chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Product administered to patient of inappropriate age, Pyrexia, Vomiting
Clinical narrative: Vomiting after vaccination; Nausea after vaccination; Fever after vaccination; administration of an adult Havrix dose to a 4 year-old patient; administration of an adult Havrix dose to a 4 year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-year-old male patient who received HAV (Havrix adult) for prophylaxis.   On 01-OCT-2024, the patient received Havrix adult. On 01-OCT-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: administration of an adult Havrix dose to a 4 year-old patient) and adult product administered to child (Verbatim: administration of an adult Havrix dose to a 4 year-old patient). In OCT-2024, the patient experienced vomiting (Verbatim: Vomiting after vaccination), nausea (Verbatim: Nausea after vaccination) and fever (Verbatim: Fever after vaccination). In OCT-2024, the outcome of the vomiting, nausea and fever were resolved. The outcome of the overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the vomiting, nausea and fever to be related to Havrix adult and Havrix Pre-Filled Syringe Device.     It was unknown if the company considered the vomiting, nausea and fever to be related to Havrix adult and Havrix 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: 16-OCT-2024 The pharmacist student reported that the patient who was 4 years old received the Havrix adult vaccine which led to overdose and adult product administered to child. After vaccination patient reported nausea, vomiting and fever. The reporter asked for expected adverse reactions. Currently, the patient had no more symptoms. The reporter did not provide lot number and expiration date of the adult Havrix dose given.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis reaction; This serious case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 43-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis.   On 28-OCT-2024, the patient received Fluarix 2024-2025 season. On 28-OCT-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced anaphylactic reaction (Verbatim: anaphylaxis reaction) (serious criteria GSK medically significant). The outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the anaphylactic reaction to be related to Fluarix 2024-2025 season and Fluarix 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: 28-OCT-2024 The HCP (Healthcare professional) reported that a patient received Fluarix TIV and suffered an anaphylaxis reaction and required ED (Emergency department).  HCP stated they were a small facility, and this was rare. This was the fourth patient with side effects after Fluarix TIV same lot number 72RF2. This was a high rate for a small facility and HCP was asking Shall we need to stop using this batch. This case was one of the cases reported by the same reporter for different patient.; Sender's Comments: Anaphylactic reaction is a listed event which is considered related to GSK vaccine Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. US-GSK-US2024AMR131525:Same Reporter US-GSK-US2024AMR131526:Same Reporter US-GSK-US2024129463:Same Reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Splenectomy
Clinical narrative: Shingrix - Splenectomy after vaccination; This serious case was reported by a other health professional via call center representative and described the occurrence of splenectomy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced splenectomy (Verbatim: Shingrix - Splenectomy after vaccination) (serious criteria clinically significant/intervention required). The outcome of the splenectomy was unknown.   It was unknown if the reporter considered the splenectomy to be related to Shingrix and Shingrix.     The company considered the splenectomy to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2024 The reporter reported that the patient had spleen removed, already received both doses of Shingrix. The patient was told they need to be re-immunized with all adult vaccines. The reporter was asked if they would need to redo Shingrix series.; Sender's Comments: Splenectomy is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The general body aches were worse with this one also; This spontaneous case was reported by a patient and describes the occurrence of PAIN (The general body aches were worse with this one also) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (The general body aches were worse with this one also). At the time of the report, PAIN (The general body aches were worse with this one also) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that patient had general body aches were worse with this one also.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to MOD-2024-776201 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: would stay in bed 3 days after her vaccines; 102F ever; chills; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (would stay in bed 3 days after her vaccines), PYREXIA (102F ever), CHILLS (chills) and MYALGIA (muscle pain) in a 65-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    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 BEDRIDDEN (would stay in bed 3 days after her vaccines), PYREXIA (102F ever), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, BEDRIDDEN (would stay in bed 3 days after her vaccines), PYREXIA (102F ever), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that she had 102 fever, chills, muscle pain and would stay in bed 3 days after her vaccines, and she hopes she had these symptoms one more time to confirm that the dose she took was working.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to MOD-2024-776251 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain, Urticaria, Vaccination site pruritus
Clinical narrative: intense itching at the vaccine site; small welt/2-3 inches red raised area; general body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (general body aches), VACCINATION SITE PRURITUS (intense itching at the vaccine site) and URTICARIA (small welt/2-3 inches red raised area) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Oct-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In October 2024, the patient experienced PAIN (general body aches). On 29-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE PRURITUS (intense itching at the vaccine site) and URTICARIA (small welt/2-3 inches red raised area). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency and Hydrocortisone acetate (Cortaid) at an unspecified dose and frequency. At the time of the report, PAIN (general body aches), VACCINATION SITE PRURITUS (intense itching at the vaccine site) and URTICARIA (small welt/2-3 inches red raised area) was resolving.            Concomitant product use was not provided by the reporter. It was reported that within an hour of the vaccine, there was intense itching at the vaccine site. There was a small welt. Their pharmacist recommended ice, so they did that, along with Benadryl cream and Cortaid cream. Consumer advised that it helped, and the next morning they noticed about a 2-3 inches red raised area. It's not as itchy, but warm. The general body aches were worse with this one also. Reporter causality was not reported. Treatment information was not provided   This case was linked to MOD-2024-776209 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Rash
Clinical narrative: developed a rash on the consumer's bilateral lower extremities like the anterior lower tibia on both lower legs; fatigue; increased chills; increased in redness; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (increased in redness), FATIGUE (fatigue), CHILLS (increased chills) and RASH (developed a rash on the consumer's bilateral lower extremities like the anterior lower tibia on both lower legs) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Hip replacement on 05-Sep-2024. Previously administered products included for COVID-19 prophylaxis: Spikevax XBB.1.5 (Dose 7) on 21-Dec-2023 and Moderna COVID-19 vaccine (previous moderna doses). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine and Spikevax XBB.1.5.    On 10-Oct-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 10-Oct-2024, the patient experienced FATIGUE (fatigue) and CHILLS (increased chills). On 11-Oct-2024, the patient experienced RASH (developed a rash on the consumer's bilateral lower extremities like the anterior lower tibia on both lower legs). In October 2024, the patient experienced ERYTHEMA (increased in redness). The patient was treated with Diphenhydramine hydrochloride (Benadryl) on 13-Oct-2024 at an unspecified dose and frequency. In October 2024, ERYTHEMA (increased in redness), FATIGUE (fatigue), CHILLS (increased chills) and RASH (developed a rash on the consumer's bilateral lower extremities like the anterior lower tibia on both lower legs) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Consumer stated that the last vaccine for the new variant was the strongest reaction she had. The consumer experienced fatigue, increased chills and developed a rash on the consumer's bilateral lower extremities like the anterior lower tibia on both lower legs. Consumer had the vaccine last 10-OCT-2024 at 8:00 or 8:30 in the morning. The fatigue started late in the afternoon and early in the evening consumer started to get chills and then all through the night and by midnight or 1:00 or 2:00 in the morning it east up but the rash started the following day. Consumer stated that she took Benadryl on the 13-OCT-2024 (Sunday), and the rash went away slowly throughout the following week. The consumer also added about two days later, it started to get the rash, very light at first and then it increased in redness.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Movement disorder, Pain, Vaccination site pain
Clinical narrative: body aches; struggled to sleep with it; Was hard to move it up and down; headache; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), INSOMNIA (struggled to sleep with it), MOVEMENT DISORDER (Was hard to move it up and down), HEADACHE (headache) and VACCINATION SITE PAIN (injection site pain) in a 27-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043157) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 31-Oct-2024, the patient experienced PAIN (body aches), INSOMNIA (struggled to sleep with it), MOVEMENT DISORDER (Was hard to move it up and down), HEADACHE (headache) and VACCINATION SITE PAIN (injection site pain). At the time of the report, PAIN (body aches), INSOMNIA (struggled to sleep with it), MOVEMENT DISORDER (Was hard to move it up and down), HEADACHE (headache) and VACCINATION SITE PAIN (injection site pain) was resolving.            Concomitant medication was not reported. Patient had injection site pain started in the arm and struggled to sleep with it. Was hard to move it up and down when woke up. Also had body aches and a headache. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Decreased appetite, Diarrhoea, Drug ineffective
Clinical narrative: felt weak; experiencing some flu symptoms; has been feeling sick; it was throwing up and diarrhea for both household members no congestion; it was throwing up and diarrhea for both household members no congestion; have a little congestion last week; had no sleep that came on; haven't eaten anything yesterday/don't have any appetite; I felt was soreness that day the next day 5 minute flu like symptoms; felt nauseated; had covid twice; had covid twice; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Oct2024, outcome "unknown", described as "I felt was soreness that day the next day 5 minute flu like symptoms"; NAUSEA (non-serious) with onset Oct2024, outcome "unknown", described as "felt nauseated"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2024, outcome "unknown" and all described as "had covid twice"; INSOMNIA (non-serious) with onset Oct2024, outcome "unknown", described as "had no sleep that came on"; ILLNESS (non-serious) with onset Oct2024, outcome "unknown", described as "has been feeling sick"; NASAL CONGESTION (non-serious) with onset Oct2024, outcome "unknown", described as "have a little congestion last week"; DECREASED APPETITE (non-serious) with onset Oct2024, outcome "unknown", described as "haven't eaten anything yesterday/don't have any appetite"; VOMITING (non-serious), DIARRHOEA (non-serious) all with onset Oct2024, outcome "recovered" (2024) and all described as "it was throwing up and diarrhea for both household members no congestion"; INFLUENZA (non-serious) with onset 29Oct2024, outcome "unknown", described as "experiencing some flu symptoms"; ASTHENIA (non-serious) with onset 30Oct2024, outcome "unknown", described as "felt weak". Clinical course: Patient don't have any appetite. No all patient felt was soreness that day the next day 5 minute flu like symptoms and then it would go away and it come back 5 minutes it was nothing but last night was nothing patient felt nauseated and felt like had the flu for 20 minutes maybe and then it would go away and it would come back and that happened 2 or 3 times and then was fine the next day and I did not throw up or end up with diarrhea or any of that. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Insomnia, Nasal congestion, Nausea
Clinical narrative: felt weak; experiencing some flu symptoms; has been feeling sick; it was throwing up and diarrhea for both household members no congestion; it was throwing up and diarrhea for both household members no congestion; have a little congestion last week; had no sleep that came on; haven't eaten anything yesterday/don't have any appetite; I felt was soreness that day the next day 5 minute flu like symptoms; felt nauseated; had covid twice; had covid twice; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Oct2024, outcome "unknown", described as "I felt was soreness that day the next day 5 minute flu like symptoms"; NAUSEA (non-serious) with onset Oct2024, outcome "unknown", described as "felt nauseated"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2024, outcome "unknown" and all described as "had covid twice"; INSOMNIA (non-serious) with onset Oct2024, outcome "unknown", described as "had no sleep that came on"; ILLNESS (non-serious) with onset Oct2024, outcome "unknown", described as "has been feeling sick"; NASAL CONGESTION (non-serious) with onset Oct2024, outcome "unknown", described as "have a little congestion last week"; DECREASED APPETITE (non-serious) with onset Oct2024, outcome "unknown", described as "haven't eaten anything yesterday/don't have any appetite"; VOMITING (non-serious), DIARRHOEA (non-serious) all with onset Oct2024, outcome "recovered" (2024) and all described as "it was throwing up and diarrhea for both household members no congestion"; INFLUENZA (non-serious) with onset 29Oct2024, outcome "unknown", described as "experiencing some flu symptoms"; ASTHENIA (non-serious) with onset 30Oct2024, outcome "unknown", described as "felt weak". Clinical course: Patient don't have any appetite. No all patient felt was soreness that day the next day 5 minute flu like symptoms and then it would go away and it come back 5 minutes it was nothing but last night was nothing patient felt nauseated and felt like had the flu for 20 minutes maybe and then it would go away and it would come back and that happened 2 or 3 times and then was fine the next day and I did not throw up or end up with diarrhea or any of that. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: felt weak; experiencing some flu symptoms; has been feeling sick; it was throwing up and diarrhea for both household members no congestion; it was throwing up and diarrhea for both household members no congestion; have a little congestion last week; had no sleep that came on; haven't eaten anything yesterday/don't have any appetite; I felt was soreness that day the next day 5 minute flu like symptoms; felt nauseated; had covid twice; had covid twice; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 61-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Oct2024, outcome "unknown", described as "I felt was soreness that day the next day 5 minute flu like symptoms"; NAUSEA (non-serious) with onset Oct2024, outcome "unknown", described as "felt nauseated"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2024, outcome "unknown" and all described as "had covid twice"; INSOMNIA (non-serious) with onset Oct2024, outcome "unknown", described as "had no sleep that came on"; ILLNESS (non-serious) with onset Oct2024, outcome "unknown", described as "has been feeling sick"; NASAL CONGESTION (non-serious) with onset Oct2024, outcome "unknown", described as "have a little congestion last week"; DECREASED APPETITE (non-serious) with onset Oct2024, outcome "unknown", described as "haven't eaten anything yesterday/don't have any appetite"; VOMITING (non-serious), DIARRHOEA (non-serious) all with onset Oct2024, outcome "recovered" (2024) and all described as "it was throwing up and diarrhea for both household members no congestion"; INFLUENZA (non-serious) with onset 29Oct2024, outcome "unknown", described as "experiencing some flu symptoms"; ASTHENIA (non-serious) with onset 30Oct2024, outcome "unknown", described as "felt weak". Clinical course: Patient don't have any appetite. No all patient felt was soreness that day the next day 5 minute flu like symptoms and then it would go away and it come back 5 minutes it was nothing but last night was nothing patient felt nauseated and felt like had the flu for 20 minutes maybe and then it would go away and it would come back and that happened 2 or 3 times and then was fine the next day and I did not throw up or end up with diarrhea or any of that. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 on 15Jan2023; COVID-19 on 15Jan2023; This is a spontaneous report received from an Other HCP. Other Case identifier(s): MOD-2024-774192 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) and in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes mellitus" (ongoing), notes: It takes longer to get better from any cuts or bruises or anything; "Procedure Breast conserving surgery" (unspecified if ongoing); "Pancreatic cyst" (unspecified if ongoing); "Pancreatic cyst" (unspecified if ongoing), notes: Had a pre-cancerous cyst in the tail of pancreas.; "Spleen disorder" (unspecified if ongoing); "Gallbladder disorder" (unspecified if ongoing); "Hypertension" (ongoing); "Hypercholesterolaemia" (unspecified if ongoing), notes: has high cholesterol; "Cholelithiasis" (unspecified if ongoing); "Hernia" (unspecified if ongoing); "Pancreatic disorder" (unspecified if ongoing); "Uterine leiomyoma" (unspecified if ongoing), notes: five cervical fibroids that are benign; "Abdominal pain upper" (unspecified if ongoing), notes: having pains in my stomach and back, way back in 2018, 2019 prior to getting the, uh, prior to getting those V vaccines; "having pains in my stomach and back", start date: 2018 (unspecified if ongoing), notes: having pains in my stomach and back, way back in 2018, 2019 prior to getting the, uh, prior to getting those V vaccines; "having pains in my stomach and back", start date: 2019 (unspecified if ongoing), notes: having pains in my stomach and back, way back in 2018, 2019 prior to getting the, uh, prior to getting those V vaccines; "Allergy: Food allergy" (ongoing), notes: Food allergies; "Allergy: Seasonal allergy" (ongoing), notes: allergies to trees/Pollen allergy; "Thyroid mass" (ongoing), notes: Thyroid nodule. Concomitant medication(s) included: DIOVAN (VALSARTAN).The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2023, outcome "unknown" and all described as "COVID-19 on 15Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (15Jan2023) Positive.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Influenza, Vomiting, Weight
Clinical narrative: flu symptoms; violently throwing up; diarrhea; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 48-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 27Oct2024, outcome "unknown", described as "flu symptoms"; DIARRHOEA (non-serious) with onset 27Oct2024, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 27Oct2024, outcome "unknown", described as "violently throwing up". Relevant laboratory tests and procedures are available in the appropriate section. Batch/lot number is not provided, and it cannot be obtained.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Diarrhoea, Stool analysis
Clinical narrative: Stomach issues: diarrhea/gets really mucousy and it's very consistent; This is a spontaneous report received from a Consumer or other non HCP.  A 4-year-old female patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 1 (maroon cap), single (Lot number: FT9142) at the age of 4 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset Aug2022, 1 week after the suspect product(s) administration, outcome "recovered" (Oct2022), described as "Stomach issues: diarrhea/gets really mucousy and it's very consistent". The events "stomach issues: diarrhea/gets really mucousy and it's very consistent" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional information: Patient was also taking a probiotic multivitamin (started taking about 3 years ago - ongoing). Stated that 2 years ago when the Covid vaccine was first available to kids under 6, her daughter received it and started having stomach issues a week after. They didn't think it was related to the Covid vaccine and she had stool samples done and those were perfectly fine/had stool samples done in 2022 and were normal. They didn't know why she was having diarrhea. Stated the diarrhea gets really mucousy and it's very consistent. It started after the 05Aug2022 (between 2pm-3:30pm early afternoon) dose and lasted almost 2 months. They even changed her diet thinking it was lactose, and it was nothing related to nothing like that. Stated the diarrhea stopped mid Oct2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400291294 same patient, different dose/events;US-PFIZER INC-202400291293 same patient, different dose/events;US-PFIZER INC-202400291297 same patient, different dose/events;
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective
Clinical narrative: got Covid after having 2 Pfizer Covid vaccines; got Covid after having 2 Pfizer Covid vaccines; This is a spontaneous report received from a Consumer or other non HCP.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 1, single (Lot number: FT9142), in arm and on 30Sep2022 as dose 2, single (Lot number: FT9142) at the age of 4 years, in arm for covid-19 immunisation. All Vaccination Time reported as between 2pm-3:30pm early afternoon. The patient had no relevant medical history. No family medical history relevant to adverse events. No other vaccines prior vaccinations (within 4 weeks). The patient took concomitant medications (probiotic multivitamin, started taking about 3 years before in 2021). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Mar2024, outcome "unknown" and all described as "got Covid after having 2 Pfizer Covid vaccines". The event "got covid after having 2 pfizer covid vaccines" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: little taller than 3 feet., notes: unknown height, she is a little taller than 3 feet.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400291214 same patient, different dose/events;
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported. No additional AE; a postpartum patient who was inadvertently administered an expired dose of MMR-II (w/ no TEs) on 01-NOV-2024.; This spontaneous report has been received from other health professional referring a 35-year-old female patient.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 01-NOV-2024, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, rHA, at a dose of 0.5 milliliter, administered as prophylaxis (strength, route and anatomical location of administration were not provided; lot # reported as W039972, which has been verified to be a valid lot # for this vaccine, expiration date provided and validated to be on 02-JUN-2024) (expired product administered). No symptoms reported. No additional adverse event (AE) (no adverse event).
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; Shingles episode after schedule completed/three minor outbreaks; doctor suggested a third shot; doctor suggested a third shot; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles episode after schedule completed/three minor outbreaks), extra dose administered (Verbatim: doctor suggested a third shot) and circumstance or information capable of leading to medication error (Verbatim: doctor suggested a third shot). The outcome of the vaccination failure, shingles, extra dose administered and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2024 The reporter reported that they had a patient who already had the two shot series of the Shingrix and she had a three minor outbreaks recently, despite received the couple of shot a few years ago and her doctor suggested a third shot and they could not find anything that was whether or not contraindicated, which led to extra dose administered and circumstance or information capable of leading to medication error. The patient had not been administered with a 3rd dose. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1, Dose 2 ).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is my first COVID infection. It followed Pfizer vaccine.; This is my first COVID infection. It followed Pfizer vaccine.; This is a spontaneous report received from a Consumer or other non HCP.  A 61-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: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2024, outcome "unknown" and all described as "This is my first COVID infection. It followed Pfizer vaccine.". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid form 27Sep2024 to 02Oct2024. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Head discomfort, Headache, Myalgia
Clinical narrative: ached in every joint and muscle; ached in every joint and muscle; The sense of coins rushing in my head; head ache; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 21Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), administration date: 2020, for covid-19 immunization, reaction(s): "covid", "Drug ineffective", "head discomfort", "dental abscess". The following information was reported: HEAD DISCOMFORT (non-serious) with onset 22Oct2024, outcome "not recovered", described as "The sense of coins rushing in my head"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 22Oct2024, outcome "not recovered" and all described as "ached in every joint and muscle"; HEADACHE (non-serious) with onset 22Oct2024, outcome "not recovered", described as "head ache". Additional information: The patient got a flu vaccines & Pfizer covid vaccines. She have never had a reaction to flu vaccine but am now in the 3rd day reacting to covid vaccine. On 22Oct2024 the day after she ached in every joint and muscle. Her head ache was especially bad with the sense of coins rushing in her head. She was still experiencing it today with move her head. Body aches are better but not gone. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 0.92
Sex: M
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: Covid vaccine 6month-4 yrs reconstituted with 0.1 ml NS
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: About 1 week after the injection, I developed shingles. I have significant nerve pain resulting from the shingles. I am 36 years old. I completed a telehealth visit and started on antivirals.
Age: 39.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: At patient's visit in clinic yesterday (11/04/24), he asked RN to administer his second HPV vaccine in his left deltoid because his right deltoid is "still sore from the first vaccine". RN asked if he had received any other injections or vaccines in his right arm since the HPV vaccine in July 2024, patient said he had not. RN asked him to rate the pain from 0-10, 10 being the worst, he states "There's no pain. Just some soreness when I lift up my arm". No soreness at rest. No soreness when abducting his arm in line with his shoulder. He only endorses soreness when lifting/abducting his arm above his head. He states it is mild. Deltoid looks normal. Provider, PA, aware in clinic. No further work up. Provider wonders if this soreness is unrelated to the vaccine administration. No further action taken.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain
Clinical narrative: Headache, body aches
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient states hives started appearing after receiving Tdap on 10/23/24 in addition to local site reaction.  Hives appeared on chest area and bilateral arms .  Patient states hives resolved in a few hours after taking OTC Benadryl.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash started in stomach been two weeks still spreading
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Diarrhoea
Clinical narrative: Received vaccine on 10/30/2024. Symptoms began with occurrence of high fever at approximately 1:00 AM on 10/31/24. After two more hours, violent chills followed with pain at the injection site. Pain started to extend to the full arm and upper back/left shoulder. Heavy nausea, diarrhea and severe weakness also occurred around the same time, followed by fainting 6 hours later. Numbness in both arms and loss of voluntary muscle movement in hands/forearms occurred for about 5 minutes prior to fainting. Weakness persisted until approximately 12 :00 PM on 10/31/24. Symptoms began to fade around 2:00 PM, and a full recovery was felt by 11/01/2024.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Nausea, Pain in extremity, Paralysis
Clinical narrative: Received vaccine on 10/30/2024. Symptoms began with occurrence of high fever at approximately 1:00 AM on 10/31/24. After two more hours, violent chills followed with pain at the injection site. Pain started to extend to the full arm and upper back/left shoulder. Heavy nausea, diarrhea and severe weakness also occurred around the same time, followed by fainting 6 hours later. Numbness in both arms and loss of voluntary muscle movement in hands/forearms occurred for about 5 minutes prior to fainting. Weakness persisted until approximately 12 :00 PM on 10/31/24. Symptoms began to fade around 2:00 PM, and a full recovery was felt by 11/01/2024.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Received vaccine on 10/30/2024. Symptoms began with occurrence of high fever at approximately 1:00 AM on 10/31/24. After two more hours, violent chills followed with pain at the injection site. Pain started to extend to the full arm and upper back/left shoulder. Heavy nausea, diarrhea and severe weakness also occurred around the same time, followed by fainting 6 hours later. Numbness in both arms and loss of voluntary muscle movement in hands/forearms occurred for about 5 minutes prior to fainting. Weakness persisted until approximately 12 :00 PM on 10/31/24. Symptoms began to fade around 2:00 PM, and a full recovery was felt by 11/01/2024.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Headache, Myalgia
Clinical narrative: Myalgia fatigue back pain headache
Age: 36.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Shoulder injury related to vaccine administration, Swelling
Clinical narrative: Shoulder injury related to vaccine administration: stiff shoulder, reduced range of motion, swollen, constant dull ache
Age: 90.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Acute myocardial infarction, Cardiac failure, Condition aggravated, Echocardiogram, Electrocardiogram
Clinical narrative: Unknown if above brands are correct. I was informed by staff that she received flu, COVID and RSV vaccines the day prior to her being sent emergently  to Hospital where she was eventually diagnosed with an acute MI and exacerbation of heart failure. She was discharged today under Hospice care to ALF.
Age: 90.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: N-terminal prohormone brain natriuretic peptide, Troponin
Clinical narrative: Unknown if above brands are correct. I was informed by staff that she received flu, COVID and RSV vaccines the day prior to her being sent emergently  to Hospital where she was eventually diagnosed with an acute MI and exacerbation of heart failure. She was discharged today under Hospice care to ALF.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Extrasystoles, Full blood count normal, Metabolic function test normal
Clinical narrative: Frequent palpitations, Trigeminy.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: Frequent palpitations, Trigeminy.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Productive cough
Clinical narrative: Patient stated adverse reactions started four days after receiving injection, patient stated he "got the flu" and is now recovering from having the flu and phlem.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PT WANTED TO RECEIVE THE CURRENT SEASON FLU VACCINE. AFTER ADMINISTRATION IT WAS DISCOVERED THE PATIENT HAD ALREADY RECEIVED THE VACCINATION FOR CURRENT FLU SEASON ON AUGUST 29TH, 2024.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Raised large red itchy/bumpy rash by injection site
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Theres was no allergic reaction to vaccine.  Patient was suppose to receive Meningococcal proquad but was given Meningococcal B
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The patient Daughter called on 11/5/24 stating that her mother's left arm was swollen and red with a little pain when she raised her arm.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe muscle pains in legs and arms
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Skin exfoliation
Clinical narrative: Patient reported injection site reaction approximately one week after administration. The area became painful and a strange discoloration developed that was brown in color and flat looking scaly and itchy.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Patient states her arthritis pain. became severe two days after the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bell's palsy, Chills, Ear pain, Eyelid function disorder, Facial paralysis
Clinical narrative: Patient states received both the Covid vaccine and flu vaccine on October 24. that evening she felt as if she had fever and chills with body aches. That improved over a few days. Three days ago felt right-sided headache, right-sided ear pain and noticed right-sided eyelid lag yesterday. Averages four hours of sleep at night. No nausea or vomiting. No dizziness or extremity weakness. No CVA risk factors. States his previously tolerated the flu vaccine without problems and had tolerated prior covid vaccines. Student came in to our urgent care today 11/5/24 with facial paralysis and was diagnosed with Bells Palsy.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: Patient states received both the Covid vaccine and flu vaccine on October 24. that evening she felt as if she had fever and chills with body aches. That improved over a few days. Three days ago felt right-sided headache, right-sided ear pain and noticed right-sided eyelid lag yesterday. Averages four hours of sleep at night. No nausea or vomiting. No dizziness or extremity weakness. No CVA risk factors. States his previously tolerated the flu vaccine without problems and had tolerated prior covid vaccines. Student came in to our urgent care today 11/5/24 with facial paralysis and was diagnosed with Bells Palsy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Palpable spot at injection site that is raised 1-2mm and roughly the size of a quarter. Red, tender to touch.
Age: 44.0
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Inadvertently administered incorrect vaccine
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received injection #1 of the 2 dose series on 10/11; she received dose #2 on 10/28. Doses should be 4 weeks apart, but patient received her dose #2 11 days earlier and only 17 days from dose #1.  She has no symptoms are adverse event related to vaccine--only was given at wrong interval
Age: 66.0
Sex: M
Vaccine: COVID19, HEP, TDAP, VARZOS
Symptoms: Arthralgia, Impaired work ability, Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The patient is reporting continued upper arm and shoulder pain as well as swelling 10 days post vaccine administration. Uncertain which vaccine caused the reaction, he received shingrix, engerix, boostrix and spikevax all the same day. The pain is limiting his range of motion of that arm which is causing difficulty performing his duties at work. He believes the pain is due to the vaccine being administered in the wrong place too high in his arm.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Back pain, Computerised tomogram thorax abnormal, Deep vein thrombosis, Echocardiogram
Clinical narrative: pt developed left thigh pain approximately one week after vaccination. then developed back pain posterior over right lung. then hemoptysis. now pt admitted with PE, DVT, acute hypoxic resp failure
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Pain in extremity, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: pt developed left thigh pain approximately one week after vaccination. then developed back pain posterior over right lung. then hemoptysis. now pt admitted with PE, DVT, acute hypoxic resp failure
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth around injection site, extending down arm and into the underarm area.  Still visibility swollen 11/5/2024.  Went to regular MD visit and mentioned it to MD, MD told her to have pharmacy report it.   Patient appears to be fine, and not incapacitated. Described as not as bad as TDap, but was found to be unusual in Spikevax.  Told her to continue to monitor and notify MD if it worsens.