chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Incorrect Diluent Used; Incorrect Preparation/ dose was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 747N3, expiry date 15-JUN-2026) and (batch number 2TN2N) for prophylaxis.   On 26-SEP-2024, the patient received Shingrix (intercostal, right deltoid) .5 ml. On 26-SEP-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Incorrect Diluent Used) and inappropriate dose of vaccine administered (Verbatim: Incorrect Preparation/ dose was administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-SEP-2024 The medical assistant reconstituted suspect vaccine with adjuvant. However, she also added a sterile saline diluent of 0.7 ml batch number 1950650 to antigen vial for reconstitution, which led inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. It was unknown if this first or second dose of the suspect vaccine series. The reporter consented to follow up.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of Engerix-B; pediatric dose of Engerix-B was administered to a 26 years old female patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 26-year-old female patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric .5 ml. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: pediatric dose of Engerix-B) and adult use of a child product (Verbatim: pediatric dose of Engerix-B was administered to a 26 years old female patient). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2024 The nurse called to report that they administered a dose of Engerix-B pediatric (from birth to 19 years old) to a 26-year-old patient which led to accidental underdose and adult use of a child product. The reporter asked that did this count as a first dose, did she needed to come back to start the adult series and when should she had to do that, or did she needed to start over the series.
Age: 46.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Underdose
Clinical narrative: administration of a pediatric dose of Engerix-B to an adult patient; administration of a pediatric dose of Engerix-B to an adult patient; Extra dose administered; Inappropriate Dose Administered; Inappropriate Dose Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 46-year-old female patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 27-SEP-2024, the patient received the 4th dose of Engerix B pediatric. On 23-JUN-2016, the patient received the 3rd dose of Engerix B. On 27-APR-2016, the patient received the 2nd dose of Engerix B. On 27-APR-2016, not applicable after receiving Engerix B pediatric and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Dose Administered). On 23-JUN-2016, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate Dose Administered). On 27-SEP-2024, the patient experienced underdose (Verbatim: administration of a pediatric dose of Engerix-B to an adult patient), adult use of a child product (Verbatim: administration of a pediatric dose of Engerix-B to an adult patient) and extra dose administered (Verbatim: Extra dose administered). The outcome of the underdose, adult use of a child product, extra dose administered, drug dose administration interval too short and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2024 The other health professional reported that the adult patient was administered of a pediatric dose of Engerix-B which led to underdose, adult use of a child product and extra dose administered.  The patient received third dose of Engerix-B shorter than the recommended interval which led to shortening of vaccination schedule. The patient received second dose of Engerix b longer than the recommended interval which led to lengthening of vaccination schedule. The other health professional stated that she believes the patient was from another country; therefore, she was unsure of why the 2016 series was done the way that it was reported.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: an adult Havrix dose to a 17 year-old patient; administration of an adult Havrix dose to a 17 year-old patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On 27-SEP-2024, the patient received Havrix 1440 adult. On 27-SEP-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: an adult Havrix dose to a 17 year-old patient) and adult product administered to child (Verbatim: administration of an adult Havrix dose to a 17 year-old patient.). The outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2024 The medical assistant called to report the administration of an adult Havrix dose to a 17 year-old patient which led to accidental overdose and adult product administered to child. The health care professional asked for guidance on this situation.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 7 year old, male patient was given a dose of Havrix adult; 7 year old male patient was given dose of Havrix adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 7-year-old male patient who received HAV (Havrix adult) (batch number 4T93r, expiry date 11-JUL-2026) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 7 year old, male patient was given a dose of Havrix adult) and adult product administered to child (Verbatim: 7 year old male patient was given dose of Havrix adult). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2024 The health care professional reported that a 7 year old patient was given a dose of Havrix adult vaccine (overdose), which led to overdose and adult product administered to child.
Sex: U
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: Engerix-B 2 pediatric doses to adult patient; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 32-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B 2 pediatric doses to adult patient) and accidental underdose (Verbatim: Underdose). The outcome of the adult use of a child product and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2024 The reporter reported that medical assistant called to report two pediatric doses of Engerix-B were given to an adult patient which led adult use of a child product and accidental underdose.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom, Seizure
Clinical narrative: Seizures; Neurological symptoms; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (Seizures) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptoms). At the time of the report, SEIZURE (Seizures) and NEUROLOGICAL SYMPTOM (Neurological symptoms) outcome was unknown.            No concomitant and treatment medication were reported.  Patient experienced seizures and neurological symptoms, after receiving the Moderna booster (the initial dose was from a different manufacturer).  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI event of Seizure, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine, received as a booster dose of COVID-19 vaccination schedule (initial dose was from a different manufacturer). The outcome of the event was reported as unknown. It was reported that patient experienced seizures and neurological symptoms, after receiving the Moderna booster. No further information was disclosed. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: prolonged dizziness that started 7 days after vaccination; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (prolonged dizziness that started 7 days after vaccination) in a 55-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 21-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DIZZINESS (prolonged dizziness that started 7 days after vaccination). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 25 milligram. At the time of the report, DIZZINESS (prolonged dizziness that started 7 days after vaccination) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Prolonged dizziness had been ongoing since (19 days since vaccination). The patient did not experience any additional symptoms/events. She had been taking Meclizine but it was not providing much help. Patient had no concomitant disease or risk factor.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Temperature difference of extremities
Clinical narrative: itchy; arm was swollen; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (itchy) and PERIPHERAL SWELLING (arm was swollen) in a 63-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042647) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 microgram. On 01-Oct-2024, the patient experienced PRURITUS (itchy) and PERIPHERAL SWELLING (arm was swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy) and PERIPHERAL SWELLING (arm was swollen) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2024, Temperature difference of extremities: arm surface temp measured 100.1.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient took Tylenol and improved daily. It was also reported that she would see doctor if there were no improvement. It is unknown if the patient experienced any additional symptoms or events.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: tenderness and a red patch at the injection site.; tenderness and a red patch at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (tenderness and a red patch at the injection site.) and VACCINATION SITE ERYTHEMA (tenderness and a red patch at the injection site) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 03-Oct-2024, the patient experienced VACCINATION SITE PAIN (tenderness and a red patch at the injection site.) and VACCINATION SITE ERYTHEMA (tenderness and a red patch at the injection site). At the time of the report, VACCINATION SITE PAIN (tenderness and a red patch at the injection site.) and VACCINATION SITE ERYTHEMA (tenderness and a red patch at the injection site) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. Reporter causality was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2024: Live non-significant follow-up received: Reference id added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid rebound; Covid rebound; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Aortic valve replacement", start date: 2016 (unspecified if ongoing), notes: Aortic valve replacement 2016; "rheumatic fever" (unspecified if ongoing), notes: rheumatic fever when 18; "partial nephrectomy", start date: 2016 (unspecified if ongoing), notes: partial nephrectomy 2016; "cancer no recurrence" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid rebound". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid was given from 21Sep2024 to 25Sep2024.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria chronic
Clinical narrative: dermatographia; I know after the second, a few hours after the second I started having chronic hives; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 2, single (Lot number: FJ9443) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot number : FJ9443 (as reported)), administration date: 20Mar2022, when the patient was 24-year-old, for COVID-19 immunization.  The following information was reported: URTICARIA CHRONIC (non-serious) with onset 10Apr2022, outcome "not recovered", described as "I know after the second, a few hours after the second I started having chronic hives"; MECHANICAL URTICARIA (non-serious) with onset 12Apr2022, outcome "not recovered", described as "dermatographia". Therapeutic measures were taken as a result of urticaria chronic, mechanical urticaria.  Additional information: The patient reported that after the second dose, a few hours after the patient started having chronic hives and had chronic hives to this day. The patient did not know what to do and have taken all sorts of medication that they do not really help. The patient stated that the name of the vaccine was PFIZER FJ9443 for both which the patient believed. The patient got chronic hives and dermatographia at the same time with those. Like dermatographia started like 2 days later after the hives. The patient took an antihistamine every day because that what decently helped. The patient still get breakouts. The patient had no previous immunization prior to the Pfizer vaccine. There were no vaccines administered on the same date with the Pfizer vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Pain at injection site; headache; fatigue; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, start date: 23Sep2024, stop date: 23Sep2024. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Oct2024, outcome "not recovered", described as "Pain at injection site"; FATIGUE (non-serious) with onset 03Oct2024, outcome "not recovered"; HEADACHE (non-serious) with onset 03Oct2024, outcome "not recovered". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue.  Additional information: The patient had received other medications within two weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old patient inadvertently given 12+ COVID vaccine. No reported side effect.
Age: 0.17
Sex: F
Vaccine: HEP, PNC20, RV5, SMALL
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt presented to clinic with mother for her 2 month shots. Shots to be given were gathered and preped. when gathering the injections I did not relize that the adult dose and pediatric dose were not placed in the proper spaces. Vaccines were give to child with the assistance of another nurse at the facility. When the vaccines when to get charted out system alerted that they were out of age range and that was when the mistake was noticed. Provider was informed and it was thought that there were no major side effects. DHHS immunization was called regarding how to procede with future inmuziation of the injection and to confirm if there are any side effect to be concered about. They pointed us in the direction of the local pharmacy to confirm info and to report the incident to VAERS. Pharmacy stated to continue regular vaccine schedual and that there should be no effects of the mistake. Patients mother was called and informed of the mistake and of the plan moving forward. Mother was okay with this. states that she has not noticed anything abnormal with her child since the immunization time.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported severe itching following vaccine all over her torso. Patient broke out in a large rash that was not raised like hives, but was all over her torso. The reaction went away after she woke up in the morning. No treatment necessary.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: I am a breastfeeding mother. Aside from feeling a little under the weather myself (fever, chills, tiredness), my 2 month old vomited and had diarrhea as a side effect while I was breast feeding her. She was showing signs of not being interested in eating and then threw up twice. We have since switched her to frozen breast milk that was previously pumped and she?s doing much better. Aside from the vaccines (I also receive flu vaccine), there were no other changes in my diet.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: NA - 53 year old patient was inadvertently given a pediatric dose of Moderna Covid 19. There are no reactions to report. We would like to know the recommendation on additional vaccinations to ensure patient is protected to the best level.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came into pharmacy on 10/2/24 stating that he would like a covid vaccine, pharmacist verified multiple times that he wanted a covid vaccine. Asked patient if moderna vaccine was ok, he stated yes he wanted that vaccine. Checked computer, showed "late refill" suggesting his last covid vaccine was the previous years. Verified 1 final time right before administration and patient confirmed.  Patient then returned about 4 hours later stating we gave him the incorrect paperwork because he got the flu shot today and not the covid vaccine. Told patient that he requested covid to which he admitted that he made the mistake. After assessing profile patient had already received the current covid vaccine on 9/9/24, advised patient to seek medical attention if he experienced any adverse effects and to wait 2 weeks before getting actual flu vaccine. Spoke with patient today and he report no issues.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vertigo
Clinical narrative: Patient stated that she was feeling dizzy (room spinning) and nausea that evening. Also her muscle was aching and her pupil seem dilated. She felt a little better the next day. I informed her that she would need to call her doctor with her concerns.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: PATIENT STATES SHE DEVELOPPED RASH AND INJECTION SITE AND SURROUNDING AREA.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster
Clinical narrative: shingles; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Sep2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Oct2022; LISINOPRIL, start date: Oct2022. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: COVID-19 (non-serious) with onset 22Sep2024 at 06:00, outcome "recovering"; HERPES ZOSTER (non-serious) with onset 25Sep2024 at 06:00, outcome "recovering", described as "shingles". Therapeutic measures were not taken as a result of covid-19. Therapeutic measures were taken as a result of herpes zoster.  Additional Information: It was reported that the patient got COVID-19 the day after her booster vaccine, and then developed shingles after getting COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine and the patient was taking other medications within 2 weeks of the events starting. The patient received another vaccine on 21Sep2024 in the right arm. The patient received valacyclovir as a treatment for shingles.
Sex: U
Vaccine: COVID19
Symptoms: Amputation
Clinical narrative: Had amputations and many surgeries; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: AMPUTATION (medically significant), outcome "unknown", described as "Had amputations and many surgeries". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Another died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: DEATH (death, medically significant), outcome "fatal", described as "Another died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia
Clinical narrative: numb; This is a spontaneous report received from a Nurse from a sales representative.  A female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Name of Drug as Reported: Unknown. The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset Nov2023, outcome "recovered" (Mar2024), described as "numb". It was unknown if therapeutic measures were taken as a result of hypoaesthesia.  Additional information: It was unknown if the patient receive any other vaccines on the same date as the vaccine(s) and receive any other vaccines within 4 weeks prior to the vaccine(s) for which patient was reporting. It was Unknown if patient was taking any other medications within 2 weeks of the event starting. Patient started the numb went numb and had further complications after vaccination  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Pain in extremity, Vaccination site pruritus
Clinical narrative: slight flu-like symptoms; Itching at injection site; sore arm; swollen glands in neck; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 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 PRURITUS (non-serious) with onset 03Oct2024, outcome "recovering", described as "Itching at injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Oct2024, outcome "recovering", described as "slight flu-like symptoms"; PAIN IN EXTREMITY (non-serious) with onset 03Oct2024, outcome "recovering", described as "sore arm"; LYMPHADENOPATHY (non-serious) with onset 03Oct2024, outcome "recovering", described as "swollen glands in neck". Therapeutic measures were not taken as a result of influenza like illness, vaccination site pruritus, pain in extremity, lymphadenopathy.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Syncope
Clinical narrative: Syncope event on airplane 16.5 hours after receiving vaccine.; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 50-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left deltoid for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 02Oct2024 as dose number unknown, single), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SYNCOPE (medically significant) with onset 03Oct2024 at 06:30, outcome "recovered" (03Oct2024), described as "Syncope event on airplane 16.5 hours after receiving vaccine.". Therapeutic measures were not taken as a result of syncope.  Clinical course: No other vaccine in four weeks. No other medications in two weeks. No known allergies.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This is a spontaneous report received from a consumer from medical information team.  A female patient received BNT162b2 (BNT162B2), 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: DISCOMFORT (non-serious), outcome "recovered".  Additional Information: For the first 3 Pfizer COVID-19 vaccines, the patient had a little discomfort, and it was all gone after 2 to 3 days.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400270575 Same patient and product; different dose and events;US-PFIZER INC-202400271881 Same patient, product, and dose; different events;US-PFIZER INC-202400271880 Same patient, product, and dose; different events;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore left arm; headache; tiredness; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Oct2024 at 17:00, outcome "recovering", described as "Sore left arm"; HEADACHE (non-serious) with onset 03Oct2024 at 17:00, outcome "recovering"; FATIGUE (non-serious) with onset 03Oct2024 at 17:00, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Additional information: The patient did not receive any other vaccines on the same date as the suspect vaccines. The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccines. The patient was not taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Running like a 100 temperature; The patient's temperature normally is 97; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Running like a 100 temperature; The patient's temperature normally is 97". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Malaise, Pyrexia
Clinical narrative: Sick; cannot even sit for 2 hours; back hurts; Feel soo tired; wife is feeling very sick; Fever; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: BACK PAIN (non-serious), outcome "unknown", described as "Sick; cannot even sit for 2 hours; back hurts"; FATIGUE (non-serious), outcome "unknown", described as "Feel soo tired"; MALAISE (non-serious), outcome "unknown", described as "wife is feeling very sick"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Additional information: His wife who took Pfizer COVID-19 Vaccine last Saturday, is feeling very sick. The first day she had fever after that first and second day she has fever and then she took it for 7 days already. Now she feel soo tired that you cannot even sit for 2 hours and then her back hurts. What shall they do? Asking if it is that common or is that very uncommon? His wife is feeling very sick.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This is a spontaneous report received from a consumer from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Discomfort". The following information was reported: DISCOMFORT (non-serious), outcome "recovered".  Additional Information: For the first 3 Pfizer COVID-19 vaccines, the patient had a little discomfort, and it was all gone after 2 to 3 days.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400270575 Same patient and product; different dose and events;US-PFIZER INC-202400270685 Same patient, product, and dose; different events;US-PFIZER INC-202400271881 Same patient, product, and dose; different events;
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This is a spontaneous report received from a consumer from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Discomfort"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Discomfort". The following information was reported: DISCOMFORT (non-serious), outcome "recovered".  Additional Information: For the first 3 Pfizer COVID-19 vaccines, the patient had a little discomfort, and it was all gone after 2 to 3 days.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400270575 Same patient and product; different dose and events;US-PFIZER INC-202400271880 Same patient, product, and dose; different events;US-PFIZER INC-202400270685 Same patient, product, and dose; different events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fall, Nausea
Clinical narrative: falling; nausea; weakness; dizzy spell; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. Vaccination history included: Pfizer covid vaccines (all the previous Pfizer covid vaccines), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "falling"; NAUSEA (non-serious), outcome "recovered"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy spell".  Additional information: The patient had the recent Pfizer covid vaccine after having had all the previous Pfizer covid vaccines updates, patient had a terrible reaction to this one. 24 hours of nausea weakness, and a dizzy spell that lead to patient's falling during the night when patient  went to the bathroom.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fall, Headache
Clinical narrative: falling; nausea; weakness; dizzy spell; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. Vaccination history included: Pfizer covid vaccines (all the previous Pfizer covid vaccines), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "falling"; NAUSEA (non-serious), outcome "recovered"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy spell".  Additional information: The patient had the recent Pfizer covid vaccine after having had all the previous Pfizer covid vaccines updates, patient had a terrible reaction to this one. 24 hours of nausea weakness, and a dizzy spell that lead to patient's falling during the night when patient  went to the bathroom.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: falling; nausea; weakness; dizzy spell; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. Vaccination history included: Pfizer covid vaccines (all the previous Pfizer covid vaccines), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "falling"; NAUSEA (non-serious), outcome "recovered"; ASTHENIA (non-serious), outcome "recovered", described as "weakness"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy spell".  Additional information: The patient had the recent Pfizer covid vaccine after having had all the previous Pfizer covid vaccines updates, patient had a terrible reaction to this one. 24 hours of nausea weakness, and a dizzy spell that lead to patient's falling during the night when patient  went to the bathroom.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Headache
Clinical narrative: asthma attack and a major asthma situation; headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 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: ASTHMA (non-serious) with onset Oct2024, outcome "recovered" (Oct2024), described as "asthma attack and a major asthma situation"; HEADACHE (non-serious) with onset Oct2024, outcome "unknown".  Additional information: The patient had a question about the Pfizer COVID vaccines and had the covid vaccine on the 24th and had a strange reaction wanting to know if she was the only one, it happened to around this morning. Patient got a headache and after about 12 hours woke up to an asthma attack and a major asthma situation and lasted about three days. She asks if she is the only one who experiences these side effects.  No follow-up attempts are possible. batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe vomiting; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 26-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "recovered", described as "severe vomiting".  Additional information: The negative side effects of the COVID vaccine were not properly communicated prior to the second dose. She had severe vomiting for 12 hours.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: boosted twice with the BNT1682 vaccine and developed a positive COVID-19; positive COVID-19 test; This is a literature report for the following literature source(s):  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant, life threatening) with onset 22Jul2022, outcome "recovered" (27Jul2022), described as "boosted twice with the BNT1682 vaccine and developed a positive COVID-19"; COVID-19 (medically significant, life threatening) with onset 22Jul2022, outcome "recovered" (27Jul2022), described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) positive, notes: COVID-19 antigen-test; (27Jul2022) negative, notes: completed a 5-day course of NM/R, had negative COVID-19 tests; (30Jul2022) positive, notes: for 3 days with COVID-19 NM/R rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The reporter considered "boosted twice with the bnt1682 vaccine and developed a positive covid-19" and "positive covid-19 test" related to BNT162b2.; Sender's Comments: A causal relationship to the suspect drug BNT162b2 (BNT162B2) cannot be excluded for the event vaccination failure and has been considered as possibly related. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202400269908 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: PARALYSIS (medically significant), outcome "unknown", described as "paralyzed".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.