| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2870347 | F | 11/03/2025 |
COVID19 |
MODERNA |
025C20A |
Lung disorder, Lung neoplasm malignant
Lung disorder, Lung neoplasm malignant
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shadows in her lungs; lung cancer; This spontaneous case was reported by a consumer and describes th...
shadows in her lungs; lung cancer; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (lung cancer) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 025C20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In September 2024, the patient experienced LUNG NEOPLASM MALIGNANT (lung cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced LUNG DISORDER (shadows in her lungs). The patient was treated with Pembrolizumab (Keytruda) for Cancer, at an unspecified dose and frequency. At the time of the report, LUNG NEOPLASM MALIGNANT (lung cancer) and LUNG DISORDER (shadows in her lungs) was resolving. No concomitant medications were provided. The patient had received 2nd dose of Moderna Covid-19 vaccine in Feb-2022. The other batch/lot numbers were reported as 017M20A, 066K214 and A43914B. The patient found out she had lung cancer in Sep-2024 after her last vaccine on 06-Apr-2024. The patient also had Keytruda for the cancer, but the doctor took her off because it was making shadows in her lungs. It was unknown if the patient experienced any additional symptoms/events. This case was linked to MOD-2025-790634 (Patient Link).; Reporter's Comments: Due to lack of biological plausibility, the causality of the event lung cancer was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
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| 2870348 | 45 | F | 11/03/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
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Erythema, Swelling; Erythema, Swelling
Erythema, Swelling; Erythema, Swelling
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swelling; redness; This spontaneous case was reported by a physician and describes the occurrence of...
swelling; redness; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (swelling) and ERYTHEMA (redness) in a 45-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 and non-company product included Influenza vaccine inact sAg 3v (Flucelvax) for an unknown indication. Concomitant products included Naproxen for an unknown indication. On 24-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine inact sAg 3v (Flucelvax) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Oct-2025, the patient experienced SWELLING (swelling) and ERYTHEMA (redness). At the time of the report, SWELLING (swelling) and ERYTHEMA (redness) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. It was reported that for patient increased swelling and redness as compared to previous years. It was unknown if the patient experienced any additional symptoms/events No treatment medications provided by the reporter.
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| 2870349 | F | 11/03/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
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Decreased appetite, Headache, Pain, Pyrexia, Sleep disorder; Fatigue, Injection ...
Decreased appetite, Headache, Pain, Pyrexia, Sleep disorder; Fatigue, Injection site oedema, Injection site pain, Injection site swelling; Decreased appetite, Headache, Pain, Pyrexia, Sleep disorder; Fatigue, Injection site oedema, Injection site pain, Injection site swelling
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Pain; Sleep; No appetite; Fever; Headache; This spontaneous case was reported by a consumer and desc...
Pain; Sleep; No appetite; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SLEEP DISORDER (Sleep), DECREASED APPETITE (No appetite), PYREXIA (Fever) and HEADACHE (Headache) in an elderly female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), SLEEP DISORDER (Sleep), DECREASED APPETITE (No appetite), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN (Pain), SLEEP DISORDER (Sleep), DECREASED APPETITE (No appetite), PYREXIA (Fever) and HEADACHE (Headache) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were provided. Patient's age at the time of reporting was 76-yeras. The patient had a side effect with every Covid vaccine which was received by the patient. The patient used to get the regular Moderna in past years, and always had horrible, the worst side effects of anyone would ever meet. Every symptom could get knocked out for 2 days, but it was important, so patient would always get it, but very severe. The patient had everything on the list, headache, fever, pain, sleep, no appetite. It lasted 2 days and then it would just go away instantly on the at the end of the 2nd day. No treatment medication was provided. This case was linked to MOD-2025-790649 (Patient Link).
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| 2870350 | 61 | F | 11/03/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
3052586 |
Muscular weakness, Pain in extremity, Peripheral swelling; Muscular weakness, Pa...
Muscular weakness, Pain in extremity, Peripheral swelling; Muscular weakness, Pain in extremity, Peripheral swelling
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weakness in that same arm; pain; swelling in the arm; This spontaneous case was reported by an other...
weakness in that same arm; pain; swelling in the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (weakness in that same arm), PAIN IN EXTREMITY (pain) and PERIPHERAL SWELLING (swelling in the arm) in a 61-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052586) for COVID-19 prophylaxis. The non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Blood pressure high. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced MUSCULAR WEAKNESS (weakness in that same arm), PAIN IN EXTREMITY (pain) and PERIPHERAL SWELLING (swelling in the arm). In 2025, PERIPHERAL SWELLING (swelling in the arm) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness in that same arm) and PAIN IN EXTREMITY (pain) had not resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medication was reported. HCP reported that her patient experienced swelling in the arm she received the vaccine in, affecting all of her arm and not only the injection site. This swelling lasted for 1 week then went down. She then experienced weakness in that same arm and pain. According to the HCP the pain was severe enough that she was unable to hold a blow dryer. Patient was a hairdresser. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Event causality was not reported.
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| 2870351 | 41 | F | 11/03/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Fatigue, Feeling hot, Headache, Nausea, Pain in extremity; Peripheral swelling
Fatigue, Feeling hot, Headache, Nausea, Pain in extremity; Peripheral swelling
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headache; nauseous/ feels like throwing up; arm is swollen; arm is tender; feeling kind of hot; very...
headache; nauseous/ feels like throwing up; arm is swollen; arm is tender; feeling kind of hot; very tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (arm is tender), FEELING HOT (feeling kind of hot), FATIGUE (very tired and fatigued) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Syndrome lupus. On 27-Oct-2025 at 5:00 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (arm is tender), FEELING HOT (feeling kind of hot), FATIGUE (very tired and fatigued) and NAUSEA (nauseous/ feels like throwing up). On 27-Oct-2025, the patient experienced HEADACHE (headache). The patient was treated with Paracetamol (Tylenol) in October 2025 at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm is swollen), PAIN IN EXTREMITY (arm is tender), FEELING HOT (feeling kind of hot), FATIGUE (very tired and fatigued), HEADACHE (headache) and NAUSEA (nauseous/ feels like throwing up) had not resolved. Patient did not receive any vaccines within the past 4 weeks. No concomitant medication was reported. The patient received Spikevax on 27-Oct-2025 and was very tired and fatigued right till the day of reporting and was experiencing a headache for two days. She was nauseous too. Her arm was swollen and tender and mostly had a headache. She was having a headache during the call and felt kind of hot. On 29-Oct-2025, her headache was bad and felt like throwing up. She used Tylenol and it did not help. It was unknown if the patient experienced any additional symptoms/events.
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| 2870352 | F | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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It killed my older sister; This is a spontaneous report received from a Consumer or other non HCP fr...
It killed my older sister; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "It killed my older sister". The date and cause of death for the patient were unknown. Clinical details: The wife stated it killed her mom, her dad, her two older sisters, her husband had relatives die, they've had friends die and no one takes it off the market. It's got a whole bunch of stuff in it that is toxic to the body and it has the spike protein which causes harm to the body. (withheld) has had several conferences with these people that have gotten the covid jab and they almost died and a lot of them have died and they're, like, crippled now and they have heart disease and nobody's doing jack about it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500213507 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: Unknown cause of death
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| 2870353 | F | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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It killed my two older sisters; This is a spontaneous report received from a Consumer or other non H...
It killed my two older sisters; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "It killed my two older sisters". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical details: The wife stated it killed her mom, her dad, her two older sisters, her husband had relatives die, they've had friends die and no one takes it off the market. It's got a whole bunch of stuff in it that is toxic to the body and it has the spike protein which causes harm to the body. (withheld) has had several conferences with these people that have gotten the covid jab and they almost died and a lot of them have died and they're, like, crippled now and they have heart disease and nobody's doing jack about it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500213507 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: Unknown cause of death
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| 2870354 | F | 11/03/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Influenza like illness; Influenza like illness
Influenza like illness; Influenza like illness
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flu-like symptoms/has residual chest congestion; This is a spontaneous report received from a Pharma...
flu-like symptoms/has residual chest congestion; This is a spontaneous report received from a Pharmacist and a Consumer or other non HCP, Program ID. An elderly female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vyndamax, start date: 26Jul2024, notes: 61 mg once daily. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovering", described as "flu-like symptoms/has residual chest congestion". Additional information: Vendor (Submitter) Occupation: Pharmacist Reported Event: this is the same patient as previously submitted Ref Patient reports she received both her flu and covid vaccine on the same day recently and then felt flu-like symptoms after. She is now recovering but has residual chest congestion. She is planning to get her pneumococcal vaccine next week. All info contained in this report is all thats available at the time of reporting. The reporting SPP does not wish to be contacted for follow up regarding this report. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2870355 | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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SARS-CoV-2 test, Vaccination site erythema
SARS-CoV-2 test, Vaccination site erythema
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red spot on the injection site; This is a spontaneous report received from a Consumer or other non H...
red spot on the injection site; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790422 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "flu" (unspecified if ongoing); "low-grade fever" (unspecified if ongoing), notes: for seven solid days. The patient's concomitant medications were not reported. Vaccination history included: spikevax nos (DOSE 4 (BOOSTER), SINGLE, 9 and 12 hours after the shot), administration date: 11Sep2023, for Covid-19 Immunization, reaction(s): "fever", "shaking chills", "feel lousy", "shoulder to elbow was beet red and itched like mad", "shoulder to elbow was beet red and itched like mad"; Spikevax nos (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 Immunization, reaction(s): "red spot at the injection site"; Spikevax nos (DOSE 2, SINGLE), administration date: 2021, for Covid-19 Immunization, reaction(s): "reaction", "24 hours of shaking chills", "fever"; Spikevax nos (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for Covid-19 Immunization, reaction(s): "reaction", "chills", "fever"; Spikevax nos (DOSE 3 (BOOSTER), SINGLE, arm got the shot in hurt for months, arm was sore for months after), administration date: 2022, for Covid-19 Immunization, reaction(s): "hurt like crazy"; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: Jun2024, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Sep2025, outcome "recovered", described as "red spot on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Additional information: stuggling with whether or not should get another shot So probably have pulled up all of shots have been COVID shots have been Moderna. From the first two, had those actually, like 28 days apart, not the, or 23 I think have 3 weeks apart. That doesn't matter. And then the very first time a booster came out, had that. And then a year after that, had the updated shot, which was not a booster. believe it was just a regular full shot and after that one, which was 3 years ago mean, had the same reaction with all but the first shots. Starting with the second shot, had the same 24 hours of shaking chills, and, but had read about that. You know, didn't like it, but, you know, it happened, it ended. Also, what think failed to report, a very, very first shot had which would have been like Feb2021, Right after the shot had a very small little red spot where the injection was, but read that, you know, that that's very common super common, and completely forgot about it, you know, when had the other shots, but after sorry, think that have reported all of reactions have always forgotten that first, that very first one of the little red spot on arm because it just was so meaningless. That started late that January had the strangest flu ever had. And just ran low-grade fever for seven solid days. Then it went kind of to digestive tract, and in 2021. had all shots at calling about because had with the 1st 12 1st booster with, with the 1st 3 shots had with the first shot, like said, basically had no reaction except that little red spot at the injection site. It was after. OK. So after the 2nd and the 3rd shot, had the chills, fever, you know, reaction. And so, you know. did, a lot of people know had the same reaction. And read about it online and it scared me. It was after the 4th shot and that was on 11Sep2022 think it was, it was, yeah, think that was 2022 because think that was last shot was. No, it could have been 23. The 4th shot, the last shot had, cause haven't had one since because it scared me so much and have called about this. And the last time, you know, called after it happened, called Moderna, and went through all of it with, because wanted to know if could have any more boosters because of, so should back up and tell you what the reaction was had, you know, fever and chills always start, say between 9 and 12 hours after the shot, get chills, and for about 24 hours have shaking chills and feel lousy, and then it just stops, goes away. But the last shot, the 4th shot, which was on 11Sep either of 22 or 23. And It's whatever the updated one was. It was a full shot, not a booster. So had that normal fever shaking chill reaction, went away, and a week later, a full week after the shot, noticed that my, the arm got the shot in from shoulder to elbow was beet red and itched like mad And thought, actually, after my 3rd shot, had mentioned to the pharmacist wher had 4th said, you know, after 3rd shot. It, the shot itself hurt like crazy when gave it to me. And thought, wow, really jabbed cause shots don't hurt. And for months, that arm, the arm got the shot in hurt for months. And it finally went away shortly before got 4th shot. And mentioned that to the pharmacist who looked at and said, that's not normal That shouldn't have happened. had the 4th shot. had the normal reaction. A week later, from shoulder to elbow turned beet red and itched. And for the next week, every day that area would get slightly smaller, slightly smaller till it eventually went away. And it took at least 1 week or 8 days for it to go away. You know, very religious about wearing masks if around other people, don't go into restaurants. Actually, wait, that shot was 2 years ago because This was the summer of 25, the summer of 2024. Yes. When was about 10 months old, got it in 20Sep. Wait a second. got it in 23Sep. That was last shot 11Sep2023. And Jun2024. who had all Pfizer's shots that's what got when went got COVID and then got COVID, an actual, we did test. No. don't have, don't have their details. just know, you know, when you're talking among people, and you're going, yeah, had a fever. Yeah, had chills. Yeah, had this, had that. And then you just move on to talk about other things. have no clue if they had other shots. One who's about age and pretty sure had and so call actually almost a year younger than am, but to call. yeah just turned And One 4 early So chills and fever. Including other people Every, everyone every, every single one. sure of that, can't, speak can't offhand. don't want to mislead you. know that talked to multiple people who've been sick, but cannot be sure of them to give you that information and feel that given you super accurate information. question is, that because of that 3rd shot and then arm being so sore, and the pharmacist questioning that being, said that that shouldn't have happened, then have the 4th shot and a week after have it, arm turns bright red, turned bright red, itched for a week, but then it went away. So question is, after that, became afraid, you know, looked online, but you shouldn't get medical advice online don't like how body is responding to the shots worried about, You know, is immune system responding too strongly Do, in more danger from the shot than mean, not, don't have any of the factors that make getting COVID even more dangerous. am not overweight weigh You know, and weigh maybe on a good day. very active. work out every day. But don't want to get COVID. But on the other hand, got COVID when had had a shot. don't know what to do. And already has had shot this year. been to had shot. has absolutely no reactions to anything. though this time, did have a red spot on arm for a short period of time, but It was a think it was Pfizer, it was Pfizer, had it 4 weeks ago. stalled on flu shot. pretty sure, pretty sure showed oh, look, have this, this little red spot, and then it went away right away, like, kind of like the very first one had, but that's the first time that had happened to at least that noticed. body is just saying you pumped this with enough. you know, and you've had COVID twice, maybe just continue to be uber vigilant about where you go. It's, It's, you know, because reactions seem to get worse with each shot. That's what That's what worries some. That, that arm thing if it, even if it had come right away, if arm had gotten red. But the fact that it was a week later that body's responding is what really scared And no one had an answer, and nobody knew why. And then after the shot the year before when arm for months was so sore, why would that happen. The pharmacist said there's no way it's because jabbed you hard. No arm was sore for months after . No. that 3rd COVID shot" Patient reported that received the covid-19 vaccine from Pfizer four weeks ago and that developed a red spot on the injection site that went away. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2870356 | 57 | F | NY | 11/03/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Body temperature, Pyrexia, Vaccination site pain; Body temperature, Pyrexia, Vac...
Body temperature, Pyrexia, Vaccination site pain; Body temperature, Pyrexia, Vaccination site pain
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Sore arm and Fever of 100.3; Sore arm and Fever of 100.3; This is a spontaneous report received from...
Sore arm and Fever of 100.3; Sore arm and Fever of 100.3; This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Oct2025 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Oct2025, in left arm. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "hypoparathyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "yellow and red food dye allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CALCITRIOL; ROSUVASTATIN; METFORMIN; WELLBUTRIN; MOUNJARO. The following information was reported: VACCINATION SITE PAIN (non-serious), PYREXIA (non-serious) all with onset 30Oct2025 at 05:45, outcome "recovering" and all described as "Sore arm and Fever of 100.3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia. Additional information: the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. 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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| 2870357 | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergic reaction to excipient
Allergic reaction to excipient
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patient has a severe allergy to an excipient in the Pfizer vaccine.; This is a spontaneous report re...
patient has a severe allergy to an excipient in the Pfizer vaccine.; This is a spontaneous report received from a Pharmacist. Other Case identifier(s): MOD-2025-790297 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, 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: ALLERGIC REACTION TO EXCIPIENT (hospitalization), outcome "recovered", described as "patient has a severe allergy to an excipient in the Pfizer vaccine.". Clinical course: HCP seeks vaccine location for a patient. She also stated that the patient has a severe allergy to an excipient in the Pfizer vaccine. Unknown if the patient experienced any additional symptoms/events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event allergic reaction to excipient and the suspect drug BNT162B2 OMICRON (LP.8.1) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 2870358 | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Petit mal epilepsy
Petit mal epilepsy
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Very minor seizures; slight absent seizures; This is a spontaneous report received from a consumer. ...
Very minor seizures; slight absent seizures; This is a spontaneous report received from a consumer. Other Case identifier(s): MOD-2025-790419 (Moderna), US-MO-MOC20251021000002 (Moderna), US-MODERNATX-MOC20251021000002 (Moderna), MOC20251021000002 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Hadn't had a seizure in several years, about 8 years; "Handicapped" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PETIT MAL EPILEPSY (disability, medically significant), outcome "unknown", described as "Very minor seizures; slight absent seizures". The patient has received 6 doses and over a period since the Pfizer vaccine became available. The patient who has previously received Pfizer vaccines had epilepsy and handicapped (disabled) and had small seizures following the Pfizer vaccine. The patient had very, very minor seizures. It's just that, the patient hadn't had a seizure in several years, about 8 years. And when developed these slight absent seizures, they really don't amount to very much, but they would still like to avoid it. The doctor does give medicine to kind of calm down before the patient has the COVID-19 vaccine. They were hoping to get away from having to do that, so they wanted to find out about mNEXSPlKE availability in the area as well as whether mNEXSPlKE has to be refrigerated or frozen. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2870359 | M | FL | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Prostate cancer
Prostate cancer
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Prostate cancer; This is a spontaneous report received from a consumer from License Party. Other Cas...
Prostate cancer; This is a spontaneous report received from a consumer from License Party. Other Case identifier(s): AE-021404 (BioNTech). A 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: "Leukemia" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: PROSTATE CANCER (medically significant) with onset 29Oct2025, outcome "unknown". At the day of reporting (29Oct2025; reported by the patient's sibling who was a participant in mRNA COVID-19 vaccine clinical trials), the patient was diagnosed with prostate cancer. The patient had leukemia a few years back and worked with his doctors and COVID-19 vaccine back then too. The patient was fully cured of leukemia. They are trying and seeking the best treatment for his cancer (prostate cancer). The patient's sibling looked up and saw that the company had trials for the mRNA vaccine for prostate cancer, but it also said ended. The patient's sibling was wondering if there are available trials the patient might be able to enter to try the prostate cancer mRNA vaccine. The patient's sibling asked for information as soon as possible as the patient begins his fight with this disease. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. BNT162b2 is under agreement with BIONTECH SE.
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| 2870360 | F | GA | 11/03/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
6315MF002C |
Pain in extremity
Pain in extremity
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little sore in arm; Initial information received on 17-Oct-2025 and 20-Oct-2025 processed together w...
little sore in arm; Initial information received on 17-Oct-2025 and 20-Oct-2025 processed together with agency 17-Oct-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 73 years old female patient (59.09 kg) who had little sore in arm after receiving NVX-COV2373 (original) adjuvanted vaccine [Nuvaxovid]. The patient's past vaccination(s) included NUVAXOVID on 01-NOV-2024 and INFLUENZA VACCINE on 02-OCT-2025 (Lot Number: Not provided; Route: Intramuscularly; Body site: Right arm; Dose in number of series: Not provided.) The patient's past medical history, past medical treatment and family history were not provided. Medical history and other illnesses at the time of vaccination and up to one month prior: No Allergies to drugs, food or other products: No Concomitant medications included Atorvastatin (Atorvastatin) for Blood cholesterol abnormal; and Raloxifene hydrochloride (Evista) for Osteoporosis. Consumer stated, "I take a bone pill raloxifene, which I think is Evista. It's for bones, for osteoporosis. I take a vitamin, I was taking a cholesterol, atorvastatin. I take a vitamin B2 or B12, calcium. And then I take a Redoxon, which is vitamin C." On 16-Oct-2025, the patient received unknown dose (dose 2) of suspect NVX-COV2373 (original) adjuvanted vaccine, Injection (strength; Not reported; lot 6315MF002C; Expiration Date: 31-DEC-2025) via intramuscular route in the right arm for prophylactic vaccination. On 16-Oct-2025 on same day the patient had little sore in arm (pain in extremity). Consumer called and stated, "I had that company on the other line, so I apologize. I hope you were going to call me today. I'll answer any of your questions, but I do have a question for you. I got the one vaccine, the Novavax on Thursday, okay: Today is Monday. Do I need to get a second Novavax? I had a Novavax vaccine last year, November 1st of 2024. And now I got another one Thursday. Do I need to get another one, a booster or anything else? And I'm 73 years old." Regarding the pain in the arm the patient received the vaccine, consumer stated, "I didn't really have any pain. I mean, it was a little sore. I mean, I could feel it, but it was no, it was not a, it was not noticeable. It wasn't a problem." Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on unknown date in October 2025 for the event.
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| 2870362 | OH | 11/03/2025 |
FLU3 MEN UNK |
SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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Max/Low Temperature reached: negative 2๏ฟฝC Duration out of labelled range: 45 minutes administered ...
Max/Low Temperature reached: negative 2๏ฟฝC Duration out of labelled range: 45 minutes administered after the excursion occurred, with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with Influenza Trivalent Recombinant Vaccine [Flublok Tiv], Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] And Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] that had a temperature excursion where max/low temperature reached: negative 2๏ฟฝc duration out of labelled range: 45 minutes administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection and received an unknown dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Solution for injection and received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine Suspension for injection all with (lot number , strength and expiry date-unknown) via unknown route in unknown administration site for Immunization that had a temperature excursion where max/low temperature reached: negative 2๏ฟฝc duration out of labelled range: 45 minutes with no reported adverse event (poor quality product administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- Human error was unknown; Products were not suitable to use after excursion. Action taken was not applicable. 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.
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| 2870363 | 61 | F | CA | 11/03/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817KA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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gave an extra Fluzone NP shot, She got one dose of FLUZONE NP back in September and got second dose ...
gave an extra Fluzone NP shot, She got one dose of FLUZONE NP back in September and got second dose of the same today with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 61 years old female patient who gave an extra INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] shot, she got one dose of fluzone NP back in september and got second dose of the same today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': No other immunizations On 12-Sep-2025, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (lot UT8817KA) via unknown route in unknown administration site; then On 21-Oct-2025 the patient received an extra dose of 0.5 ml of same vaccine (Frequency: once, Strength: standard) (lot-U8881AA, expiry date: 30-Jun-2026) via intramuscular route in the left arm; for Influenza (Influenza immunization); with no reported adverse event (extra dose administered) (latency- same day). It was reported, ''Medical assistant is asking for guidance after they gave an extra Fluzone NP shot given to patient, or if there is anything that would affect her. Treatment: No''. Action taken was not applicable. 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.
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| 2870364 | 1.25 | VA | 11/03/2025 |
FLU3 |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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fluzone np was given to a 15-month-old patient last 13oct2025 and it was readministered with no repo...
fluzone np was given to a 15-month-old patient last 13oct2025 and it was readministered with no reported adverse event; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15 months old and unknown gender patient who received two dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] in one month with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation. On 22-Oct-2025 the patient received an extra dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation, with no reported adverse event (extra dose administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. 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.
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| 2870365 | 73 | F | IL | 11/03/2025 |
COVID19 FLU3 |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
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Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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patient receiving fluzone hd again today when it was supposed to be the covid-19 vaccine with no rep...
patient receiving fluzone hd again today when it was supposed to be the covid-19 vaccine with no reported ae; patient receiving fluzone hd again today when it was supposed to be the covid-19 vaccine with no reported ae; Initial information received on 22-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 74 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] again today when it was supposed to be the COVID-19 vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient received (dose 1) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe and on 22-Oct-2025, she also received an unknown dose 0.5ml (dose 2) (lot U8855AA) (expiry date 30-Jun-2026 and strength high dose, frequency once) via unknown route in unknown administration site for prophylactic vaacination (Immunisation) and received fluzone hd again today when it was supposed to be COVID-19 Vaccine not produced by Sanofi Pasteur (formulation unknown) with no reported adverse event (extra dose administered) (wrong product administered) (latency 7 days). Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA316300:2nd patient
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| 2870366 | 4 | F | MD | 11/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
948417 |
Circumstance or information capable of leading to medication error, Crying, Nerv...
Circumstance or information capable of leading to medication error, Crying, Nervousness, Panic reaction, Underdose
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Very nervous; Very panicked; Half the dose was given; This spontaneous case, initially received on 1...
Very nervous; Very panicked; Half the dose was given; This spontaneous case, initially received on 17-Oct-2025, was reported by a health professional and concerns a child female patient. Administration of company suspect drug: On 16-Oct-2025, the patient received Flucelvax (TIV) for indicated for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: 948417. No additional suspect drugs. Adverse reactions/events and outcomes: On 16-Oct-2025, same day of vaccination, the patient experienced Very nervous (outcome: Not Reported), Very panicked (outcome: Not Reported), Half the dose was given (outcome: Not Reported). The patient was very panicked, and after the pharmacist had punctured the skin with the needle, she moved out away from the needle. The pharmacist looked at the barrel again and looked like they gave her half the dose of the Flucelvax. Event description: The child was within the mom's arms of wrapping around, but the mom did not wrap the child tight enough, so when the pharmacist went to administer the shot, the pharmacist was slowly pushing the plunger to give the dose, as the pharmacist was doing that, she moved her arm so quickly that she got away from the needle, but the needle was already insider her left deltoid, and she was crying, she was nervous, the pharmacist did not want to scar her again with the needle. There was nothing wrong with the syringe. Treatment measures associated with event: No, the patient didn't get the flu dose Outcome of event: Half the dose was given, no injuries. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter provided seriousness assessment as unknown for all of the events and did not provide causality assessment.; Reporter's Comments: The events Very nervous, Very panicked are related due to temporal relationship plausibility. The event Half the dose was given is not related due to nature of event (special situation).
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| 2870367 | 64 | M | PA | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
407244 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Patient was to receive fluarix, but was mistakenly given fluad on 10/31/25. I left a message for the...
Patient was to receive fluarix, but was mistakenly given fluad on 10/31/25. I left a message for the patient to call the pharmacy back once I realized what happened. Patient PCP was contacted and was also making an attempt to contact the patient.
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| 2870369 | 48 | M | ME | 11/03/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Amnesia, Asthenia, Balance disorder, Brain stem stroke, Central pain syndrome; C...
Amnesia, Asthenia, Balance disorder, Brain stem stroke, Central pain syndrome; Cerebrovascular accident, Cluster headache, Dizziness, Dysphagia, Facial paralysis; Fatigue, Headache, Hypertension, Lateral medullary syndrome, Magnetic resonance imaging head; Obstructive sleep apnoea syndrome, Pain in extremity, Restless legs syndrome, Speech disorder
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Weakness, fatigue, headaches, under left foot pain, unable to swallow, dizziness, left face side ...
Weakness, fatigue, headaches, under left foot pain, unable to swallow, dizziness, left face side dropped off, speeching issues. In the morning of September 11 2023. Went to ER, diagnosed with brainstem stroke . I am still in treatments , speeching therapy, OT, PT, neurology appointments , primary care appointments. Taking strrong medications
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| 2870370 | 64 | F | UT | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
407981 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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FLUAD SR DOSE GIVEN TO 64 YEAR OLD IN ERROR
FLUAD SR DOSE GIVEN TO 64 YEAR OLD IN ERROR
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| 2870371 | 79 | F | NJ | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
948415 |
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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Pt has experienced pain and difficulty moving arm since vaccine given
Pt has experienced pain and difficulty moving arm since vaccine given
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| 2870372 | 61 | F | MI | 11/03/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA4459 KL47G |
Muscle tightness; Muscle tightness
Muscle tightness; Muscle tightness
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Approx 10 minutes after vaccines patient reports feeling of muscular "tightness" across up...
Approx 10 minutes after vaccines patient reports feeling of muscular "tightness" across upper chest. Denies dyspnea, chest pain, N/V. VS 130/90-72 regular. O2 sat 100%.
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| 2870374 | 19 | F | UT | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
407981 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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FLUAD SR DOSE GIVEN IN ERROR TO 19 YEAR OLD
FLUAD SR DOSE GIVEN IN ERROR TO 19 YEAR OLD
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| 2870375 | 28 | F | CA | 11/03/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9548 TFAA2547 |
Dizziness, Fall; Dizziness, Fall
Dizziness, Fall; Dizziness, Fall
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PT felt dizzy and lightheaded after given 2nd vaccine(flu) and felt off the chair while in the seate...
PT felt dizzy and lightheaded after given 2nd vaccine(flu) and felt off the chair while in the seated position. Pt laid on her back on the floor with legs elevated for about 5 minutes and was helped to her chair where she sat for about 20-30 minutes until she felt normal and better again before leaving pharmacy with her mother.
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| 2870377 | 81 | F | AZ | 11/03/2025 |
COVID19 |
MODERNA |
3052579 |
Underdose
Underdose
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PATIENT WAS GIVEN A PEDIATRIC DOSE OF SPIKEVAX (NDC: 80777-0113-80). I REPORTED THE INCIDENT TO MOD...
PATIENT WAS GIVEN A PEDIATRIC DOSE OF SPIKEVAX (NDC: 80777-0113-80). I REPORTED THE INCIDENT TO MODERNA. FOLLOWING CDC GUIDANCE ON MANAGEMENT OF ADMINISTRATION ERRORS, PT WAS GIVEN ANOTHER DOSE OF PEDIATRIC DOSE OF SPIKEVAX ON THE SAME CLINIC DAY TO MAKE IT 1 FULL DOSE FOR AN ADULT. BOTH DOSES WERE GIVEN ON HER RIGHT ARM.
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| 2870378 | 35 | M | UT | 11/03/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052581 407003 |
Chills, Pain, Pyrexia; Chills, Pain, Pyrexia
Chills, Pain, Pyrexia; Chills, Pain, Pyrexia
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PATIENT CALLED TO REPORT A VERY "ROUGH REACTION" : FEVER, CHILLS, VERY SORE AND WANTED TO ...
PATIENT CALLED TO REPORT A VERY "ROUGH REACTION" : FEVER, CHILLS, VERY SORE AND WANTED TO VERIFY BRAND TO NEVER GET IT AGAIN. DID RECEIVE FLU AND COVID ON SAME DAY.
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| 2870379 | 44 | M | TX | 11/03/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
MY9548 MY9548 |
No adverse event, Wrong product administered; Wrong product administered; No adv...
No adverse event, Wrong product administered; Wrong product administered; No adverse event, Wrong product administered; Wrong product administered
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PATIENT CAME TO GET COVID19 SHOT, WAS ORIGINALLY PUT IN FOR PFIZER (COMIRNATY), AND WHEN TECHNICIAN ...
PATIENT CAME TO GET COVID19 SHOT, WAS ORIGINALLY PUT IN FOR PFIZER (COMIRNATY), AND WHEN TECHNICIAN WENT IN TO GIVE SHOT PATIENT COMMUNICATED THAT HE WANTED THE MODERNA (MNEXSPIKE). TECHNICIAN CHANGED VACCINE IN OUR SYSTEM TO MODERNA, GOT CAUGHT AT REGISTER AND ASKED OUR INTERN TO ADMINISTER. ORIGINAL VACCINE PAPERWORK AND SYRINGE (PFIZER) WERE STILL SET ASIDE FOR PATIENT AND INTERN GAVE THOSE, NOT KNOWING THAT PATIENT HAD REQUESTED CHANGE TO MODERNA. PATIENT HAS REPORTED NO ADVERSE EFFECT FROM RECEIVING NON-PREFERRED VACCINE, OTHER THAN HE FEELS THAT IT IS ALREADY NOT AS EFFECTIVE BECAUSE HE DOES NOT FEEL A STRONG IMMUNE REACTION LIKE HE USUALLY DOES WITH MODERNA VACCINE.
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| 2870381 | 9 | M | UT | 11/03/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052581 948409 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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MODERNA SPIKEVAX FOR 12+ GIVEN IN ERROR TO 9 YEAR OLD
MODERNA SPIKEVAX FOR 12+ GIVEN IN ERROR TO 9 YEAR OLD
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| 2870384 | 9 | F | AR | 11/03/2025 |
FLU3 |
SANOFI PASTEUR |
u8864aa |
Syncope
Syncope
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Patient experienced Vasovagal Syncope shortly after receiving her vaccine. This could have been bec...
Patient experienced Vasovagal Syncope shortly after receiving her vaccine. This could have been because she watched her sister get her vaccine after her. Patient fainted but came back within seconds and no further issues.
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| 2870385 | 82 | M | AZ | 11/03/2025 |
COVID19 |
MODERNA |
3052579 |
Underdose
Underdose
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PATIENT WAS GIVEN A PEDIATRIC DOSE OF SPIKEVAX (NDC: 80777-0113-80). I REPORTED THE INCIDENT TO MODE...
PATIENT WAS GIVEN A PEDIATRIC DOSE OF SPIKEVAX (NDC: 80777-0113-80). I REPORTED THE INCIDENT TO MODERNA. FOLLOWING CDC GUIDANCE ON MANAGEMENT OF ADMINISTRATION ERROS, PTWAS GIVEN ANOTHER DOSE OF PEDIATRIC DOSE OF SPIKEVAX ON THE SAME CLINIC DAY TO MAKE IT 1 FULL DOSE FOR AN ADULT. FIRST DOSE WAS GIVEN ON HIS LEFT ARM AND THE SECOND DOSE WAS GIVEN ON HIS RIGHT ARM PER PT REQUEST.
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| 2870387 | 67 | F | 11/03/2025 |
FLU3 RSV VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8875BA E75E5 9C75Y |
Erythema, Fatigue, Peripheral swelling; Erythema, Fatigue, Peripheral swelling; ...
Erythema, Fatigue, Peripheral swelling; Erythema, Fatigue, Peripheral swelling; Erythema, Fatigue, Peripheral swelling
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Red swollen arm... feeling fatigued...
Red swollen arm... feeling fatigued...
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| 2870388 | 72 | F | NM | 11/03/2025 |
COVID19 |
MODERNA |
3052035 |
Hypoaesthesia, Paraesthesia
Hypoaesthesia, Paraesthesia
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patient had numbess and a tingly feeling in right arm and right thigh
patient had numbess and a tingly feeling in right arm and right thigh
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| 2870420 | 37 | F | MI | 11/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia, Pain, Pain in extremity
Arthralgia, Pain, Pain in extremity
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Severe arm pain 24 hours post vaccination, continue to have left shoulder/ arm pain 30+ days after ...
Severe arm pain 24 hours post vaccination, continue to have left shoulder/ arm pain 30+ days after vaccine. Pain when moving arm above head.
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| 2870422 | 63 | M | NM | 11/03/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Pharmacy technician administered FLUZOND HD, indicated for 65 years and up, to patient at an off-sit...
Pharmacy technician administered FLUZOND HD, indicated for 65 years and up, to patient at an off-site vaccination clinic. Patient was not 65 years of age at the time of vaccination. Pharmacy staff attempted to reach patient with contact information provided by patient. No patient contact was established to review the incident as of 11.03.2025.
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| 2870423 | 66 | M | CA | 11/03/2025 |
FLU3 |
SANOFI PASTEUR |
UT8804CA |
Eyelid function disorder, Hypoaesthesia, Ocular hyperaemia
Eyelid function disorder, Hypoaesthesia, Ocular hyperaemia
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ON SATUDAY MORNING (11/1/25) PATIENT REPORTED LEFT SIDE OF FACE IS SHOWING NUMBNESS, LEFT EYE CANNOT...
ON SATUDAY MORNING (11/1/25) PATIENT REPORTED LEFT SIDE OF FACE IS SHOWING NUMBNESS, LEFT EYE CANNOT COMPLETELY CLOSE, AND REDNESS OF LEFT EYE. PT CALLED PHARMACY TODAY (11/3/25 AT 6:20 PM) AND REPORTED SYMPTOMS HAVE NOT GOTTEN WORSE. REDNESS OF EYE HAS GOTTEN BETTER, BUT NUMBNESS IN LEFT SIDE OF FACE REMAINS. COUNSELED PT TO GO TO ER OR SEEK MD ADVICE.
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| 2870424 | 7 | F | TX | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
409415 |
Incorrect route of product administration
Incorrect route of product administration
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Flucelvax is supposed to be given intramuscularly. The immunizer gave the vaccine subcutaneously. Pe...
Flucelvax is supposed to be given intramuscularly. The immunizer gave the vaccine subcutaneously. Per RN at Dr's office, patient family made an appointment with them and the provider's current plan is to revaccinate the patient in 1 week with Flumist in-clinic.
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| 2870425 | 55 | F | OH | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
70461-0655-03 |
Chills, Fatigue, Myalgia, Nausea, Pyrexia
Chills, Fatigue, Myalgia, Nausea, Pyrexia
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Pain in lateral side of arm from proximal deltoid to elbow for 4 days. Fever, chills, fatigue, naus...
Pain in lateral side of arm from proximal deltoid to elbow for 4 days. Fever, chills, fatigue, nausea, myalgias for 3 days.
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| 2870442 | 37 | M | ID | 11/03/2025 |
FLU3 |
SEQIRUS, INC. |
40728 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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I reached into the immunization fridge and took out from the left box thinking that was the normal d...
I reached into the immunization fridge and took out from the left box thinking that was the normal dose. I handed to [withheld name] MA who I was supervising and she filled out on database immunization. She did not verify lot number and I did not notice her error. Was not until end of day count that mistake was realized.
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| 2869981 | 27 | F | PA | 11/02/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
Na0739 Na0739 |
C-reactive protein increased, Chest pain, Computerised tomogram thorax normal, D...
C-reactive protein increased, Chest pain, Computerised tomogram thorax normal, Dyspnoea, Exposure during pregnancy; Painful respiration, Pericarditis, Red blood cell sedimentation rate increased
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I am 33 weeks pregnant. 2 days after the Covid shot I started to get chest pains and short of breath...
I am 33 weeks pregnant. 2 days after the Covid shot I started to get chest pains and short of breathe. Felt like stabbing sharp pain and when breathing it was sharp. I went to the hospital on 10/31/25 and had a work up for blood clots and heart attack it was negative doctor said it s most likely an effect of Covid shot. 11/01/25 I woke up in worst pain. Called cardiologist she said go to hospital again. I went back had a full work up. My inflammatory markers C-reactive protein and esr was elevated and was diagnosed with pericarditis from Covid shot. I was started on colcahine 0.6 mg once a day till I can see my cardiologist.
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| 2869983 | 58 | F | SC | 11/02/2025 |
FLU3 |
SEQIRUS, INC. |
406988 |
Injected limb mobility decreased, Injection site haemorrhage, Injection site pai...
Injected limb mobility decreased, Injection site haemorrhage, Injection site pain, Product administered at inappropriate site
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Normal expected pain at injection site following vaccine but the pain got worse and didn't go a...
Normal expected pain at injection site following vaccine but the pain got worse and didn't go away. Woke up with pain four days later that got progressively worse and now I have limited mobility and range of motion. The injection was given very high up on my left deltoid. It did bleed when the syringe was taken out.
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| 2869988 | 77 | F | CO | 11/02/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Abdominal pain, Chills, Malaise, Pain, Pyrexia
Abdominal pain, Chills, Malaise, Pain, Pyrexia
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Patient reports that she was fine until around evening that day. Then she began experiencing fever/c...
Patient reports that she was fine until around evening that day. Then she began experiencing fever/chills (which I would consider normal), body achiness (normal), and front-sided abdominal pain (not normal). She says this continued for around 48 hours and that she was so sick that she didn't feel able to get up and take her temperature so I'm not sure how severe her fever was. The front-sided abdominal pain is why I'm reporting this.
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| 2869989 | 1 | M | MD | 11/02/2025 |
MMR MMR MMR PNC13 PNC13 PNC13 VARCEL VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Cough, Developmental delay, Developmental regression, Dyspnoea, Lethargy; Measle...
Cough, Developmental delay, Developmental regression, Dyspnoea, Lethargy; Measles antibody positive, Methylenetetrahydrofolate reductase gene mutation, Moaning, Pneumonia, Pyrexia; Respiratory tract congestion; Cough, Developmental delay, Developmental regression, Dyspnoea, Lethargy; Measles antibody positive, Methylenetetrahydrofolate reductase gene mutation, Moaning, Pneumonia, Pyrexia; Respiratory tract congestion; Cough, Developmental delay, Developmental regression, Dyspnoea, Lethargy; Measles antibody positive, Methylenetetrahydrofolate reductase gene mutation, Moaning, Pneumonia, Pyrexia; Respiratory tract congestion
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This was the second time my son was hospitalized after a round of vaccines. He was having high temp,...
This was the second time my son was hospitalized after a round of vaccines. He was having high temp, moaning, lethargic, trouble breathing. He was taken to MC for persistent fever, cough and congestion on 2/11/2023, 2 days prior to that he was seen by his pediatrician and was given amoxicillin for presumed pneumonia. Was dismissed from MC. Fever persisted and got to 105 was taken to MC where he was seen for the same symptoms. ( starting symptoms on 2/10/2023 so about 2 weeks since vaccines. ) was admitted to MC from 2/13/2023-2/15/2023
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| 2869990 | 21 | M | NJ | 11/02/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8731 |
Cardiac flutter, Electrocardiogram normal, Fear, Hyperhidrosis, Palpitations
Cardiac flutter, Electrocardiogram normal, Fear, Hyperhidrosis, Palpitations
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Sweats racing/fluttering sensation in chest in the middle of the night- woke up scared but went back...
Sweats racing/fluttering sensation in chest in the middle of the night- woke up scared but went back to sleep because in room with roomate
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| 2869992 | 41 | F | SC | 11/02/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
Cy53g |
Deep vein thrombosis
Deep vein thrombosis
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Dvt in leg
Dvt in leg
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| 2869993 | 66 | F | PA | 11/02/2025 |
FLU3 |
SANOFI PASTEUR |
U8874BA |
Pain in extremity, Pruritus, Rash, Skin warm
Pain in extremity, Pruritus, Rash, Skin warm
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SORE ARM, RASH ABOUT THE SIZE OF HAND, ITCHY AND WARM
SORE ARM, RASH ABOUT THE SIZE OF HAND, ITCHY AND WARM
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| 2869995 | 59 | F | PA | 11/02/2025 |
UNK |
UNKNOWN MANUFACTURER |
Z010457 |
Pain, Pyrexia, Urticaria
Pain, Pyrexia, Urticaria
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Fever, aches, hives for 4 days post-vaccination. Seen in urgent care today. Started on steroids for ...
Fever, aches, hives for 4 days post-vaccination. Seen in urgent care today. Started on steroids for allergic reaction to vaccination.
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| 2869997 | 46 | F | NV | 11/02/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Cough, Dizziness, Dyspnoea, Fatigue, Local reaction; Pyrexia
Cough, Dizziness, Dyspnoea, Fatigue, Local reaction; Pyrexia
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Trouble breathing, local reaction, fatigue, dizziness, slight cough, fever
Trouble breathing, local reaction, fatigue, dizziness, slight cough, fever
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| 2869998 | 79 | M | NY | 11/02/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Confus...
Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Confusional state, Dysstasia; Gait disturbance, Incoherent, Influenza virus test negative, SARS-CoV-2 test negative, Urinary incontinence; Urine analysis normal
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During the night, my husband was extremely confused and incoherent (unlike his usual issues due to d...
During the night, my husband was extremely confused and incoherent (unlike his usual issues due to dementia), he could not walk easily, he was incontinent (urinating on the floor), I could not get him into the bed completely. In the morning (October 15,2025) he was sitting on the toilet in excrement and was unable to stand. I called EMS, and he was taken to Hospital ER and was there all day. All tests were normal (chest x-ray; CT scan of brain; urinalysis; blood work; negative for COVID and the flu. They could find no reason for his symptoms except for a possible reaction to the COVID vaccination. He was able to come home after determining that he was able to stand and walk unassisted. For a few more days, he was not back to his "normal."
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