| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2874778 | 11/25/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Contusion, Pruritus
Contusion, Pruritus
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Itchy circular type bruise; It was very itchy; This spontaneous case, initially received on 12-Nov-2...
Itchy circular type bruise; It was very itchy; This spontaneous case, initially received on 12-Nov-2025, was reported by a non-health professional and concerns an patient of unknown age/gender. There was no patient history and no allergy information. Medical history reported as unknown. There was no product complaint associated with the case. Administration of company suspect drug: On an unknown date in Nov-2025, the patient received Fluad (TIV) for Unknown indication, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Arm, Lot number: No batch number available, and will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date in Nov-2025, the patient experienced Itchy circular type bruise (outcome: Unknown), It was very itchy (outcome: Unknown). Consumer called and stated patient got the high dose flu vaccine about a week previous this report. That was way high on patient's arm, there was a circular type bruise and it was itchy, very Itchy. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter (patient) did not provide a seriousness or causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes
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| 2874782 | 70 | M | MO | 11/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Heart rate increased, Heart rate irregular
Heart rate increased, Heart rate irregular
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Extremely Rapid heart beat, irregular heart beat & pulse 3 readings 141 BPM, SYS- 94 DIS- 68 th...
Extremely Rapid heart beat, irregular heart beat & pulse 3 readings 141 BPM, SYS- 94 DIS- 68 then started to drop back to more normal 60/70 bpm
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| 2874852 | 55 | F | GA | 11/25/2025 |
FLU3 |
SEQIRUS, INC. |
4F2AJ |
Headache, Migraine, Reaction to previous exposure to any vaccine
Headache, Migraine, Reaction to previous exposure to any vaccine
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Migraine Headache
Migraine Headache
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| 2874871 | 54 | F | MN | 11/25/2025 |
COVID19 FLUX RSV |
MODERNA UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
3052784 948412 4TY55 |
Blood loss anaemia, Intestinal ischaemia, Small intestinal resection; Blood loss...
Blood loss anaemia, Intestinal ischaemia, Small intestinal resection; Blood loss anaemia, Intestinal ischaemia, Small intestinal resection; Blood loss anaemia, Intestinal ischaemia, Small intestinal resection
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Small bowel ischemia. Underwent ex lap with small bowel resection. Complicated by acute blood loss a...
Small bowel ischemia. Underwent ex lap with small bowel resection. Complicated by acute blood loss anemia
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| 2874878 | 39 | F | AR | 11/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0590 U8864CA |
Injection site erythema, Injection site swelling, Injection site warmth, Lymphad...
Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Pyrexia; Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Pyrexia
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Pt called pharmacy on 11/25/25 reporting swelling and intense warmth and redness of the site of her ...
Pt called pharmacy on 11/25/25 reporting swelling and intense warmth and redness of the site of her covid-19 injection (left arm), generalized fever, and swollen lymph nodes on the side of vaccination. She reports she had a similar but milder reaction to the same vaccine last year. At that time her physician suggested administering mupirocin to the site which she has repeated this year. She has a call into her provider and is awaiting a response. She will consider taking benadryl.
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| 2874886 | 65 | F | WI | 11/25/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3052586 407246 |
Back pain, Chest discomfort, Dyspnoea; Back pain, Chest discomfort, Dyspnoea
Back pain, Chest discomfort, Dyspnoea; Back pain, Chest discomfort, Dyspnoea
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chest tightness, shortness of breath and back pain
chest tightness, shortness of breath and back pain
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| 2874891 | 62 | F | TX | 11/25/2025 |
COVID19 |
MODERNA |
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Epilepsy
Epilepsy
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Led to seizures and put on epilepsy medication which has led to cerebral ataxia
Led to seizures and put on epilepsy medication which has led to cerebral ataxia
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โ | โ | ||||
| 2874896 | 60 | F | FL | 11/25/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792NA |
Arthralgia, Peripheral swelling, Ultrasound Doppler normal
Arthralgia, Peripheral swelling, Ultrasound Doppler normal
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within 48 hours developed pain in my elbow with some swelling to medial antecubital fossa, then deve...
within 48 hours developed pain in my elbow with some swelling to medial antecubital fossa, then developed swelling to forearm and hand which has persisted
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| 2874903 | 36 | F | WA | 11/25/2025 |
FLU3 |
SANOFI PASTEUR |
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Arthralgia, Pain in jaw, Toothache
Arthralgia, Pain in jaw, Toothache
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About 1 week later I noticed that all of my joint started hurting really bad, not just spots that I ...
About 1 week later I noticed that all of my joint started hurting really bad, not just spots that I have arthritis like every joint, even my jaw causing all of my teeth to hurt, like a burning sensation.
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| 2874907 | 75 | F | FL | 11/25/2025 |
COVID19 |
JANSSEN |
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Alopecia, Alopecia areata, Autoimmune disorder, Blood test, Hair colour changes
Alopecia, Alopecia areata, Autoimmune disorder, Blood test, Hair colour changes
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6 weeks after vaccination I experienced bald patches on my scalp, later diagnosed as alopecia areata...
6 weeks after vaccination I experienced bald patches on my scalp, later diagnosed as alopecia areata. After several months, hair started to grow back but much thinner and pure white in color. The alopecia destroys the color pugmentation. So I now suffer with auto-immune disease because of the Johnson and Johnson vaccine. In 2024 I experienced another flare up and have been suffering with much greater patches. I am forced to wear head coverings whenever I go out or having company. My self esteem is greatly affected and do not socialize like I did before. The J and J vaccine has greatly ruined my life. I have received treatments via steroid creams from my dermatologist over the last few years.
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| 2874916 | 37 | F | TX | 11/25/2025 |
FLU3 FLU3 FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
AX9140A AX9140A AX9140A AX9140A AX9140A |
Abdominal discomfort, Allergy test, Angioedema, Arteriogram carotid, Blood immun...
Abdominal discomfort, Allergy test, Angioedema, Arteriogram carotid, Blood immunoglobulin E; Bradycardia, C-reactive protein, Computerised tomogram head, Computerised tomogram neck, Electrocardiogram; Full blood count, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Muscular weakness; Pruritus, Rash, Scan with contrast, Thyroid function test, Troponin; Urticaria
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Hives, Angioedema, GI Upset, Bradycardia, treated with prednisone 20mg each morning for 2 days, pepc...
Hives, Angioedema, GI Upset, Bradycardia, treated with prednisone 20mg each morning for 2 days, pepcid 20mg twice daily, benadryl 25mg every 4 hours as needed, started 2 hours after administration. Dr. {withheld} in the ED gave course of meds to be taken, PCP called and Medrol Dosepak prescribed for itching and rash. Third day weakness in upper extremities bilaterally, symptomatic bradycardia, went to the ED and was admitted to the hospital for 4 days of observation and testing.
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| 2874929 | 58 | F | MI | 11/25/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
409109 3053483 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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Redness, Swelling in arm at vaccine site
Redness, Swelling in arm at vaccine site
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| 2874965 | F | 11/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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COVID-19, Fibrin D dimer, Fibrin D dimer increased, Hypertension, Vaccination si...
COVID-19, Fibrin D dimer, Fibrin D dimer increased, Hypertension, Vaccination site erythema; Vaccination site pruritus
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Very itchy, don't have systemic itching or anything else. It's all localized on the arm th...
Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection; COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle; Elevated D-dimer; Very sick with COVID 2024; Severe hypertension; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Severe hypertension) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced HYPERTENSION (Severe hypertension) (seriousness criterion medically significant), FIBRIN D DIMER INCREASED (Elevated D-dimer) and COVID-19 (Very sick with COVID 2024). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection) and VACCINATION SITE ERYTHEMA (COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle). At the time of the report, HYPERTENSION (Severe hypertension), VACCINATION SITE PRURITUS (Very itchy, don't have systemic itching or anything else. It's all localized on the arm that got the injection), VACCINATION SITE ERYTHEMA (COVID arm, where it gets all like almost looks purple from like shoulder to elbow in a big round circle), FIBRIN D DIMER INCREASED (Elevated D-dimer) and COVID-19 (Very sick with COVID 2024) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, Fibrin D dimer: elevated. Concomitant medications were not reported. It was reported that patient had Moderna vaccines in the past for COVID, and it has been a couple of years though. And last year patient got very sick with COVID and had an elevated D-dimer and severe hypertension. The patient was at risk for blood clots if patient get COVID again, so the patient was looking at getting a booster, just wanted to make sure, it was unclear with the primary doctor if there was an elevated risk of blood clots from the vaccine itself, or if it was only like myocarditis risks from the vaccine. Patient had received vaccine in January or February of 2021, patient was in one of the first batches. It was reported that whenever patient had Moderna in the past, patient had the big, it was COVID arm, where it gets all like almost looks purple from like the shoulder to my elbow in a big round circle, but it's very hard. And it gets very itchy, but patient don't have systemic itching or anything else. It was all localized on the arm that got the injection on. Patient was told earlier on when that happened that it was probably just a really robust immune response and it definitely wasn't mNEXSPIKE, and don't even know if it was Spikevax that patient had left. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. This case was linked to MOD-2025-791160 (Patient Link).; Reporter's Comments: COVID-19 could be a confounder for the event hypertension. Further information is being requested. The benefit-risk relationship of product is not affected by this report.
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| 2874966 | M | NC | 11/25/2025 |
COVID19 |
MODERNA |
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Asthenia, Fatigue
Asthenia, Fatigue
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Severe and persistent fatigue and lack of energy following their second Covid vaccine; Lack of energ...
Severe and persistent fatigue and lack of energy following their second Covid vaccine; Lack of energy following their second Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe and persistent fatigue and lack of energy following their second Covid vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe and persistent fatigue and lack of energy following their second Covid vaccine) (seriousness criterion medically significant) and ASTHENIA (Lack of energy following their second Covid vaccine). At the time of the report, FATIGUE (Severe and persistent fatigue and lack of energy following their second Covid vaccine) and ASTHENIA (Lack of energy following their second Covid vaccine) had not resolved. Relevant medical history details of vaccines within the past 4 weeks, medical conditions were not provided. Concomitant medication was not provided. Patient reported severe and persistent fatigue with lack of energy following the second Covid vaccine in Spring 2021, which had significantly impacted his quality of life. He was in bed for two weeks after the vaccine with zero energy and 99 percent fatigue. For the last four and half years it had been fatigue 90 percent of the time and no energy 95 percent of the time. Patient stated that vaccine had screwed up his life. Despite consulting over 20 physicians, patient had not received any helpful insights. He felt that his life had deteriorated since the vaccination and was seeking any potential guidance or support. He expressed frustration with the lack of acknowledgment from healthcare providers and hopes Moderna might have information that could help address his symptoms. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2025: Non-significant follow up received and updated narrative, references.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2874990 | F | TX | 11/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood viscosity abnormal, Cardiac disorder, Dyspnoea exertional, Hypoaesthesia, ...
Blood viscosity abnormal, Cardiac disorder, Dyspnoea exertional, Hypoaesthesia, Myocarditis; Peripheral swelling, Poor peripheral circulation, Restless legs syndrome, Vein disorder
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Myocarditis; severe shortness of breath whenever she was walking; extreme swelling in her legs and f...
Myocarditis; severe shortness of breath whenever she was walking; extreme swelling in her legs and feet; restless leg syndrome; weird feels in and around her heart area; affected circulation in her legs/poor circulation in her legs; severely affected her veins throughout her body; changes of blood viscosity; numbness throughout her whole body including in her hands, legs, arms; This is a spontaneous report received from a Consumer or other non HCP and a Lawyer from legal division. Other Case identifier(s): D-1-GN-25-009967 . A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker/did not smoke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 2025, outcome "unknown"; POOR PERIPHERAL CIRCULATION (non-serious) with onset 2025, outcome "unknown", described as "affected circulation in her legs/poor circulation in her legs"; BLOOD VISCOSITY ABNORMAL (non-serious) with onset 2025, outcome "unknown", described as "changes of blood viscosity"; PERIPHERAL SWELLING (non-serious) with onset 2025, outcome "unknown", described as "extreme swelling in her legs and feet"; HYPOAESTHESIA (non-serious) with onset 2025, outcome "unknown", described as "numbness throughout her whole body including in her hands, legs, arms"; RESTLESS LEGS SYNDROME (non-serious) with onset 2025, outcome "unknown", described as "restless leg syndrome"; DYSPNOEA EXERTIONAL (non-serious) with onset 2025, outcome "unknown", described as "severe shortness of breath whenever she was walking"; VEIN DISORDER (non-serious) with onset 2025, outcome "unknown", described as "severely affected her veins throughout her body"; CARDIAC DISORDER (non-serious) with onset 2025, outcome "unknown", described as "weird feels in and around her heart area". The events "extreme swelling in her legs and feet" and "affected circulation in her legs/poor circulation in her legs" required emergency room visit. Clinical information: She was filing this civil lawsuit because of the negative severe side effects she had experienced from receiving the Pfizer COVID-19 Vaccine. Since receiving that vaccine she had experienced severe shortness of breath whenever she was walking, she had experienced extreme swelling in her legs and feet, she had also experienced restless leg syndrome, the vaccine seems to have affected her overall circulation in her legs and she has experienced weird feels in and around her heart area. None of these things was happening to her until she received the Pfizer COVID-19 vaccine. She was able to walk long periods of time without having shortness of breath. She did not smoke, or do drugs, and hardly drinks and so she knew these things she was experiencing was tied to the vaccine because she was not in poor health. After the shot her overall body side effects have been horrible. She had to go to the emergency room because of the severe swelling she had in her legs because of the poor circulation in her legs. She believed that not only did the vaccine affect her legs and her heart, but it severely affected her veins throughout her body. She believed the poor circulation was because of the changes of blood viscosity she had experienced after getting the COVID-19 vaccine. She also experiences weird sensations in her heart area. She had also experienced numbness throughout her whole body including in her hands, legs, arms, etc. and she believed that was tied to the changes in blood flow through her vein which was tied to the poor circulation, numbness, restless legs syndrome, and possibly the weird sensations she was experiencing in her heart region of the body. She believed the Defendant falsely advertised their vaccine as being good and effective, but she believed the way the Defendants advertised their vaccine was a lie and the company downplayed the side effects of their vaccine. She believed she might be one of those people who developed Myocarditis from Pfizer's COVID-19 vaccine. She believed that company was negligent in misrepresenting the effectiveness of their vaccine and downplaying the side effects.
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| 2874991 | 29 | M | 11/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac disorder, Death
Cardiac disorder, Death
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He just passed away age 32; it damaged about 25% of his heart; This is a spontaneous report received...
He just passed away age 32; it damaged about 25% of his heart; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021665 (BioNTech). A 32-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years 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 "He just passed away age 32"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "it damaged about 25% of his heart". Clinical course: Patient was 29 years old when he had the Pfizer vaccine it damaged about 25% of his heart and now he can no longer work. He just passed away age 32. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. BNT162B2 is under agreement with BIONTECH SE.; Reported Cause(s) of Death: Unknown cause of death
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| 2874992 | F | TN | 11/25/2025 |
FLU3 |
SANOFI PASTEUR |
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Influenza, Influenza A virus test positive, Malaise, Vaccination failure
Influenza, Influenza A virus test positive, Malaise, Vaccination failure
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lack of intended effect, had influenza A 6 weeks later; got sick at home, took a home test and was i...
lack of intended effect, had influenza A 6 weeks later; got sick at home, took a home test and was influenza A+ positive; Initial information received on 10-Nov-2025 regarding an unsolicited valid serious case received from a patient. This case involves Elderly female patient who experienced lack of intended effect, had influenza a 6 weeks later and got sick at home, took a home test and was influenza A+ positive after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in January 2025, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as flu vaccination (immunization). On an unknown date in 2025, the patient developed lack of intended effect, had influenza a 6 weeks later (vaccination failure) (unknown latency) and took a home test and was influenza a+ positive (influenza) (latency: 6 weeks). Relevant laboratory test results included: Influenza A virus test - In 2025: Positive Action taken: not applicable. A Patient took baloxavir for influenza, felt less bad 12-16 hours later (later got sick at home) and was not reported for other event. At time of reporting, the outcome was Unknown for the event vaccination failure and was Recovered / Resolved on an unknown date in 2025 for the event influenza. This event (vaccination failure) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated on 17-Nov-2025: This case involves Elderly female patient who experienced lack of intended effect, had influenza a 6 weeks later and got sick at home, took a home test and was influenza A+ positive after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. Lack of information regarding medical history or family history, preexisting and concurrent medical condition and concomitant medication laboratory investigations excluding other predisposing etiologies precludes the complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
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| 2875008 | 73 | M | PA | 11/25/2025 |
COVID19 |
MODERNA |
3052733 |
Blood thyroid stimulating hormone decreased
Blood thyroid stimulating hormone decreased
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pt caregiver came in and picked up med for pt. said med is for treatment of pt having thyroiditis an...
pt caregiver came in and picked up med for pt. said med is for treatment of pt having thyroiditis and needing methimazole. pt caregiver said pt tsh almost zero right now and due to covid vaccine.
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| 2875036 | 20 | M | OH | 11/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Aplastic anaemia, Bone marrow transplant
Aplastic anaemia, Bone marrow transplant
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Develop a plastic anemia and had to go through a bone marrow transplant
Develop a plastic anemia and had to go through a bone marrow transplant
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| 2874338 | 58 | F | CA | 11/24/2025 |
COVID19 |
PFIZER\BIONTECH |
FJ1611 |
Bursitis, Pain, Periarthritis, Shoulder injury related to vaccine administration...
Bursitis, Pain, Periarthritis, Shoulder injury related to vaccine administration, X-ray
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SIRVA, bursitis, frozen shoulder within a month of the shot. Extreme pain in doing daily tasks like ...
SIRVA, bursitis, frozen shoulder within a month of the shot. Extreme pain in doing daily tasks like showering and dressing.
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| 2874345 | 67 | F | 11/24/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Chills, Fatigue, Headache, Myalgia; Chills, Fatigue, Headache, Myalgia
Chills, Fatigue, Headache, Myalgia; Chills, Fatigue, Headache, Myalgia
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fatigue; body aches; headaches; chills; This spontaneous case was reported by a consumer and describ...
fatigue; body aches; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) in a 67-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. The non-company product included Influenza vaccine for an unknown indication. 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 and dose of Influenza vaccine (unknown route) 1 dosage form. In September 2025, the patient experienced FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills). In September 2025, FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) had resolved. Patient had no vaccines within the past 4 weeks. No concomitant medication was reported. It was reported that 10 to 12 hours after taking the vaccine she experienced severe fatigue, body aches, headaches and chills but no fever. She stated that she had always experienced these symptoms after Spikevax in all 6 previous years. She described them as not debilitating, and that fatigue is the worst of it. She always spaces the Covid vaccine and Flu vaccine to know the side effects are due to which vaccine, and she knows they are due to Spikevax. The symptoms would away after 24 hours. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-791655 (Patient Link).
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| 2874370 | 74 | F | WI | 11/24/2025 |
COVID19 |
MODERNA |
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Arthralgia, Asthenia, Diarrhoea, Fatigue, Headache
Arthralgia, Asthenia, Diarrhoea, Fatigue, Headache
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Fatigue, headache, joint pain and weakness, diarrhea
Fatigue, headache, joint pain and weakness, diarrhea
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| 2874374 | 4 | M | UT | 11/24/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
5racy |
Circumstance or information capable of leading to medication error, Inadequate a...
Circumstance or information capable of leading to medication error, Inadequate aseptic technique in use of product, Injection site erythema
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Site: Redness at Injection Site-Mild, Systemic: Sticking multiple times-Mild, Additional Details: Co...
Site: Redness at Injection Site-Mild, Systemic: Sticking multiple times-Mild, Additional Details: Complaint of sticking patient multiple times. The patient was squirming. Complaint of not wiping the arm after the first stick.
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| 2874376 | 65 | F | PA | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
u8862da |
Rash
Rash
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Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash on lower back-Mild...
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: rash on lower back-Mild, Additional Details: within 24 hours of receiving flu shot patient reports rash along lower back. has not seen provider yet, but suspects shingles.
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| 2874377 | 68 | F | MD | 11/24/2025 |
FLUA4 |
SEQIRUS, INC. |
407243 |
Circumstance or information capable of leading to medication error, Wrong techni...
Circumstance or information capable of leading to medication error, Wrong technique in product usage process
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Systemic: 1" needle used instead of 1.5" needle for female > 200 pounds-Mild, Additiona...
Systemic: 1" needle used instead of 1.5" needle for female > 200 pounds-Mild, Additional Details: Pharmacy Store was missing supply of unexpired 1.5" needles for intramuscular vaccinations for females > 200lb and males > 260 lb. Patient self-reported weighing > 200lb, was informed of missing supply, and with patient's consent, 1" needles were used for all three vacinations instead with tightening/stretching of skin instead of bunching of muscle., Other Vaccines: VaccineTypeBrand: mnexspike 2025-26; Manufacturer: Moderna; LotNumber: 3052734; Route: IM; BodySite: Right Deltoid; Dose: 1; VaxDate: 11/07/2025, VaccineTypeBrand: Boostrix Tdap Vaccine; Manufacturer: GlaxoSmithKline; LotNumber: k4979; Route: IM; BodySite: Right Deltoid; Dose: ; VaxDate: 11/07/2025
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| 2874378 | 75 | F | TX | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
u8875aa |
Hypoaesthesia, Pain
Hypoaesthesia, Pain
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Systemic: Body Aches Generalized-Mild, Systemic: patient felt numbness for 5 minutes on oppsite side...
Systemic: Body Aches Generalized-Mild, Systemic: patient felt numbness for 5 minutes on oppsite side of vaccine-Mild
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| 2874379 | 66 | F | IL | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
u8874ba |
Injection site bruising, Injection site pain
Injection site bruising, Injection site pain
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Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Other Vaccines: VaccineTy...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: nuvaxovid; Manufacturer: novavax; LotNumber: 6315mf002c; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2874383 | 77 | F | SC | 11/24/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3053115 |
Diarrhoea, Joint injury
Diarrhoea, Joint injury
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Diarrhea-Medium
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Diarrhea-Medium
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| 2874384 | 60 | M | DC | 11/24/2025 |
FLUN4 |
MEDIMMUNE VACCINES, INC. |
407010 |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild
Site: Bruising at Injection Site-Mild
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| 2874385 | 37 | M | MD | 11/24/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild
Site: Bruising at Injection Site-Mild
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| 2874386 | 36 | F | MD | 11/24/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild
Site: Bruising at Injection Site-Mild
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| 2874387 | 61 | F | MD | 11/24/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild
Site: Bruising at Injection Site-Mild
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| 2874388 | 63 | M | MD | 11/24/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild
Site: Bruising at Injection Site-Mild
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| 2874389 | 69 | F | MD | 11/24/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
6315mf002c |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Mild
Site: Bruising at Injection Site-Mild
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| 2874391 | 80 | M | CA | 11/24/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052996 |
Bell's palsy, Injection site pain, Visual impairment
Bell's palsy, Injection site pain, Visual impairment
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Site: Pain at Injection Site-Severe, Systemic: Bell's Palsy-Severe, Systemic: localized to pati...
Site: Pain at Injection Site-Severe, Systemic: Bell's Palsy-Severe, Systemic: localized to patient's right side of face-Severe, Systemic: Visual Changes/Disturbances-Medium, Other Vaccines: VaccineTypeBrand: Fluad; Manufacturer: SeQirus; LotNumber: 407274; Route: intramuscular; BodySite: left arm; Dose: n/a; VaxDate: 10/28/2025
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| 2874393 | 67 | M | PA | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
u8837da |
Cerebrovascular accident
Cerebrovascular accident
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Systemic: Stroke-Medium
Systemic: Stroke-Medium
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| 2874395 | 73 | F | NY | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
U876488 |
Chills, Pruritus, Rash, Sleep disorder
Chills, Pruritus, Rash, Sleep disorder
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Genera...
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chills-Mild, Systemic: Unable to Sleep-Severe
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| 2874396 | 78 | F | NY | 11/24/2025 |
FLUA4 |
SEQIRUS, INC. |
407243 |
Myalgia
Myalgia
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Systemic: patient is stating she has mild pain, she is pointing to her bicep muscle on the anterior ...
Systemic: patient is stating she has mild pain, she is pointing to her bicep muscle on the anterior of her upper arm-Mild, Additional Details: None
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| 2874397 | 49 | F | MA | 11/24/2025 |
FLU4 FLU4 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7cf5m 7cf5m |
Injection site erythema, Injection site pain, Injection site swelling, Joint inj...
Injection site erythema, Injection site pain, Injection site swelling, Joint injury, Mobility decreased; Pain, Pain in extremity
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injecti...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Started right after vaccination, progressively got worse and still ongoing, from shoulder going down to forearm. Most significance in shoulder joint. Weakness and mobility restriction due to pain. Went to PCP to check on it, referred to orthopedist and to here
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| 2874398 | 78 | F | PA | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
u8862da |
Chills, Fatigue, Lethargy
Chills, Fatigue, Lethargy
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Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild
Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild
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| 2874399 | 37 | F | OH | 11/24/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3052834 |
Nausea
Nausea
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Systemic: Nausea-Severe, Other Vaccines: VaccineTypeBrand: Fluarix 2025-26; Manufacturer: GSK; LotN...
Systemic: Nausea-Severe, Other Vaccines: VaccineTypeBrand: Fluarix 2025-26; Manufacturer: GSK; LotNumber: JE74J; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 10/11/2025
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| 2874400 | 71 | F | MO | 11/24/2025 |
FLUA4 |
SEQIRUS, INC. |
407244 |
Injection site swelling
Injection site swelling
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Site: Swelling at Injection Site-Medium
Site: Swelling at Injection Site-Medium
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| 2874401 | 13 | F | TN | 11/24/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
5R4CY |
Musculoskeletal stiffness, Seizure, Tremor, Unresponsive to stimuli
Musculoskeletal stiffness, Seizure, Tremor, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient rece...
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient received vaccine and immediately lent forward and was caught by the immunizer. The patient then began to shake and extremities became rigid. That lasted for about 15-30 seconds. The patient then came to and was placed on the ground with legs elevated. Monitored Blood pressure, heart rate and breathing. After about 30 mins, patient was escorted to her car and mom was taking her to the emergency room for evaluation.
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| 2874402 | 63 | F | AL | 11/24/2025 |
COVID19-2 |
MODERNA |
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Dizziness, Feeling drunk
Dizziness, Feeling drunk
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Systemic: felt drunk and light headed-Mild, Additional Details: a day after the vaccine patient clai...
Systemic: felt drunk and light headed-Mild, Additional Details: a day after the vaccine patient claims felt drunk and light headed after i offered to vaccinate her. said id document it for her. , Other Vaccines: VaccineTypeBrand: arvexy; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2874404 | 48 | M | MD | 11/24/2025 |
FLUC4 |
SEQIRUS, INC. |
410515 |
Device connection issue
Device connection issue
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Systemic: aspiration of blood-Mild, Additional Details: syringe detached from needle during first ad...
Systemic: aspiration of blood-Mild, Additional Details: syringe detached from needle during first administration attempt and a small amount of blood was aspirated into the syringe. Needle and syringe were wasted. Full dose was repeated.
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| 2874406 | 63 | F | CA | 11/24/2025 |
FLUC4 |
SEQIRUS, INC. |
406983 |
Arthralgia, Joint injury, Loss of personal independence in daily activities
Arthralgia, Joint injury, Loss of personal independence in daily activities
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: patient cam...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: patient came to pharmacy to pick up prescription for diclofenac gel which was prescribed on 11/08/2025 and informed pharmacist that the day after she got the flu shot she started to have severe shoulder pain. She is not able to use her caine anymore due to the shoulder pain. Also, she had to cancel her trip because of the pain. She saw her doctor on 11/08/2025 and doctor prescribed voltaren gel. I apologized and informed patient that I am going to write a report on this.
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| 2874410 | 75 | M | IN | 11/24/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3053756 3053756 |
Asthenia, Contusion, Hypoaesthesia, Injection site bruising, Joint injury; Muscu...
Asthenia, Contusion, Hypoaesthesia, Injection site bruising, Joint injury; Muscular weakness, Paraesthesia
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Site: Bruising at Injection Site-Mild, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-...
Site: Bruising at Injection Site-Mild, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: left arm has faint bruizing and is weak and tingling. is better when rubbs area but comes back after a few minutes. pt has been taking tylenol., Other Vaccines: VaccineTypeBrand: Fluzone hd 2025-26; Manufacturer: Sanofi-pasteur; LotNumber: ut8763ea; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
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| 2874412 | 69 | F | CA | 11/24/2025 |
FLU4 |
SANOFI PASTEUR |
ut88201ba |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2874413 | 40 | M | MI | 11/24/2025 |
COVID19 |
PFIZER\BIONTECH |
na4457 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Medium
Systemic: Fainting / Unresponsive-Medium
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| 2874415 | 37 | F | NV | 11/24/2025 |
FLUC4 FLUC4 FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
410515 410515 410515 410515 |
Injection site erythema, Injection site swelling; Injection site bruising, Injec...
Injection site erythema, Injection site swelling; Injection site bruising, Injection site pain, Injection site swelling; Injection site erythema, Injection site swelling; Injection site bruising, Injection site pain, Injection site swelling
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
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