chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painfull; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painfull). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-Mar-2024 This case was reported by a patient via interactive digital media. Patient got two shots after having shingles. Patient stated vaccine was not too bad and was worth it though. He/she will not get them again as they were painful.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: feel sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the first shingle vaccine and felt sick. Follow-up would not possible as no contact details were available.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site dryness, Injection site reaction, Injection site urticaria, Skin exfoliation
Clinical narrative: dry scaly flat circle around injection site/flat wheel, a perfect circle, of dry scaly skin around the injection site; scaly skin around injection site; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site dryness in a 45-year-old female patient who received HAB (Twinrix) (batch number 327E3, expiry date 14-MAY-2025) for prophylaxis.   On 08-FEB-2024, the patient received the 1st dose of Twinrix (intramuscular, right deltoid). In FEB-2024, more than 3 days after receiving Twinrix, the patient experienced injection site dryness (Verbatim: dry scaly flat circle around injection site/flat wheel, a perfect circle, of dry scaly skin around the injection site) and injection site exfoliation (Verbatim: scaly skin around injection site). The outcome of the injection site dryness and injection site exfoliation were resolving.   It was unknown if the reporter considered the injection site dryness and injection site exfoliation to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site dryness and injection site exfoliation to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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: 12-MAR-2024 The nurse reported that, a patient was administered a dose of Twinrix. Today (on the day of reporting) the patient reported to the nurse that more than 72 hours after the vaccination, she had a flat wheel, a perfect circle, of dry scaly skin around the injection site in the right upper deltoid. The area was not red, itchy, and there was no discomfort.  The area was not raised. The area was improving, but not resolved.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: Possible interchanging of Rotavirus vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and ROTATEQ. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced interchange of vaccine products (Verbatim: Possible interchanging of Rotavirus vaccines). The outcome of the interchange of vaccine products was 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: 12-MAR-2024 Possible interchanging of Rotavirus vaccines was reported which led to interchange of vaccine products. A healthcare professional raised a medical inquiry via an agent and asked for information about the continuation of the Rotavirus vaccine series and asked how to proceed with a series if a patient already received Rotateq.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the administration of Shingrix after the recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the administration of Shingrix after the recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 14-MAR-2024 An healthcare professional requested information about the administration of Shingrix after the recommended interval which led to lengthening of vaccinations schedule. Possible adverse event reported.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: NEAR-DEATH EXPERIENCE AFTER TAKING JNJ'S VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series:1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had near-death experience after taking JNJ's vaccine  (Dose number in series:1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of near-death experience after taking JNJ's vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Near death experience. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Pt received TDAP vaccine, after 10 minutes patient developed hives around the mouth eyes. No swelling, difficulty breathing, no stridor or drooling noted. Pt was administered Diphenhydramine 12.5mg/5mL orally, pt overall felt comfortable. Pt was prescribed Benadryl to use as needed.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Agonal respiration, Blood glucose, Bradycardia, Chest X-ray, Cyanosis
Clinical narrative: Patient suffered a 60 second seizure that was afebrile without any previous symptoms to onset. Patient then went agonal, cyanotic and bradycardic then pulseless. Patient received a minute of cpr and was in a postictal state for approximately 20 minutes. Patient came more to normal orientation upon ems ride to emergency room. Patient underwent an er admission, floor admission and neurology consult.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Postictal state, Pulse absent
Clinical narrative: Patient suffered a 60 second seizure that was afebrile without any previous symptoms to onset. Patient then went agonal, cyanotic and bradycardic then pulseless. Patient received a minute of cpr and was in a postictal state for approximately 20 minutes. Patient came more to normal orientation upon ems ride to emergency room. Patient underwent an er admission, floor admission and neurology consult.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Resuscitation, Seizure
Clinical narrative: Patient suffered a 60 second seizure that was afebrile without any previous symptoms to onset. Patient then went agonal, cyanotic and bradycardic then pulseless. Patient received a minute of cpr and was in a postictal state for approximately 20 minutes. Patient came more to normal orientation upon ems ride to emergency room. Patient underwent an er admission, floor admission and neurology consult.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Fatigue, Headache
Clinical narrative: nausea; rigors; arthralgia; low grade fever; Fatigue/tired; slight headache; Day of injection: site become itchy within a 1/2 hour; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Day of injection: site become itchy within a 1/2 hour), HEADACHE (slight headache), CHILLS (rigors), ARTHRALGIA (arthralgia) and PYREXIA (low grade fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 30327813) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Fibromyalgia, Coronary artery disease and Hypertension.    On 16-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 16-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PRURITUS (Day of injection: site become itchy within a 1/2 hour). On 17-Mar-2024, the patient experienced HEADACHE (slight headache) and FATIGUE (Fatigue/tired). On 18-Mar-2024, the patient experienced CHILLS (rigors), ARTHRALGIA (arthralgia) and PYREXIA (low grade fever). On 20-Mar-2024, the patient experienced NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) from 17-Mar-2024 to 21-Mar-2024 at a dose of 1000 milligram, q 8-12 hours and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Mar-2024 for Itching, at a dose of 25 milligram twice a day. On 20-Mar-2024, VACCINATION SITE PRURITUS (Day of injection: site become itchy within a 1/2 hour) had resolved. At the time of the report, HEADACHE (slight headache), CHILLS (rigors), FATIGUE (Fatigue/tired) and NAUSEA (nausea) had not resolved and ARTHRALGIA (arthralgia) and PYREXIA (low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2024, Blood pressure measurement: BP elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient felt tired since day 2. The patient did not experience any additional symptoms/events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pruritus
Clinical narrative: nausea; rigors; arthralgia; low grade fever; Fatigue/tired; slight headache; Day of injection: site become itchy within a 1/2 hour; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Day of injection: site become itchy within a 1/2 hour), HEADACHE (slight headache), CHILLS (rigors), ARTHRALGIA (arthralgia) and PYREXIA (low grade fever) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 30327813) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Fibromyalgia, Coronary artery disease and Hypertension.    On 16-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 16-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PRURITUS (Day of injection: site become itchy within a 1/2 hour). On 17-Mar-2024, the patient experienced HEADACHE (slight headache) and FATIGUE (Fatigue/tired). On 18-Mar-2024, the patient experienced CHILLS (rigors), ARTHRALGIA (arthralgia) and PYREXIA (low grade fever). On 20-Mar-2024, the patient experienced NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) from 17-Mar-2024 to 21-Mar-2024 at a dose of 1000 milligram, q 8-12 hours and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Mar-2024 for Itching, at a dose of 25 milligram twice a day. On 20-Mar-2024, VACCINATION SITE PRURITUS (Day of injection: site become itchy within a 1/2 hour) had resolved. At the time of the report, HEADACHE (slight headache), CHILLS (rigors), FATIGUE (Fatigue/tired) and NAUSEA (nausea) had not resolved and ARTHRALGIA (arthralgia) and PYREXIA (low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2024, Blood pressure measurement: BP elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient felt tired since day 2. The patient did not experience any additional symptoms/events.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: feeling exhausted; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling exhausted) and PAIN IN EXTREMITY (arm soreness) in an 86-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Mar-2024, the patient experienced FATIGUE (feeling exhausted) and PAIN IN EXTREMITY (arm soreness). At the time of the report, FATIGUE (feeling exhausted) and PAIN IN EXTREMITY (arm soreness) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms/events  No concomitant medications was provided. No treatment medications was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Heart rate
Clinical narrative: Double Vision after vaccination; This spontaneous case was reported by a patient and describes the occurrence of DIPLOPIA (Double Vision after vaccination) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure and Cholesterol.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (Double Vision after vaccination). At the time of the report, DIPLOPIA (Double Vision after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Irregular.          Patient was taking medication for Cholesterol Control and Blood Pressure Control. The Double Vision lasted for only 3 weeks and subsided without any medical Intervention, but Irregular Heartbeat was troubling since then.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 06Mar2024 to 10Mar2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Started with sore throat that gradually got worse. Day 8, better but still not feeling great, still slight sore throat.; slight cough; Ran a fever of 101+ for a day; Achy; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Mar2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM [DILTIAZEM HYDROCHLORIDE], start date: 01Oct2019, stop date: 22Mar2024; ELIQUIS, start date: 01Oct2019, stop date: 22Mar2024. Past drug history included: Timolol, reaction(s): "allergies". The following information was reported: PAIN (non-serious) with onset Mar2024, outcome "recovering", described as "Achy"; PYREXIA (non-serious) with onset Mar2024, outcome "recovering", described as "Ran a fever of 101+ for a day"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2024, outcome "recovering", described as "Started with sore throat that gradually got worse. Day 8, better but still not feeling great, still slight sore throat."; COUGH (non-serious) with onset Mar2024, outcome "recovering", described as "slight cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, cough, pyrexia, pain.  Additional information: It was reported that patient started with sore throat that gradually got worse. Ran a fever of 101+ for a day. Achy, slight cough. Day 8, better but still not feeling great, still slight sore throat. The patient did not receive any other vaccines on the same date or 4 week prior to the reported vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cardiac sarcoidosis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Dec2018, stop date: 22Mar2024. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 14Mar2024 to 16Mar2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Took Paxlovid two years ago; Took Paxlovid two years ago; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Cardiac Artery disease" (unspecified if ongoing); "stent" (not ongoing); "heart disorder" (ongoing); "Lung disorder" (ongoing); "Blood pressure abnormal" (ongoing); "Thyroid disorder" (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; ZETIA taken for cardiac disorder (ongoing); SPIRONOLACTONE taken for blood pressure abnormal (ongoing); LEVOTHYROXINE SODIUM taken for thyroid disorder (ongoing); PREDNISONE taken for thyroid disorder (ongoing); ADVIL [IBUPROFEN] taken for lung disorder (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Took Paxlovid two years ago". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid in Aug2022.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400070893 same patient/drug, different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Person described nightly headaches in the evening since receiving his second dose.; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (COMIRNATY), on 05May2022 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Person indicated did have Covid but did not indicate before or after vaccination. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Batch/Lot No: Unknown.), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 05May2022, outcome "unknown", described as "Person described nightly headaches in the evening since receiving his second dose.". Therapeutic measures were not taken as a result of headache.  Additional information: Never experienced before vaccination.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm 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; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 13Mar2024 to 18Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a physician.  A 70-year-old female patient (not pregnant) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: ALENDRONATE, start date: Sep2020, stop date: 11Mar2024. Vaccination history included: COVID-19 vaccine (DOSE 1, 2, 3, 4, and 5; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered with sequelae" (Mar2024) and all described as "COVID-19". Therapeutic measures were taken as a result of the events which included nirmatrelvir/ ritonavir (PAXLOVID) from 17Mar2024 to 21Mar2024 as antiviral treatment.  The information on the batch/lot number for BNT162b2 OMI XBB.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: his eyesight is not great; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "his eyesight is not great". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria; Aka Hives; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in Nov2021 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: URTICARIA CHRONIC (non-serious) with onset 2021, 4 weeks after the suspect product(s) administration, outcome "unknown", described as "Chronic urticaria; Aka Hives".  Additional information: Patient received three doses of Covid vaccine, the last was Nov2021 (unspecified date). 4 weeks later patient developed chronic urticaria. Aka Hives. Patient  suffer every day yet no one was talking about it. Patient was not the only person who has experienced vaccine injury. There needed to be more awareness Both Pfizer and Moderna have caused life changing issues. Patient wish patient could post photos of what patient look like when patient have an outbreak of Urticaria.
Sex: U
Vaccine: COVID19
Symptoms: Jaw disorder
Clinical narrative: jaw issue; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. 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 immunisation, reaction(s): "no side effects"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation, reaction(s): "no side effects". The following information was reported: JAW DISORDER (non-serious), outcome "not recovered", described as "jaw issue". Additional information: Patient had side effects when taking the COVID boosters. Patient took the first 2 shots with no side effects but the 3 shot or booster patient encountered a jaw issue which lasted a year and still was an issue, stated had to suck everything through a straw for a year.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400040642 same patient/drug, different dose/event;US-PFIZER INC-PV202400040643 same patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Pain in extremity
Clinical narrative: heart pains for hours; a leg pains; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation, reaction(s): "No side effects"; COVID-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation, reaction(s): "No side effects"; Bnt162b2 nos (Dose 3 (booster)), for COVID-19 immunisation, reaction(s): "a jaw issue"; Bnt162b2 NOS (Dose 4 (booster)), for COVID-19 immunisation, reaction(s): "effected my back/ it quits hurting". The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "heart pains for hours"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "a leg pains". The 3rd booster patient had heart pains for hours and then had a leg pains which patient was still having.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400040641 same patient/drug, different dose/event;US-PFIZER INC-PV202400040642 same patient/drug, different dose/event;
Age: 6.0
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 21-Mar-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves 7 years child patient who experienced flu after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On 09-Oct-2023, the patient received a unknown dose of suspect influenza usp trival a-b subvirion no preservative vaccine  (Suspension for injection) lot number, strength, expiry date not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization). The information on batch number was requested.  On 09-Mar-2024, the patient developed flu (influenza) (latency: 5 months) following the administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 1.17
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1-year-old patient was inadvertently administered a dose of typhim vi with no reported ae; Initial information was received on 25-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was inadvertently administered a dose of typhoid VI polysaccharide vaccine [Typhim VI]with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Mar-2024, the patient received a 0.4 ml dose of suspect typhoid VI polysaccharide vaccine (Solution for injection) (lot W1A441M, expiry date:07-Mar-2025, strength:standard) via intramuscular route in the left thigh for Immunisation and 1-year-old patient was inadvertently administered a dose of typhim vi with no reported ae (product administered to patient of inappropriate age) (Latency:same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Lethargy, Pyrexia
Clinical narrative: Fever, sweating, lethargic.
Age: 11.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: PATIENT CAME IN FOR HER 7TH GRADE TDAP VACCINE. HER MOTHER WAS ALSO HERE FOR HER FIRST SHINGRIX.  I INADVERTENTLEY GAVE THE SHINGRIX VACCINE INTENDED FOR HER MOTHER. I IMMEDIATLEY WENT TO MY SUPERVISOR -PA AND LET HIM KNOW ABOUT THE INCIDENT. I WENT BACK IN THE ROOM TO INFORM THE MOTHER OF MY ERROR. -PA THEN CAME TO TALK TO THE FAMILY. MOTHER CALLED TO LET US KNOW THAT PATIENT HAD A FEVER, SORE ARM RED AND SWOLLEN.
Age: 11.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong patient received product
Clinical narrative: PATIENT CAME IN FOR HER 7TH GRADE TDAP VACCINE. HER MOTHER WAS ALSO HERE FOR HER FIRST SHINGRIX.  I INADVERTENTLEY GAVE THE SHINGRIX VACCINE INTENDED FOR HER MOTHER. I IMMEDIATLEY WENT TO MY SUPERVISOR -PA AND LET HIM KNOW ABOUT THE INCIDENT. I WENT BACK IN THE ROOM TO INFORM THE MOTHER OF MY ERROR. -PA THEN CAME TO TALK TO THE FAMILY. MOTHER CALLED TO LET US KNOW THAT PATIENT HAD A FEVER, SORE ARM RED AND SWOLLEN.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery thrombosis
Clinical narrative: Heart blood clot
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness and swelling at injection site, injection site pain
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: March 23, 2024 Received COVID19 vaccination left arm March 24,  2024 soreness fever March 25, 2024 soreness,  fever chills, pain in Left arm. March 26, 2024 no fever or chills. Some soreness in left arm. Huge painful swollen lump under armpit.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: March 23, 2024 Received COVID19 vaccination left arm March 24,  2024 soreness fever March 25, 2024 soreness,  fever chills, pain in Left arm. March 26, 2024 no fever or chills. Some soreness in left arm. Huge painful swollen lump under armpit.
Age: 67.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Arthralgia, Dermatitis, Erythema, Hypersensitivity, Injection site erythema
Clinical narrative: PT RECEIVED VACCINATION ON 3/19/24 - LEFT DELTOID - APPROXIMATELY 48-72 HOURS LATER DEVELOPED INCREASING PAIN IN LEFT SHOULDER, SKIN BECAME RED AND INFLAMMED, THIS EXTENDED DOWN THE ARM TO THE ELBOW, SKIN WAS IRRITATED AND ITCHING. PT ALSO DEVELOPED A MILD FEVER AROUND THIS SAME TIME. WENT TO URGENT CARE ON 3/23/24 WHERE PROVIDER DETERMINED SHE HAD EXPERIENCED AN ALLERGIC REACTION (TREATED WITH DEXAMETHASONE INJECTION IN OFFICE, ORAL PREDNISONE, & LORATADINE) AND PROVIDER ALSO PRESCRIBED ORAL ANTIBIOTICS TO COVER POTENTIAL FOR CELLULITIS (CEPHALEXIN). PT'S SYMPTOMS HAVE SUBSIDED, NOT YET COMPLETELY RESOLVED AT TIME OF REPORTING TO PHARMACY.
Age: 67.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site inflammation, Injection site irritation, Injection site pruritus, Pyrexia
Clinical narrative: PT RECEIVED VACCINATION ON 3/19/24 - LEFT DELTOID - APPROXIMATELY 48-72 HOURS LATER DEVELOPED INCREASING PAIN IN LEFT SHOULDER, SKIN BECAME RED AND INFLAMMED, THIS EXTENDED DOWN THE ARM TO THE ELBOW, SKIN WAS IRRITATED AND ITCHING. PT ALSO DEVELOPED A MILD FEVER AROUND THIS SAME TIME. WENT TO URGENT CARE ON 3/23/24 WHERE PROVIDER DETERMINED SHE HAD EXPERIENCED AN ALLERGIC REACTION (TREATED WITH DEXAMETHASONE INJECTION IN OFFICE, ORAL PREDNISONE, & LORATADINE) AND PROVIDER ALSO PRESCRIBED ORAL ANTIBIOTICS TO COVER POTENTIAL FOR CELLULITIS (CEPHALEXIN). PT'S SYMPTOMS HAVE SUBSIDED, NOT YET COMPLETELY RESOLVED AT TIME OF REPORTING TO PHARMACY.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Irritability
Clinical narrative: One day after the left buttocks DTAP injection, her buttocks swelled to twice the normal size, was hard, red and very painful. She was tearful and irritable. We notified the pediatrician, applied ice packs and gave ibuprofen for 2 days around the clock and the swelling began to subside. by day 3 after the vaccine, the patient was not longer reporting pain and no longer acting irritable.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered at inappropriate site, Tearfulness
Clinical narrative: One day after the left buttocks DTAP injection, her buttocks swelled to twice the normal size, was hard, red and very painful. She was tearful and irritable. We notified the pediatrician, applied ice packs and gave ibuprofen for 2 days around the clock and the swelling began to subside. by day 3 after the vaccine, the patient was not longer reporting pain and no longer acting irritable.
Age: 43.0
Sex: M
Vaccine: FLU4, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Approximately 10 minutes after receiving 6 vaccines, patient stated that he felt "sweaty and dizzy". Patient stated that he "didn't have breakfast". Patient alert, oriented and talking throughout the entire episode that lasted about 10 minutes. Vital signs, Temperature 97.5, Blood Pressure 130/80, Heart rate 73, Respiratory Rate 18, Oxygen saturation 99%.  Patient without complaints of shortness of breath or chest discomfort. No hives, facial swelling or unusual symptoms noted. Patient given water and ate a breakfast bar without nausea or vomiting. Pt observed for an additional 10 minutes prior to release and seen by clinic provider, NP. Patient alert, oriented and stated he "feels much better". Patient instructed to seek medical attention if symptoms return. Patient in no apparent distress prior to being released.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Other Relevant HX: No vaccine records/details of side effect available in chart. Other: URTICARIA (8/12/22@12:33:23)
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: Reported Symptoms: 10067482:NO ADVERSE EVENT; Narrative: Other Relevant HX: Other: none
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue
Clinical narrative: Reported Symptoms:  10016256:FATIGUE; Narrative: Pt received flu vaccine and stated that he had faitgue for a full month. Other Relevant HX: Other:  FATIGUE
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaemia, Asthenia, COVID-19, Dementia, Lung neoplasm malignant
Clinical narrative: LUNG CANCER; RESPIRATORY DEPRESSION: WEAKNESS; Hosp; Covid, pneumonia, lung CA, severe anemia, 1 unit PROC, dementia, decreased oxygen sats, weak. Covid +, Moderna x 4 Other Relevant HX:  Other: weak,lung CA
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pneumonia, Red blood cell transfusion, Respiratory depression, SARS-CoV-2 test positive
Clinical narrative: LUNG CANCER; RESPIRATORY DEPRESSION: WEAKNESS; Hosp; Covid, pneumonia, lung CA, severe anemia, 1 unit PROC, dementia, decreased oxygen sats, weak. Covid +, Moderna x 4 Other Relevant HX:  Other: weak,lung CA
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Breakthrough COVID-19, Chest X-ray normal, Chills, Cough, Dyspnoea
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 74 YOM with history of COPD not on home oxygen and tobacco use disorder who reported here in ED in company of twin brother with similar complain of SOB with chills, body aches and cough. Noted with tachycardia, tachypnea and hypoxia on arrival and tested positive for COVID-19. The patient started treatment with IV dexamethasone and remdesivir. He received total of 3 days. Other Relevant HX: Smoker Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fibrin D dimer normal, Hypoxia, Leukocytosis, Oxygen saturation decreased, Pain
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 74 YOM with history of COPD not on home oxygen and tobacco use disorder who reported here in ED in company of twin brother with similar complain of SOB with chills, body aches and cough. Noted with tachycardia, tachypnea and hypoxia on arrival and tested positive for COVID-19. The patient started treatment with IV dexamethasone and remdesivir. He received total of 3 days. Other Relevant HX: Smoker Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Tachycardia, Tachypnoea, Wheezing
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 74 YOM with history of COPD not on home oxygen and tobacco use disorder who reported here in ED in company of twin brother with similar complain of SOB with chills, body aches and cough. Noted with tachycardia, tachypnea and hypoxia on arrival and tested positive for COVID-19. The patient started treatment with IV dexamethasone and remdesivir. He received total of 3 days. Other Relevant HX: Smoker Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19 pneumonia, Cardiac failure, Cardiac failure congestive, Chest X-ray abnormal
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION;  Narrative: 77 year old MALE with a PMH significant for afib, HFpEF, DM2, COPD, HLD,  and chronic myeloid leukemia admitted for management of COVID-19 pneumonia, decompensated heart failure and afib w/ RVR on 1/24/2024. Was discharged home on 1/27/2024. Other Relevant HX: 77 year old MALE with a PMH significant for afib, HFpEF, DM2, COPD, HLD,  and chronic myeloid leukemia admitted for management of COVID-19 pneumonia,  decompensated heart failure and afib w/ RVR. Other: HOSPITALIZATION
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory disease, Hypervolaemia, Pleural effusion, Pulmonary oedema, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION;  Narrative: 77 year old MALE with a PMH significant for afib, HFpEF, DM2, COPD, HLD,  and chronic myeloid leukemia admitted for management of COVID-19 pneumonia, decompensated heart failure and afib w/ RVR on 1/24/2024. Was discharged home on 1/27/2024. Other Relevant HX: 77 year old MALE with a PMH significant for afib, HFpEF, DM2, COPD, HLD,  and chronic myeloid leukemia admitted for management of COVID-19 pneumonia,  decompensated heart failure and afib w/ RVR. Other: HOSPITALIZATION
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Breakthrough COVID-19, Cardiac telemetry abnormal, Chest X-ray normal, Pyrexia
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;  Narrative:  Patient admitted to the hospital with fever, COVID positive, and AFIB with RVR and was discharged home 2 days later. Patient did not require any treatment for COVID-19 infection. Other Relevant HX: PMH- HLD, AFIB, HFrEF Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19;  Narrative:  Patient admitted to the hospital with fever, COVID positive, and AFIB with RVR and was discharged home 2 days later. Patient did not require any treatment for COVID-19 infection. Other Relevant HX: PMH- HLD, AFIB, HFrEF Other: Hospitalization due to Covid-19 infection after having received Covid-19 vaccination
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Angiogram abnormal, Angiogram pulmonary abnormal, Aortic aneurysm, Asthenia
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10011232:COUGHING; 10013573:DIZZINESS; Narrative: Patient is a 76 y/o male with PMH of CAD s/p stents x5, Aortic aneursym s/p EVAR (07/2021), hx of ablation, HLD, and Parkinson's disease who presents with several days of chest pain and fatigue. Patient thought it " was a cold". Reports 1+ week prior he started coughing and feeling fatigued with weakness. During this time patient reports having productive sputum which was solid white color. Reports "shaking like crazy" which feels similar to when he had a heart attack in the past. He took a few ASA's and ibuprofen and lied down until the pain subsided, lasting a total for 30 mins on (01/20/2024). Reports sweating with blankets pulled over until the shaking improved. Reports chest being sore the next two days (01/21 - 22), cont to be light headed. In the ED, found to be covid 19 positive, BP 111/71, HR 76, Temp 36.3, RR 16, and on rm air O2 96%. WBCs 7.6, hbg 15.9, Na 136, K 7.1, Cr 1.1, BNP 102, Trop < 0.1, EKG showing normal sinus rhythm, CTA chest showing LLL mucus plug suggestive of developing PNA, and found to be Covid19 positive. Found to have AAA, cardio rec outpt cath, pt discharged home in stable condition 2/2/24 + procedure completed 2/21/24. Other Relevant HX: PMH of CAD s/p stents x5, Aortic aneursym s/p EVAR (07/2021), hx of ablation, HLD, and Parkinson's disease who presents with several days of chest pain and fatigue found to be COVID+ 1/29/24 Other: