| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2871503 | 70 | F | NC | 11/08/2025 |
COVID19 |
MODERNA |
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Anti-ganglioside antibody positive, Dry eye, Glycosylated haemoglobin normal, Hy...
Anti-ganglioside antibody positive, Dry eye, Glycosylated haemoglobin normal, Hypoaesthesia, Visual impairment
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fingers were numb so I went to urgent care to get A1c checked on 11/23/2023. About 2 weeks later st...
fingers were numb so I went to urgent care to get A1c checked on 11/23/2023. About 2 weeks later started having vision problems so went to get eyes checked. A1c was fine. Diagnosed with dry eye. Don?t kno exactly but numbness in legs occurred like never before. Had mentioned to doctor about numbness in legs after 15 hour drive, the drive occurred in July but numbness had subsided gradually. She still referred me to Neurologist. Can?t remember if that was before or after vaccination. Numbness increased in legs so I changed doctors for neurology and ophthalmology. Dry eye was still the diagnosis until lab results in October 2024 came back.
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| 2871504 | 48 | F | TX | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8864aa |
Injected limb mobility decreased
Injected limb mobility decreased
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Patient is still having difficuly moving the immunized arm 2 weeks later. She has tried NSAIDS otc a...
Patient is still having difficuly moving the immunized arm 2 weeks later. She has tried NSAIDS otc and IcyHot. We have also suggested applying an icepack. There has not been any relief
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| 2871505 | 82 | F | GA | 11/08/2025 |
COVID19 |
PFIZER\BIONTECH |
na4452 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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I gave the second Covid Vaccine a month apart rather than two-month interval as recommended by CDC. ...
I gave the second Covid Vaccine a month apart rather than two-month interval as recommended by CDC. Patient forgot she had the first dose a month ago, and reports no symptoms, or adverse events at this time.
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| 2871508 | 66 | F | WI | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8862BA |
Erythema, Peripheral swelling
Erythema, Peripheral swelling
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Red, raised area below deltoid spreading slightly to bicep.
Red, raised area below deltoid spreading slightly to bicep.
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| 2871509 | 70 | M | IA | 11/08/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA0590 NA0590 |
Brachiocephalic vein thrombosis, Injection site haematoma, Injection site reacti...
Brachiocephalic vein thrombosis, Injection site haematoma, Injection site reaction, Injection site swelling, Peripheral swelling; Ultrasound Doppler abnormal
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Patient received vaccination on 11/3/2025. On the evening of 11/4/2025, patient noticed some swelli...
Patient received vaccination on 11/3/2025. On the evening of 11/4/2025, patient noticed some swelling and broken blood vessels around vaccination site. By 11/5/2025, he noticed swelling of the entire upper arm. On 11/7/2025, the swelling had spread down to his wrist.
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| 2871511 | 7 | M | OR | 11/08/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3052668 5PP37 |
Circumstance or information capable of leading to medication error, Incorrect do...
Circumstance or information capable of leading to medication error, Incorrect dose administered; Circumstance or information capable of leading to medication error, Incorrect dose administered
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When administering the COVID vaccine, Pt did not want to cooperate and MOC had to hold child down, i...
When administering the COVID vaccine, Pt did not want to cooperate and MOC had to hold child down, in the confusion the wrong dose of the COVID19 vaccine was administered. Instead of 0.25mL, 0.5mL was administered. This was reported to CTS, Mom of patient, and Provider onsite NP. Will call MOC to verify is second dose will be needed. Did let MOC know common side effects to be on the look at for per provider onsite. Pt waited 30 mins after administration to watch out for any allergic reactions. No reactions noted.
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| 2871512 | 59 | M | 11/08/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
AX5811A AX5811A |
Abdominal pain upper, Arthralgia, C-reactive protein increased, Diaphragmalgia, ...
Abdominal pain upper, Arthralgia, C-reactive protein increased, Diaphragmalgia, Fatigue; Injection site pain, Neck pain, Night sweats
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1. Flu vaccination received (10/07/2025, 9:15 am) --Mild pain in left shoulder near injection site ...
1. Flu vaccination received (10/07/2025, 9:15 am) --Mild pain in left shoulder near injection site --Mild pain on the left side of the neck 2. ~30 minutes post-vaccination: --Onset of moderate pain in the upper left abdomen 3. Progression: --Abdominal pain gradually intensified --Developed sharp pain in the diaphragm, making it painful to talk and take deep breaths 4. Late evening: --Severe abdominal pain, requiring constant position changes to manage discomfort (8/10 scale) 5. Emergency Room visit (10/08/2025, 1am) --Hospital treatment including narcotic pain medication 6. Following days: --Pain decreased from moderate to weak --Persistent exhaustion and night sweats 7. Doctor visit (10/14/2025) --C-Reactive Protein (CRP): 141 mg/L
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| 2871513 | 62 | F | NC | 11/08/2025 |
FLU3 FLU3 FLU3 RSV RSV RSV |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8823BA U8823BA U8823BA F4AC3 F4AC3 F4AC3 |
Anxiety, Brain natriuretic peptide, Cardiac imaging procedure, Cardiac monitorin...
Anxiety, Brain natriuretic peptide, Cardiac imaging procedure, Cardiac monitoring, Chest X-ray; Diarrhoea, Differential white blood cell count, Dyspnoea, Electrocardiogram ST segment depression, Fibrin D dimer; Full blood count, Heart rate increased, Palpitations, Scan myocardial perfusion, Troponin; Anxiety, Brain natriuretic peptide, Cardiac imaging procedure, Cardiac monitoring, Chest X-ray; Diarrhoea, Differential white blood cell count, Dyspnoea, Electrocardiogram ST segment depression, Fibrin D dimer; Full blood count, Heart rate increased, Palpitations, Scan myocardial perfusion, Troponin
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rapid heart beat/palpitations, anxiety, out of breath, loose stools, loss of appetite
rapid heart beat/palpitations, anxiety, out of breath, loose stools, loss of appetite
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| 2871514 | 36 | F | GA | 11/08/2025 |
FLU3 |
SEQIRUS, INC. |
407004 |
Dyspnoea, Paraesthesia oral
Dyspnoea, Paraesthesia oral
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Patient came to us at 1:20 after shot and stated she felt like her tongue was "tingly", sh...
Patient came to us at 1:20 after shot and stated she felt like her tongue was "tingly", she stated she felt like it was an allergic reaction so we called EMS. At 1:30 ish she did not feel any better, she felt like it was starting to affect her breathing and Benadryl was administered. At 1:40 ish she started to feel like she was "breathing through a straw" and I administered an Epipen. Five minutes later I asked how she felt and she stated that she felt a little bit better and as we were discussing if she felt a second dose needed to be administered, the EMS arrived and took her to the ER.
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| 2871515 | 15 | M | WI | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Chest discomfort, Dizziness, Electrocardiogram normal, Syncope
Chest discomfort, Dizziness, Electrocardiogram normal, Syncope
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patient fainted, regained conciousnees after 5 seconds, felt dizziness and chest tightnes, I called ...
patient fainted, regained conciousnees after 5 seconds, felt dizziness and chest tightnes, I called 911 and gave patient water and orange juice to drink. Paramedic came in 5 minutes, paramedic checked patient afterwards. Mother and patient went to ER in ambulance. In ER Dr. checked his EKG, BP AND SEIZURE response, everything came back normal per his mother. They went home and rested.
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| 2871518 | 70 | F | NV | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8874AA |
Injection site pain
Injection site pain
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Patient stated the vaccine at the time of the injection was the most painful vaccine she has receive...
Patient stated the vaccine at the time of the injection was the most painful vaccine she has received. She is using icy hot patches OTC for pain even after a week. Patient stated she thinks the vaccine was given too high compared to others in the past.
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| 2871519 | 74 | F | IL | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8800AA |
Contusion, Injected limb mobility decreased, Pain in extremity
Contusion, Injected limb mobility decreased, Pain in extremity
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Patient Received a Fluzone HD vaccination on 10-25-25. On 10-27-25 patient started experiencing brui...
Patient Received a Fluzone HD vaccination on 10-25-25. On 10-27-25 patient started experiencing bruising and soreness in her left arm. Bruising is improving, but arm soreness is still present. Per Patient it is constant. Pt went to MD and the thought is that maybe a nerve was hit. Patient state it is hard to get arm above head. Patient is currently on steroids for a separate issue and they are waiting to see if there is improvement. If not, MD placed orders for physical therapy.
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| 2871520 | 70 | F | VT | 11/08/2025 |
COVID19 |
MODERNA |
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Injection site reaction, Injection site warmth, Rash erythematous, Rash papular
Injection site reaction, Injection site warmth, Rash erythematous, Rash papular
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On the morning of 10/11 I noticed, while taking my shower, that below the site of the injection I ha...
On the morning of 10/11 I noticed, while taking my shower, that below the site of the injection I had a raised red area that was warm to the touch. It appeared to be a hive. It was not itchy.
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| 2871521 | 70 | F | MI | 11/08/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
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Dysarthria, Facial paralysis, Hemiparesis; Dysarthria, Facial paralysis, Hemipar...
Dysarthria, Facial paralysis, Hemiparesis; Dysarthria, Facial paralysis, Hemiparesis
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Patient was hospitalized the next morning due to left-sided weakness, dysarthria, and left facial dr...
Patient was hospitalized the next morning due to left-sided weakness, dysarthria, and left facial droop. She is pending neurology evaluation and MRI brain.
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| 2871523 | 75 | M | FL | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8874CA |
Syringe issue
Syringe issue
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When the vaccine was administered, the patient felt some spots of vaccine on arm. Technician brough...
When the vaccine was administered, the patient felt some spots of vaccine on arm. Technician brought syringe out to me and when we saw that the glass was cracked. When needle was attached to syringe, it was not cracked
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| 2871524 | 12 | F | NM | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8864AA |
Pallor, Syncope, Vision blurred
Pallor, Syncope, Vision blurred
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Patient was very pale, had blurry vision, and fainted. This all happened >20 minutes after vaccin...
Patient was very pale, had blurry vision, and fainted. This all happened >20 minutes after vaccination
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| 2871525 | 87 | F | AZ | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8864AA |
Burning sensation, Rash, Rash vesicular
Burning sensation, Rash, Rash vesicular
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Pt noticed a rash all over body started 10/30/2025, burning, not itching, some rash developed into b...
Pt noticed a rash all over body started 10/30/2025, burning, not itching, some rash developed into blisters. Started prednisone on 11/4/2025
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| 2871528 | 62 | F | NH | 11/08/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Dysgeusia, Immediate post-injection reaction
Dysgeusia, Immediate post-injection reaction
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Pt stated a few minutes after her vaccine while we were ringing her out at the register that she had...
Pt stated a few minutes after her vaccine while we were ringing her out at the register that she had a very strong metallic taste in her mouth. She said she could taste it right away after she got the shot. I looked through the package insert to see if that was listed and then did an internet search for her. I had her sit for a few minutes. She walked away without checking back in. My tech said she called to ask about a receipt later in the day.... I left her a voice mail to check in with her even later in the day (around 5pm)-no answer
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| 2871531 | 31 | F | AZ | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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Patient presented to pharmacy for a scheduled covid vaccine appointment. After verbally confirming m...
Patient presented to pharmacy for a scheduled covid vaccine appointment. After verbally confirming my request for the covid vaccine with the pharmacist, I was taken to the administration room and injected. I did not receive a receipt of my vaccine and later discovered that Flublok had been administered to me instead of the covid vaccine. I had already received the flu vaccine in Sept 2025 and therefore was not indicated for another flu shot until next year. I was expecting the covid vaccine to be administered and instead received the flu shot by pharmacy's mistake.
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| 2871533 | 32 | F | CA | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Headache, Injection site mass, Pyrexia
Headache, Injection site mass, Pyrexia
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Fever, headache, hard lump at injection site
Fever, headache, hard lump at injection site
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| 2871534 | 77 | F | CA | 11/08/2025 |
FLU3 |
SANOFI PASTEUR |
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Dizziness, Fall, Hypotension, Intensive care
Dizziness, Fall, Hypotension, Intensive care
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pt arrived to our hospital today after receiving a flu vaccine yesterday per her. She does not know ...
pt arrived to our hospital today after receiving a flu vaccine yesterday per her. She does not know what type of flu vaccine it was. This patient had become dizzy and possibly lost consciousness at home and fell. she arrived very hypotensive and is being admitted to ICU
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| 2871224 | 45 | M | TN | 11/07/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9FG5M 9FG5M |
Arthralgia, Asthenia, Full blood count, Gait inability, Joint swelling; Lumbar p...
Arthralgia, Asthenia, Full blood count, Gait inability, Joint swelling; Lumbar puncture, Metabolic function test, Mobility decreased, Musculoskeletal disorder
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Initial Symptoms:- Weakness- Joint pain- Swelling of extremities (shoulders, knees, and other joints...
Initial Symptoms:- Weakness- Joint pain- Swelling of extremities (shoulders, knees, and other joints)- Reduced mobility Progression:- Pain and swelling increased over several days, leading to severe limitation of movement.- The patient became unable to walk or use one arm effectively.- Persistent swelling and pain despite initial treatments. Duration: Symptoms have persisted and still active since onset, with limited improvement.
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| 2871225 | 63 | F | MN | 11/07/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Ataxia, Diplopia, Dizziness, Dysgraphia, Dysstasia; Gait disturbance, Laboratory...
Ataxia, Diplopia, Dizziness, Dysgraphia, Dysstasia; Gait disturbance, Laboratory test, Loss of personal independence in daily activities, Movement disorder, Nausea; Reading disorder
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Trunchal ataxia,functional movement disorder,as per clinic diagnosis. Severe dizziness,nausea,double...
Trunchal ataxia,functional movement disorder,as per clinic diagnosis. Severe dizziness,nausea,double vision,inability to perform everyday tasks eg: read write walk stand.
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| 2871239 | 11/07/2025 |
FLUX PPV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Pneumonia; Pneumonia
Pneumonia; Pneumonia
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suspected pneumonia/sick with pneumonia type symptoms; This serious case was reported by a consumer ...
suspected pneumonia/sick with pneumonia type symptoms; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a 68-year-old patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. Previously administered products included Flu vaccine (patient have taken flu vaccines for many years) and Pneumonia vaccine (patient have taken pneumonia vaccines for many years). Concurrent medical conditions included chronic obstructive pulmonary disease, heart disease, unspecified and peripheral arterial disease. On an unknown date, the patient received Flu vaccine and Pneumococcal vaccine. In OCT-2025, less than a year after receiving Flu vaccine and Pneumococcal vaccine, the patient experienced pneumonia (Verbatim: suspected pneumonia/sick with pneumonia type symptoms) (serious criteria GSK medically significant). The outcome of the pneumonia was not resolved. It was unknown if the reporter considered the pneumonia to be related to Flu vaccine and Pneumococcal vaccine. The company considered the pneumonia to be unrelated to Flu vaccine. It was unknown if the company considered the pneumonia to be related to Pneumococcal vaccine. Additional Information: GSK Receipt Date: 31-OCT-2025 This case was reported by a patient via interactive digital media. Patient have PAD. Patient have taken flu shots and pneumonia vaccines separately for many years and this year took both together and have been sick with pneumonia type symptoms for two weeks and stated that he/she will never take the vaccine. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Pneumonia, Less than a year after receiving Flu vaccine, in a 68-year-old patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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| 2871241 | 1.17 | F | 11/07/2025 |
FLU3 MMR VARCEL |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8767BA Y018703 Y004555 |
Petechiae, Rash; Petechiae, Rash; Petechiae, Rash
Petechiae, Rash; Petechiae, Rash; Petechiae, Rash
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20 min after vaccinations given noted petechial rash on posterior neck. no other symptoms. No abnorm...
20 min after vaccinations given noted petechial rash on posterior neck. no other symptoms. No abnormal vital signs. Pt given 5 ml zyrtec and observed x 1 hour noting no progression of rash and decreased redness. Discharged to home
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| 2871287 | TX | 11/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
AH2G4 |
Syringe issue, Underdose
Syringe issue, Underdose
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Leaking syringe; Leaking syringe; Underdose; This non-serious case was reported by a pharmacist via ...
Leaking syringe; Leaking syringe; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AH2G4, expiry date 30-JUN-2026) for prophylaxis. This case was associated with a product complaint. On 17-OCT-2025, the patient received FluLaval 2024-2025 season. On 17-OCT-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: Underdose). On an unknown date, the patient experienced syringe leak (Verbatim: Leaking syringe) and pharmaceutical product complaint (Verbatim: Leaking syringe). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 17-OCT-2025 The health care professional reported that one Flulaval syringe leaked out at the plunger while administering the vaccine. The patient had to receive another full dose. The defect discovered during administration of the product. The product was partially administered, with most of the product running out of the syringe. The leak occurs at the first stopper, at the bottom of the stopper rings. 25 G size gauge needle was used.
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| 2871294 | 11/07/2025 |
FLUX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Malaise; Malaise
Malaise; Malaise
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made me so sick; Made us ill; This non-serious case was reported by a consumer and described the oc...
made me so sick; Made us ill; This non-serious case was reported by a consumer and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient received Flu vaccine and Shingles vaccine. After receiving Flu vaccine and not applicable after receiving Shingles vaccine, the patient experienced sickness (Verbatim: made me so sick) and illness (Verbatim: Made us ill). The outcome of the sickness and illness were not reported. It was unknown if the reporter considered the sickness and illness to be related to Flu vaccine and Shingles vaccine. It was unknown if the company considered the sickness and illness to be related to Flu vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 27-OCT-2025 The reporter stated that the patient does not do vaccine that made the patient sick. The patient experienced horrible sick over flu shot, was worst for a month and then took shingles vaccine made the patient ill for over a week. The patient does not want any more vaccines and had been missing work due to this. The batch number was not provided, and we are unable to contact the reporter.
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| 2871295 | M | 11/07/2025 |
FLUX |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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I was sick; This non-serious case was reported by a consumer via interactive digital media and descr...
I was sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, 1 week after receiving Flu vaccine, the patient experienced sickness (Verbatim: I was sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Flu vaccine. It was unknown if the company considered the sickness to be related to Flu vaccine. Additional Information: GSK Receipt Date: 30-OCT-2025 This case was reported by a patient via interactive digital media. The patient had gotten flu shots three times since they came out, three times he/she was sick as a dog for over a week. During covid he was a critical worker, over a year he watched them around him getting it. He never did, then wife got cancer and he decided to get the shot so he wouldn't get sick and not care for her. A week later he was sick as shit. So, since that he had not gotten anything that involves a lab made so called protector. The batch number was not provided, and we are unable to contact the reporter.
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| 2871298 | 11/07/2025 |
COVID19 FLUX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Herpes zoster, Thyroidectomy, Vaccination failure; Herpes zoster, Thyroidectomy,...
Herpes zoster, Thyroidectomy, Vaccination failure; Herpes zoster, Thyroidectomy, Vaccination failure; Herpes zoster, Thyroidectomy, Vaccination failure
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Suspected vaccination failure; I had a lobectomy; Shingles; This serious case was reported by a cons...
Suspected vaccination failure; I had a lobectomy; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine, Influenza vaccine (left arm) and COVID-19 vaccine (left arm). On an unknown date, an unknown time after receiving Herpes Zoster vaccine and not applicable after receiving Influenza vaccine and COVID-19 vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), lobectomy (thyroid) (Verbatim: I had a lobectomy) (serious criteria clinically significant/intervention required) and shingles (Verbatim: Shingles). The outcome of the vaccination failure, lobectomy (thyroid) and shingles were not reported. It was unknown if the reporter considered the vaccination failure, lobectomy (thyroid) and shingles to be related to Herpes Zoster vaccine. It was unknown if the reporter considered the lobectomy (thyroid) and shingles to be related to Influenza vaccine and COVID-19 vaccine. The company considered the vaccination failure, lobectomy (thyroid) and shingles to be unrelated to Herpes Zoster vaccine and Influenza vaccine. It was unknown if the company considered the lobectomy (thyroid) and shingles to be related to COVID-19 vaccine. Additional Information: GSK Receipt Date: 28-OCT-2025 This case was reported by a patient via interactive digital media. Two after flu/covid in left arm and the same side that patient had a lobectomy 24th March, patient started to experienced pain almost unbearable, then itching, then a rash. Knew something was wrong, then the blisters. Thought patient's cancer had returned. Physician confirmed shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Thyroidectomy, unknown time after receiving a dose of Herpes Zoster vaccine and Influenza vaccine in a subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2871301 | 11/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Herpes zoster oticus, Pain, Vaccination failure; Herpes zoster, H...
Herpes zoster, Herpes zoster oticus, Pain, Vaccination failure; Herpes zoster, Herpes zoster oticus, Pain, Vaccination failure
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Suspected vaccination failure; have shingles right now. Started in my hair then down my face real cl...
Suspected vaccination failure; have shingles right now. Started in my hair then down my face real close to my eye, around my ear and inside of it. Its very painful; have shingles right now. Started in my hair then down my face real close to my eye, around my ear and inside of it. Its very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: have shingles right now. Started in my hair then down my face real close to my eye, around my ear and inside of it. Its very painful) and herpes zoster oticus (Verbatim: have shingles right now. Started in my hair then down my face real close to my eye, around my ear and inside of it. Its very painful) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the shingles and herpes zoster oticus were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and herpes zoster oticus to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and herpes zoster oticus to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 04-NOV-2025 This case was reported by a patient via interactive digital media. Patient stated that shots didn't work for them. Patient have had them 4 times in 70 yrs. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, an unknown time after receiving 1st and 2nd dose of Shingles vaccine, in a 70-year-old patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2871303 | 55 | F | MN | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
406983 |
Arthralgia, Limb injury, Mobility decreased
Arthralgia, Limb injury, Mobility decreased
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Shoulder injury -- pain, limited range of motion ongoing x 3 weeks after vaccine without improvement...
Shoulder injury -- pain, limited range of motion ongoing x 3 weeks after vaccine without improvement. Physical therapy and orthopedic referral placed. Likely will need imaging as well.
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| 2871305 | 74 | F | MI | 11/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
na0739 u8874ba |
Syringe issue, Underdose; Syringe issue, Underdose
Syringe issue, Underdose; Syringe issue, Underdose
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about half the dose of the vaccine leaked out the syringe during administration and patient declined...
about half the dose of the vaccine leaked out the syringe during administration and patient declined repeating then dose or getting additional dose to make full dose
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| 2871307 | 66 | F | NV | 11/07/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Confusional state, Constipation, Diarrhoea, Fatigue, Headache; Pyrexia
Confusional state, Constipation, Diarrhoea, Fatigue, Headache; Pyrexia
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Extreme fatigue, confusion, fever, diarrhea, constipation, headache
Extreme fatigue, confusion, fever, diarrhea, constipation, headache
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| 2871309 | 45 | F | FL | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
u8823ba |
Chills, Extra dose administered, Pain
Chills, Extra dose administered, Pain
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Patient received a second dose of flu vaccine. Patient came into flu clinic and was mistakenly admi...
Patient received a second dose of flu vaccine. Patient came into flu clinic and was mistakenly administered a flu vaccine, and she had already received a dose earlier this season. Patient reported chills and body aches. Patient recovering well.
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| 2871312 | 45 | F | OH | 11/07/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
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Dizziness, Dysgeusia, Erythema, Hypoaesthesia oral, Limb discomfort; Lip swellin...
Dizziness, Dysgeusia, Erythema, Hypoaesthesia oral, Limb discomfort; Lip swelling, Paraesthesia, Swollen tongue
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pt says her left arm felt very heavy and she had tingling and heaviness going down into her fingers....
pt says her left arm felt very heavy and she had tingling and heaviness going down into her fingers. Her skin on her left arm was bright red. This redness went away after 4 or 5 hours but the heaviness and tingling last until late in the afternoon. Her tongue and lips felt swollen and she had a metallic taste in her mouth. These symptoms lasted all day. Today she is light headed and dizzy. She continues to have a slight numbness of the tongue and still has tingling in her fingers. She contacted her doctor and was told she could take Tylenol and Benadryl. They will FU with her later today.
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| 2871313 | 47 | F | KS | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
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Dysphagia, Dyspnoea, Pruritus
Dysphagia, Dyspnoea, Pruritus
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Patient received the vaccine from the Health Department in her place of work around 0930am. Patient ...
Patient received the vaccine from the Health Department in her place of work around 0930am. Patient reported to our ER at 1100am seeking treatment. Pt presented with severe itching diffusely, trouble swallowing, and a sensation of not being able to breathe. Patient was given 0.3mg of Epinephrine IM at 11:12am. Pt was given 125mg of methylprednisolone sodium succinate at 11:14. Pt was given 2.5mg of albuterol via nebulizer at 11:14. Pt was given 50mg diphenhydramine IV push at 11:16.
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| 2871314 | F | NY | 11/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
T7245 |
Expired product administered
Expired product administered
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Expired Product Used; This non-serious case was reported by a nurse via call center representative ...
Expired Product Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T7245, expiry date 30-JUN-2025) for an unknown indication. On 20-OCT-2025, the patient received Fluarix 2024-2025 season. On 20-OCT-2025, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 21-OCT-2025 A staff member got an expired dose of a flu vaccine. She wanted to know if revaccination was needed and if there were any safety concerns. She was not able to recall the name of the vaccine nor the expiration date and only provided the lot number T7245.
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| 2871316 | 60 | F | MI | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
406984 |
Injection site induration, Injection site mass, Paraesthesia
Injection site induration, Injection site mass, Paraesthesia
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Small, hard lump at injection site and tingling in the fingers of left hand. Lump not red or hot. Pa...
Small, hard lump at injection site and tingling in the fingers of left hand. Lump not red or hot. Patient unsure if size has changed or if there is loss of strength in affected fingers. No pain reported. Patient will give symptoms 1 more week before contacting PCP.
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| 2871318 | 30 | F | CA | 11/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
Unknown |
Diarrhoea, Vomiting
Diarrhoea, Vomiting
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Woke up around 2am, had diarrhea and then have been throwing up four times between 2am - 8am.
Woke up around 2am, had diarrhea and then have been throwing up four times between 2am - 8am.
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| 2871320 | 44 | F | WA | 11/07/2025 |
FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3F7A5 3F7A5 3F7A5 |
Anaphylactic reaction, Anaphylaxis treatment, Dizziness, Epiglottitis, Flushing;...
Anaphylactic reaction, Anaphylaxis treatment, Dizziness, Epiglottitis, Flushing; Hyperaemia, Hypersensitivity, Laryngeal inflammation, Laryngeal oedema, Laryngitis; Laryngoscopy abnormal, Throat tightness
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Patient reports, "I had a severe allergic reaction that occurred within 10minutes of receiving ...
Patient reports, "I had a severe allergic reaction that occurred within 10minutes of receiving the vaccine. I experienced flushing, throat tightness, dizziness, lightheaded ness. And had to administer an epi pen and be seen in the ER for severe allergic reaction. The reaction was confirmed by a ENT MD that scope my throat and saw the inflammation related to the reaction. I additionally had a rebound severe allergic reaction the next day about 30hrs after the first one and then a delayed reaction less than a week later. All 3 reactions required epinephrine and steroids." Per initial visit ER chart notes dated : 10/7/25: In summary patient was treated for suspected anaphylactic reaction to flu vaccine. "In summary patient was treated for suspected anaphylactic reaction to flu vaccine. She was given multiple doses of epinephrine and racemic epinephrine along with breathing treatments in the EC. ENT did evaluate her and saw some mild swelling and edema the cords and posterior glottis."
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| 2871323 | 66 | F | NY | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
u8874ba |
Dizziness, Erythema, Flushing
Dizziness, Erythema, Flushing
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patient reported to nurse who administered the vaccine of feeling : red, flush, light headed, blood ...
patient reported to nurse who administered the vaccine of feeling : red, flush, light headed, blood pressure elevated, nurse had patient sit for 10-15 minutes then reported feeling better, blood pressure rechecked and went down, nurse advised patient to either return or check in with primary care dr
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| 2871325 | 47 | M | MD | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
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Ocular hyperaemia, Photophobia
Ocular hyperaemia, Photophobia
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Redness of left eye followed by photophobia which appeared after 6 days of receiving the seasonal f...
Redness of left eye followed by photophobia which appeared after 6 days of receiving the seasonal flu vaccine. The patient, who is a physician, who has had a prior history of recurrent uveitis, for which he had been extensively investigated was found to have HLA-B27 positivity, which is associated with Ankylosing Spondylitis/seronegative spondyloarthropathies/ recurrent uveitis. The patient's ophthalmologist had previously advised him to use topical steroid whenever experiencing such signs and do to this he used the medication and has been using to present times. With the application of the eye drops the symptoms resolved. The
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| 2871331 | 37 | F | CO | 11/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4D255 |
Extra dose administered
Extra dose administered
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Pt received 2nd dose. First dose on 9/23/2025. 2nd dose on 11/6/2025.
Pt received 2nd dose. First dose on 9/23/2025. 2nd dose on 11/6/2025.
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| 2871332 | 72 | M | AZ | 11/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pruritus, Rash erythematous, Skin swelling
Pruritus, Rash erythematous, Skin swelling
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Large areas of Red rash, itchy and swollen skin on upper Body torso and lower stomach. Lasted 7 da...
Large areas of Red rash, itchy and swollen skin on upper Body torso and lower stomach. Lasted 7 days
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| 2871333 | 53 | F | AR | 11/07/2025 |
COVID19 |
MODERNA |
AS7145B |
COVID-19
COVID-19
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covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
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| 2871335 | 75 | M | AR | 11/07/2025 |
COVID19 |
MODERNA |
AS7171B |
COVID-19
COVID-19
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covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
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| 2871336 | 71 | F | NH | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8837CA |
Pruritus, Urticaria
Pruritus, Urticaria
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She reports she developed a very large hive over the entire upper arm deltoid muscle that lasted 3 d...
She reports she developed a very large hive over the entire upper arm deltoid muscle that lasted 3 days and was itchy
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| 2871339 | 8 | M | OH | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802MA |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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Rcv'd flu vaccine mid-morning 11/4/2025, woke up morning of 11/5/25 with widespread redness, sw...
Rcv'd flu vaccine mid-morning 11/4/2025, woke up morning of 11/5/25 with widespread redness, swelling and warmth to left upper arm immediately surrounding injection site, extending approx halfway btwn shoulder and elbow, approx 50% of circumference LUE. As of 11/7/2025, redness, swelling and warmth extends from just below injection site distally just past elbow, approx 85-90% circumference of left upper arm. Steroid Rx BID x 3days given, recommended cool compresses often, if worsens instead of improves, may need cephalexin Rx.
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| 2871340 | 78 | F | GA | 11/07/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
MA2488 |
Contusion, Dyspnoea, Loss of consciousness, Peripheral swelling, Vomiting; Contu...
Contusion, Dyspnoea, Loss of consciousness, Peripheral swelling, Vomiting; Contusion, Dyspnoea, Loss of consciousness, Peripheral swelling, Vomiting
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Arm bruised and swollen, shortness of breath, Passed out at her home, woke up and vomited.
Arm bruised and swollen, shortness of breath, Passed out at her home, woke up and vomited.
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| 2871343 | 71 | F | GA | 11/07/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
407265 z010457 |
Diarrhoea, Dizziness, Nausea, Vomiting; Diarrhoea, Dizziness, Nausea, Vomiting
Diarrhoea, Dizziness, Nausea, Vomiting; Diarrhoea, Dizziness, Nausea, Vomiting
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nausea and vomiting and diarrhea with dizziness which lasted through the night and into the next day
nausea and vomiting and diarrhea with dizziness which lasted through the night and into the next day
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