| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2868426 | 85 | DE | 10/27/2025 |
FLU3 |
SANOFI PASTEUR |
UTAA04CA |
Injection site bruising, Product administered at inappropriate site
Injection site bruising, Product administered at inappropriate site
|
report that an 85-year-old patient who received fluzone hd developed bruising on their thigh, which ...
report that an 85-year-old patient who received fluzone hd developed bruising on their thigh, which was injection site; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 85 years old and unknown gender patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] and had bruising on their thigh, which was injection site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot UTAA04CA, expiry date :30-Jun-2026, strength not reported via unknown route in the thigh nos (not otherwise specified) for Immunization. On 10-Oct-2025 the patient had bruising on their thigh, which was injection site (Injection site bruising) (latency: same day). Reportedly,The pharmacist stated that the patient had been "getting flu shots for years" and described the adverse reaction as "truly new". Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovering / Resolving for the event.
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| 2868430 | 48 | M | CA | 10/27/2025 |
FLU3 |
SANOFI PASTEUR |
U8847CA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
received the wrong dose of fluzone hd with no reported adverse event; Initial information received o...
received the wrong dose of fluzone hd with no reported adverse event; Initial information received on 18-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 48 years old male patient who received the wrong dose of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8847CA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in the left arm for Immunization and the wrong dose of fluzone hd with no reported adverse event (incorrect dose administered) (latency same day). 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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| 2868431 | 10/27/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Cough, Headache, Oropharyngeal pain, Pain, Pyrexia
Cough, Headache, Oropharyngeal pain, Pain, Pyrexia
|
Fever; Aches; Sore throat; Headache; Cough; This spontaneous case, initially received on 09-Oct-2025...
Fever; Aches; Sore throat; Headache; Cough; This spontaneous case, initially received on 09-Oct-2025, was reported by a non-health professional and concerns a patient of unknown age/gender. Concomitant medication and medical history was reported as unknown. Administration of company suspect drug: On 08-Oct-2025, the patient received Flucelvax (TIV) for not reported indication, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Oct-2025, the patient experienced Fever (outcome: Unknown), Aches (outcome: Unknown), Sore throat (outcome: Unknown), Headache (outcome: Unknown), Cough (outcome: Unknown). The patient had reaction: fever, aches, sore throat, headache, cough. It could be weather changes as well or kids but received the flu vaccine on 08-Oct-2025. Treatment measures associated with event was reported as unknown. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, the event were considered related for reporting purposes.
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| 2868453 | 14 | M | NC | 10/27/2025 |
FLUN3 FLUN3 FLUN3 |
MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. |
YF3413B YF3413B YF3413B |
Blood test abnormal, Blunted affect, Chest X-ray normal, Computerised tomogram h...
Blood test abnormal, Blunted affect, Chest X-ray normal, Computerised tomogram head normal, Concussion; Gaze palsy, Headache, Influenza virus test negative, Injury, Loss of consciousness; Loss of personal independence in daily activities, Myalgia, Syncope
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Patient had an episode of syncope that lead to an injury that caused concussion symptoms following h...
Patient had an episode of syncope that lead to an injury that caused concussion symptoms following his first dose of Flumist. He was seen/treated in the ER on 10/22/2025 and diagnosed with syncope and collapse, and loss of consciousness (30 mins or less). He had labs, a chest Xray, and a head CT. He followed up with our office post-ER visit where he had additional labwork completed. Rapid flu test was negative. Provider is concerned that patient's syncopal episode occured as a direct reaction to the dose of FluMist. Patient's main findings in office on 10/24/2025 are a blunt affect and eye muscle pain with upward gaze. The provider is keeping him out of school x 1 week for recovery/brain rest and having him abstain from sports/physical activity for 2 weeks after headaches resolve. Plan to re-evaluate him in office again in 2 weeks.
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| 2868527 | 43 | M | FL | 10/27/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
030L20A 030L20A 039K20A 039K20A |
Aphasia, Barium swallow, Blood test, Endoscopy, Full blood count; Oesophageal ac...
Aphasia, Barium swallow, Blood test, Endoscopy, Full blood count; Oesophageal achalasia, Oesophageal manometry, Oesophagocardiomyotomy, Oesophagram; Aphasia, Barium swallow, Blood test, Endoscopy, Full blood count; Oesophageal achalasia, Oesophageal manometry, Oesophagocardiomyotomy, Oesophagram
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Progressive dysphasia which progressed to a diagnosis of Type II Achalasia. Had POEM surgery Oct 202...
Progressive dysphasia which progressed to a diagnosis of Type II Achalasia. Had POEM surgery Oct 2025.
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โ | โ | ||||
| 2868528 | 34 | F | ME | 10/27/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5EF45 |
Asthenia, Mobility decreased, Pain
Asthenia, Mobility decreased, Pain
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increasing pain, weakness, and decreased ROM since receiving vaccine
increasing pain, weakness, and decreased ROM since receiving vaccine
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| 2868529 | 67 | M | NC | 10/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Injection site pain, Pain, Sleep disorder
Arthralgia, Injection site pain, Pain, Sleep disorder
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Ongoing and severe pain in the deltoid muscle and shoulder area of the left arm. Started October 5 a...
Ongoing and severe pain in the deltoid muscle and shoulder area of the left arm. Started October 5 and continues through today. Range of motion has been reduced 50% and pain is experienced when moving arm up and down or sideways. Cannot carry objects more than 10 pounds without registering pain. Cannot put on clothes without experienciing pain or discomfort. Sleep is interrupted by severe and chronic pain (8 on a 10 point scale).
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| 2868530 | 28 | F | IL | 10/27/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0739 U8832BA |
Nasal congestion, Swelling of eyelid; Nasal congestion, Swelling of eyelid
Nasal congestion, Swelling of eyelid; Nasal congestion, Swelling of eyelid
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Swelling of the left eyelid, stuffy nose
Swelling of the left eyelid, stuffy nose
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| 2868531 | 25 | F | MA | 10/27/2025 |
FLU3 |
SANOFI PASTEUR |
U8889DA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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I administered the flu vaccine to the patient, even though she was not due for it, as she had alread...
I administered the flu vaccine to the patient, even though she was not due for it, as she had already received it on 9/25/25. I get confused between the flu vaccine and another vaccine that the patient was due for. The patient specifically requested the flu vaccine, even though her visit was originally scheduled for the HPV vaccine.
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| 2868533 | 12 | M | KY | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0846 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Grandma (guardian) called a few weeks ago and was wanting covid vaccine for her 2 grandchildren. I...
Grandma (guardian) called a few weeks ago and was wanting covid vaccine for her 2 grandchildren. I told her currently I did not have the covid 5y-11y dose, but it was on the way. When it arrived I called her and the childrens were scheduled. They came in on 10/24/2025 at 4 for the vaccine. I brought the patient back to lab, in walking back I verified name, birth date and the vaccine they were here for. Vaccine given to first child, after I gave vaccine I looked at my computer to chart and realized his age was 12 years old even after verifying BD. I just had it in my head that the 5y-11y vaccine I had ordered were for both kids. I finished charting, called immunization branch and filled out reports. Called the grandma back to inform and let her know that the child would need the adult dose 12+ to be considered valid. Child had no adverse reactions and done well with this covid vaccine and the ones prior.
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| 2868535 | 77 | M | NY | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0739 |
Balance disorder, Condition aggravated, Coordination abnormal, Dysstasia, Gait d...
Balance disorder, Condition aggravated, Coordination abnormal, Dysstasia, Gait disturbance
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October 2023 after 6th Covid vaccine, developed neuropathy, and problems with coordination and balan...
October 2023 after 6th Covid vaccine, developed neuropathy, and problems with coordination and balance, standing and walking. Symptoms improved at a steady and consistent rate over the next 2 years, Then one week after the 7th Covid vaccination on October 6, 2025 a sudden and precipitous reoccurrence decrease in balance, coordination and difficult standing and walking reoccurred.
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| 2868537 | 0.75 | F | MA | 10/27/2025 |
DTAPIPV FLU3 |
GLAXOSMITHKLINE BIOLOGICALS SEQIRUS, INC. |
YN2X2 406987 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Kinrix given at incorrect age, was given at 9 months of age, no adverse effect from patient
Kinrix given at incorrect age, was given at 9 months of age, no adverse effect from patient
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| 2868538 | 46 | M | UT | 10/27/2025 |
FLU3 |
SANOFI PASTEUR |
UT8836LA |
Hypoaesthesia oral, Pruritus, Skin exfoliation
Hypoaesthesia oral, Pruritus, Skin exfoliation
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Numbness around the lips, flakiness, angular chelation (corners of the mouth), itchiness on the fing...
Numbness around the lips, flakiness, angular chelation (corners of the mouth), itchiness on the fingers, what looks like eczema on the fingers.
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| 2868539 | 48 | F | TX | 10/27/2025 |
FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
u8827aa u8827aa u8827aa u8827aa |
Butterfly rash, Fatigue, Gait disturbance, Headache, Hypoaesthesia oral; Influen...
Butterfly rash, Fatigue, Gait disturbance, Headache, Hypoaesthesia oral; Influenza like illness, Muscle fatigue, Muscular weakness, Myalgia, Neurological symptom; Paraesthesia, Pyrexia, Rash, Rash erythematous, Skin exfoliation; Somnolence
More
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Pt has reported an adverse reaction to the Flu Vaccine. She received the Flu vaccine on Wednesday 10...
Pt has reported an adverse reaction to the Flu Vaccine. She received the Flu vaccine on Wednesday 10/22/2025 at Rehab. She is a RN with Rehab who reports that she started having general flu-like symptoms of muscle aches, fever, and headache on Wednesday. On Thursday night she reports symptoms of Guillain-Barre Syndrome. Both of her legs had extreme muscle weakness and pain. By Friday she states her lips had some numbness, her toes and fingertips had tingling. She states she was fatigued all weekend and could hardly wake up. She did not seek any medical treatment. Today she woke up with a butterfly rash over her face. She states it is red and flaky. The muscle fatigue and pain are still present and causes difficulty when walking.
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| 2868540 | 41 | F | LA | 10/27/2025 |
UNK |
UNKNOWN MANUFACTURER |
410514 |
Oral mucosal erythema, Oral pain, Oral pruritus, Oropharyngeal erythema, Urticar...
Oral mucosal erythema, Oral pain, Oral pruritus, Oropharyngeal erythema, Urticaria
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STATES SHE DEVELOPED HIVES AND ITCHING/REDNESS/PAIN OF MOUTH AND THROAT
STATES SHE DEVELOPED HIVES AND ITCHING/REDNESS/PAIN OF MOUTH AND THROAT
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| 2868542 | 57 | F | WI | 10/27/2025 |
UNK |
UNKNOWN MANUFACTURER |
93NL9 |
Arthralgia
Arthralgia
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Teammate stated she is having joint pain to left thumb that started after receiving flu shot to left...
Teammate stated she is having joint pain to left thumb that started after receiving flu shot to left arm on 9/29/25. Teammate stated is now having joint pain all over her body. Teammate is not sure if related to Flu shot. Teammate stated pain started after receiving Flu shot and doesn't know if the flu shot "kicked off an autoimmune response". Teammate stated she is seeing her primary doctor today, 10/27/25.
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| 2868543 | 35 | F | IL | 10/27/2025 |
FLU3 |
SEQIRUS, INC. |
AX5589A |
Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in...
Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
More
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Pain at the injection site with some shoulder pain with movements at rest same day . Some limitat...
Pain at the injection site with some shoulder pain with movements at rest same day . Some limitation and restrictions with certain Range of motion :-- Left Deltoid- Injection site -- Left arm pain. Worsened as the day went on.
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| 2868544 | 4 | M | MN | 10/27/2025 |
FLU3 |
SEQIRUS, INC. |
948400 |
Vomiting
Vomiting
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4-year-old client vomited after vaccine, no other symptoms. Nurse advised to go to ED / urgent care ...
4-year-old client vomited after vaccine, no other symptoms. Nurse advised to go to ED / urgent care if other symptoms arise. Nurse monitored for 15 minutes. After vomiting parent reported that prior to vaccine administration, child had a "tummy ache" - this was not reported by parent when nurse asked if child was feeling well prior to getting the vaccine.
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| 2868545 | 6 | M | MA | 10/27/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052579 407005 |
Circumstance or information capable of leading to medication error, Underdose; C...
Circumstance or information capable of leading to medication error, Underdose; Circumstance or information capable of leading to medication error, Underdose
More
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When administering the Covid vaccine the patient moved and the needle came out of the patients arm. ...
When administering the Covid vaccine the patient moved and the needle came out of the patients arm. The patient received less than 1/4 of the dose. Per CDC recommendation when less than half the dose is administered the patient should receive the full dose immediately. With patients mothers consent the patient received the full dose. Patient was observed for 15 minutes and had no reactions.
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| 2868547 | 78 | F | IN | 10/27/2025 |
FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8862DA U8862DA U8862DA U8862DA |
Flatulence, Mobility decreased, Pain; Abdominal discomfort, Abdominal distension...
Flatulence, Mobility decreased, Pain; Abdominal discomfort, Abdominal distension, Abdominal pain upper, Dysgeusia, Flatulence; Hernia, Mobility decreased, Musculoskeletal discomfort, Neck pain, Pain; Spinal cord disorder; Flatulence, Mobility decreased, Pain; Abdominal discomfort, Abdominal distension, Abdominal pain upper, Dysgeusia, Flatulence; Hernia, Mobility decreased, Musculoskeletal discomfort, Neck pain, Pain; Spinal cord disorder
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PATIENT CALLED AND STATED THAT THE DAY AFTER RECEIVING THE HIGH DOSE FLU VACCINE THAT SHE FELT LIKE ...
PATIENT CALLED AND STATED THAT THE DAY AFTER RECEIVING THE HIGH DOSE FLU VACCINE THAT SHE FELT LIKE HER WHOLE BODY WAS FULL OF GAS AND SHE TOOK SOME OVER THE COUNTER MEDICATION TO TRY TO RESOLVE IT AND NOTHING TOUCHED IT. IT TOOK 3 DAYS FOR THE GAS TO LEAVE HER BODY, BUT IN THE MEAN TIME IT CAUSED HER A LOT OF PAIN AS SHE HAS FLANK HERNIA. SHE HAS NOT SEEN HER PROVIDER YET, BUT STATED SHE PLANS ON SEEING HIM AS SHE WAS STRUGGLING TO MOVE HER BODY AT ALL DUE TO THE GAS.
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| 2868548 | 4 | M | WI | 10/27/2025 |
COVID19 |
MODERNA |
3052581 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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On 10/22/25 patient seen for a WCE with provider and received a covid high dose vaccine. This was or...
On 10/22/25 patient seen for a WCE with provider and received a covid high dose vaccine. This was order by accident and not a vaccine that we were going to carry. We discovered this the next day. Provider called parent to let them know and to answer any questions they may have. Provider gave information on what they should watch for as a adverse reaction. Patient is so far tolerating well.
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| 2868549 | 33 | F | FL | 10/27/2025 |
FLU3 |
SANOFI PASTEUR |
U8864BA |
Dysphagia, Urticaria
Dysphagia, Urticaria
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Outbreak of hives on her chest, abdomen the day of injection. Next day, having trouble swallowing an...
Outbreak of hives on her chest, abdomen the day of injection. Next day, having trouble swallowing and hives are spreading to her back. Symptoms persisting after taking Benadryl.
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| 2868550 | 90 | F | NY | 10/27/2025 |
COVID19 |
MODERNA |
3052579 |
No adverse event, Underdose
No adverse event, Underdose
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No adverse reaction. Patient was given pediatric dose of vaccine instead of adult dose.
No adverse reaction. Patient was given pediatric dose of vaccine instead of adult dose.
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| 2868554 | 54 | F | TN | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
na445a |
Anaphylactic reaction, Injection site swelling
Anaphylactic reaction, Injection site swelling
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Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Additional Details:...
Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Additional Details: patient claims that that the er diagnosed her with covid arm, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: na4452; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
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| 2868555 | 82 | F | MA | 10/27/2025 |
COVID19-2 |
MODERNA |
3053669 |
Cardiac disorder, Cardiac failure, Condition aggravated
Cardiac disorder, Cardiac failure, Condition aggravated
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Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Additional Details: Patients son called the pha...
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Additional Details: Patients son called the pharmacy to report that patient had gone to the ER with a heart failure exacerbation, symptoms started after leaving the pharmacy when she recived the two vaccines. Pateint is currently in the hospital. , Other Vaccines: VaccineTypeBrand: FLUZONE High-Dose; Manufacturer: Sanofi-Pasteur; LotNumber: U8859AA; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 10/17/2025
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| 2868556 | 78 | F | PA | 10/27/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3053669 |
Arthralgia, Injection site pain, Injection site swelling, Tinnitus
Arthralgia, Injection site pain, Injection site swelling, Tinnitus
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Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint I...
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Joint Pain-Severe, Systemic: Tinnitus-Medium, Additional Details: patient also reported lack of control/movement of fingers in the arm used to vaccinate. Administration site was reviewed and found no issues with injectino site/technique. Due to the proper administration of the vaccine, likely a true side effect of the vaccine. Patient was counseled to inform doctor of the likely side effect. , Other Vaccines: VaccineTypeBrand: mnex; Manufacturer: moderna; LotNumber: 3053669; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
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| 2868558 | 51 | M | CA | 10/27/2025 |
FLU4 |
SANOFI PASTEUR |
U8500AA |
Influenza like illness, Pain, Pyrexia
Influenza like illness, Pain, Pyrexia
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Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Additional Details: Patient reports tha...
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Additional Details: Patient reports that every time she gets the flu vaccine, she experiences body pain and aches, fever and flu like symptoms.
More
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| 2868559 | 67 | M | MI | 10/27/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
8146743 |
Wrong product administered
Wrong product administered
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Systemic: wrong vaccine given-Mild, Additional Details: Patient was supposed to get mNexSpike, but i...
Systemic: wrong vaccine given-Mild, Additional Details: Patient was supposed to get mNexSpike, but instead received Spikevax
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| 2868560 | 41 | F | MN | 10/27/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA4452 NA4452 |
Dysphagia, Dyspnoea, Flushing, Hyperhidrosis, Injection site erythema; Pruritus,...
Dysphagia, Dyspnoea, Flushing, Hyperhidrosis, Injection site erythema; Pruritus, Throat tightness
More
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Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller...
Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported feeling an itchy throat and some difficulty breathing around 10 minutes after the vaccines. Patient carries an albuterol inhaler and used it. Patient states that she usually only has an asthma flare up from exercise. Gave patient 2 banophen capsules from the vaccine kit. Monitored patient for the next 15 minutes. Patient felt much better after using inhaler. Patient purchased benadryl to take home and will call back if symptoms change/worsen., Other Vaccines: VaccineTypeBrand: Influenza Quad (Flucelvax); Manufacturer: ; LotNumber: 406981; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 10/17/2025
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| 2868561 | 62 | F | MI | 10/27/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
3053669 |
Wrong product administered
Wrong product administered
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Systemic: wrong vaccine given-Mild, Additional Details: patient was supposed to receive Spikevax, bu...
Systemic: wrong vaccine given-Mild, Additional Details: patient was supposed to receive Spikevax, but instead got mNexSpike
More
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| 2868564 | 41 | M | CA | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
my9548 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Site: Pain at Injection Site-Mild, Additional Details: reporting wrong route of administration. no a...
Site: Pain at Injection Site-Mild, Additional Details: reporting wrong route of administration. no adverse effects reproted by patient. vaccines was give subq not IM
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| 2868565 | 66 | F | CA | 10/27/2025 |
FLUA4 |
SEQIRUS, INC. |
407244 |
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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| 2868566 | 4 | M | KS | 10/27/2025 |
FLU4 |
SANOFI PASTEUR |
ut8873ka |
Injection site erythema, Injection site reaction, Injection site swelling, Injec...
Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
More
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Lar...
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Large red, hot rash about 2x3in on arm around vaccine site. Counseled to use ice pack to help clear faster, denied any pain
More
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| 2868567 | 38 | F | CA | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
my9548 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Site: Pain at Injection Site-Mild, Additional Details: vaccine was administred subq not IM. no adver...
Site: Pain at Injection Site-Mild, Additional Details: vaccine was administred subq not IM. no adverse reactions, Other Vaccines: VaccineTypeBrand: flucelavax; Manufacturer: ; LotNumber: 407008; Route: subq; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
More
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| 2868568 | 67 | M | FL | 10/27/2025 |
COVID19-2 COVID19-2 |
MODERNA MODERNA |
3052549 3052549 |
Asthenia, Cardiac disorder, Injection site bruising, Injection site erythema, In...
Asthenia, Cardiac disorder, Injection site bruising, Injection site erythema, Injection site pruritus; Pyrexia
More
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at In...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Fever-Medium, Systemic: Weakness-Severe
More
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| 2868569 | 4 | F | NV | 10/27/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
je74j |
Circumstance or information capable of leading to medication error, Scratch
Circumstance or information capable of leading to medication error, Scratch
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Systemic: Patient pulled out syringe and the needle scratched her arm-Mild, Additional Details: The ...
Systemic: Patient pulled out syringe and the needle scratched her arm-Mild, Additional Details: The mother did not hold the patient appropriately and also did not advise us the child was not good at getting vaccines. The child offered to go first and after the shot was injected into her arm she grabbed the syringe and pulled it out - scratching her arm. Unsure if entire vaccine was administered - offered to readminster but child would not calm down enough for us to be comfortable enough attempting a second try.
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| 2868570 | 46 | F | NY | 10/27/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Wrong technique in product usage process
Wrong technique in product usage process
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Systemic: Ineffective: vaccine was given incorrectly, at 45 degree angle on back of the arm-Mild, Ad...
Systemic: Ineffective: vaccine was given incorrectly, at 45 degree angle on back of the arm-Mild, Additional Details: Patient called pharmacy after receiving vaccine (along with her daughter - separate report submitted for her daughter). As pharmacist on duty, spoke to patient and confirmed incorrect administration. Counseled immunizer on the proper technique for intramuscular injection; will repeat training as corrective action. Apologized to patient and informed that she and her daughter can return at any time to receive vaccine correctly at no cost. Informed Pharmacy District leader of occurrence.
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| 2868571 | 9 | F | NY | 10/27/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Incorrect route of product administration, Wrong technique in product usage proc...
Incorrect route of product administration, Wrong technique in product usage process
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Systemic: Ineffective, vaccine giving incorrectly at 45 degree angle on back of arm like subcutaneou...
Systemic: Ineffective, vaccine giving incorrectly at 45 degree angle on back of arm like subcutaneous instead of intramuscular injection-Mild, Additional Details: Patient's mother called pharmacy after receiving vaccine (separate report submitted for the mother's immunization). As pharmacist on duty, spoke to patient and confirmed incorrect administration. Counseled immunizer on the proper technique for intramuscular injection; will repeat training as corrective action. Apologized to patient's mother and informed that she and her daughter can return at any time to receive vaccine correctly at no cost. Informed Pharmacy District leader of occurrence.
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| 2868572 | 50 | F | CA | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Mild
Site: Pain at Injection Site-Mild
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| 2868578 | 77 | F | PA | 10/27/2025 |
FLU4 |
SANOFI PASTEUR |
u8862ba |
Joint injury, Paraesthesia
Joint injury, Paraesthesia
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild, Systemic: Tingling (specify: faci...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling of nerves in arm
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| 2868580 | 17 | M | PA | 10/27/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie...
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted twice post vaccination. Myself and his mother lowered him from the chair to the floor gently after the second episode and elevated his legs. The patient's breathing remained normal and conciousness was reagained. I followed up with a phone call 3 hours later and the patient states he is fine.
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| 2868581 | 49 | F | PA | 10/27/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
407010 |
Chills, Nausea, Vomiting
Chills, Nausea, Vomiting
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Systemic: Chills-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Pat...
Systemic: Chills-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient called several hours post-vaccination to report she had developed chills, nausea, and vomitting. She sought medical care outside of the pharmacy as evidenced by a prednisone prescription we received, but the medication has yet to be picked up. I have called the patient twice by phone but not reached her yet to get an update.
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| 2868582 | 59 | M | NE | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Injection site bruising, Injection site erythema, Injection site pain
Injection site bruising, Injection site erythema, Injection site pain
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Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: injection giving a little lower which caused brusing aroung the area of the shot. pt did state the brusing is starting to go away and that he has been putting ice bag on it to help with the healing, Other Vaccines: VaccineTypeBrand: fluarixq; Manufacturer: ; LotNumber: 73bn2; Route: injection; BodySite: right arm; Dose: ; VaxDate: 10/02/2025
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| 2868583 | 81 | F | HI | 10/27/2025 |
FLU4 |
SANOFI PASTEUR |
UT8820BA |
Arthralgia, Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Pain i...
Arthralgia, Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
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Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Addition...
Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reports onset of symptoms about 8 hours after receiving shot, left wrist/hand pain. she said painful, can't close her hand. fingers appear to be very stiff, can't bend well. can't hold a cup she said. if she swings her hand up over her head she said that motion relieves the pain but she can't do that all day. No improvement in symptoms from last night til this morning. she said mostly pain but some numness. isolated to her wrist and hands/fingers. No pain in forearm/elbow region.
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| 2868584 | 58 | F | NC | 10/27/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ln0591 ln0591 LN0591 LN0591 |
No adverse event, Refusal of vaccination, Wrong product administered; Wrong prod...
No adverse event, Refusal of vaccination, Wrong product administered; Wrong product administered; No adverse event, Refusal of vaccination, Wrong product administered; Wrong product administered
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Systemic: no issues, just says she received the wrong shot-Mild, Additional Details: Pt came into th...
Systemic: no issues, just says she received the wrong shot-Mild, Additional Details: Pt came into the pharmacy on 10/16 stating that we gave her a COVID shot that she did not ask for. She states she asked for a flu shot and received the COVID shot. She has also lodged a complaint with corporate. The vaccination sheet we print out does not have questions answered and we do not have original paperwork. Pt also states she has the printed out vaccination information from 3/8 and we gave her another copy on 10/16 and told her we would contact our DL for further instruction.
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| 2868586 | 11 | F | MA | 10/27/2025 |
FLUC4 |
SEQIRUS, INC. |
407010 |
Dizziness, Injection site erythema, Syncope, Unresponsive to stimuli
Dizziness, Injection site erythema, Syncope, Unresponsive to stimuli
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Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting /...
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient felt dizzy and fainted at the front store after receiving her flu vaccine. Ambulance was called, she got checked out, all vital signs were normal. She was given some water, she sat on a chair, rested for a little while and got sent home.
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| 2868587 | 48 | M | MO | 10/27/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
JE74J |
Arthralgia, Injection site pain, Joint injury, Product administered at inappropr...
Arthralgia, Injection site pain, Joint injury, Product administered at inappropriate site
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Site: Pain at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Me...
Site: Pain at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Systemic: Joint Pain-Medium, Additional Details: Shot given too high. Patient feels like it was administered in the shoulder only about 1/2-1 inch from shoulder bone. Feels like it was administered in the shoulder socket. Experiencing dull ache/pain in the joint, states pain is 3 out of 10.
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| 2868588 | 15 | F | MA | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
na0589 |
Dizziness
Dizziness
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Systemic: Dizziness / Lightheadness-Mild, Other Vaccines: VaccineTypeBrand: fluarix 2025-2026; Manu...
Systemic: Dizziness / Lightheadness-Mild, Other Vaccines: VaccineTypeBrand: fluarix 2025-2026; Manufacturer: galaxosmithkline; LotNumber: 73bn2; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 10/18/2025
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| 2868589 | 78 | F | FL | 10/27/2025 |
COVID19-2 |
PFIZER\BIONTECH |
my9550 |
Joint injury
Joint injury
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Mild
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| 2868590 | 47 | F | MA | 10/27/2025 |
COVID19 |
PFIZER\BIONTECH |
na4452 |
Hypoaesthesia, Injection site hypoaesthesia
Hypoaesthesia, Injection site hypoaesthesia
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Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reported nu...
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reported numbing sensation starting at injection site and moving upward. Discussed potential injection site reaction as cause, patient did not report any other symptoms., Other Vaccines: VaccineTypeBrand: fluarix 2025-2026; Manufacturer: gsk; LotNumber: 2l353; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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