monitor and checked that. His blood pressure readings were 160-188 systolic and 112-120 diastolic. I advised him to go to the ER. Blood pressure was still 130/95 when he arrived, but went down after about another hour. He still felt cold, but within 2 hours there he started with a fever of 100 degrees. It was treated with acetaminophen and he received 1 liter of IV fluid. After fever started to resolve and blood pressure was normal he was sent home instructed to follow up with primary care if needed.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Biopsy skin abnormal, Erythema, Pityriasis rosea
Clinical narrative: Pityriasis Rosea Started with red spots on stomach, then spread to legs on both sides, back, arms.  Went to dermatologist after a week and a half. No itching.  As of 10/11 the 2 on my arms have recovered, the original and others that had popped up are stilll there  Using Triamcinolone 0.1% Cream 80Gm
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears, sounds like a high-pitched ringing sound. Moderate volume. Interferes with hearing other sounds and speech.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lichen sclerosus
Clinical narrative: I have Lichen Sclerosus all over my torso, several spots on my back and arms
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: pt said the arm is itchy red and swollen. around the size of an egg. happened around 24 hours after she recieved the immunization
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Hyperhidrosis, Hypotension
Clinical narrative: Following day reported low blood pressure, dizziness, light-headedness, "hot flash", sweating
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site erythema, Injection site swelling, Myalgia, Pruritus
Clinical narrative: I thought I was having a delayed allergic reaction. At first, I just felt muscle soreness and no other abnormal reactions. However, over the next 12 hours, the rash slowly appeared. The itching was so bad that I couldn't sleep anymore. At first, the most obvious redness and swelling were only at the injection site, but soon became densely in the armpits, chest, back and buttocks. The other parts which are included on the palms, soles of the feet, anus and oral are slowly diffusion. Some rashes have even small blisters. The current trend is still in the process of getting worse. I have started taking Benadryl Allergy Tablets from today (10/11/2023), 1PC/day. Hope these adverse reactions will be more helpful to your research, but please also give me a solution.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash vesicular, Sleep disorder, Swelling
Clinical narrative: I thought I was having a delayed allergic reaction. At first, I just felt muscle soreness and no other abnormal reactions. However, over the next 12 hours, the rash slowly appeared. The itching was so bad that I couldn't sleep anymore. At first, the most obvious redness and swelling were only at the injection site, but soon became densely in the armpits, chest, back and buttocks. The other parts which are included on the palms, soles of the feet, anus and oral are slowly diffusion. Some rashes have even small blisters. The current trend is still in the process of getting worse. I have started taking Benadryl Allergy Tablets from today (10/11/2023), 1PC/day. Hope these adverse reactions will be more helpful to your research, but please also give me a solution.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adjustment disorder with mixed anxiety and depressed mood, Anaemia, Autonomic nervous system imbalance, Blood disorder, Cardiomyopathy
Clinical narrative: My long covid symptoms worsened over the coming days and weeks, eventually years. I still have symptoms to this day and developed chronic Epstein Barr Virus, Multiple Anemic (D, B12, Ferretin) Blood Disorders, POTs dysautonomia (diagnosed 6/9/22), Cardiomyopathy and worsening ischemic heart disease, Systemic Lupus (diagnosed 2/13/23) and Adjustment Disorder with Anxiety and Depression (diagnosed 4/11/23).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Echocardiogram, Electrocardiogram, Epstein-Barr virus infection, Functional residual capacity
Clinical narrative: My long covid symptoms worsened over the coming days and weeks, eventually years. I still have symptoms to this day and developed chronic Epstein Barr Virus, Multiple Anemic (D, B12, Ferretin) Blood Disorders, POTs dysautonomia (diagnosed 6/9/22), Cardiomyopathy and worsening ischemic heart disease, Systemic Lupus (diagnosed 2/13/23) and Adjustment Disorder with Anxiety and Depression (diagnosed 4/11/23).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myocardial ischaemia, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Systemic lupus erythematosus
Clinical narrative: My long covid symptoms worsened over the coming days and weeks, eventually years. I still have symptoms to this day and developed chronic Epstein Barr Virus, Multiple Anemic (D, B12, Ferretin) Blood Disorders, POTs dysautonomia (diagnosed 6/9/22), Cardiomyopathy and worsening ischemic heart disease, Systemic Lupus (diagnosed 2/13/23) and Adjustment Disorder with Anxiety and Depression (diagnosed 4/11/23).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tilt table test
Clinical narrative: My long covid symptoms worsened over the coming days and weeks, eventually years. I still have symptoms to this day and developed chronic Epstein Barr Virus, Multiple Anemic (D, B12, Ferretin) Blood Disorders, POTs dysautonomia (diagnosed 6/9/22), Cardiomyopathy and worsening ischemic heart disease, Systemic Lupus (diagnosed 2/13/23) and Adjustment Disorder with Anxiety and Depression (diagnosed 4/11/23).
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Immunisation reaction, Swelling
Clinical narrative: Vaccine reaction Redness to arm and swelling
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: Nurse delivered/vaccinated patient with Boostrix Tdap that was purchased with special funds by mistake  Tday/Boostrix was the intended vaccine for use
Age: 63.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received FLUZONE HIGH DOSE (FOR age 65 and older) by accident instead of a different flu vaccine for under age 65
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient came in for vaccine clinic, was initially asked if here for both covid and flu vaccine. Did not state she already had received a flu vaccine the previous week - only stated after receiving flu vaccine that she had already had one.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient with dizziness, numbness of face and tongue. Transported in a wheelchair to the emergency room, she was administered solumedrol 125 mg IU and benadryl 50 mg IO. EKG.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Pain, Rash
Clinical narrative: 100  DEGREE TEMP.  BODY ACHES,  DISORIENTATION,  SUBSEQUENTLY A RASH ABOUT 2 1/2" DIAM.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT