chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 4 (Booster); Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken with paxlovid as a result of vaccination failure, covid-19 from 16Jan2024 till 20Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 17Jan2024 to 22Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycillan, reaction(s): "Known allergies: amoxycillan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxlovid from 14Jan2024 till 18Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid from 19Jan2024 to 23Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Pt. was accidentally given >12yrs Moderna vaccine instead of Moderna 6mo-5yr bivalent vaccine. Patient is being monitored by mother for side-effects and clinic will follow-up.
Age: 86.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Pain in arm and swelling since vaccination date as per patient reported over the phone today
Age: 86.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Injection site pain
Clinical narrative: Pain in arm and swelling since vaccination date as per patient reported over the phone today
Age: 61.0
Sex: M
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Discomfort, Musculoskeletal chest pain
Clinical narrative: The morning after I woke up with what felt like an injured lower rib on the right side. I assumed I had slept oddly and injured it. After a week the pain faded a bit but moved slightly lateral and the the rear (back). After 8 weeks I still have minor discomfort on both sides which led me to question if this was a renal issue.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Exposure during pregnancy, Headache, Pyrexia
Clinical narrative: Fever, joint aches (specifically hips), headache @ 36w5d gestation
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient got Adacel on 11/4/2023 and Boostrix on 1/30/2024.  Two doses are not 10 years apart.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: continuing soreness near site of injection, now 4 weeks out, including upon extending the arm. no itching. very light redness in area of vaccination at 28 days, but never materialized to significant degree
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: This is rare and only has a few case reports which is why I am reporting this. I developed a macula papular rash on the right side of the rib cage which was in the same nerve distribution as a Zoster rash. This has not been painful but itching has been prominent symptom. This itching persists till date Jan 2024. There is no increase in rash size but has not reduced either.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Gait disturbance, Muscular weakness, Myalgia
Clinical narrative: Patient reported thigh muscle soreness and weakness, he considers it to be severe and has said it has been difficult to walk. I asked him to reach out to his physician to report and discuss. He said he was unsure of the cause but due to the timeframe of when symptoms started which was shortly after receiving his Arexvy vaccine, he thought it may be a side effect of the vaccination. We discussed that muscle pain and weakness are common side effects following vaccination but to be on the safe side he should be evaluated by his physician.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Laboratory test normal
Clinical narrative: Approximately 1 week after receiving this vaccine patient started to have dizziness.  This dizziness has now been on and off for almost 2 years.
Age: 5.0
Sex: F
Vaccine: EBZR
Symptoms: Decreased appetite, Dizziness, Feeling hot, Swelling
Clinical narrative: heat and swelling extremely dizziness and no appetite
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Oropharyngeal pain, Otitis media, Paranasal sinus discomfort
Clinical narrative: Approximately 2 weeks after vaccination around 1/17/24, I developed a sore throat and fatigue that persisted.. After another 4-5 days, I developed sinus pressure and congestion. This later turned into ear pain and a middle ear infection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Approximately 2 weeks after vaccination around 1/17/24, I developed a sore throat and fatigue that persisted.. After another 4-5 days, I developed sinus pressure and congestion. This later turned into ear pain and a middle ear infection.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Dry needling, Immediate post-injection reaction, Impaired work ability, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: Moderna covid booster vaccine.   Arm was immediately more tender and generally painful than with other vaccines that I have had.   Within the time immediately following vaccine, made a point of moving the arm and used cold packs several times that day and in the next few days.  As arm became increasingly painful in the following days,interfering with sleep, home and occupational use, I began with alternating heat and cold, topical pain creams/ ointments, increase of intentional ROM. In the next few weeks, added dry needling, therapeutic ultrasound, low level pulsed laser treatments and mechanical massage to address pain and limitation.  Before Thanksgiving, walked in to the orthopedic clinic for assessment due to pain and reduced range of motion.  X-rays and evaluation were performed. MRI ordered. Continued with conservative care for symptoms. MRI performed 1/25/24. ROM is somewhat improved from November, yet as of 1/30/24, continuing with chronic pain of upper arm and reduced ROM. Pain and limited ROM continue to disturb sleep and require modification of daily tasks, dressing self, and occupational activities. Continuing to self treat with conservative measures to maintain ROM and to control pain.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Low-level laser therapy, Magnetic resonance imaging, Massage, Pain in extremity, Sleep disorder
Clinical narrative: Moderna covid booster vaccine.   Arm was immediately more tender and generally painful than with other vaccines that I have had.   Within the time immediately following vaccine, made a point of moving the arm and used cold packs several times that day and in the next few days.  As arm became increasingly painful in the following days,interfering with sleep, home and occupational use, I began with alternating heat and cold, topical pain creams/ ointments, increase of intentional ROM. In the next few weeks, added dry needling, therapeutic ultrasound, low level pulsed laser treatments and mechanical massage to address pain and limitation.  Before Thanksgiving, walked in to the orthopedic clinic for assessment due to pain and reduced range of motion.  X-rays and evaluation were performed. MRI ordered. Continued with conservative care for symptoms. MRI performed 1/25/24. ROM is somewhat improved from November, yet as of 1/30/24, continuing with chronic pain of upper arm and reduced ROM. Pain and limited ROM continue to disturb sleep and require modification of daily tasks, dressing self, and occupational activities. Continuing to self treat with conservative measures to maintain ROM and to control pain.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness, Ultrasound therapy, X-ray
Clinical narrative: Moderna covid booster vaccine.   Arm was immediately more tender and generally painful than with other vaccines that I have had.   Within the time immediately following vaccine, made a point of moving the arm and used cold packs several times that day and in the next few days.  As arm became increasingly painful in the following days,interfering with sleep, home and occupational use, I began with alternating heat and cold, topical pain creams/ ointments, increase of intentional ROM. In the next few weeks, added dry needling, therapeutic ultrasound, low level pulsed laser treatments and mechanical massage to address pain and limitation.  Before Thanksgiving, walked in to the orthopedic clinic for assessment due to pain and reduced range of motion.  X-rays and evaluation were performed. MRI ordered. Continued with conservative care for symptoms. MRI performed 1/25/24. ROM is somewhat improved from November, yet as of 1/30/24, continuing with chronic pain of upper arm and reduced ROM. Pain and limited ROM continue to disturb sleep and require modification of daily tasks, dressing self, and occupational activities. Continuing to self treat with conservative measures to maintain ROM and to control pain.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment elevation, Intensive care, Pericarditis, Troponin increased
Clinical narrative: Patient had pericarditis and was in the  ICU for one day. Elevated troponins, ST elevation diffusely on EKG. He was treated with NSAIDS ATC which he will continue for 5 days. Outpatient f/u with cardiology. He was hospitalized for 2 days.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Blister, Rash
Clinical narrative: Pt states on 1/24/24 she had blisters on head which lasted for 3 days. On 1/27/24 a rash started under her breast which spread all over her back and body on the 1/28/24.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Dysgeusia, Eructation
Clinical narrative: Less than 48hrs after the vaccine pt reports yellow diarrhea, abdomen pain and bloating, fatigue. Yellow stools 4-5 times a day. "tangy taste" in mouth, lost 10-15 lbs. frequent belching, night sweats, feels "full"
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Faeces discoloured, Fatigue, Gamma-glutamyltransferase abnormal, Hepatic steatosis, Metabolic function test abnormal
Clinical narrative: Less than 48hrs after the vaccine pt reports yellow diarrhea, abdomen pain and bloating, fatigue. Yellow stools 4-5 times a day. "tangy taste" in mouth, lost 10-15 lbs. frequent belching, night sweats, feels "full"
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Night sweats, Ultrasound abdomen, Ultrasound liver abnormal, Weight decreased
Clinical narrative: Less than 48hrs after the vaccine pt reports yellow diarrhea, abdomen pain and bloating, fatigue. Yellow stools 4-5 times a day. "tangy taste" in mouth, lost 10-15 lbs. frequent belching, night sweats, feels "full"
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Death, Diabetic ketoacidosis
Clinical narrative: According to online sources that monitored his social media, first dose was 03/22/21 with P-B#ER8730, Second Dose on 04/12/2021, Lot# unknown. His social media post on April 12, 2021 stated proud of city and facility for executing well. Event was called. Victim seemed active on social media until April 18, 2021. Stated cause of death diabetic ketoacidosis, according to aunt, a doctor. DOD 04/23/2021
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Sudden death
Clinical narrative: According to online reports this 35-year-old nurse and recent mother, second child 4 months old, died suddenly in her sleep on July 01, 2022. Date of Dose 1 is unk, Date of Dose 2 is 01/07/21, Dose 1 lot# EH9899, Dose 2 lot# EX9231, PHOTO OF VAX CARD ONLINE
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in mid 60's male. DOSE1 011A21A on 02/25/201 DOSE2 020B21A on 03/25/21 DOD 07/02/2022 according to online obituary
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Sudden death
Clinical narrative: Recipient died suddenly on April 05, 2021 days shy of her 45th birthday. An online source was able to obtain a copy of her vax card after first inoculation on 02/10/2021 with Moderna 039K20A. Not able to determine if the second inoculation occurred. Online photos of victim seem to indicate she suffered from a skin disorder, Vitiligo, as she has white patches on her face. VAX card listed CC as site, is that for Community College?
Age: 24.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Death
Clinical narrative: Vaccine card of victim obtained after DOSE#1 on 12/29/2020. Her photo indicates she was on duty as an RN. It is likely she received at least two doses based on her profession. She may have been inoculated at Hospital however her place of employment at the time of inoculations should be confirmed. Online reports state she passed away on 12/27/2022. Any adverse events prior to death area unknown and should be researched. This event does not appear to be in the system based on research.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death on 11/02/2023 in fully vaccinated victim. DOSE1 date 06/04/2021 DOSE2 date 06/25/2021 with lots EW0183 and EW0196. Other information from online obituary
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Sudden death
Clinical narrative: Victim died suddenly on 08/21/23, copy of vax card obtained with two dose dates, 03/27/21 and 04/17/21 and two lot# ER8734 and ER8735. On the vaccine card there is a number above the victims name, and below his gender -dob. Any prior adverse events prior to sudden illness and death are unknown. Online info implies victim has recently newborn child
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Online report with photo of victim after first inoculation on 12/30/20 with Moderna Lot#025J20A. Obituary indicates victims was employed in Health Care thus was likely fully vaccinated and maybe "up to date". Online obituary states victim died on 10/25/23.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Victim died suddenly on June 24, 2022 during travel. A portion of the victim's vaccine card after DONE#1 on March 23, 2021 was online. DOSE#1 was with Pfizer-Biontech EN6208. Was not able to confirm DOSE#2 through source. Case requires further research.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: An online report stated victim had a heart attack at airport in early November 2023. Source was able to obtain a copy of vaccine card with all three dates and lot #s. DOSE#1 03/03/21 EN6205 DOSE#2 03/25/2021ER8727 DOSE#3 10/22/2021 FE3590. Online obituary states DOD 11/10/2023. Based on the info from online source found the most likely matching obituary
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hostility
Clinical narrative: Report of death after inoculation with Pfizer-Biontech. Vax card available online. Online information can't confirm if victim received second inoculation. Victim made hostile social media posts prior to death. Dose#1 on 08/12/21 with PB LOT#FA7485
Age: 67.0
Sex: F
Vaccine: FLUR4, RSV
Symptoms: Mobility decreased, Pain, Periarthritis, Swelling
Clinical narrative: PT EXPERIENCED SIGNIFICANT PAIN AND SWELLING ON THE LEFT SIDE (AREXVY SIDE) AND SLIGHT REDUCED MOBILITY ON THAT SIDE, WHICH STARTED SHORTLY AFTER THE INJECTION WAS GIVEN.  PATIENT WAS DIAGNOSED WITH FROZEN SHOULDER, WHICH HER DOCTOR SUSPECTED WAS CAUSED BY THE VACCINE.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains, Menstruation irregular, Ventricular extrasystoles
Clinical narrative: Patient reports chill blains on right foot on 12/16/2023 and 1/29/2024; chill blains on her left foot on 1/29/24; chill blains on her right pinky finger on 1/26/24. She reports multiple, frequent episodes of  PCVs starting on 12/25/23 and ending on 12/28/23 with each episode lasting 6-10 minutes. She reports irregular menses as well.
Sex: F
Vaccine: RSV, RSV
Symptoms: Blister, Burning sensation, Erythema, Injection site exfoliation, Injection site scar
Clinical narrative: bad shakes, in body, hands, legs, and feet; Injection site rash; Injection site erythema; Lightheaded and dizzy spells; Vertigo; confusion; lack of focus; Tinitus; Vomiting; Nausea; bowel issues; sweaty hands and feet; hot flashes create dripping sweat; rashes on body; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site rash in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   Concomitant products included duloxetine and ropinirole hcl.   On 05-DEC-2023, the patient received Arexvy (left arm). On 21-JAN-2024, 47 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site erythema), dizziness (Verbatim: Lightheaded and dizzy spells), vertigo (Verbatim: Vertigo), confusion (Verbatim: confusion), concentration loss (Verbatim: lack of focus), tinnitus (Verbatim: Tinitus), vomiting (Verbatim: Vomiting), nausea (Verbatim: Nausea), bowel discomfort (Verbatim: bowel issues), sweating (Verbatim: sweaty hands and feet), hot flashes (Verbatim: hot flashes create dripping sweat) and generalized rash (Verbatim: rashes on body). On an unknown date, the patient experienced tremor (Verbatim: bad shakes, in body, hands, legs, and feet). The outcome of the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes and generalized rash were not resolved and the outcome of the tremor was not reported.   It was unknown if the reporter considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient had lightheaded, dizzy spells, vertigo, tininess, confusion, lack of focus, vomiting, nausea, bowel issues, sweaty hands and feet, hot flashes create dripping sweat, rashes on body and injection site reaction. The reporter asked if there was a way to stop or reverse the side effects of Arexvy vaccine.  The patient have been to primary care physician twice and spoke with other medical professionals regarding this. The reporter asked for help to get past this. The patient still don't feel well. The patient also had bad shakes, in body, hands, legs, and feet. The patient was on medicines from primary care physician to help control shakes got bad and still vomiting once or twice a day. The symptoms were treated.
Sex: F
Vaccine: RSV, RSV
Symptoms: Rash, Swelling
Clinical narrative: bad shakes, in body, hands, legs, and feet; Injection site rash; Injection site erythema; Lightheaded and dizzy spells; Vertigo; confusion; lack of focus; Tinitus; Vomiting; Nausea; bowel issues; sweaty hands and feet; hot flashes create dripping sweat; rashes on body; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site rash in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   Concomitant products included duloxetine and ropinirole hcl.   On 05-DEC-2023, the patient received Arexvy (left arm). On 21-JAN-2024, 47 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site erythema), dizziness (Verbatim: Lightheaded and dizzy spells), vertigo (Verbatim: Vertigo), confusion (Verbatim: confusion), concentration loss (Verbatim: lack of focus), tinnitus (Verbatim: Tinitus), vomiting (Verbatim: Vomiting), nausea (Verbatim: Nausea), bowel discomfort (Verbatim: bowel issues), sweating (Verbatim: sweaty hands and feet), hot flashes (Verbatim: hot flashes create dripping sweat) and generalized rash (Verbatim: rashes on body). On an unknown date, the patient experienced tremor (Verbatim: bad shakes, in body, hands, legs, and feet). The outcome of the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes and generalized rash were not resolved and the outcome of the tremor was not reported.   It was unknown if the reporter considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient had lightheaded, dizzy spells, vertigo, tininess, confusion, lack of focus, vomiting, nausea, bowel issues, sweaty hands and feet, hot flashes create dripping sweat, rashes on body and injection site reaction. The reporter asked if there was a way to stop or reverse the side effects of Arexvy vaccine.  The patient have been to primary care physician twice and spoke with other medical professionals regarding this. The reporter asked for help to get past this. The patient still don't feel well. The patient also had bad shakes, in body, hands, legs, and feet. The patient was on medicines from primary care physician to help control shakes got bad and still vomiting once or twice a day. The symptoms were treated.
Sex: F
Vaccine: RSV, RSV
Symptoms: Abdominal discomfort, Confusional state, Disturbance in attention, Dizziness, Hot flush
Clinical narrative: bad shakes, in body, hands, legs, and feet; Injection site rash; Injection site erythema; Lightheaded and dizzy spells; Vertigo; confusion; lack of focus; Tinitus; Vomiting; Nausea; bowel issues; sweaty hands and feet; hot flashes create dripping sweat; rashes on body; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site rash in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   Concomitant products included duloxetine and ropinirole hcl.   On 05-DEC-2023, the patient received Arexvy (left arm). On 21-JAN-2024, 47 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site erythema), dizziness (Verbatim: Lightheaded and dizzy spells), vertigo (Verbatim: Vertigo), confusion (Verbatim: confusion), concentration loss (Verbatim: lack of focus), tinnitus (Verbatim: Tinitus), vomiting (Verbatim: Vomiting), nausea (Verbatim: Nausea), bowel discomfort (Verbatim: bowel issues), sweating (Verbatim: sweaty hands and feet), hot flashes (Verbatim: hot flashes create dripping sweat) and generalized rash (Verbatim: rashes on body). On an unknown date, the patient experienced tremor (Verbatim: bad shakes, in body, hands, legs, and feet). The outcome of the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes and generalized rash were not resolved and the outcome of the tremor was not reported.   It was unknown if the reporter considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient had lightheaded, dizzy spells, vertigo, tininess, confusion, lack of focus, vomiting, nausea, bowel issues, sweaty hands and feet, hot flashes create dripping sweat, rashes on body and injection site reaction. The reporter asked if there was a way to stop or reverse the side effects of Arexvy vaccine.  The patient have been to primary care physician twice and spoke with other medical professionals regarding this. The reporter asked for help to get past this. The patient still don't feel well. The patient also had bad shakes, in body, hands, legs, and feet. The patient was on medicines from primary care physician to help control shakes got bad and still vomiting once or twice a day. The symptoms were treated.
Sex: F
Vaccine: RSV, RSV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site rash, Nausea, Rash
Clinical narrative: bad shakes, in body, hands, legs, and feet; Injection site rash; Injection site erythema; Lightheaded and dizzy spells; Vertigo; confusion; lack of focus; Tinitus; Vomiting; Nausea; bowel issues; sweaty hands and feet; hot flashes create dripping sweat; rashes on body; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site rash in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   Concomitant products included duloxetine and ropinirole hcl.   On 05-DEC-2023, the patient received Arexvy (left arm). On 21-JAN-2024, 47 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site erythema), dizziness (Verbatim: Lightheaded and dizzy spells), vertigo (Verbatim: Vertigo), confusion (Verbatim: confusion), concentration loss (Verbatim: lack of focus), tinnitus (Verbatim: Tinitus), vomiting (Verbatim: Vomiting), nausea (Verbatim: Nausea), bowel discomfort (Verbatim: bowel issues), sweating (Verbatim: sweaty hands and feet), hot flashes (Verbatim: hot flashes create dripping sweat) and generalized rash (Verbatim: rashes on body). On an unknown date, the patient experienced tremor (Verbatim: bad shakes, in body, hands, legs, and feet). The outcome of the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes and generalized rash were not resolved and the outcome of the tremor was not reported.   It was unknown if the reporter considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient had lightheaded, dizzy spells, vertigo, tininess, confusion, lack of focus, vomiting, nausea, bowel issues, sweaty hands and feet, hot flashes create dripping sweat, rashes on body and injection site reaction. The reporter asked if there was a way to stop or reverse the side effects of Arexvy vaccine.  The patient have been to primary care physician twice and spoke with other medical professionals regarding this. The reporter asked for help to get past this. The patient still don't feel well. The patient also had bad shakes, in body, hands, legs, and feet. The patient was on medicines from primary care physician to help control shakes got bad and still vomiting once or twice a day. The symptoms were treated.
Sex: F
Vaccine: RSV, RSV
Symptoms: Tinnitus, Tremor, Vertigo, Vomiting
Clinical narrative: bad shakes, in body, hands, legs, and feet; Injection site rash; Injection site erythema; Lightheaded and dizzy spells; Vertigo; confusion; lack of focus; Tinitus; Vomiting; Nausea; bowel issues; sweaty hands and feet; hot flashes create dripping sweat; rashes on body; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site rash in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   Concomitant products included duloxetine and ropinirole hcl.   On 05-DEC-2023, the patient received Arexvy (left arm). On 21-JAN-2024, 47 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site erythema), dizziness (Verbatim: Lightheaded and dizzy spells), vertigo (Verbatim: Vertigo), confusion (Verbatim: confusion), concentration loss (Verbatim: lack of focus), tinnitus (Verbatim: Tinitus), vomiting (Verbatim: Vomiting), nausea (Verbatim: Nausea), bowel discomfort (Verbatim: bowel issues), sweating (Verbatim: sweaty hands and feet), hot flashes (Verbatim: hot flashes create dripping sweat) and generalized rash (Verbatim: rashes on body). On an unknown date, the patient experienced tremor (Verbatim: bad shakes, in body, hands, legs, and feet). The outcome of the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes and generalized rash were not resolved and the outcome of the tremor was not reported.   It was unknown if the reporter considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema, dizziness, vertigo, confusion, concentration loss, tinnitus, vomiting, nausea, bowel discomfort, sweating, hot flashes, generalized rash and tremor to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-JAN-2024 This report was submitted via the online direct entry reporting system.  The patient had lightheaded, dizzy spells, vertigo, tininess, confusion, lack of focus, vomiting, nausea, bowel issues, sweaty hands and feet, hot flashes create dripping sweat, rashes on body and injection site reaction. The reporter asked if there was a way to stop or reverse the side effects of Arexvy vaccine.  The patient have been to primary care physician twice and spoke with other medical professionals regarding this. The reporter asked for help to get past this. The patient still don't feel well. The patient also had bad shakes, in body, hands, legs, and feet. The patient was on medicines from primary care physician to help control shakes got bad and still vomiting once or twice a day. The symptoms were treated.
Age: 72.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Headache
Clinical narrative: Patient reports pain in the back of the head after a day or so after receiving the vaccine. Tried tylenol and ibuprofen but has not improved.
Age: 72.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Hypertension
Clinical narrative: Patient reports pain in the back of the head after a day or so after receiving the vaccine. Tried tylenol and ibuprofen but has not improved.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller stated no patient symptoms have been reported; Nurse called back about AE case #02526922 with patient information. Caller stated patient received 1 dose of GARDASIL 9 after the product was involved in a temperature excursion.; This spontaneous report was received from a nurse and refers to a 10-year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.  On 27-DEC-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #X019863, expiration date: 14-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 13.08 degrees celsius for 1 hours and 15 minutes. No previous temperature excursions were reported  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2312USA010648: US-009507513-2312USA010597: US-009507513-2312USA010641: US-009507513-2312USA010804:MSD
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for improperly stored vaccine administration of ROTATEQ.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1933911, expiration date: 18-APR-2024, strength, dose and route of administration were not provided) experience temperature excursion. Temperature showed 52.7 degree Fahrenheit (F) for 8 hours 31 minutes. There's no previous temperature excursion. On 03-JAN-2024, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1933911, expiration date: 18-APR-2024, administered orally for prophylaxis (strength, dose and route of administration were not provided) (product storage error). No side effects reported (no adverse event).
Age: 1.25
Sex: U
Vaccine: FLUC3, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: HCP reports that the patient has no symptoms or side effects.; HCP called to report that a provider in the office used the Flucelvax Quadrivalent vaccine was used instead of DILUENT to dilute the VARIVAX vaccine. HCP reports that both the VARIVAX and the FLUCELVAX vaccines were administered to a patient in the s; This spontaneous report was received from a medical assistant regarding a 15-month-old patient of unspecified gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-JAN-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X018952, expiration date: 13-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided). However, it the vaccine was prepared not with a diluent but with influenza vaccine inact sag 3v (FLUCELVAX), 0.5 milliliter, once, lot #370647, expiration date: 24-MAY-2024 (strength, formulation, and route of administration were not provided) (Product preparation error). Both vaccines were administered to the patient. According to the health care professional (HCP) the patient did not have symptoms or side effects (no adverse event).
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration. No other AE information was able to be provided during the call.; Improperly stored vaccine was administered to the patient.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medications were not provided.   On 04-DEC-2023, HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# X019196, expiry date: 25-APR-2025) was stored at 54.3 degree Fahrenheit (F) for 9 hour 32 minutes and 0 seconds; on 05-DEC-2023, at 57.7F for 15 hours 30 minutes 0 seconds; on 06-DEC-2023, at 50.2F for 5 hours 43 minutes 0 seconds; on 07-DEC-2023, at 30.6F for 1 hour 55 minutes 0 seconds and 52.7F for 11 hours 3 minutes 0 seconds; on 11-DEC-2023, at 48.4F for 1 hour 47 minutes 0 seconds. There was no other reported current or previous temperature excursions. On 13-DEC-2023, after temperature excursion, the patient was vaccinated with the improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection 0.5 mL once (route of administration, and anatomical location not provided) as prophylaxis (product storage error). The patient did not report any adverse issues or side effects from the administration. No other adverse event (AE) information was able to be provided (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015432: US-009507513-2401USA015463:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Pharmacist calling to report the administration of an expired dose of MMR II on 01/25/2024.  Caller confirmed no previous temperature excursions for this product and stored in the recommended range until the time of administration.  Pharmacist states; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 25-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, recombinant Human albumin (rHA), administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) (lot number W017557 has been verified to be a valid lot number, expiration date reported and validated as 07-JAN-2024) (expired product administered). There were no symptoms, adverse event or further details to report.
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient is only behind in DTaP/ did not receive further DTaP doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old patient who received DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received GSK vaccine containing DTaP in 2016), Infanrix (received GSK vaccine containing DTaP in 2017) and DTaP vaccine (received DTaP containing vaccine (unknown brand by Sanofi) in 2020).   On an unknown date, the patient did not receive Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: The patient is only behind in DTaP/ did not receive further DTaP doses). The outcome of the incomplete course of vaccination 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: 18-JAN-2024 The reporter reported that a patient who was 8 years old received GSK vaccine containing DTaP (unknown brand) in 2016 and 2017, and a DTaP containing vaccine (unknown brand by Sanofi) in 2020. The patient was only behind in DTaP. The reporter declined to provide more information for adverse event report. Till the time of reporting, the patient did not receive further doses of DTaP (Infanrix) vaccine, which led to an incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm, having aches; sore arm, having aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 02536561 (Merck).  A female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious), outcome "unknown" and all described as "sore arm, having aches".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400023657 Same patient and event, different dose number;US-PFIZER INC-202400023659 Same patient and event, different dose number;US-PFIZER INC-202400023658 Same patient and event, different dose number;US-PFIZER INC-202400023660 Same patient, different dose/AE;US-PFIZER INC-202400023661 Same patient, different dose/AE;
Sex: F
Vaccine: RSV
Symptoms: Malaise, Mental impairment
Clinical narrative: she's not feeling very well; she can't think straight; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old female patient received nirmatrelvir, ritonavir (PAXLOVID), for covid-19 treatment; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she's not feeling very well"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "she can't think straight". The action taken for nirmatrelvir, ritonavir was unknown. Additional information: Pt (patient) adv she's not feeling very well, she can't think straight. Pt (patient) took the covid vaccine from Pfizer in the past and you just got her rsv shot from Pfizer as well.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: may have taken the Pfizer vaccine a year ago/patient received Paxlovid; may have taken the Pfizer vaccine a year ago/patient received Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 76-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "may have taken the Pfizer vaccine a year ago/patient received Paxlovid". Clinical course: Patient states she may have taken the Pfizer vaccine a year ago, she doesn't remember. The patient received Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.