| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2862601 | 45 | F | TX | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
73bn2 |
Arthralgia, Tendonitis
Arthralgia, Tendonitis
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Pain to L shoulder, worsening x 10 days.
Pain to L shoulder, worsening x 10 days.
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| 2862602 | 85 | F | NY | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8837BA |
Abdominal distension, Back pain, Flatulence, Sleep disorder
Abdominal distension, Back pain, Flatulence, Sleep disorder
|
Patient reported feeling fine immediately after the shot, but in the middle of the night (about 12 h...
Patient reported feeling fine immediately after the shot, but in the middle of the night (about 12 hours later) woke from her sleep with severe gas pains in her stomach, and a general feeling of bloat. She took Gas-X and it relieved the issue. She then reported the following day, experiencing back pain and soreness from her lower back up to her shoulders.
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| 2862603 | 79 | M | MI | 10/01/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
u8837ca 3403047 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
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Patient left arm at and all around the injection sites ("palm/hand size area") is swollen,...
Patient left arm at and all around the injection sites ("palm/hand size area") is swollen, red, warm to touch, and itchy ("a deep down itch") and painful. Started about 7-8 hours after injections and is continuing through today (today is Wednesday, and patient received on Monday). Patient does say it is getting less painful, but still hurts a little.
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| 2862604 | 37 | F | KS | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8848BA |
Immediate post-injection reaction, Injection site bruising, Injection site eryth...
Immediate post-injection reaction, Injection site bruising, Injection site erythema, Mobility decreased, Pain
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Vaccine administered at approximate 0945, Pt with immediate soreness after administration, within 2 ...
Vaccine administered at approximate 0945, Pt with immediate soreness after administration, within 2 hours severe pain and limited range of motion. Pt seen by provider, reports taking Tylenol and ibuprofen without relief, ice applied immediately. Injection site measures 15 mm from acromion process, erythema and bruising noted.
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| 2862605 | 53 | F | GA | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817KA |
Injection site pain, Injection site swelling, Muscle fatigue, Pyrexia, Swelling ...
Injection site pain, Injection site swelling, Muscle fatigue, Pyrexia, Swelling of eyelid
More
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left eyelid swelling, muscle fatigue and injection site swelling and tender to the touch, low grade ...
left eyelid swelling, muscle fatigue and injection site swelling and tender to the touch, low grade fever
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| 2862606 | 24 | F | CO | 10/01/2025 |
FLU3 |
SEQIRUS, INC. |
406990 |
Cold sweat, Dizziness, Dyspnoea, Flushing, Nausea
Cold sweat, Dizziness, Dyspnoea, Flushing, Nausea
|
Approximately 15 minutes post injection, HCA reported feeling flushed, lightheaded and dizzy. Vital ...
Approximately 15 minutes post injection, HCA reported feeling flushed, lightheaded and dizzy. Vital signs were checked, cold compress to face and throat examined. No Uvular swelling or tongue swelling noted. After minimal interventions, HCA reported feeling somewhat better. Shortly after feeling better, she began to feel worse again with nausea, flushed and clammy. It was not reported to this nurse of SOB or trouble breathing. Sent to urgent care and at that time she developed SOB and was sent to the ER. Given Epi, Benadryl, Famotidine and Zofran. DC'd from the ED to home by 1800. HCA reported not having an Influenza vaccine in many years and also had not consumed any food that day prior to the vaccine.
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| 2862607 | 0.17 | M | MI | 10/01/2025 |
DTPPVHBHPB HPV9 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U8314AA Y018398 2139674 |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
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Patient was ordered Vaxelis, Prevnar & Rotateq by NP, but the Medical Assistant mistakenly gave ...
Patient was ordered Vaxelis, Prevnar & Rotateq by NP, but the Medical Assistant mistakenly gave Gardasil (HPV) instead of Prevnar
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| 2862608 | 72 | M | MN | 10/01/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052296 u5855BA |
Chest pain, Headache, Night sweats; Chest pain, Headache, Night sweats
Chest pain, Headache, Night sweats; Chest pain, Headache, Night sweats
|
headache, night sweats, chest pain that radiants down both arms
headache, night sweats, chest pain that radiants down both arms
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| 2862609 | 74 | M | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
na0587 |
Chills, Dizziness, Lymphadenopathy, Malaise, Pain in extremity
Chills, Dizziness, Lymphadenopathy, Malaise, Pain in extremity
|
swollen lymph nodes, limbs aching, bp 168/89, hr 101, chills, dizzy, didnt feel well, . pt took tyle...
swollen lymph nodes, limbs aching, bp 168/89, hr 101, chills, dizzy, didnt feel well, . pt took tylenol and went to bed. better after 36hours
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| 2862610 | 22 | F | KS | 10/01/2025 |
RSV |
PFIZER\WYETH |
MM9161 |
Extra dose administered, Maternal exposure before pregnancy, Wrong product admin...
Extra dose administered, Maternal exposure before pregnancy, Wrong product administered
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Pt is 34 weeks pregnant and received an RSV instead of a flu vaccine
Pt is 34 weeks pregnant and received an RSV instead of a flu vaccine
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| 2862611 | F | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
had already received a COVID booster but still ended up getting; had already received a COVID booste...
had already received a COVID booster but still ended up getting; had already received a COVID booster but still ended up getting; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: four times. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had already received a COVID booster but still ended up getting". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2862612 | 65 | M | NV | 10/01/2025 |
PNC21 |
MERCK & CO. INC. |
Z009681 |
Injection site induration, Injection site rash, Injection site swelling
Injection site induration, Injection site rash, Injection site swelling
|
Patient received vaccine, then 3 rashes came up next day, one over immunization site and 2 others ar...
Patient received vaccine, then 3 rashes came up next day, one over immunization site and 2 others around the area in the upper arm. All of them were swollen and hard, stayed for about 3 days, and then started to subside afterwards. Patient reported adverse reaction to pharmacy one week later, symptoms; localized symptoms already subsided. Patient did not seek treatment and condition has resolved.
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| 2862613 | 46 | F | ME | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5EF45 |
Arthralgia, Pain, Pain in extremity
Arthralgia, Pain, Pain in extremity
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right arm pain developed a few hours after vaccine was administered and continued to worsen. now has...
right arm pain developed a few hours after vaccine was administered and continued to worsen. now has radiating pain from shoulder to bicep
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| 2862614 | 15 | M | NY | 10/01/2025 |
FLU3 |
SEQIRUS, INC. |
406989 |
Loss of personal independence in daily activities, Nausea, Pain, Vomiting
Loss of personal independence in daily activities, Nausea, Pain, Vomiting
|
Pt reported body aches on 9/28. Pt then developed nausea and vomiting and missed school for 3 days.
Pt reported body aches on 9/28. Pt then developed nausea and vomiting and missed school for 3 days.
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| 2862615 | 63 | M | CA | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2L353 |
Cold sweat, Dyskinesia, Pain, Pyrexia, Unresponsive to stimuli
Cold sweat, Dyskinesia, Pain, Pyrexia, Unresponsive to stimuli
|
Developed body aches the evening of vaccination (9/11/25). Next day, 9/12/25, increase in body aches...
Developed body aches the evening of vaccination (9/11/25). Next day, 9/12/25, increase in body aches (legs and back), low grade fever (no temp taken) and clammy. Approx 10 pm patient's wife witnessed patient having all extremity jerking movements for approx 1 hour. Was not arousable by voice, wife did not shake him. On 9/13/25- 9/14/25 still achy but decrease in feeling feverish. Patient looked up Influenza reactions and feels that he had a FND reaction. Did not go to ER or have medical evaluation
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| 2862616 | 85 | F | MN | 10/01/2025 |
DF FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
|
Feeling cold, Headache, Tremor, Trismus; Feeling cold, Headache, Tremor, Trismus
Feeling cold, Headache, Tremor, Trismus; Feeling cold, Headache, Tremor, Trismus
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Background Patient received the Covid- 19 immunization yesterday morning and Flu shot in clinic toda...
Background Patient received the Covid- 19 immunization yesterday morning and Flu shot in clinic today. Patient given flu shot this morning at 10:00 am and symptoms started around 11:00 am Assessment: Patient was out all morning shopping and symptoms hit her out of nowhere Patient started shaking violently, was cold, her jaw locked up and had a minor headache. Patients husband called 911 and was examined by EMS, and advised to follow-up with PCP. -Reports symptoms subsided by the time the paramedics were done talking to her. Episode occurred for approximately 30 minutes -Patients husband denies symptoms now. Patient is currently resting. -Patient has not had previous reactions to vaccines. Denies fever, shortness of breath, cough, runny nose, sore throat.
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| 2862617 | 17 | F | NH | 10/01/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
47KS7 |
Facial paralysis, Hypersensitivity, Injection site pain, Pain in extremity, Swel...
Facial paralysis, Hypersensitivity, Injection site pain, Pain in extremity, Swelling face
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Yesterday afternoon she started with having increasing pain in the right upper arm. Patient then dev...
Yesterday afternoon she started with having increasing pain in the right upper arm. Patient then developed some swelling of the left of her jaw. As the day went along she was complaining that her arm really hurt and her face was droopy. Parents took her to the ED at 21:38 because she was having a allergic reaction to the Men B. Patient had no swelling of the lips ,tongue or back or throat. No shortness of breath. Pain in right arm was described as sharp nature, constant,8 our of 10 and not relieved by ibuprofen.
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| 2862618 | 60 | M | 10/01/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052087 407247 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
|
Fluad was mistakenly administered to patient instead of Flucelvax. Given patient age 60, Fluad not i...
Fluad was mistakenly administered to patient instead of Flucelvax. Given patient age 60, Fluad not indicated. Patient was informed of the error and had no concerns. No adverse events have occurred within the several hours since vaccination based on when this report is being filed; only incorrect vaccine administered. Patient was informed to let us know if any adverse events so that we can report. Also encouraged to report any if they would prefer.
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| 2862620 | 33 | F | IA | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Full blood count abnormal, Mouth ulceration, Neutropenia
Full blood count abnormal, Mouth ulceration, Neutropenia
|
Developed severe, painful mouth ulcers, got a CBC on 10/1 and was neutropenic
Developed severe, painful mouth ulcers, got a CBC on 10/1 and was neutropenic
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| 2862621 | 30 | F | MI | 10/01/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
j53tb |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
|
Quarter sized redness and mild swelling at injection site
Quarter sized redness and mild swelling at injection site
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| 2862622 | 84 | F | GA | 10/01/2025 |
COVID19 |
MODERNA |
3052549 |
Diarrhoea
Diarrhoea
|
PATIENT WAS HAVING UNCONTROLLED PERSISTENT DIARRHEA SINCE THE NIGHT VACCINE WAS RECEIVED .
PATIENT WAS HAVING UNCONTROLLED PERSISTENT DIARRHEA SINCE THE NIGHT VACCINE WAS RECEIVED .
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| 2862623 | 33 | F | NC | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Tinnitus
Tinnitus
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Whoosing/rushing water sound in left ear
Whoosing/rushing water sound in left ear
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| 2862624 | 73 | F | WI | 10/01/2025 |
COVID19 COVID19 RSV RSV |
MODERNA MODERNA PFIZER\WYETH PFIZER\WYETH |
|
Dysstasia, Fall, Gait inability, Hypoaesthesia, Hypoaesthesia oral; Lumbar punct...
Dysstasia, Fall, Gait inability, Hypoaesthesia, Hypoaesthesia oral; Lumbar puncture, Magnetic resonance imaging, Muscular weakness; Dysstasia, Fall, Gait inability, Hypoaesthesia, Hypoaesthesia oral; Lumbar puncture, Magnetic resonance imaging, Muscular weakness
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Numbness began in fingers on July 9, 2025. Numbness progressed to toes, legs, lips and tongue over t...
Numbness began in fingers on July 9, 2025. Numbness progressed to toes, legs, lips and tongue over the next 3 days. Weakness in legs started on July 10. Lost the ability to walk or stand on July 14, 2025. Fell and was transported to Emergency Room. Was hospitalized a total of 3 weeks,. One week in Neurology Unit and two weeks in Inpatient Physical Therapy.
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โ | โ | ||||
| 2862625 | 71 | F | NC | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8859da |
Headache, Nausea, Pain
Headache, Nausea, Pain
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Nausea, headache, body aches
Nausea, headache, body aches
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| 2862627 | 73 | F | AL | 10/01/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
407244 z006076 |
Abdominal discomfort, Breast swelling, Peripheral swelling, Rash, Rash pustular;...
Abdominal discomfort, Breast swelling, Peripheral swelling, Rash, Rash pustular; Abdominal discomfort, Breast swelling, Peripheral swelling, Rash, Rash pustular
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Severe rash and swelling from left arm to breast and GI upset for several days. Rash included includ...
Severe rash and swelling from left arm to breast and GI upset for several days. Rash included included pus filled blisters.
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| 2862628 | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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got Covid "bad" in Jun2025; got Covid "bad" in Jun2025; This is a spontaneous re...
got Covid "bad" in Jun2025; got Covid "bad" in Jun2025; This is a spontaneous report received from an Other HCP. Other Case identifier(s): MOD-2025-789599 (Moderna), US-MODERNATX-MOC20250924000006 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "recovered" (2025) and all described as "got Covid "bad" in Jun2025". The patient did not experience any additional symptoms/events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (COVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.
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| 2862629 | 76 | M | OH | 10/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
u8764d8 |
Chest discomfort, Paraesthesia oral
Chest discomfort, Paraesthesia oral
|
tingling in lips tightness in chest
tingling in lips tightness in chest
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| 2862630 | 13 | F | CO | 10/01/2025 |
HPV9 |
MERCK & CO. INC. |
Z002903 |
Loss of consciousness, Pallor, Syncope, Unresponsive to stimuli
Loss of consciousness, Pallor, Syncope, Unresponsive to stimuli
|
Prior to administering vaccines, patient stated to RN that she "hadn't eaten all day"...
Prior to administering vaccines, patient stated to RN that she "hadn't eaten all day". RN offered and provided crackers and juice. When RN returned after drawing up vaccines, pt had consumed her crackers and half of the juice. RN administered Tdap and HPV vaccine, about 1 minute post vaccination; pt fainted/"passed out". Pt was unresponsive and pale. RN and RN applied ice packs to patient's back of neck, forehead, and chest. RN also applied the supplemental O2 via Nasal Cannula. Pt became responsive after approximately 20 seconds. Vitals steadily improved (see adverse event form and below), pupils were equal and reactive throughout incident. Pt's color returned and pt was alert & oriented after less than a minute. Pt was provided water and sat on exam table being monitored by RN staff. Program director, RN; was notified of the adverse event. Pt remained in clinic and monitored for approximately 25 min. Pt left clinic independently with mother and sister. RN reported event to VAERS. @1324: BP: 108/95 (laying down), Pulse: 61, Resp rate: 24, O2: 83 @1330: BP: 96/83(sitting), Pulse: 73, Resp rate: 16, O2: 98 @1335: BP 103/88 (sitting), Pulse: 80, Resp rate: 16, O2: 98
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| 2862631 | 81 | F | MN | 10/01/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
3052549 3052549 3052549 |
Aphasia, Arteriogram carotid, Cerebrovascular accident, Computerised tomogram he...
Aphasia, Arteriogram carotid, Cerebrovascular accident, Computerised tomogram head abnormal, Dysarthria; Echocardiogram abnormal, Ejection fraction normal, Magnetic resonance imaging head abnormal, Mitral valve incompetence, Scan with contrast normal; Tricuspid valve incompetence
More
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Acute Stroke. Symptom onset reports within hours of her Moderna Covid Vaccine given at Pharmacy. t...
Acute Stroke. Symptom onset reports within hours of her Moderna Covid Vaccine given at Pharmacy. this is her 9th covid vaccine. Within hours word-finding difficulty, dysarthria. Presented to ER following day with worsening. denied slurring of speech or facial droop.
More
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โ | โ | ||||
| 2862632 | 76 | F | KS | 10/01/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3051997 u8859DA |
Fall, Haemorrhage, Head injury; Fall, Haemorrhage, Head injury
Fall, Haemorrhage, Head injury; Fall, Haemorrhage, Head injury
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Patient received the vaccines, and then shortly after, she was walking back to her car and fell. She...
Patient received the vaccines, and then shortly after, she was walking back to her car and fell. She hit her head, and we called the ambulance. She was bleeding from her face. She was transported to the nearest ER.
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| 2862633 | 57 | M | WA | 10/01/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
AX5586C AX5586C |
Chills, Fatigue, Feeling cold, Feeling hot, Hyperhidrosis; Pain
Chills, Fatigue, Feeling cold, Feeling hot, Hyperhidrosis; Pain
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I woke up at 4am and I had the chills really bad, I went and drank alot of fluids and took some dayq...
I woke up at 4am and I had the chills really bad, I went and drank alot of fluids and took some dayquil and i waited for an hour and half and the chills got worse and i put on a bunch of clothes and went back to bed. I woke up 3 hours later and i was buring up and was sweating and put on a shirt and tshirt and i was freezing. I took my temp and it was 100.1, I laid back down around 9 and i fell asleep for a bit and i was freezing again and i went to sleep again and i woke up and i feel like i got ran over by a truck and i am so exhausted.
More
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| 2862634 | 75 | F | FL | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Contusion
Contusion
|
bad bruise on left arm
bad bruise on left arm
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| 2862635 | 57 | F | WA | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8800BA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Received HD influenza vaccination when she is not of age. She's only 57 years old not 65 years ...
Received HD influenza vaccination when she is not of age. She's only 57 years old not 65 years old or older.
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| 2862636 | 17 | F | AL | 10/01/2025 |
DTAP MNQ |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
5KR3R U8508AA |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
|
Patient was scheduled to receive the Tdap vaccine and the DTap vaccine was given
Patient was scheduled to receive the Tdap vaccine and the DTap vaccine was given
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| 2862637 | 74 | M | IN | 10/01/2025 |
COVID19 HEPAB |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3052296 AZ2A3 |
Blood test, Musculoskeletal stiffness, Peripheral swelling, Rash, Rash erythemat...
Blood test, Musculoskeletal stiffness, Peripheral swelling, Rash, Rash erythematous; Blood test, Musculoskeletal stiffness, Peripheral swelling, Rash, Rash erythematous
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Patient developed a rash all over his body a day after receiving the Twinrix and mNEXSPIKE vaccine. ...
Patient developed a rash all over his body a day after receiving the Twinrix and mNEXSPIKE vaccine. His rash was not elevated and was large dark red spots. He had swelling in his hands and on one leg and also tightness in his hands but no pain. Patient started developing symptoms 24 hours after receiving the vaccinations. He has went to his provider to be seen for the rash and is receiving blood tests but I have not heard the outcome of the doctor visit yet.
More
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| 2862638 | 12 | M | OR | 10/01/2025 |
COVID19 FLU3 HPV9 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
3052736 FHY4R Y015560 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
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Patient has not had any adverse effects from this vaccination. The incorrect version of COVID vaccin...
Patient has not had any adverse effects from this vaccination. The incorrect version of COVID vaccine was given to this patient. He received the mNexspike vaccine (0.2 ml) instead of the Spikevax (0.5ml). This does not put the patient in any danger. The provider spoke with the family via phone to discuss the error. The family expressed understanding and declines to have patient further vaccinated with the correct dose.
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| 2862639 | 24 | F | PA | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2501 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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skin reaction, small circular spot, reddish, slightly swollen, warm to the touch 1-1.5 inch below in...
skin reaction, small circular spot, reddish, slightly swollen, warm to the touch 1-1.5 inch below injection site
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| 2862640 | 72 | F | CA | 10/01/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
|
Mobility decreased, Product administered at inappropriate site; Mobility decreas...
Mobility decreased, Product administered at inappropriate site; Mobility decreased, Product administered at inappropriate site
More
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pt was vaccinated too high in shoulder and has limited mobility
pt was vaccinated too high in shoulder and has limited mobility
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| 2862641 | 51 | F | MS | 10/01/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
my9550 u8823ca |
Rash; Rash
Rash; Rash
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Patient stated there was a rash all over her body and went to the Dermotologist - was prescribed a s...
Patient stated there was a rash all over her body and went to the Dermotologist - was prescribed a steroid
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| 2862642 | 35 | F | CA | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0846 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Wrong age dose given (5-11 yr Pfizer)
Wrong age dose given (5-11 yr Pfizer)
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| 2862643 | 86 | F | NC | 10/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
bg5j4 |
Extra dose administered
Extra dose administered
|
Patient received a second RSV vaccine by error.
Patient received a second RSV vaccine by error.
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| 2862644 | F | 10/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8800CA |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered
More
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ages of 18 ๏ฟฝ64 yearswas administered the Fluzone high dose instead of the Fluzone (standard dose) ...
ages of 18 ๏ฟฝ64 yearswas administered the Fluzone high dose instead of the Fluzone (standard dose) with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult female patient (160 cm and 128 kg) who experienced ages of 18-64 years was administered the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose instead of the fluzone (standard dose) with no reported adverse event. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Sep-2025, the patient ages of 18-64 years received 0.5ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine; Suspension for injection in pre-filled syringe with unknown (strength) (lot U8800CA with expiry date JUN-2026) via intramuscular route for prophylactic vaccination (Immunisation) with no reported adverse event (product administered to patient of inappropriate age). Reportedly: The nurse grabbed the vaccine from the standard dose storage cooler and fluzone standard dose box or packaging. Administered the vaccine. Nurse identified the error upon documentation when she was selecting the name of the vaccine and entering the lot number and reading that the lot number wasnt matching up and noticed the label on the syringe read high dose. She retrieved the box she had just used to pull the vaccine from and noticed another Flu high dose syringe mixed in with the rest of the standard dose vaccines in the Fluzone standard dose box/ packaging. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2862645 | 92 | M | NC | 10/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered
Extra dose administered
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Patient accidently received a second dose of the RSV vaccine.
Patient accidently received a second dose of the RSV vaccine.
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| 2862647 | 64 | F | GA | 10/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2hj99 |
Blood glucose increased, Condition aggravated
Blood glucose increased, Condition aggravated
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Reported blood glucose levels of ~400s shortly after vaccination. Denies any other changes during th...
Reported blood glucose levels of ~400s shortly after vaccination. Denies any other changes during that time.
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| 2862648 | 77 | NC | 10/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5JA |
Extra dose administered
Extra dose administered
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Patient accidently received a second RSV shot.
Patient accidently received a second RSV shot.
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| 2862649 | 43 | F | KY | 10/01/2025 |
FLU3 |
SEQIRUS, INC. |
AX4607A |
Cough, Oropharyngeal pain, Sensation of foreign body
Cough, Oropharyngeal pain, Sensation of foreign body
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APROXIMATELY 30 MINUTES AFTER VACCINATION, PT STARTED COUGH. PROGRESSIVELY WORSENED, THEN HER THROAT...
APROXIMATELY 30 MINUTES AFTER VACCINATION, PT STARTED COUGH. PROGRESSIVELY WORSENED, THEN HER THROAT FELT LIKE SHE HAD STREPT THROAT (FELT LIKE SHE WAS TRYING TO "SWOLLOW A GOLFBALL" VERY PAIN. PT TOOK 50MG OF DIPHENHYDRAMINE AND WENT TO AN URGENT CARE
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| 2862650 | 35 | M | CA | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0846 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Wrong age dose given (5-11 yr Pfizer)
Wrong age dose given (5-11 yr Pfizer)
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| 2862651 | 5 | F | WY | 10/01/2025 |
DTAPIPVHIB PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
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Inappropriate schedule of product administration, No adverse event, Product admi...
Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
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Pentacel given. Dtap, Hib, and IPV were all needed. She was behind in her vaccinations. This dose wa...
Pentacel given. Dtap, Hib, and IPV were all needed. She was behind in her vaccinations. This dose was given after the age of 5 years. PCV 20 was given even though she had 3 previously before the age of 1 year.
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| 2862653 | 64 | F | CT | 10/01/2025 |
COVID19 COVID19 COVID19 COVID19-2 |
MODERNA MODERNA MODERNA MODERNA |
058K21A AS7171B |
Tinnitus; Tinnitus; Tinnitus; Tinnitus
Tinnitus; Tinnitus; Tinnitus; Tinnitus
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Tinnitus occred after covid also when I had my pneumonia shot 1 or 2 yrs ago the tinnitus got worse ...
Tinnitus occred after covid also when I had my pneumonia shot 1 or 2 yrs ago the tinnitus got worse so I will not have another pneumonia shot. I still have tinnitus
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| 2862654 | 4 | F | CA | 10/01/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse reaction. MD was called and advised the parents to give Benadryl when they got home and ...
No adverse reaction. MD was called and advised the parents to give Benadryl when they got home and to monitor for any signs of a reaction and to got to ER if needed.
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