| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2871442 | 17 | M | MI | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8863BA |
Extrasystoles, No adverse event
Extrasystoles, No adverse event
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dose today was administered in error because he already had a flu shot with Fluzone earlier this sea...
dose today was administered in error because he already had a flu shot with Fluzone earlier this season on 07Oct2025, with no reported adverse event; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old male patient who was administered in error because he already had a flu shot with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] earlier this season on 07-Oc-t2025, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for Product used for unknown indication. On 31-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot U8863BA, expiry date 30-Jun-2026 and strength not reported) via unknown route in the left deltoid for Immunisation and today was administered in error because he already had a flu shot with fluzone earlier this season on 07oct2025, with no reported adverse event (extra 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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| 2871443 | 0.42 | IN | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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medication error (unintentional) due to a patient younger than indicated population receiving the im...
medication error (unintentional) due to a patient younger than indicated population receiving the immunization with no reported adverse event; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old and unknown gender patient who was unintentionally administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] who was younger than indicated population with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation, younger than indicated population with no reported adverse event (product use issue) (latency Same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. 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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| 2871444 | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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an expired Fluzone High Dose was administered to a patient with no adverse event; This unsolicited (...
an expired Fluzone High Dose was administered to a patient with no adverse event; This unsolicited (Non-serious, valid) case belongs to the batch of ICSRs (Individual Case Safety Report) that has been forwarded to the company by the Health Authorities (HA) via Other healthcare professional on 11-Oct-2025 in the format of line listing. This case involves an unknown age/gender patient who received an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2025, the patient received a expired dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (30-May-2025) with no adverse event (expired product administered) (latency same day) (dose, strength, lot, route and administration site: unknown) for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. It was reported that:- The patient is not exhibiting any signs/symptoms of adverse reaction. 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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| 2871446 | 75 | M | FL | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
407272 |
Arthralgia, Myalgia
Arthralgia, Myalgia
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had an unusual amount of pain that night. Then progressively had muscle/joint pain throughout entire...
had an unusual amount of pain that night. Then progressively had muscle/joint pain throughout entire body and still has to this day
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| 2871447 | 46 | F | MA | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
948406 |
Hypoaesthesia, Neuralgia, Pain
Hypoaesthesia, Neuralgia, Pain
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Patient called pharmacy 11/2/25 at 310 pm to ensure we were aware she has been experiencing nerve pa...
Patient called pharmacy 11/2/25 at 310 pm to ensure we were aware she has been experiencing nerve pain/hand numbness "burning pain" the last few weeks. Asked patient approximately when specifically this started. she did not have an exact date but stated 3 to 3+1/2 weeks ago. She was at an existing physician appointment and mentioned it to the MD. The MD stated that it could have been from her vaccine. MD advising patient that if it was the vaccine injection it may have hit a nerve. Patient denies any pain or other effects at time of appointment.
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| 2871451 | 35 | M | NY | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
409608 |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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the patient requested a covid shot but instead was administered a flu shot. the patient has already ...
the patient requested a covid shot but instead was administered a flu shot. the patient has already recieved a flu vaccine two weeks prior.
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| 2871452 | 36 | F | 11/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
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Tinnitus
Tinnitus
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Hx of tinnitus since resolved for a long time. Recurred 2 days s/p flu vaccination. Incidentally pre...
Hx of tinnitus since resolved for a long time. Recurred 2 days s/p flu vaccination. Incidentally previous tinnitus onset around same time of the year when I would have received flu vaccination. Im a healthcare professional and support vaccination.
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| 2871453 | 87 | F | 11/07/2025 |
COVID19 |
MODERNA |
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Extra dose administered
Extra dose administered
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Given 2 doses of mnexspike
Given 2 doses of mnexspike
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| 2871456 | 54 | F | MO | 11/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
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Dyspnoea, Injection site vesicles, Pyrexia
Dyspnoea, Injection site vesicles, Pyrexia
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Symptoms involved high fever for more than 7 days, blisters in the injection site, difficulty breath...
Symptoms involved high fever for more than 7 days, blisters in the injection site, difficulty breathing after shot
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| 2871471 | 75 | F | 11/07/2025 |
COVID19 |
MODERNA |
3051995 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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Patient developed pain and swlling near to admission site. lasted for more than 2 week
Patient developed pain and swlling near to admission site. lasted for more than 2 week
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| 2871472 | 75 | F | PA | 11/07/2025 |
COVID19 |
MODERNA |
3051995 |
Arthralgia, Tenderness
Arthralgia, Tenderness
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My R shoulder became increasingly sore and painful to move. By that evening, the whole shoulder joi...
My R shoulder became increasingly sore and painful to move. By that evening, the whole shoulder joint was painful and tender to touch everywhere on the ball of the humerus. I became increasingly unable to move my R shoulder joint at all without severe pain, especially outward from my body. I immediately applied an ice pack and took a NSAID dose. It continued to be very painful during the night and I was unable to get comfortable. This went on for several days; I got an appointment with my pcp and by the time I saw her, it was already starting to resolve. I had continually used Advil, Tylenol, and Ice until it resolved
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| 2871476 | 62 | F | AZ | 11/07/2025 |
COVID19 FLU3 VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Rash, Rash erythematous; Arthralgia, Rash, Rash erythematous; Arthra...
Arthralgia, Rash, Rash erythematous; Arthralgia, Rash, Rash erythematous; Arthralgia, Rash, Rash erythematous
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Pain, red rash on neck. Checked with doctor and doctor stated it is not shingles.
Pain, red rash on neck. Checked with doctor and doctor stated it is not shingles.
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| 2871478 | 65 | F | CT | 11/07/2025 |
PNC13 PNC13 VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, ...
Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Pain; Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Pain
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Severe swelling of entire upper left arm at site of Shingrix vaccine. Redness, pain, lots of heat/bu...
Severe swelling of entire upper left arm at site of Shingrix vaccine. Redness, pain, lots of heat/burning, itching. Painful to lift arm. For 36 hours, arm was severely sore, as if broken. Also, severe general body aches and fatigue. After that, body aches went away and arm pain reduced, but still significant,. That and other symptoms still continue 3 days later. Needed to ice arm and take Tylenol for pain relief. Helped only modestly.
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| 2871479 | 27 | M | IL | 11/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA4457 TFAA2504 |
Pallor, Syncope; Pallor, Syncope
Pallor, Syncope; Pallor, Syncope
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Per our front end store associates, patient was at checkout with groceries and looked pale and sudde...
Per our front end store associates, patient was at checkout with groceries and looked pale and suddenly fainted. Per our front end associates, this occurred at 5:38 PM and that is when they called paramedics. Patient received both Flu and COVID-19 vaccines at approximately 5:27 PM prior to adverse event. At the time both vaccines were done, patient seemed fine and did not show any signs of dizziness or fainting.
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| 2871480 | 63 | F | MO | 11/07/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
UT8779NA Z007870 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Rhinorrhoea; Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Rhinorrhoea
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Patient presented to pharmacy evening of 11/7/25 and showed the pharmacist on duty her right upper a...
Patient presented to pharmacy evening of 11/7/25 and showed the pharmacist on duty her right upper arm, which had two large areas of redness, one on top of the other, that covered her whole right deltoid muscle area. Patient c/o some soreness, not overwhelming, runny nose, but could not say for sure if she had been running a fever or not. Pharmacist palpated the two red areas. The upper red area felt like there was a harder mass under the skin than the lower red area on the deltoid muscle. Patient did not grimace. She said she discovered the reaction on 11/6/25 (no time given), which she decided to take OTC essential lavender oil because it was "a little itchy". She has had nothing regarding the area since then. Pharmacist encouraged her to seek medical attention with urgent care or at least her PCP on Monday (11/9/25) since she presented to the pharmacy on Friday evening (11/7/25) almost near closing time. Pharmacist also encouraged her to take OTC IBU, antihistamine, and/or hydrocortisone cream for reaction. Patient stated understanding.
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| 2871481 | 14 | F | CA | 11/07/2025 |
FLU3 |
SEQIRUS, INC. |
ax9142a |
Loss of consciousness, Musculoskeletal stiffness, Syncope
Loss of consciousness, Musculoskeletal stiffness, Syncope
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After providing the shot, patient fainted and become rigid for few seconds. Dad and I helped her on ...
After providing the shot, patient fainted and become rigid for few seconds. Dad and I helped her on the floor, and she regained her consciousness. After lying on the floor with her legs up for about 15 minutes she started feeling better. We checked her pulse, and it was normal (78/min). She was also very vocal and aware of the surrounding and the situation. She tried sitting down on the chair afterwards but felt uneasy and went back to lying on the floor with her legs up for few minutes and tried sitting down again and after about 5 minutes she started feeling better. She had a sip of water, and she was able to stand up and walk. We provided consultation to dad about syncope. They also mentioned that this happened before but without the rigidity and stiffness and that she usually has to lie down in the doctor's office to get shots. We recommended to get a follow up with MD.
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| 2871483 | 26 | F | PA | 11/07/2025 |
FLU3 |
SANOFI PASTEUR |
U8823CA |
Rash erythematous, Rash pruritic
Rash erythematous, Rash pruritic
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Diffuse pruritic erythematous rash, no treatment
Diffuse pruritic erythematous rash, no treatment
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| 2871484 | 27 | F | NV | 11/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0589 U8832CA |
Urticaria; Urticaria
Urticaria; Urticaria
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pt developed hives over entire body approximately 4 hours later
pt developed hives over entire body approximately 4 hours later
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| 2871487 | 19 | M | CA | 11/07/2025 |
COVID19 |
JANSSEN |
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Cardiac disorder, Cardiac flutter, Palpitations
Cardiac disorder, Cardiac flutter, Palpitations
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I now have heart problems and it flutters and beats very hard since I received the vaccine. I feel l...
I now have heart problems and it flutters and beats very hard since I received the vaccine. I feel like I have mini heart attacks now
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| 2871488 | 67 | M | CA | 11/07/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052296 407242 |
Discomfort, Pain in extremity; Discomfort, Pain in extremity
Discomfort, Pain in extremity; Discomfort, Pain in extremity
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Patient said the following day his arm was sore, he said it feels much better now but he is still aw...
Patient said the following day his arm was sore, he said it feels much better now but he is still aware of discomfort and he has had a lot of vaccines and has not felt a lingering discomfort. He did note that he has muscle loss from Trulicity.
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| 2871489 | 17 | F | NC | 11/07/2025 |
FLU3 MENB |
GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS |
7NT95 47KS7 |
Bone marrow oedema, Magnetic resonance imaging abnormal, Pain in extremity, Tend...
Bone marrow oedema, Magnetic resonance imaging abnormal, Pain in extremity, Tendon disorder; Bone marrow oedema, Magnetic resonance imaging abnormal, Pain in extremity, Tendon disorder
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A Medical Assistant administered flu vaccine and Meningococcal B vaccine to the patient on 10/7/25 w...
A Medical Assistant administered flu vaccine and Meningococcal B vaccine to the patient on 10/7/25 who returned on 10/17/25 due to left arm pain. The medical assistant does not recall there being an issue at the time of administration.
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| 2870873 | F | OR | 11/06/2025 |
COVID19 |
MODERNA |
3052731 |
Device leakage, No adverse event, Occupational exposure to product, Product clos...
Device leakage, No adverse event, Occupational exposure to product, Product closure removal difficult
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No adverse effect; very tight caps, resulting in the loss of the doses. The vaccine spilled from the...
No adverse effect; very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes; The vaccine spilled from the syringes, and one of the technicians touched the areas; We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss; This spontaneous case was reported by a physician and describes the occurrence of DEVICE LEAKAGE (very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes), OCCUPATIONAL EXPOSURE TO PRODUCT (The vaccine spilled from the syringes, and one of the technicians touched the areas), PRODUCT CLOSURE REMOVAL DIFFICULT (We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss) and NO ADVERSE EVENT (No adverse effect) in an adult female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052731) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052731) for COVID-19 prophylaxis. No Medical History information was reported. In October 2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced DEVICE LEAKAGE (very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes), OCCUPATIONAL EXPOSURE TO PRODUCT (The vaccine spilled from the syringes, and one of the technicians touched the areas) and PRODUCT CLOSURE REMOVAL DIFFICULT (We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE LEAKAGE (very tight caps, resulting in the loss of the doses. The vaccine spilled from the syringes), OCCUPATIONAL EXPOSURE TO PRODUCT (The vaccine spilled from the syringes, and one of the technicians touched the areas), PRODUCT CLOSURE REMOVAL DIFFICULT (We had two vaccines which spilled when trying to remove the top / Problem: vaccine cap excessively tight, difficulty removing cap without using excessive force resulting in vaccine loss) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. It was reported an issue with two vaccine doses that had very tight caps, which resulted in the loss of the doses. It was also reported that the vaccine spilled from the syringes, and one of the technicians touched the areas and it caused contamination to the vaccine. The vaccine was not administrated to any patient. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live non-significant follow-up received in which new reference number was added. On 25-Oct-2025: Live non-significant follow-up received in which reporter details were updated and new reference number was added.
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| 2870910 | F | 11/06/2025 |
COVID19 |
MODERNA |
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Pain in extremity
Pain in extremity
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slightly painful arm; This spontaneous case was reported by a consumer and describes the occurrence ...
slightly painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly painful arm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slightly painful arm). At the time of the report, PAIN IN EXTREMITY (slightly painful arm) outcome was unknown. No concomitant medication was reported. The patient had zero reaction in the arm; the other Covid shots (All Moderna) had been at least slightly painful. The patient feared that she had got a dud. The patient received the recent Spikevax the day before reporting. When the pharmacy teacher got the box out, it had "Out 10/9" on the box. That was 15 days ago, the patient asked about it, and they said it was fine. The patient didn't think RNA would hang around that long. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-790892 (Patient Link).
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| 2870911 | OR | 11/06/2025 |
COVID19 |
MODERNA |
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No adverse event, Product closure removal difficult
No adverse event, Product closure removal difficult
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the caps were very tight and required a lot of force to open, and we ended up losing them; No advers...
the caps were very tight and required a lot of force to open, and we ended up losing them; No adverse effect; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT CLOSURE REMOVAL DIFFICULT (the caps were very tight and required a lot of force to open, and we ended up losing them) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT CLOSURE REMOVAL DIFFICULT (the caps were very tight and required a lot of force to open, and we ended up losing them) and NO ADVERSE EVENT (No adverse effect). At the time of the report, PRODUCT CLOSURE REMOVAL DIFFICULT (the caps were very tight and required a lot of force to open, and we ended up losing them) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that there was one little issue that the reporter was trying to troubleshoot. It was basically that the reporter had difficulty with two vaccine doses where the caps were very tight and required a lot of force to open and ended up losing them. Reporter was trying to replace two doses, but though they came in boxes of 10๏ฟฝ. Reporter was asking about any suggestions for how they can replace those vaccines. Treatment information was not reported.
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| 2870912 | 0.5 | MD | 11/06/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Hypotonic-hyporesponsive episode; Hypotonic-hyporesponsive episode
Hypotonic-hyporesponsive episode; Hypotonic-hyporesponsive episode
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Hypotonic Hypo-responsiveness reaction; This spontaneous case was reported by a pharmacist and descr...
Hypotonic Hypo-responsiveness reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction) in a 6-month-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction) (seriousness criterion medically significant). At the time of the report, HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The reporter had incident where the patient getting concomitant flu and Covid vaccines was going unresponsive (Hypotonic Hypo-responsiveness reaction). They were looking into lots of medication. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790769 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2025: Live follow-up received contains non-significant information (reporter's contact details added).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790769:Same reporter for different patient
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| 2870913 | F | IA | 11/06/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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Dizziness, Headache, Illness, Pain in extremity, Pyrexia
Dizziness, Headache, Illness, Pain in extremity, Pyrexia
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Horribly sick; Dizzy; Feverish; Headache; Arm hurt top to bottom; Initial information received on 21...
Horribly sick; Dizzy; Feverish; Headache; Arm hurt top to bottom; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves a 66 years old female patient (14.224 cm and 81.82 kg) who was horribly sick, dizzy, feverish, headache and arm hurt top to bottom after receiving NVX-COV2705 (omicron JN.1) adjuvanted vaccine [Nuvaxovid JN.1]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity with Codeine. Patient ever had an AE following any previous vaccine; Probably 2021 or 2022, mRNA Covid vaccine (Brand name: Moderna and Pfizer) Consumer stated she had Novavax Covid vaccine in September 2024, and March 2025 Concomitant medications included Multivitamin Centrum Women 50+ , Atorvastatin 10mg at night, calcium and Vit D3 in the morning , Loratadine 10mg daily in the morning. On 02-Oct-2025, the patient received unknown dose of suspect NVX-COV2705 (omicron JN.1) adjuvanted vaccine, Solution for injection in pre-filled syringe, 5ug (lot number and expiry date not reported) via unknown route in the right arm. On 02-OCT-2025 same day the patient was horribly sick (illness), dizzy (dizziness), feverish (pyrexia), headache and arm hurt top to bottom (pain in extremity). It was reported that "I was completely nonfunctional, said to my husband, don't know if I'm going to need to go to an ER. felt horrible sick. And it, again, is so scary that I feel like now I'm afraid to try it again because one of these times I'm not going to recover. The second day was a little -Saturday was a little better. I went for a short walk outside, came back in. I was going to go to my granddaughter's soccer, and I realized I just can't go. I'm too sick. I just don't feel well. So I just need a shot that works that doesn't make me sick. I really want to be vaccinated for COVID, but I don't know if you guys can tell me that there's something different in this new 2526 vaccine that was different from the one a year before or not. But I just wanted to share my reaction in case it helps other people. The first vaccines in about 2021, or 2022 when those Moderna and Pfizer did not work for me. And, you know, I've never had reactions to any other vaccine. I've had RSV, pneumonia, shingles, you know. I've not had a problem like these COVID shots give me. And, again, I've only had COVID two times in my life, but the first time I was sick 21 days, in bed, fever, chill, nonfunctional. That's why I would like to be able to be vaccinated for this. But I'm afraid now that I had a problem with your vaccine this time. I was vaccinated, both Moderna and Pfizer, the first two Moderna and then the Pfizer booster. So I thought maybe I had protection, and it was probably, you know, some months after that I went to a concert. And that was like a Thursday, and Saturday I woke up sick. It would have been probably might have been in the fall. I can't remember the dates, but it would have been probably 2023. You know, or it might have been the fall of 22 or 23. I'm the type of person in the beginning I was extremely careful. I wore a mask faithfully. I stayed away from crowds. Then finally when I was vaccinated, I went ahead and went to this concert. I got COVID. I was horribly sick. And then the only other time would have been almost two years ago this coming February. I was sick for eight days that time. So it would have been February of 2024" The patient ever tested positive for covid-19: Months after having mRNA Vaccine, fall of 2022 or 2023, and in February 2024 (method of COVID-19 diagnosis was not known) Action taken: Not applicable. Treatment given: Only Tylenol taken. At time of reporting, the outcome was Unknown for all events.
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| 2870916 | 5 | F | GA | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8873JA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient inadvertently received a second influenza vaccine this season with no reported adverse event...
patient inadvertently received a second influenza vaccine this season with no reported adverse event; Initial information received on 27-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who inadvertently received second dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] this season with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine (Influenza Vaccine) for Immunisation on 10-Oct-2025. On 27-Oct-2025, the patient received an extra 0.5ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Suspension for injection, (unknown strength) lot UT8873JA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for immunisation, with no reported adverse event (extra dose administered) (Latency Same day). Reportedly, nurse reported a patient who was inadvertently administered a second dose of fluzone pre-filled syringe and asked if we had any information on patients receiving an extra dose and no other vaccines were administered concomitantly. 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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| 2870918 | 55 | F | SC | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8415KA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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patient received an accidental dose of the 2024-2025 FLUZONE vaccine with no adverse event; Initial ...
patient received an accidental dose of the 2024-2025 FLUZONE vaccine with no adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with other case US-SA-2025SA323293. This case involves a 55 years old female patient who received an accidental dose of the 2024-2025 influenza USP trival A-B subvirion NO preservative vaccine [Fluzone] vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Oct-2025, the patient received 0.5 ml of suspect influenza USP trival A-B Subvirion No Preservative Vaccine Suspension for injection of standard strength frequency once with lot UT8415KA and expiry date 30-jun-2025 via intramuscular route in the right deltoid for Influenza immunization of 2024-2025 with no adverse event (expired product administered) (Latency same day). It was reported, "mentioned that they had 2 employees that received an accidental dose of the 2024-2025 fluzone vaccine" Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA323293:
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| 2870920 | 21 | F | WA | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8804CA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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FLUZONE HD was accidentally given to a 21-year-old, with no reported adverse event; Initial informat...
FLUZONE HD was accidentally given to a 21-year-old, with no reported adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 years old female patient who was accidentally given to 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. Concomitant medications included Elasomeran (Spikevax) for Immunisation. On 28-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 UT8804CA, expiry date 30-Jun-2026, frequency once and strength Fluzone High Dose) via intramuscular route in the right deltoid for Immunisation and was accidentally given to a 21-year-old, with no reported adverse event (product administered to patient of inappropriate age) (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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| 2870921 | 72 | M | MT | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8437AA |
Haemorrhage, Thrombocytopenia
Haemorrhage, Thrombocytopenia
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Reported Symptoms: 10005103:BLEEDING; 10043554:THROMBOCYTOPENIA; Narrative: Patient presented to a s...
Reported Symptoms: 10005103:BLEEDING; 10043554:THROMBOCYTOPENIA; Narrative: Patient presented to a small rural clinic and was flown by life-flight to trauma center Other Relevant HX: Was hospitalized Other:
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| 2870926 | 24 | M | TX | 11/06/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Blister
Blister
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Reported Symptoms: 10047368:VESICLES; Narrative: Other Relevant HX: Other: VESICLES IN SKIN
Reported Symptoms: 10047368:VESICLES; Narrative: Other Relevant HX: Other: VESICLES IN SKIN
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| 2870929 | 58 | M | NV | 11/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
025B21A 025B21A |
Blister, Burning sensation, Injection site rash, Pruritus, Rash; Rash pruritic, ...
Blister, Burning sensation, Injection site rash, Pruritus, Rash; Rash pruritic, Swelling, Urticaria
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Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Seen in PCP clin...
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10046735:URTICARIA; Narrative: Seen in PCP clinic. Complained of rash after receiving his second dose of the Moderna COVID vaccine on 4/9/2021. Patient states that he developed the rash 2 days later on his L arm near the injection site; over the next few days the rash spread from his left arm to his chest/abdomen and to his right arm, then to legs. He states that the rash is itchy, painful with a burning sensation and noticed mild swelling. Clear vesicles that burn/itch. Per provider, felt that could be erysipelas vs impetigo vs shingles. Saw PCP at a follow up visit with improvement. Remains unclear whether reaction truly due to injection or not, did receive subsequent COVID vaccines without apparent issues. Other Relevant HX: Other: URTICARIA
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| 2870930 | 69 | M | GA | 11/06/2025 |
COVID19 |
MODERNA |
3031897 |
Asthenia
Asthenia
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Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Patient required hos...
Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Patient required hospitalization for two day after receiving a COVID vaccination. Other Relevant HX: Other: WEAKNESS
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| 2870991 | 88 | M | 11/06/2025 |
FLU3 |
SEQIRUS, INC. |
407272 |
Death
Death
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Patient was in hospice care received Flu vaccine at 1215pm and passed away at 1157pm the same day 11...
Patient was in hospice care received Flu vaccine at 1215pm and passed away at 1157pm the same day 11/3/25
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| 2870993 | 85 | F | GA | 11/06/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
ut8781da ut8781da |
Dysstasia, Fall, Fractured coccyx, Injected limb mobility decreased, Intensive c...
Dysstasia, Fall, Fractured coccyx, Injected limb mobility decreased, Intensive care; Lumbar vertebral fracture, Multiple organ dysfunction syndrome, Musculoskeletal stiffness
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Reported by daughter 11-5@5:30PM: After receiving flu shot, left arm became super stiff and could no...
Reported by daughter 11-5@5:30PM: After receiving flu shot, left arm became super stiff and could not move finger(s) (did not clarify which finger(s). Used heat, ice and APAP. Reports MD told her to continue current practices, possible pinched nerve. Still did not help. Then daughter reports patient could not move her arm and she fell out of chair when trying to get up, fracturing her tail bone and L1 spine. All organs then went into trauma, was in hosp ICU for 10 days and has been transferred to the trauma floor, where she is currently
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| 2870994 | 9 | F | VT | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4459 |
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 events
no adverse events
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| 2870995 | 9 | M | VT | 11/06/2025 |
COVID19 |
PFIZER\BIONTECH |
Na4459 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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n/a
n/a
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| 2870996 | 51 | F | PA | 11/06/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7CF5M 7CF5M |
Fatigue, Headache, Herpes zoster, Influenza like illness, Pain; Pain in extremit...
Fatigue, Headache, Herpes zoster, Influenza like illness, Pain; Pain in extremity, Pyrexia, Rash
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Vaccination given on left deltoid on 10/16/2025 that manifested to shingles. Flu like symptoms, fat...
Vaccination given on left deltoid on 10/16/2025 that manifested to shingles. Flu like symptoms, fatigue, left arm pain and headache experienced10/17/2025 gradually worsening throughout the week. Saturday 10/25 developed a painful rash under left shoulder blade that traveled under arm, breast to sternum. This was accompanied by headache, low grade fever, fatigue and intermittent shooting pain along deltoid of left arm.
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| 2870998 | 1.83 | M | CT | 11/06/2025 |
FLU3 |
SEQIRUS, INC. |
90661 |
Injection site erythema, Injection site induration, Injection site warmth
Injection site erythema, Injection site induration, Injection site warmth
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Red, warm, circular induration around injection site for 3 days
Red, warm, circular induration around injection site for 3 days
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| 2870999 | 83 | F | MI | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
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No adverse event
No adverse event
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Patient has no symptoms and is doing fine
Patient has no symptoms and is doing fine
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| 2871000 | 8 | M | CT | 11/06/2025 |
COVID19 |
MODERNA |
3052668 |
Incorrect dose administered
Incorrect dose administered
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Pt received 12+ dose
Pt received 12+ dose
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| 2871002 | 54 | F | OH | 11/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Biopsy, Rash, Rash pruritic, Scar, Skin burning sensation; Skin discolouration
Biopsy, Rash, Rash pruritic, Scar, Skin burning sensation; Skin discolouration
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Health Dept and the pharmacy has her vaccine records. Pt says after getting very 1st dose of the Mod...
Health Dept and the pharmacy has her vaccine records. Pt says after getting very 1st dose of the Moderna vaccine, she felt fine for the 1st 15 minutes but after that when she starts eating the acid in the food starts burning her skin on the inside. She developed black skin bumps on the outside of the skin that were like sore pimples that were itchy. These are all over her body. Now she has bad scar tissue. She went to Hospital for treatment. She was given topical ointment diclofenac sodium gel and antibiotics ic cephalexin 500mg. that made it worse. They took a biopsy but was told to continue her prescribed meds. Nothing she had tried using has helped with her symptoms. She has been going back and forth to the same hospital for treatment but still continues to suffer.
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| 2871003 | 64 | F | TN | 11/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Chills, Headache, Migraine, Nausea, Pain; Pain in extremity, Peripheral swelling...
Chills, Headache, Migraine, Nausea, Pain; Pain in extremity, Peripheral swelling, Sluggishness, Tremor, Vomiting
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Late in the afternoon arm swollen and sore to move, than my whole right side of body was aching, had...
Late in the afternoon arm swollen and sore to move, than my whole right side of body was aching, had the chills with uncontrollable shaking, than came a huge migraine, had some nausea and vomiting next day with a full size painful headache on right side of head, was in bed all day with a low fever of 99.0 the headache finally subsided in late evening Nov5th around 9 pm, today Nov 6 th arm feeling better, still have headache but not as bad Tylenol helping, feeling sluggish with some chills still
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| 2871005 | 35 | F | IL | 11/06/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Mydriasis, Vision blurred
Mydriasis, Vision blurred
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PATIENT WAS HOPITALIZED AT HOSPITAL, SHE HAS DILATED PUPILES AND BLURRED VISION , SHE STILL BEEN TR...
PATIENT WAS HOPITALIZED AT HOSPITAL, SHE HAS DILATED PUPILES AND BLURRED VISION , SHE STILL BEEN TREATED BY EYE DR
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| 2871006 | 19 | F | NC | 11/06/2025 |
COVID19 |
MODERNA |
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Chills, Dizziness, Limb discomfort, Pain
Chills, Dizziness, Limb discomfort, Pain
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Severe body aches, chills, dizziness, heavy limbs
Severe body aches, chills, dizziness, heavy limbs
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| 2871007 | 61 | F | WI | 11/06/2025 |
FLU3 |
SEQIRUS, INC. |
406996 |
Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
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Patient contacted us 11/06/2025, stating yesterday, 11/05/2025 she noticed around the injection site...
Patient contacted us 11/06/2025, stating yesterday, 11/05/2025 she noticed around the injection site of the flu vaccine that it is red, itchy, swelling and warm to the touch.
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| 2871008 | 12 | M | AZ | 11/06/2025 |
COVID19 |
MODERNA |
3052859 |
Underdose
Underdose
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I gave the 6months to 11years covid vaccine. The patient is 12 years old. Needs higher dose.
I gave the 6months to 11years covid vaccine. The patient is 12 years old. Needs higher dose.
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| 2871009 | 44 | F | FL | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
UT8873JA |
Death
Death
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Patient was current employee at DOH received Influenza Vaccine through Employee Health on Friday, O...
Patient was current employee at DOH received Influenza Vaccine through Employee Health on Friday, October 24, 2025 after signed consent obtained. DOH - was notified Monday, October 27, 2025, that employee had been found deceased the previous evening, October 26th, 2025 at 1818. There is no other information available surrounding this event, that was provided to us, as an employer. Per SHOTS record, employee received Influenza Vaccination in years 2007-2009, 2010-2015, then again in 2024 & 2025.
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| 2871010 | 47 | F | MA | 11/06/2025 |
COVID19 |
MODERNA |
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Abdominal pain, Sleep disorder, Vomiting
Abdominal pain, Sleep disorder, Vomiting
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Extreme abdominal pain, similar to mensration cramping but much much worse, to the point of causing ...
Extreme abdominal pain, similar to mensration cramping but much much worse, to the point of causing vomiting from pain and inability to sleep.
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| 2871011 | 68 | F | NY | 11/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8832AA |
Urticaria
Urticaria
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Patient developed hives on torso down to the upper thighs. She developed this after taking a hot sh...
Patient developed hives on torso down to the upper thighs. She developed this after taking a hot shower. She was now sure if this was related to the flu shot that she got earlier in the day.
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