chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: for the right arm where the covid shot was given there could not move it could not touch it extremely painful; had fever; Chills; extreme headache; for the right arm where the covid shot was given there could not move it could not touch it extremely painful; sunlight bothered her to open her eyes; Diarrhea; is very nauseous; extremely tired; 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)), on 23Nov2024 as dose 1, single (Lot number: LP776) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization; Janssen (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 23Nov2024, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 23Nov2024, outcome "not recovered", described as "extremely tired"; NAUSEA (non-serious) with onset 23Nov2024, outcome "not recovered", described as "is very nauseous"; CHILLS (non-serious) with onset 24Nov2024, outcome "not recovered"; HEADACHE (non-serious) with onset 24Nov2024, outcome "not recovered", described as "extreme headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset 24Nov2024, outcome "not recovered" and all described as "for the right arm where the covid shot was given there could not move it could not touch it extremely painful"; PYREXIA (non-serious) with onset 24Nov2024, outcome "not recovered", described as "had fever"; PHOTOPHOBIA (non-serious) with onset 24Nov2024, outcome "not recovered", described as "sunlight bothered her to open her eyes".  Additional information: She got it on Saturday at 12:30 pm and woke up on Sunday which was yesterday and for the right arm where the Covid shot was given there could not move it could not touch it extremely painful, had fever and chills and had extreme headache where even sunlight bothered her to open her eyes, had diarrhea and was very nauseous since Saturday and the only thing she was able to eat was one granola bar and she was just extremely tired. The vaccine was administered on 23Nov2024 and she was tired and did not notice completely but was uncomfortable on Sunday 24Nov2024. States she had some minor side effects before and did not know if it was relevant or not but her prior shots were Janssen and Moderna and she never had the Pfizer shot before until this one and knows they specifically for certain strains of the Covid virus this year and did wonder why did not they do it based on weight; she did not want to continue the report for too long as she was not there to save the world but was just surprised that 2 days later she was still feeling this awful and sick.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: for the right arm where the covid shot was given there could not move it could not touch it extremely painful; had fever; Chills; extreme headache; for the right arm where the covid shot was given there could not move it could not touch it extremely painful; sunlight bothered her to open her eyes; Diarrhea; is very nauseous; extremely tired; 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)), on 23Nov2024 as dose 1, single (Lot number: LP776) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization; Janssen (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 23Nov2024, outcome "not recovered", described as "Diarrhea"; FATIGUE (non-serious) with onset 23Nov2024, outcome "not recovered", described as "extremely tired"; NAUSEA (non-serious) with onset 23Nov2024, outcome "not recovered", described as "is very nauseous"; CHILLS (non-serious) with onset 24Nov2024, outcome "not recovered"; HEADACHE (non-serious) with onset 24Nov2024, outcome "not recovered", described as "extreme headache"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset 24Nov2024, outcome "not recovered" and all described as "for the right arm where the covid shot was given there could not move it could not touch it extremely painful"; PYREXIA (non-serious) with onset 24Nov2024, outcome "not recovered", described as "had fever"; PHOTOPHOBIA (non-serious) with onset 24Nov2024, outcome "not recovered", described as "sunlight bothered her to open her eyes".  Additional information: She got it on Saturday at 12:30 pm and woke up on Sunday which was yesterday and for the right arm where the Covid shot was given there could not move it could not touch it extremely painful, had fever and chills and had extreme headache where even sunlight bothered her to open her eyes, had diarrhea and was very nauseous since Saturday and the only thing she was able to eat was one granola bar and she was just extremely tired. The vaccine was administered on 23Nov2024 and she was tired and did not notice completely but was uncomfortable on Sunday 24Nov2024. States she had some minor side effects before and did not know if it was relevant or not but her prior shots were Janssen and Moderna and she never had the Pfizer shot before until this one and knows they specifically for certain strains of the Covid virus this year and did wonder why did not they do it based on weight; she did not want to continue the report for too long as she was not there to save the world but was just surprised that 2 days later she was still feeling this awful and sick.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: now I have COVID; I had all the boosters, all by you guys too, uh, Pfizer. But, uh, I had COVID at the end of July, uh, August; I had all the boosters, all by you guys too, uh, Pfizer. But, uh, I had COVID at the end of July, uh, August; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 62-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing), notes: I am immunosuppressed; "rheumatoid arthritis" (unspecified if ongoing), notes: I have rheumatoid arthritis; "Covid-19" (unspecified if ongoing), notes: twice. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "I had all the boosters, all by you guys too, uh, Pfizer. But, uh, I had COVID at the end of July, uh, August"; DISEASE RECURRENCE (medically significant) with onset Nov2024, outcome "unknown", described as "now I have COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient stated, "I have Covid, I tested positive this morning, but we think I've had it since the weekend, but it's getting close to the 5 days. I am immunosuppressed, and I have rheumatoid arthritis, so unfortunately, this is my fourth time with COVID. So, I'm quite scared. I had all the boosters, all by you guys too, uh, Pfizer. But, uh, I had COVID at the end of July, uh, August. I took the Paxlovid, and it dissolved very quickly. And now I have COVID, and my doctor put in a prescription for me to get Paxlovid, and I am being denied because I had it like three months ago and you can only get it like every 6 months, but obviously, I didn't want to get COVID".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Red blood cell abnormality
Clinical narrative: my infusions seem to be inhibited from reaching correct receptors for production of red blood cells; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Severe Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete, manufacturer unknown), for covid-19 immunisation. The following information was reported: RED BLOOD CELL ABNORMALITY (non-serious), outcome "unknown", described as "my infusions seem to be inhibited from reaching correct receptors for production of red blood cells". Additional information: the patient have had under control for 8 years Chronic Severe Anima. Through iron infusions, by Hematologist. Until 9 months after Pfizer booster of Covid. As the patient is now concerned as infusions seem to be inhibited from reaching correct receptors for production of red blood cells.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Disorientation, Loss of consciousness, Posture abnormal, Seizure like phenomena
Clinical narrative: Patient received both vaccines and within 2 minutes, head swung back an d looked like they were having a seizure that lasted about 30 seconds. came to  alert but disoriented
Age: 66.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Erythema, Malaise, Pain in extremity, Pruritus, Rash
Clinical narrative: The patient reports having an itchy arm area soon after the immunization as well as redness and rash. She did not feel well and had a sore arm as well. She came in today stating that the redness and rash had spread and was still quite itchy but that it was starting to lessen. She had taken benadryl to reduce the itching with some relief.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Sudden outbreak of large psoriasis plaques on both lower legs that later spread to arms
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported, this was a second dose of the 2024-2025 Fluad vaccine this season.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypoacusis, Visual impairment
Clinical narrative: Parent reported dizziness, chill, poor vision and hearing, had to call EMS. Vital signs were taken and they were normal. Pharmacist advised parent/patient to follow up with PCP for monitoring.
Age: 71.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Fall, Rash, Skin laceration
Clinical narrative: After consenting to vaccine patient stated he thought he had a rash to a tetanus vaccine when he was a young child. We spoke at length about his reaction. He said he thought he had a tetanus vaccine since then with no issues. We spoke about risks vs. benefit of getting the vaccine and he said he "might as well get the vaccine". I offered for him to speak with his provider but he consented to receiving both verbally and written. Patient received all three vaccines with counseling the shingles vaccine may cause a rash at the injections site. Patient received with no immediate reaction. He left and returned 7 days later on 11/27/24 stating he got up to go to the bathroom that evening and fell in the bathroom. He cut his hand and broke his glasses. He said he went to the emergency room to get checked out and told me he was told "everything was fine". He then later stated he got a rash on his left arm. I asked if it was just where the vaccine was given or all over and he could not specify. I asked if he had a picture but he did not. I left a message for his primary care provider but have not received a phone call back. He stated he went to the emergency room that night 11/20/24 but was not able to confirm that.
Age: 0.75
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: Dose administered past the expiration/beyond-use-date
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Cough, Haematemesis, Malaise, Rhinorrhoea
Clinical narrative: Per patient 3 days after receiving vaccines they said they stared to feel sick, coughing, running nose, and threw up blood.  Pt received vaccines on 10/21/2024, Patient called to report symptoms to pharmacy on 11/27/24.  Per patient they had called multiple different drs. and they refused to see her, saying the pharmacy shouldn't have given 3 vaccines at once, you need to call them for them so they can tell you what to do.  The patient said that the throwing up had stopped at this point.  The pharmacist recommend cough syrup and allergy meds for runny nose and coughing (which the patient was already taking) but reiterated that the patient needed to be seen by a Dr.  if they have been this sick for this long.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Patient states she has severe arm soreness. She has taken tylenol and iced the area. It was recommended for her to go to a provider to get it looked at
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given high dose flu vaccine instead of regular dose flu vaccine. He had no adverse symptoms or reactions.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: Dose administered past expiration/beyond-use-date
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Vertigo
Clinical narrative: Patient reported being increasingly lightheaded with with room spinning and passing out 1-2 days post vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Syncope
Clinical narrative: patient fainted a few minutes after
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Contusion
Clinical narrative: PT HAD SIGNIFICANT BRUISING. WHEN SHE CAME BACK TO REPORT THE ISSUE IT WAS MORE THAN 3 WEEKS SINCE THE INJECTION. SHE STILL HAD A SIZABLE BRUISE. MEASURED AT 2 1/4" BY 1 1/2" DARK PURPLE WITH YELLOW ON THE MARGINS. PT SAYS BRUSING STARTED THE NIGHT OF THE VACCINE AND STAYED PRETTY MUCH THE SAME - SHE KEPT EXPECTING IT TO RESOLVE...BUT IT JUST STAYED.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Laboratory test, Magnetic resonance imaging joint
Clinical narrative: Night sweats, low grade fever, significant pain of right deltoid 3 days after injection was given. Also with nausea/vomiting.  Decreased mobility of shoulder with associated pain persisted and patient was diagnosed with SIRVA by Sports Medicine and Orthopedics.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Night sweats, Pyrexia, Shoulder injury related to vaccine administration, Vomiting
Clinical narrative: Night sweats, low grade fever, significant pain of right deltoid 3 days after injection was given. Also with nausea/vomiting.  Decreased mobility of shoulder with associated pain persisted and patient was diagnosed with SIRVA by Sports Medicine and Orthopedics.
Age: 91.0
Sex: M
Vaccine: COVID19, HEPAB
Symptoms: Dizziness, Syncope
Clinical narrative: The patient got dizzy and fainted.  The pharmacist caught him and there was no injury.  911 was called.  The patient was breathing and had a pulse and the pharmacist stayed by him until the ambulance arrived.  They took his pulse and checked his blood pressure.  The patient was alert, talking, and doing well when emergency service arrived.   The patient told EMS that he had not eaten for a while.  The EMS transported the patient for further evaluation only as a precautionary measure since the patient was 91 years old and frail.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after Covid-19 shot. After a few minutes of sitting, patient felt better. He was hungry after eating snacks he felt ok.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was given a vaccine that expired on 6/30/2024.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Sleep disorder
Clinical narrative: Throat constricted; Trouble breathing; This non-serious case was reported by a consumer via call center representative and described the occurrence of throat constriction in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included automobile accident and walking difficulty. Concurrent medical conditions included antiphospholipid syndrome.   On 08-DEC-2023, the patient received the 1st dose of Shingrix. In DEC-2023, 24 hrs after receiving Shingrix, the patient experienced throat constriction (Verbatim: Throat constricted) and difficulty breathing (Verbatim: Trouble breathing). The patient was treated with cetirizine. The outcome of the throat constriction and difficulty breathing were resolved.   It was unknown if the reporter considered the throat constriction and difficulty breathing to be related to Shingrix.     It was unknown if the company considered the throat constriction and difficulty breathing to be related to Shingrix.   Additional Information: GSK receipt date: 29-OCT-2024 The reporter was the patient. The patient received the first dose of Shingrix on December 8, 2023. About 24 hours later, the patient woke up during the night having trouble breathing and her throat was constricted. There were no local symptoms experienced. The patient did not call EMS or go to the emergency room because the symptoms did not worsen. The patient took cetirizine for treatment. The patient stated she experienced hesitancy with first foot when started to ambulate. This began shortly after being involved in an auto accident July 3rd 2024. The patient had not received the second dose of Shingrix because of the adverse events experienced after the first dose (throat constricted, trouble breathing). This adverse may had already been reported shortly after the event. The patient stated that she received a letter from GlaxoSmithKline.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Sleep disorder, Throat tightness
Clinical narrative: Throat constricted; Trouble breathing; This non-serious case was reported by a consumer via call center representative and described the occurrence of throat constriction in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included automobile accident and walking difficulty. Concurrent medical conditions included antiphospholipid syndrome.   On 08-DEC-2023, the patient received the 1st dose of Shingrix. In DEC-2023, 24 hrs after receiving Shingrix, the patient experienced throat constriction (Verbatim: Throat constricted) and difficulty breathing (Verbatim: Trouble breathing). The patient was treated with cetirizine. The outcome of the throat constriction and difficulty breathing were resolved.   It was unknown if the reporter considered the throat constriction and difficulty breathing to be related to Shingrix.     It was unknown if the company considered the throat constriction and difficulty breathing to be related to Shingrix.   Additional Information: GSK receipt date: 29-OCT-2024 The reporter was the patient. The patient received the first dose of Shingrix on December 8, 2023. About 24 hours later, the patient woke up during the night having trouble breathing and her throat was constricted. There were no local symptoms experienced. The patient did not call EMS or go to the emergency room because the symptoms did not worsen. The patient took cetirizine for treatment. The patient stated she experienced hesitancy with first foot when started to ambulate. This began shortly after being involved in an auto accident July 3rd 2024. The patient had not received the second dose of Shingrix because of the adverse events experienced after the first dose (throat constricted, trouble breathing). This adverse may had already been reported shortly after the event. The patient stated that she received a letter from GlaxoSmithKline.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fall, Muscular weakness
Clinical narrative: The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak) in a 77-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043157) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Dose 3), COVID-19 vaccine (Dose 4), COVID-19 vaccine (Dose 2), COVID-19 vaccine (Dose 1) and COVID-19 vaccine (Dose 5). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Diabetic peripheral neuropathy.    On 20-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 21-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced NEUROPATHY PERIPHERAL (The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had many medical conditions.  No concomitant medication was reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   The patient had peripheral neuropathy that got markedly worse a day after the vaccine. Patient had seen a neurologist, but nobody knows about this. The patient fell down because his legs were weak. The man's legs still feel weak, but a little better.   No treatment medication was reported.; Reporter's Comments: The Concurrent medical condition Diabetic peripheral neuropathy.is a contributor for the event.  The benefit -risk relationship of product is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak) in a 77-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043157) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Dose 3), COVID-19 vaccine (Dose 4), COVID-19 vaccine (Dose 2), COVID-19 vaccine (Dose 1) and COVID-19 vaccine (Dose 5). Past adverse reactions to the above products included No adverse effect with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Diabetic peripheral neuropathy.    On 20-Oct-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 21-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced NEUROPATHY PERIPHERAL (The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (The man has peripheral neuropathy that got markedly worse right after the vaccine/ The man fell down because his legs were weak) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had many medical conditions.  No concomitant medication was reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   The patient had peripheral neuropathy that got markedly worse a day after the vaccine. Patient had seen a neurologist, but nobody knows about this. The patient fell down because his legs were weak. The man's legs still feel weak, but a little better.   No treatment medication was reported.; Reporter's Comments: The Concurrent medical condition Diabetic peripheral neuropathy.is a contributor for the event.  The benefit -risk relationship of product is not affected by this report.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC15, PNC21, PPV
Symptoms: Discomfort, Rash
Clinical narrative: Sick; Both arms broke out bad; This spontaneous report was received from a 66-year-old non-pregnant female patient referring to herself via other company.  The patient's medical history was not reported. Her concurrent conditions included dermatitis atopic. Concomitant medications included baclofen, bupropion hydrochloride, diclofenac sodium, duloxetine hydrochloride, estradiol, estrogens conjugated, fluticasone propionate, furosemide, gabapentin, hydroxyzine hydrochloride, morphine sulfate, olmesartan medoxomil, omeprazole, rosuvastatin calcium and triamcinolone.   On 15-SEP-2023, the patient started therapy with dupilumab (DUPIXENT) solution for injection, 300 milligram, qow (strenght: 300 mg/2ml), administered subcutaneously for dermatitis atopic (strength, lot #, and expiry date were not provided). On an unknown date, the patient was vaccinated with influenza vaccine, administered in the right arm for immunisation (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) or with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), or with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) (reported as "pneumococcal vaccine"), administered in the left arm for immunisation (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date following the first doses of the previously reported drug/vaccines, the patient experienced sick (illness) and she was taking influenza vaccine (reported as "flu shots") for illness. Moreover, both arms broke out bad (rash) when she got "the flu shot, and pneumonia shot" (as previously reported). The patient stated that it was very uncomfortable in the following week then they went down (conflicting information). At the time of reporting, the outcome of the events was unknown. The patient was scheduled to take respiratory syncytial virus (RSV) vaccine on 23-OCT-2924 and then she would take a coronavirus disease 2019 (COVID) vaccine. The action taken with dupilumab (DUPIXENT) regarding illness was discontinued (reported as the patient decided to hold on to taking dupilumab [DUPIXENT] when she was taking "shots for pneumonia and flu" because she knew that dupilumab [DUPIXENT] could lower the immune system) and regarding rash was not applicable.  The causal relationship between the events and dupilumab (DUPIXENT) was related and was not reported for the suspect vaccines.  Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: administration of expired dose of Kinrix; Inappropriate schedule of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 53NB2, expiry date 10-NOV-2018) for prophylaxis.   Previously administered products included Pediarix (1st dose of DTaP and IPV on 22-MAR- 2013), Pediarix (2nd dose of DTaP and IPV on 22-MAY-2013), Pediarix (3rd dose of DTaP and IPV on 23-JUL-2013) and Pentacel (on 17-JUN-2015 of Pentacel (4th dose of DTaP and IPV)).   On 26-NOV-2018, the patient received Kinrix. On 26-NOV-2018, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administration of expired dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the expired vaccine used and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 29-OCT-2024 The reporter called inquiring what the expiration date was for Kinrix.  She stated that she was a school nurse and a patient they had documentation that the DTaP on file was administered after the expiration date and that it's invalid but she was unsure what that expiration date was, which led to expired vaccine used and inappropriate schedule of vaccine administered. The Pentacel dose was coming up invalid for polio because the minimum age not met. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: still have pain in their arm and their arms are sore/ there is pain lifting in arm where they got the shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 63-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Oct2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: Blood pressure high and it fluctuates. Concomitant medication(s) included: LISINOPRIL oral taken for hypertension (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "recovering", described as "still have pain in their arm and their arms are sore/ there is pain lifting in arm where they got the shot". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient called about him and his wife. They both received the Comirnaty vaccine on 29Oct2024 as well as a flu shot that same day. He stated it was two shots. They still have pain in their arm and their arms are sore. The problem is that there was pain lifting in arm where they got the shot. He wanted to know if that was normal.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400310519 same reporter/drug/event, different patient;
Sex: M
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: felt ill; This is a spontaneous report received from an Other HCP, Program ID.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2019 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 "recovered", described as "felt ill".  Additional information: It was reported that patient felt ill after receiving Prevnar 13, symptoms lasted for about 2 weeks and then resolved. No other adverse reactions came up after the vaccine administration and resolution of symptoms.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6-month-old child was inadvertently administered the fluzone high -dose vaccine with no reported adverse event; Initial information received on 18-Nov-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 6 months old male patient was inadvertently administered the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 18-Nov-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot U8524CA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the lower right vastus lateralis for Immunization and 6-month-old child was inadvertently administered the fluzone high -dose vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.08
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 1-year-old patient received two doses of IPV in one day, with no reported adverse event; Initial information received on 18-Nov-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who received two doses of IPV (VERO) [IPOL] in one day, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza vaccine (Fluzone) and Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Quadracel) for Immunisation.  On 11-Nov-2024, the patient received 0.5 ml (dose 5) (standard) (twice daily) IPV (VERO) Suspension for injection (lot W1A191M) (unknown expiry date) via intramuscular route in the left thigh for Immunization.  On 11-Nov-2024, the 1-year-old patient received two doses of IPV (VERO) in one day with no reported adverse event (extra dose administered) (latency-same day).  Reportedly, the patient should have only been receiving QUADRACEL, but they later realized that QUADRACEL already includes the Polio component. As a result, an additional separate IPOL dose was administered on the same day. The patient received Polio doses at 6 months old, 8 months old, 9 months old and at 12 months old.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Injection site redness; I would imagine the injections were give subcutaneous and not intramuscular; This spontaneous case (out of a cluster of 5 cases), initially received on 07-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On 05-Nov-2024, the patient received Flucelvax (TIV) for an indication not reported., Dose regimen: Not reported, Route of administration: Subcutaneous, Site of administration: Not reported, Lot number: 946594. CSL Seqirus Batch number to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Redness at the injection site (outcome: Not Reported), I would imagine the injections were give subcutaneous and not intrauscular (outcome: Not Reported).   Reporter stated that one of the nurses gave a few flu shots on 05-Nov-2024 and they had some site reactions. 5 people had redness at the injection site. Based on the location of the redness, she would imagine the injections were give subcutaneous and not intramuscular.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provided a seriousness assessment neither causality.; Reporter's Comments: Event injection site redness is considered related to the vaccine and the special situation is considered not related
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Injection site rednesss; I would imagine the injections were give subcutaneous and not intramuscular; This spontaneous case (out of a cluster of 5 cases), initially received on 07-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On 05-Nov-2024, the patient received Flucelvax (TIV) for an indication not reported., Dose regimen: Not reported, Route of administration: Subcutaneous, Site of administration: Not reported, Lot number: 946594. CSL Seqirus Batch number to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Redness at the injection site (outcome: Not Reported), I would imagine the injections were give subcutaneous and not intrauscular (outcome: Not Reported).   Reporter stated that one of the nurses gave a few flu shots on 05-Nov-2024 and they had some site reactions. 5 people had redness at the injection site. Based on the location of the redness, she would imagine the injections were give subcutaneous and not intramuscular.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provided a seriousness assessment neither causality.; Reporter's Comments: Event injection site redness is considered related to the vaccine and the special situation is considered not related
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Redness at the injection site; I would imagine the injections were give subcutaneous and not intramuscular; This spontaneous case (out of a cluster of 5 cases), initially received on 07-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On 05-Nov-2024, the patient received Flucelvax (TIV) for an indication not reported., Dose regimen: Not reported, Route of administration: Subcutaneous, Site of administration: Not reported, Lot number: 946594. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Redness at the injection site (outcome: Not Reported), I would imagine the injections were give subcutaneous and not intrauscular (outcome: Not Reported).   Reporter stated that one of the nurses gave a few flu shots on 05-Nov-2024 and they had some site reactions. 5 people had redness at the injection site. Based on the location of the redness, she would imagine the injections were give subcutaneous and not intramuscular.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provided a seriousness assessment neither causality.; Reporter's Comments: Event injection site redness is considered related to the vaccine and the special situation is considered not related.
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Injection site redness; I would imagine the injections were give subcutaneous and not intramuscular; This spontaneous case (out of a cluster of 5 cases), initially received on 07-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On 05-Nov-2024, the patient received Flucelvax (TIV) for an indication not reported., Dose regimen: Not reported, Route of administration: Subcutaneous, Site of administration: Not reported, Lot number: 946594. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Redness at the injection site (outcome: Not Reported), I would imagine the injections were give subcutaneous and not intrauscular (outcome: Not Reported).   Reporter stated that one of the nurses gave a few flu shots on 05-Nov-2024 and they had some site reactions. 5 people had redness at the injection site. Based on the location of the redness, she would imagine the injections were give subcutaneous and not intramuscular.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provided a seriousness assessment neither causality.; Reporter's Comments: Event injection site redness is considered related to the vaccine and the special situation is considered not related
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Injection site redness; I would imagine the injections were give subcutaneous and not intramuscular; This spontaneous case (out of a cluster of 5 cases), initially received on 07-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On 05-Nov-2024, the patient received Flucelvax (TIV) for an indication not reported., Dose regimen: Not reported, Route of administration: Subcutaneous, Site of administration: Not reported, Lot number: 946594. CSL Seqirus Batch number to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Redness at the injection site (outcome: Not Reported), I would imagine the injections were give subcutaneous and not intrauscular (outcome: Not Reported).   Reporter  stated that one of the nurses gave a few flu shots on 05-Nov-2024 and they had some site reactions. 5 people have redness at the injection site. Based on the location of the redness, she would imagine the injections were give subcutaneous and not intramuscular.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provided a seriousness assessment neither causality.; Reporter's Comments: Event injection site redness is considered related to the vaccine and the special situation is considered not related
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient got chicken pox all over body, 7 days after vaccine, not just at vaccine site. Also had one day of fever. However, patient may have also been exposed to shingles. Patient did not require treatment, is improving and doing well without treatment.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: tingling sensation of right shoulder; burning sensation in right shoulder, underarm, and lateral torso; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number X4535, expiry date 19-JUN-2026) for prophylaxis.   Co-suspect products included Influenza vaccine (Flu) for prophylaxis.   On 16-OCT-2024, the patient received Shingrix (intramuscular, right deltoid). In OCT-2024, the patient received Flu (right deltoid). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced tingling sensation (Verbatim: tingling sensation of right shoulder) and burning sensation (Verbatim: burning sensation in right shoulder, underarm, and lateral torso). The outcome of the tingling sensation and burning sensation were not resolved.   It was unknown if the reporter considered the tingling sensation and burning sensation to be related to Shingrix.     It was unknown if the company considered the tingling sensation and burning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-OCT-2024 The pharmacist reported that the patient received Shingrix vaccine and the patient subsequently received a flu vaccine in the right deltoid at his physician's office.  The pharmacist was unsure the date of the flu vaccine, and unsure which flu vaccine was administered.  The patient notified the pharmacist that he had been experiencing a burning, tingling sensation like a sunburn going into the shoulder area, under arm, and side of torso underneath the armpit area on the right side.  There was no rash, just a sensation.  The pharmacist was unsure the start date of the symptoms, just that the patient reported it had been going for about a week and remained ongoing.  The patient had called provider's office but had not yet been seen. The pharmacist stated that the flu vaccine was administered about a week after Shingrix and he thought that the symptoms began after the flu vaccine since it's been going on for about a week.  After attempted to clarify symptoms further with pharmacist if it was like a shingles or neuropathy type of feeling, Pharmacist was thinking might be since patient mentioned burning, tingling, nerves like a superficial sensation. It was unknown if the reporter considered the tingling sensation and burning sensation to be related to flu vaccine.