| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2872394 | 11/12/2025 |
COVID19 |
MODERNA |
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Death
Death
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Three of my neighbors are dead thanks to your vax; This spontaneous case was reported by a non-healt...
Three of my neighbors are dead thanks to your vax; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Three of my neighbors are dead thanks to your vax) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. This case was for 1st patient out of 3 patients. Concomitant medications were not reported. Reporter had not administered the moderna vaccine. It was reported that the individual expresses intense dissatisfaction with the COVID vaccine, attributing the deaths of three neighbors because of the vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790994, US-MODERNATX, INC.-MOD-2025-790993 (E2B Linked Report).; Reporter's Comments: At this time, only limited information has been received. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790994:Patient 3 US-MODERNATX, INC.-MOD-2025-790993:Patient 2; Reported Cause(s) of Death: Three of my neighbors are dead thanks to your vax
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| 2872395 | 76 | F | CT | 11/12/2025 |
COVID19 |
MODERNA |
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Pruritus, Urticaria
Pruritus, Urticaria
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itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRU...
itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (hives) in a 76-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 29-Sep-2025, the patient experienced PRURITUS (itching) and URTICARIA (hives). The patient was treated with Vitamin e at a dose of Oil/Cream. At the time of the report, PRURITUS (itching) and URTICARIA (hives) was resolving. No concomitant medication was reported. The patient had hives appearing on her right hand on the evening of 29-Sep-2025 and a shot was received on the upper right arm & on 08-Nov-2025, the itching had decreased but she was still sensitive to using warm water and any article of material that touches her right hand. Of course, scratching the affected area did not help, but very cold water or ice pack helped tremendously to control the itching and vitamin E Oil/Cream was used to heal. The affected area was wrapped with non-adherent pads held on with an elastic conforming bandage. It was unknown if the patient experienced any additional symptoms/events.
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| 2872397 | M | OH | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hyperhidrosis, Tremor
Hyperhidrosis, Tremor
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shaking; sweating; This is a spontaneous report received from a Consumer or other non HCP from medic...
shaking; sweating; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 74-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: went to hospital. He spent 11 days in the ICU.; "Chronic Lymphocytic Leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 2020, outcome "recovered" (2020), described as "shaking"; HYPERHIDROSIS (non-serious) with onset 2020, outcome "recovered" (2020), described as "sweating". Additional information: Patient was administered with Comirnaty in 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2872398 | M | OH | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Discomfort, Hyperhidrosis, Tremor
Discomfort, Hyperhidrosis, Tremor
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shaking; Very uncomfortable; sweating; This is a spontaneous report received from a Consumer or othe...
shaking; Very uncomfortable; sweating; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: . A 77-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: went to hospital. He spent 11 days in the ICU. The patient's concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 2023, outcome "unknown", described as "Very uncomfortable"; TREMOR (non-serious) with onset 2023, outcome "unknown", described as "shaking"; HYPERHIDROSIS (non-serious) with onset 2023, outcome "unknown", described as "sweating". Additional information: It was reported In 2020, he got COVID and went to hospital. He spent 11 days in the ICU. Then he took the COVID vaccine and experienced shaking & sweating on a 12 hour period, after 3 years he was administered with COVID vaccine and had the same reaction. that the caller experience shaking and sweating after the Pfizer COVID-19 Vaccine and then, it takes 12 hours to get rid of what they experienced." When paraphrased the above concern, consumer stated, "I started, in 2020, I got COVID and spend 11 days in ICU. 21 comes along and I took the shot (Pfizer COVID-19 Vaccine) and that evening until the next morning, I had sweats and shaking and very uncomfortable. Next year comes around, I do the same thing, this year, I come around I do the same thing, except this time, I throw up and my heart was just pounding. My concern is like I said I spend 11 days in ICU. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2872399 | F | FL | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Arthritis, Gait disturbance, Malaise, Pain in extremity
Arthralgia, Arthritis, Gait disturbance, Malaise, Pain in extremity
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she can hardly walk; acute arthritis; she feels a little icky; pain in her legs, when she sleeps/Her...
she can hardly walk; acute arthritis; she feels a little icky; pain in her legs, when she sleeps/Her legs hurt and knees hurt; Her legs hurt and knees hurt; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 85-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Nov2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "acute arthritis" (unspecified if ongoing); "cholesterol " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: ARTHRALGIA (non-serious) with onset Nov2025, outcome "unknown", described as "Her legs hurt and knees hurt"; ARTHRITIS (non-serious) with onset Nov2025, outcome "unknown", described as "acute arthritis"; PAIN IN EXTREMITY (non-serious) with onset Nov2025, outcome "unknown", described as "pain in her legs, when she sleeps/Her legs hurt and knees hurt"; GAIT DISTURBANCE (non-serious) with onset Nov2025, outcome "not recovered", described as "she can hardly walk"; MALAISE (non-serious) with onset Nov2025, outcome "recovered" (Nov2025), described as "she feels a little icky". Therapeutic measures were taken as a result of arthritis, arthralgia. Additional Information: She was calling the covid shot. She had the covid shot last week probably was Wednesday or Thursday then states maybe it was Thursday and she did not have a reaction the first day, had no reaction. Her arm was not sore like normal and she has had all of the Pfizer shots and her arm was usually sore and with this covid shot her arm was not sore and she did not feel a little icky like she wanted to take a nap, did not feel like she had a reaction at all. Mentions she has acute arthritis and has bad knees. She just wants to speak to someone about the reaction, the day after the first day of receiving the covid shot and from there on in, her arthritis has been awful and like something in the shot that does not agree with medication she is taking. Her legs hurt and knees hurt. Caller stated she received a Pfizer Covid 19 vaccine last week, Thursday. The first day she had no reaction, usually she feels a little icky, she has received all Pfizer vaccines so far and had no reaction, no sore arm and her previous dose was on December last year. She stated she lives in REDACTED, with damp weather and today was cold, so that could be an issue. She has never had covid, so maybe she does not have a lot of immunity. She has acute arthritis and a bad knee, but she was taking medication for it (generic of 'mobic') since a couple months ago. It has been wonderful, she has felt terrific, she takes the 'mobic' generic twice a day, she takes tylenol arthritis and tramadol 1 and a half a day, so she believes it is the covid, she does not know what else it could be. Since the day after the shot she can hardly walk, she has pain in her legs, when she sleeps. She walks indoors every day 30-45 minutes, she was still doing it but now she can hardly walk due to her arthritis. She was told by a friend of hers that other people she knew had this type of reaction with their arthritis. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2872400 | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Conjunctivitis, Eye movement disorder, Eye pain, Headache, Muscle strain
Conjunctivitis, Eye movement disorder, Eye pain, Headache, Muscle strain
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Left eye conjunctivitis/the pinkness between the pupil; tenderness on the white of the eye/It is not...
Left eye conjunctivitis/the pinkness between the pupil; tenderness on the white of the eye/It is not like, sharp pain, like someone stabbing me in the eye; feeling like, I have a strained muscles or something; movement of my eyeball does not feel normal/lowered mobility of the eyeball/moving it down is hard; It makes me feel like I have like a headache; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 28Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONJUNCTIVITIS (non-serious), outcome "unknown", described as "Left eye conjunctivitis/the pinkness between the pupil"; EYE PAIN (non-serious), outcome "unknown", described as "tenderness on the white of the eye/It is not like, sharp pain, like someone stabbing me in the eye"; MUSCLE STRAIN (non-serious), outcome "unknown", described as "feeling like, I have a strained muscles or something"; EYE MOVEMENT DISORDER (non-serious), outcome "unknown", described as "movement of my eyeball does not feel normal/lowered mobility of the eyeball/moving it down is hard"; HEADACHE (non-serious), outcome "unknown", described as "It makes me feel like I have like a headache". Additional Information: Consumer stated, "I had the 2025-26, COVID Vaccine (Suspect captured as provided) on October 28th and I am experiencing left eye conjunctivitis, tenderness on the white of the eye and the feeling like, I have a strained muscles or something. It is not like, sharp pain, like someone stabbing me in the eye, but when I move the eye, I guess it is called ocular mobility or motility I do not know. The movement of my eyeball does not feel normal, it feel like, if there, but it is not sharp pain. It is just, like I look up certain ways, and it is unconformable. If I move the eyeball in certain ways, it is uncomfortable. I think moving it down is hard. Anyways, that kind of changes. It started with the conjunctive, the pinkness between the pupil and the inner eyelid, the inner, the bridge of my nose. It is between the pupil and the bridge of my nose and in the lower quadrant, not the upper but the lower quadrant, so the lower quarter of the eye and there is a diffuse, not like the burst blood vessel but it diffuses pinkness, and it is gotten worse. It gets worse if I use the computer. I rest it and thought maybe this will just make it go away, what is this, and I do not have any previous experiencer of conjunctivitis or any of these eye problems, this is all normal, never happened before and I was looking up think about the eye. There is some history of ocular complications following vaccination for COVID-19, a one year retrospective, and I believe. I do not know if they specifies mRNA or not. I think somewhere else I saw that was related to mRNA. So, I do not have sharp pain. I have generalized sensitivity and lowered mobility of the eyeball. It makes me feel like I have like a headache, if I move it in a certain direction. I do not have loss of vision at this point but also it get worse when, if I use the eye too much, it gets worse. If I just like lay down and keep my eye closes which, also I have been using." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2872402 | 58 | F | NJ | 11/12/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Chills, Extrasystoles, Fatigue, Feeling abnormal, Feeling of body temperature ch...
Chills, Extrasystoles, Fatigue, Feeling abnormal, Feeling of body temperature change; Headache, Oral herpes, Pyrexia, Tinnitus, Vertigo
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Chills; Hot and cold; First few days felt my heart in my ears and maybe a few times maybe skipping a...
Chills; Hot and cold; First few days felt my heart in my ears and maybe a few times maybe skipping a beat; Ringing in ears/ First few days felt my heart in my ears and maybe a few times maybe skipping a beat; Brief fever; feeling vertigo; headaches; Tired; Two cold sores never get two at a time; feeling off; This is a spontaneous report received from a Nurse. A 58-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Nov2025 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dairy allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "erythromycin allergy". The following information was reported: PYREXIA (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Brief fever"; CHILLS (non-serious) with onset 04Nov2025, outcome "not recovered"; EXTRASYSTOLES (non-serious) with onset 04Nov2025, outcome "not recovered", described as "First few days felt my heart in my ears and maybe a few times maybe skipping a beat"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Hot and cold"; TINNITUS (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Ringing in ears/ First few days felt my heart in my ears and maybe a few times maybe skipping a beat"; FATIGUE (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Tired"; ORAL HERPES (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Two cold sores never get two at a time"; FEELING ABNORMAL (non-serious) with onset 04Nov2025, outcome "not recovered", described as "feeling off"; VERTIGO (non-serious) with onset 04Nov2025, outcome "not recovered", described as "feeling vertigo"; HEADACHE (non-serious) with onset 04Nov2025, outcome "not recovered", described as "headaches". Therapeutic measures were taken as a result of chills, feeling of body temperature change, extrasystoles, tinnitus, pyrexia, vertigo, headache, fatigue, oral herpes, feeling abnormal. Additional information: The patient did not receive any other vaccines on the same date as the vaccine COMIRNATY. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine COMIRNATY. The patient was not taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event was Tylenol which was told to take by the pharmacist
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| 2872403 | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pericarditis
Pericarditis
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Pericarditis; This is a spontaneous report received from a Consumer or other non HCP. Other Case ide...
Pericarditis; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20251030000016 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (life-threatening, hospitalization, medically significant) with onset 2021, outcome "recovered". The clinical course was reported as follows: The patient received the Pfizer vaccine for the coronavirus in the spring of 2021, three weeks later the patient was in the Intensive Care Unit (ICU) for a short stay with pericarditis. The patient was hospitalized for pericarditis (start date: 2021). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2872404 | 81 | M | PA | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
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tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a C...
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. An 81-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 02Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer vaccines (gotten every Pfizer COVID vaccine/ booster shots), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2025, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2025) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The report was about a male patient, who tested positive for COVID and was prescribed Paxlovid". The patient stated "My wife and I are in our early 80s, and we do everything to avoid getting sick and somehow, I got COVID. I thought it was just a regular head cold over the weekend, and, you know. all the symptoms, but then I got worse. So finally, I called up my physician and my PCP, and he recommended, I don't even know what he recommended, to be honest with you, but I went to pick it up at the pharmacy wearing a N95 mask and everything, I don't wanna make anyone else sick..." When advised of the programs available, withheld stated, "My wife, One of the reasons that I'm so concerned is she's having surgery, and I don't want her, obviously, to get COVID, and cause any problems with the surgery, I mean, she's been waiting for this surgery for a couple of months." When asking for information to be repeated, withheld stated, "I'm a little hard of hearing". When discussing eligibility requirements, withheld stated, "I haven't worked in 20 years". Later in the call, patient stated, "My wife, and I have been getting Pfizer COVID shots from, I guess, 2020, I mean, we've gotten every Pfizer COVID vaccine. Everyone, I mean, booster shots, and everything because we're concerned, and the last one that we got was, I think, 02Oct. We went to a withheld Pharmacy, and we got the COVID vaccination, Pfizer COVID vaccination. But, I guess, I called the doctor, and I said, 'How come I got COVID, if a little over a month ago I got the Pfizer Vaccination?' He said, "Well, the vaccination keeps you from getting it more seriously. But, it doesn't protect you from getting COVID at all'. All of our vaccinations, our Pfizer COVID vaccinations, going back probably to 2020". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2872405 | 61 | F | GA | 11/12/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID-19; COVID-19; This is a spontaneous report and received from consumers, Program ID:. A 62-yea...
COVID-19; COVID-19; This is a spontaneous report and received from consumers, Program ID:. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Exposure to COVID-19" (unspecified if ongoing), notes: Grandchildren. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient's husband called for retail vaccine assistance program from the company for the patient (COVID-19 shot) as the patient doesn't have the ability to pay for hers. They're saying they needed a doctor or a prescription to go in. The patient had her COVID-19 shots when they were free. They were planning on doing this before they leave town, because they don't want to go around their grandkids or their children. They don't want to go around them and take anything or not have gotten their vaccination because the last time they caught COVID-19, they got it from the grandchildren. The patient had 7 shots. The patient had COVID-19 after the Pfizer shots.
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| 2872406 | 11/12/2025 |
COVID19 PPV |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Insomnia, Peripheral swelling, Vaccination site pain; Insomnia, Peripheral swell...
Insomnia, Peripheral swelling, Vaccination site pain; Insomnia, Peripheral swelling, Vaccination site pain
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When the vaccines were administered it really hurt; My arm is swollen and feels hard in the area whe...
When the vaccines were administered it really hurt; My arm is swollen and feels hard in the area where the vaccines were administered; I'm having difficulty sleeping; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Nov2025 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 05Nov2025 as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: INSOMNIA (non-serious) with onset Nov2025, outcome "unknown", described as "I'm having difficulty sleeping"; PERIPHERAL SWELLING (non-serious) with onset Nov2025, outcome "unknown", described as "My arm is swollen and feels hard in the area where the vaccines were administered"; VACCINATION SITE PAIN (non-serious) with onset Nov2025, outcome "unknown", described as "When the vaccines were administered it really hurt". Additional Information: I received the Covid and Pneumonia vaccine yesterday at redacted. My arm is swollen and feels hard in the area where the vaccines were administered. When the vaccines were administered it really hurt. I'm having difficulty sleeping. Are the pharmacists trained to give vaccines? I know this is an intramuscular shot but I have never experienced anything like this. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2872407 | 82 | M | NY | 11/12/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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Contusion
Contusion
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some bruising at various places on his body; Initial information received on 31-Oct-2025 regarding a...
some bruising at various places on his body; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 82 years old male patient (167.64 cm and 65.91 kg) who had some bruising at various places on his body after receiving NVX-COV2705 (OMICRON JN.1) Adjuvanted Vaccine [Nuvaxoid JN.1]. The patient's past vaccination(s) included INFLUENZA VACCINE in 2025. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Hypertension, Depression and Gastrooesophageal reflux disease. Information related to Allergies to drugs, food or other products was not provided. Concomitant medications included: blood pressure medication, antidepressants, reflux medication, thiazide diuretics. On 24-Oct-2025, the patient received unknown dose (dose 1) of suspect NVX-COV2705 (OMICRON JN.1) Adjuvanted Vaccine, Solution for injection in pre-filled syringe, strength 5 ug (expiry date unknown) lot number not reported via intramuscular route in the right deltoid for Prophylactic vaccination (immunization). On 30-Oct-2025, the patient developed some bruising at various places on his body (contusion) (Latency 6 days). It was reported, the patient was tested positive for covid-19 in 2023, Method of Covid-19 diagnosis (e.g., antibody test, rapid antigen test, Molecular test (Nucleic acid, RNA (Ribonucleic Acid) and PCR (Polymerase Chain Reaction): Patient reports taking a test at home. Action taken was not applicable. No corrective treatment was received for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
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| 2872411 | 74 | F | 11/12/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number |
Erythema, Myalgia, Myosclerosis, Skin abrasion, Sleep disorder; Tenderness
Erythema, Myalgia, Myosclerosis, Skin abrasion, Sleep disorder; Tenderness
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Arm in the deltoid area has red area; Arm in the deltoid area has solid area; Deltoid got extremely ...
Arm in the deltoid area has red area; Arm in the deltoid area has solid area; Deltoid got extremely soared; Warm to the touch; This spontaneous case, initially received on 31-Oct-2025, was reported by a non health professional and concerns an elderly female patient. At the time of the event the patient had Allergy to latex, Allergy to gluten, Allergy to corn, Allergy to soy. Concomitant medication was reported as unknown. Administration of company suspect drug: On 27-Oct-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5ml, Route of administration: Not reported, Anatomical location: Deltoid, Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 27-Oct-2025, same day of vaccination, the patient experienced Deltoid got extremely soared (outcome: Not recovered / Not resolved), Warm to the touch (outcome: Not recovered / Not resolved). On 31-Oct-2025, 4 days after vaccination, the patient experienced Arm in the deltoid area has red area (outcome: Not recovered / Not resolved), Arm in the deltoid area has solid area (outcome: Not recovered / Not resolved). The patient was experiencing an adverse reaction to vaccine Fluad. On 27-Oct-2025, the patient received the vaccine in her deltoid and right after receiving it, it got extremely soared to the point she could not have anything touching it, she could not sleep on it. It was warm to the touch. The patient thought it would got away eventually, however, on the morning of this report (31-Oct-2025), 5 days (sic!) after receiving the vaccine, while she was getting dressed, she noticed that her arm in the deltoid area had solid red area about the size of a baseball ball (this was new, it had not been like this, not until this morning). Treatment measures associated with event: Nothing was done until now Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter assessed provides seriousness assessment as unknown for all events and did not provide causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, all events are considered related for reporting purposes.
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| 2872413 | 13 | M | IL | 11/12/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
B0021 FH4YR |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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The Covid vaccine that was administered to the patient was expired (expiration date 09/14/2025). No ...
The Covid vaccine that was administered to the patient was expired (expiration date 09/14/2025). No adverse event at this time.
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| 2872414 | 26 | F | AL | 11/12/2025 |
FLU3 |
SANOFI PASTEUR |
u8832aa |
Extra dose administered
Extra dose administered
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Patient received flu shot 08/24/2025, then it was repeated on 10/2/2025
Patient received flu shot 08/24/2025, then it was repeated on 10/2/2025
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| 2872416 | 10 | M | IL | 11/12/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3046979 FH4YR |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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The Covid vaccine that was administered to the patient was expired (expiration date 09/12/2025). No ...
The Covid vaccine that was administered to the patient was expired (expiration date 09/12/2025). No adverse event at this time.
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| 2872438 | 56 | F | FL | 11/12/2025 |
FLU3 |
SANOFI PASTEUR |
u8864ca |
Product administered at inappropriate site, Rash, Tenderness
Product administered at inappropriate site, Rash, Tenderness
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The patient's right arm and shoulder hurts still after getting the injection. She has a tender...
The patient's right arm and shoulder hurts still after getting the injection. She has a tender spot high on her arm and her arm is in a sling. It appears the shot may have been given higher in her arm than is typically recommended.
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| 2872439 | 41 | F | MT | 11/12/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA4459 P394K |
Neuralgia; Neuralgia
Neuralgia; Neuralgia
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Patient reported suffering nerve pain the next day. It was not indicated to us which vaccine was t...
Patient reported suffering nerve pain the next day. It was not indicated to us which vaccine was the offending site.
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| 2872443 | 73 | F | GA | 11/12/2025 |
COVID19 RSV |
MODERNA PFIZER\WYETH |
3052733 mm9151300924651 |
Erythema, Skin abrasion; Erythema, Skin abrasion
Erythema, Skin abrasion; Erythema, Skin abrasion
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red raised area size of a nickle, warm to touch extending further down arm about two inches. patient...
red raised area size of a nickle, warm to touch extending further down arm about two inches. patient took tylenol and had doctor look at it at a regularly scheduled appointment and said to give it a few more days. when she came to the pharmacy today I measured the area to document and applied benadryl cream to the entire area affected, told her to continue tylenol and sold her a tube of cortisone cream to apply when she got home over the course of the next couple days, to watch and observe. I told her i would call her tomorrow to check on symptoms, improvement or no improvement,
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| 2872444 | 32 | F | RI | 11/12/2025 |
COVID19 |
MODERNA |
|
Genital herpes simplex, Oral herpes
Genital herpes simplex, Oral herpes
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Genital HSV-1 outbreak, cold sores around labia
Genital HSV-1 outbreak, cold sores around labia
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| 2871982 | 87 | F | PA | 11/11/2025 |
PPV PPV PPV UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Pain in extremity, Pruritus, Rash macular, Skin warm; Pain in extremity, Pruritu...
Pain in extremity, Pruritus, Rash macular, Skin warm; Pain in extremity, Pruritus, Rash macular, Skin warm; Pain in extremity, Pruritus, Rash macular, Skin warm; Pain in extremity, Pruritus, Rash macular, Skin warm
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arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch.";...
arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch."; arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch."; her right arm that received the Pneumonia shot in was hurting; arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch."; This spontaneous report was received from a Consumer or other non-health professional and referred to an 87-years-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Congestive Heart Failure, and she had a pace maker. Concomitant medications included Metoprolol (Metoprolol fumarate), Losartan (Losartan potassium), Potassium (Potassium chloride), Furosemide (Furosemide sodium), Jardiance (Empagliflozin), Thyroidine (Thyroid), Simvastatinx (Simvastatin), Prolia (Denosumab). On 17-Sep-2025, the patient started therapy with an unspecified Pneumonia Vaccine (Manufacturer unknown) (strength, dose, dose number, frequency, vaccination scheme, and route were not reported), in her right arm, as prophylaxis. On the same date, the patient started therapy with Unspecified Flu Vaccine (strength, dose, dose number, frequency, vaccination scheme, and route were not reported), in her left arm, as prophylaxis. On 24-Sep-2025 ("seven days later"), the patient woke up and her right arm that received the Pneumonia shot in was hurting, she stated that arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch." Patient then called the doctor's office on the same day to report and was only told it was a Pneumonia Vaccine from the company that she received in that arm, however she was not provided a brand name. The office advised this patient to take diphenhydramine (BENADRYL) and acetaminophen (TYLENOL), which she did not take. She was also advised to ice it and move her arm around, which she did do; the patient stated that within 24 to 48 hours, on an unknown date in September 2025, the arm was back to normal. At the reporting time, the outcome of the events was recovered. The reporter did not assess the causal relationship between the events and the suspect vaccines.; Reporter's Comments: Keywords : OCL
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| 2871987 | 11/11/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Dyspnoea, Respiratory syncytial virus infection, Vaccination failure
Dyspnoea, Respiratory syncytial virus infection, Vaccination failure
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RSV; Suspected vaccination failure; This serious case was reported by a consumer via interactive dig...
RSV; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included covid-19 (in December and January), pneumonia (in February) and shingles (in March). Previously administered products included Covid-19 vaccine with an associated reaction of covid-19 (had the Covid shot got covid in December and January). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 28-OCT-2025 This case was reported by a patient via interactive digital media. The patient had RSV vaccine and had the shot, was in the hospital for six days. The patient got a lot of shots all the breathing treatments lot of everything. Respiratory syncytial virus infection was absolutely terrible. The patient could not breathe because the rescue to scary thing get the shots. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, an unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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โ | ||||||||
| 2871990 | 11/11/2025 |
FLUX |
UNKNOWN MANUFACTURER |
No batch number |
Malaise, Pyrexia
Malaise, Pyrexia
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Felt terrible; Fever for a long time; This spontaneous case, initially received on 24-Oct-2025, was ...
Felt terrible; Fever for a long time; This spontaneous case, initially received on 24-Oct-2025, was reported by a non health professional and concerns a patient of an unknown age/gender. The patient had no relevant medical history. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported indication, Dose regimen: not reported, Route of administration: Unknown, Lot number: No batch numbner available and would not be obtained due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Felt terrible (outcome: Unknown), Fever for a long time (outcome: Unknown). When patient injected to self with the flu vaccine, patient felt terrible, had a fever for a long time. It had been years since patient had done it more. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter considered the events as non-serious and causality assessment was reported as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, the events (Felt terrible, Fever for a long time) are considered related for reporting purposes.
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| 2872010 | F | MO | 11/11/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Vaccination failure
Vaccination failure
|
Felt the vaccine was ineffective or did not work; This spontaneous case, initially received on 30-Oc...
Felt the vaccine was ineffective or did not work; This spontaneous case, initially received on 30-Oct-2025, was reported by a health professional and concerns a female patient. Medical history and concomitant medication was reported as unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: not reported, Route of administration: not reported, Anatomical Location: not reported, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient felt the vaccine was ineffective or did not work (Medically Significant, outcome: Unknown). A patient received a flu vaccine but felt the vaccine was ineffective or did not work. The patient went to the pharmacy requested revaccination. Pharmacist inquired and tried to get some information about Flucelvax, and whether a patient could receive two doses. The patient who received immunization said she did not felt like going, so she was convinced she did not get it and wanted another one. The pharmacist just needed to know whether there's any guideline so she could have a second dose. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter did not provide causality assessment of the event and seriousness was assessed as unknown.; Reporter's Comments: Due to the spontaneous nature of the case, the event vaccination failure is considered related for reporting purposes. However, the information provided is insufficient (vaccine administration date, whether patient actually developed influenza virus infection in the time frame of 21 to 180 days after vaccination and its confirmation with laboratory tests are not known) to perform a more in-depth analysis.
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| 2872059 | F | LA | 11/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Eye pruritus, Inappropriate schedule of product administration, Nasal polyps, Oc...
Eye pruritus, Inappropriate schedule of product administration, Nasal polyps, Ocular hyperaemia, Ophthalmic herpes zoster
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she got shingles in her right eye/the right eye is red and itchy.; increased eye pressure; This seri...
she got shingles in her right eye/the right eye is red and itchy.; increased eye pressure; This serious case was reported by a nurse via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received mepolizumab (Nucala) solution for injection in pre-filled pen for nasal polyp. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Caller reports she had one dose of Shingrix about 3 years ago but never received the second dose.). On an unknown date, the patient started Nucala (subcutaneous) 100 mg and the 3rd dose of Shingrix. On an unknown date, an unknown time after starting Nucala and an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: she got shingles in her right eye/the right eye is red and itchy.) (serious criteria GSK medically significant) and increased intraocular pressure (Verbatim: increased eye pressure). The action taken with Nucala was unknown. The outcome of the ophthalmic herpes zoster was not resolved and the outcome of the increased intraocular pressure was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and increased intraocular pressure to be related to Nucala, Nucala Autoinjector Device and Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Nucala, Nucala Autoinjector Device and Shingrix. It was unknown if the company considered the increased intraocular pressure to be related to Nucala, Nucala Autoinjector Device and Shingrix. 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 23-OCT-2025 The patient, a retired nurse, reported that she received one injection of Nucala Autoinjector for nasal polyps a few months ago, although she could not recall the exact date or month. Approximately two weeks following the injection, she developed shingles in her right eye. The patient mentioned that she had received one dose of the Shingrix vaccine about three years ago but did not complete the second dose, indicating an inappropriate schedule of vaccination. The caller states she kept going on and off the steroid eye drops because they was raising the pressure in her right eye. The shingles was still not resolved, and the right eye was red and itchy. Caller states she only took the one dose of Nucala and her HCP decided it. Steroid consider as co-suspect.; Sender's Comments: The company has assessed that it is unlikely that Ophthalmic herpes zoster was caused by the Nucala drug, Nucala AUTOINJECTOR DEVICE .Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought. A case of Ophthalmic herpes zoster, an unknown time after receiving Shingrix, in a female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2872060 | 11/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Guillain-Barre syndrome
Guillain-Barre syndrome
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it gave me Guillain-Barr๏ฟฝ-syndrome in 2022; This serious case was reported by a consumer via inter...
it gave me Guillain-Barr๏ฟฝ-syndrome in 2022; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: it gave me Guillain-Barr๏ฟฝ-syndrome in 2022) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-NOV-2025 This case was reported by a patient via interactive digital media. The patient got the shot, and it gave guillain barre syndrome to patient in 2022. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2872067 | 11/11/2025 |
FLUX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
|
I've gotten flu shots three times since they came out, three times I was sick as a dog for over...
I've gotten flu shots three times since they came out, three times I was sick as a dog for over a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced sickness (Verbatim: I've gotten flu shots three times since they came out, three times I was sick as a dog for over a week). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Flu vaccine. It was unknown if the company considered the sickness to be related to Flu vaccine. Linked case(s) involving the same patient: US2025AMR140641, US2025AMR145562 Additional Information: GSK Receipt Date: 26-OCT-2025 This case was reported by a patient via interactive digital media. The patient had gotten flu shots three times since they came out, three times he/she was sick as a dog for over a week. During covid he was a critical worker, over a year he watched them around him getting it. He never did, then wife got cancer and he decided to get the shot so he wouldn't get sick and not care for her. A week later he was sick as shit. So, since that he had not gotten anything that involves a lab made so called protector. The batch number was not provided, and we are unable to contact the reporter. This was 1 of the 3 cases, reported by the same reporter.
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| 2872068 | 11/11/2025 |
FLUX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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sick; This non-serious case was reported by a consumer via interactive digital media and described t...
sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Flu vaccine. On an unknown date, 1 week after receiving Flu vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Flu vaccine. It was unknown if the company considered the sickness to be related to Flu vaccine. Linked case(s) involving the same patient: US2025AMR140641, US2025AMR145551 Additional Information: GSK Receipt Date: 26-OCT-2025 This case was reported by a patient via interactive digital media. The patient had gotten flu shots three times since they came out, three times he/she was sick as a dog for over a week. During covid he was a critical worker, over a year he watched them around him getting it. He never did, then wife got cancer and he decided to get the shot so he wouldn't get sick and not care for her. A week later he was sick. So, since that he had not gotten anything that involves a lab made so called protector. The batch number was not provided, and we are unable to contact the reporter. This was 1 of the 3 cases, reported by the same reporter.
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| 2872070 | 24 | F | LA | 11/11/2025 |
FLU3 |
SEQIRUS, INC. |
410514 |
Pain, Rash pruritic
Pain, Rash pruritic
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Reports throat soreness & severely itchy rash
Reports throat soreness & severely itchy rash
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| 2872071 | 8 | F | 11/11/2025 |
FLU3 |
SEQIRUS, INC. |
407001 |
Device leakage
Device leakage
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Per staff part of the vaccine leaked out of the junction of the needle and the syringe. After inspe...
Per staff part of the vaccine leaked out of the junction of the needle and the syringe. After inspection of the needle the threads that hold the needle on to the syringe they were found to be faulty
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| 2872072 | 10 | F | MI | 11/11/2025 |
COVID19 |
MODERNA |
3052835 |
No adverse event
No adverse event
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no adverse event, treatment, or outcome
no adverse event, treatment, or outcome
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| 2872073 | 55 | F | KY | 11/11/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site pain, Injection site warmth, Pain; Injec...
Injection site erythema, Injection site pain, Injection site warmth, Pain; Injection site erythema, Injection site pain, Injection site warmth, Pain
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Left entire deltoid covered with redness. Heat from the readiness. Pain with palpating and movemen...
Left entire deltoid covered with redness. Heat from the readiness. Pain with palpating and movement of deltoid.
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| 2872077 | 52 | F | OH | 11/11/2025 |
FLU3 |
SANOFI PASTEUR |
U8837CA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient did not have any adverse events. Vaccine was administered outside of indication by pharmaci...
Patient did not have any adverse events. Vaccine was administered outside of indication by pharmacist at a flu vaccine clinic.
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| 2872079 | 44 | M | OK | 11/11/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9CC9K |
Blood test, Computerised tomogram head, Lumbar puncture, Magnetic resonance imag...
Blood test, Computerised tomogram head, Lumbar puncture, Magnetic resonance imaging spinal, Neurological symptom
More
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yearly influenza vaccine taken 10/26, GBS symptoms started 11/6 leading to hospitalization
yearly influenza vaccine taken 10/26, GBS symptoms started 11/6 leading to hospitalization
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โ | โ | ||||
| 2872080 | 31 | F | MN | 11/11/2025 |
FLU3 |
SEQIRUS, INC. |
|
Nasopharyngitis, Rash, Urticaria
Nasopharyngitis, Rash, Urticaria
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Two days after the vaccine was administered, I started having cold like symptoms. On Monday, Novembe...
Two days after the vaccine was administered, I started having cold like symptoms. On Monday, November 10, I developed rashes and hives all over my body (stomach, shoulders, neck and hip area).
More
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| 2872082 | 87 | F | WI | 11/11/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
3053756 3053756 3053756 3053756 |
Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increase...
Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase increased; Blood bilirubin normal, Computerised tomogram abdomen abnormal, Cytomegalovirus test negative, Decreased appetite, Epstein-Barr virus antibody; Haemoglobin decreased, Hepatitis viral test negative, Mean cell volume normal, Nausea, Pancreatic atrophy; Platelet count decreased, Scan with contrast abnormal, Thrombocytopenia
More
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She presented to the ED on 11/3 with weakness, nausea, and decreased appetite. Lab work demonstrate...
She presented to the ED on 11/3 with weakness, nausea, and decreased appetite. Lab work demonstrated anemia, hemoglobin 9.6 with MCV 92.8, thrombocytopenia platelets 123, elevated liver enzymes AST 505, ALT 231, alk phos 374 and normal T. bili at 0.75. CT A/P with IV contrast revealed unremarkable liver, gallbladder, and biliary tree. Pancreas revealed parenchymal atrophy but no mention of PD dilatation. No lymphadenopathy. Acute hep panel negative. EBV and CMV serology revealed prior but no current infection. Further lab work was ordered to rule out possible causes of cholestatic liver injury negative for autoimmune hepatitis, PBC, PSC, alcoholic hepatitis, and celiac disease.
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| 2872085 | 69 | F | PA | 11/11/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR |
|
Chills, Cough, Eye discharge, Eye pain, Eyelid margin crusting; Ocular hyperaemi...
Chills, Cough, Eye discharge, Eye pain, Eyelid margin crusting; Ocular hyperaemia, Oesophageal pain, Oropharyngeal pain, Pyrexia, Wheezing; Chills, Cough, Eye discharge, Eye pain, Eyelid margin crusting; Ocular hyperaemia, Oesophageal pain, Oropharyngeal pain, Pyrexia, Wheezing
More
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About 2 1/2 hours after the Covid and Flu shot I started getting bad symptoms or side effects. I�...
About 2 1/2 hours after the Covid and Flu shot I started getting bad symptoms or side effects. I've had about 7 Covid shots so far and did okay but have never gotten the Fluzone high dose Flu shot before so am assuming it was the Flu shot. I had regular flu shots the past 2 years and did fine. This was first time for Fluzone high dose. It started with severe pain from my throat down my esophagus and into my stomach, I thought it was acid reflux but it was worse than I've ever had. It finally stopped but then I started having wheezing (and normally my Asthma is very mild and under control) and had a very croupy cough. Finally I fell asleep about 6 pm and woke up to my eyes crusted shut with yellowish liquid and the whites of my eyes were very red and sore. I started running a 101 fever and had bad chills but I had expected that. Most concerning was the throat and esophagus pain and the eye issues. The eye issues lasted until this morning and finally the whites of my eyes aren't pink and not crusted or sore.
More
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| 2872086 | 86 | F | CO | 11/11/2025 |
COVID19 |
MODERNA |
3052668 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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Patient came into the pharmacy on 11/11/25 & showed me a red area surrounding vaccine site appro...
Patient came into the pharmacy on 11/11/25 & showed me a red area surrounding vaccine site approximately 2x3inches. Patient reports that the area itches. Recommended that patient report adverse reaction to provider.
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| 2872087 | 60 | F | PA | 11/11/2025 |
FLU3 |
SEQIRUS, INC. |
AX6340A |
Burning sensation, Limb discomfort, Nausea, Pain in extremity
Burning sensation, Limb discomfort, Nausea, Pain in extremity
|
Heaviness and burning sensation pain down my arm, nausea.
Heaviness and burning sensation pain down my arm, nausea.
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| 2872090 | 2 | F | CA | 11/11/2025 |
FLU3 |
SANOFI PASTEUR |
UT8861KA |
Pyrexia
Pyrexia
|
Fever starting 7 days post immunization. Patient given Ibuprofen, with improvement, office appointm...
Fever starting 7 days post immunization. Patient given Ibuprofen, with improvement, office appointment offered for further evaluation but declined by family.
More
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| 2872092 | 71 | M | IA | 11/11/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
NA4452 407252 |
Hypoaesthesia, Magnetic resonance imaging, Pain in extremity; Hypoaesthesia, Mag...
Hypoaesthesia, Magnetic resonance imaging, Pain in extremity; Hypoaesthesia, Magnetic resonance imaging, Pain in extremity
More
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rec'd injection 10/30/25, reported arm soreness and numbness 10/31/25. patient reported to ER, ...
rec'd injection 10/30/25, reported arm soreness and numbness 10/31/25. patient reported to ER, staff did MRI and stroke evaluation
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| 2872097 | 17 | F | MD | 11/11/2025 |
FLU3 MENB |
SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS |
UT8858 X2TC2 |
Head injury, Immediate post-injection reaction, Loss of consciousness, Tremor; H...
Head injury, Immediate post-injection reaction, Loss of consciousness, Tremor; Head injury, Immediate post-injection reaction, Loss of consciousness, Tremor
More
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Per mother's report: Immediately after vaccine administration patient passed out, hit head on s...
Per mother's report: Immediately after vaccine administration patient passed out, hit head on side of windowsill and had symmetric shaking of arms and legs for less than a minute. Patient fully recovered and went home appx 40 minutes after episode.
More
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| 2872101 | 45 | M | PA | 11/11/2025 |
FLU3 |
SANOFI PASTEUR |
U8859CA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient is only 45 years old and got the Fluzone High Dose without having any conditions to qualify ...
Patient is only 45 years old and got the Fluzone High Dose without having any conditions to qualify the patient to receive the high dose.
More
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| 2872103 | 68 | F | PA | 11/11/2025 |
FLU3 |
SEQIRUS, INC. |
407275 |
Arthralgia, Peripheral swelling, Rash macular
Arthralgia, Peripheral swelling, Rash macular
|
patient experienced red blotchy swollen arm from shoulder to the elbow and towards the back from und...
patient experienced red blotchy swollen arm from shoulder to the elbow and towards the back from under the arm the night of the vaccine. shoulder was very sore. took allegra and tylenol for a couple of days, says still a faint red mark on 11/11/25
More
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| 2872105 | 88 | M | MO | 11/11/2025 |
FLU3 |
SEQIRUS, INC. |
407255 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
No adverse event to my knowledge, but pt requested a covid vaccine and was given the flu shot. He...
No adverse event to my knowledge, but pt requested a covid vaccine and was given the flu shot. He had already had the flu shot at his doctors office. We asked him if he was here for flu shot, but he misunderstood us and agreed that is what he wanted. We are reporting that pt has received 2 flu shots this season.
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| 2872106 | 38 | M | CA | 11/11/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Dizziness, Nausea, Seizure like phenomena, Unresponsive to stimuli, Vomiting
Dizziness, Nausea, Seizure like phenomena, Unresponsive to stimuli, Vomiting
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The patient presented for covid 19 and influenza immunizations. Consent forms were reviewed prior to...
The patient presented for covid 19 and influenza immunizations. Consent forms were reviewed prior to vaccination and all screening question were answered in the negative. Per record, the patient previously received Pfizer Covid 19 vaccinations, with the most recent dose administered in 2022. The Pfizer Comirnaty vaccine was administered 11/7/2025. Shortly after administration, the patient exhibited brief seizure-like activity lasting very briefly. The patient regained responsiveness promptly and reported dizziness and nausea. the patient experienced two episodes of vomiting, after which he reported feeling slightly better. I remained with the patient throughout the entire event and continued close observation. An EpiPen was prepared and kept at the side. However administration was not indicated as the patient maintained normal respiratory effort. Emergency medical services were contacted, and paramedics arrived on site. the Patient s vital signs were assessed and found to be with normal limits, with the exception of mildly decrease blood pressure. The patient remained alert and oriented and was able to walk on his own power. The patient expressed a desire to be evaluated at the hospital. The patient walked on his own power, supported by his accompanying friend and monitored closely by paramedics, from the immunization room to the ambulance for transport.
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| 2872107 | 4 | F | MN | 11/11/2025 |
FLU3 FLU3 UNK UNK |
SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
U8832CA U8832CA U8832CA U8832CA |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Pt received Flublok at 1130. No signs of symptoms of an adverse event. Nurse reached out to manger. ...
Pt received Flublok at 1130. No signs of symptoms of an adverse event. Nurse reached out to manger. Manger contacted Sanofi Pasteur rep for guidance. Manager also reached out to Chief of Staff, Dr. [withheld], Pharmacy, and looked for insight from immunize.org
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| 2872108 | 65 | F | AZ | 11/11/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Chills, Headache, Pain, Pyrexia
Chills, Headache, Pain, Pyrexia
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low grade fever, aches, headache, sweating, chills
low grade fever, aches, headache, sweating, chills
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| 2872109 | 3 | F | FL | 11/11/2025 |
FLU3 |
SANOFI PASTEUR |
Ut8873ka |
Circumstance or information capable of leading to medication error, Underdose
Circumstance or information capable of leading to medication error, Underdose
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The child pulled away during administration. This caused the needle to come out and most of the dose...
The child pulled away during administration. This caused the needle to come out and most of the dose was lost. Patient did not receive entire dose.
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| 2872110 | 49 | F | AZ | 11/11/2025 |
COVID19 |
MODERNA |
3052864 |
Injection site swelling
Injection site swelling
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swelling at injection site, gave benadryl, counseled patient to monitor symptoms if they get worse t...
swelling at injection site, gave benadryl, counseled patient to monitor symptoms if they get worse to see emergency provider. told patient to take zyrtec for the next few days for possible reaction
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