| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2864773 | 65 | F | FL | 10/09/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781DA |
Injection site erythema, Injection site mass, Injection site warmth
Injection site erythema, Injection site mass, Injection site warmth
|
SITE OF VACCINE, HAS TURNED, RED, AREA FEELS WARM AS WELL, AND A LUMP HAS DEVELOPED. PT WILL CONTIN...
SITE OF VACCINE, HAS TURNED, RED, AREA FEELS WARM AS WELL, AND A LUMP HAS DEVELOPED. PT WILL CONTINUE TO MONITOR AND WILL GO TO DR IF AREA GETS WORST
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| 2864774 | 31 | F | FL | 10/09/2025 |
RSV |
PFIZER\WYETH |
MF2162 |
Exposure during pregnancy, Extra dose administered
Exposure during pregnancy, Extra dose administered
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pt states she is 34 weeks plus one day pregnant and received Abrysvo. Found out the following da...
pt states she is 34 weeks plus one day pregnant and received Abrysvo. Found out the following day that the patient had received Abrysvo on 11/06/2023. Patient has had no negative reaction to the vaccine. The patients doctor was aware of this but he wanted the patient to repeat the vaccination.
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| 2864775 | 71 | M | TX | 10/09/2025 |
FLU3 |
SANOFI PASTEUR |
U8875AA |
Neck pain, Pain in extremity
Neck pain, Pain in extremity
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Patient woke up next day after getting the vaccine with a pain in his arm where the vaccine was admi...
Patient woke up next day after getting the vaccine with a pain in his arm where the vaccine was administered. Pain started in the back of his neck and traveled to the arm. He went to the doctor today to get pain meds. MD did not think it was due to the vaccine and patient feels the same per patient. He is going to see his specialist that operated on him for herniated disk soon when he is able to see him. pt was given tylenol with codeine number 3 and medrol dose pack on 10/9/25 for pain
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| 2864776 | 81 | F | FL | 10/09/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered
Extra dose administered
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VACCINE WAS CONSIDERED EXTRANEOUS AND UNNECESSARY AS PATIENT RECEIVED ONE DOSE IN 2023
VACCINE WAS CONSIDERED EXTRANEOUS AND UNNECESSARY AS PATIENT RECEIVED ONE DOSE IN 2023
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| 2864777 | 38 | F | CO | 10/09/2025 |
COVID19 FLU3 |
NOVAVAX SANOFI PASTEUR |
6315MF001C U8832BA |
Loss of consciousness, Urinary incontinence; Loss of consciousness, Urinary inco...
Loss of consciousness, Urinary incontinence; Loss of consciousness, Urinary incontinence
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The patient stated that she had passed out in the past due to a vaccination but had done well on her...
The patient stated that she had passed out in the past due to a vaccination but had done well on her last vaccination. After receiving both vaccines, eating a grape or two, and drinking some water, the patient then involuntarily passed out for about 15 seconds before starting wake back up. Upon regaining consciousness, the patient urinated without realizing. After resting for about 15 minutes, drinking some more water, and eating more grapes, the patient was able to leave of her own volition.
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| 2864779 | 76 | F | FL | 10/09/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered
Extra dose administered
|
VACCINE WAS CONSIDERED EXTRANEOUS AND UNNECESSARY AS PATIENT RECEIVED DOSE IN 2023
VACCINE WAS CONSIDERED EXTRANEOUS AND UNNECESSARY AS PATIENT RECEIVED DOSE IN 2023
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| 2864780 | 72 | F | FL | 10/09/2025 |
COVID19 |
MODERNA |
3052583 |
Rash
Rash
|
PATIENT GOT VACCINE ON 10/04/2025 AND GOT RASHES ALL OVER THE BODY ON 10/08/2025
PATIENT GOT VACCINE ON 10/04/2025 AND GOT RASHES ALL OVER THE BODY ON 10/08/2025
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| 2864781 | 25 | M | NM | 10/09/2025 |
COVID19 FLU3 HPV9 |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. |
NA0589 UT8861KA Y015760 |
Dyskinesia, Injection site haemorrhage, Malaise, Pain, Posture abnormal; Dyskine...
Dyskinesia, Injection site haemorrhage, Malaise, Pain, Posture abnormal; Dyskinesia, Injection site haemorrhage, Malaise, Pain, Posture abnormal; Dyskinesia, Injection site haemorrhage, Malaise, Pain, Posture abnormal
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Patient came in to receive three vaccines (Fluzone, Comirnaty, and Gardasil). Patient listed on immu...
Patient came in to receive three vaccines (Fluzone, Comirnaty, and Gardasil). Patient listed on immunization pre-paperwork they fainted with the MRR over 5 years ago. Intern asked if he was okay with receiving 3 vaccines today, patient agreed. Upon vaccinating, patient received Fluzone shot in right arm while the COVID and Gardasil was injected in the left. Intern noticed bleeding in the arm where Gardasil was injected, as she went to grab a cotton ball, she mentioned that patient became "pale" at this point. From her point of view she placed the band-aid and the patient's head rolled back and his body had several jerking movements which lasted about 2 seconds. Patient then responded saying they didn't feel well and said he felt "hypotensive". She called for me, the pharmacist, to get water for the patient, while she was on the phone with 911 waiting for EMS with the patient. We gave the patient water, a small Twix (candy), cold compresses, and measured his blood pressure which read BP: 99/75 HR: 65. Patient said he normally ranges in "110-120/ 80". Paramedics then arrived and we left the vaccine room. After the patient was checked out by paramedics, patient remained sitting down for 15+ minutes for monitoring.
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| 2864782 | 35 | F | NV | 10/09/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802NA |
Chills, Erythema, Headache, Pruritus, Urticaria
Chills, Erythema, Headache, Pruritus, Urticaria
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Received the flu shot on 10/05. Noticed the symptoms after work on 10/06. Symptoms include itchiness...
Received the flu shot on 10/05. Noticed the symptoms after work on 10/06. Symptoms include itchiness and redness throughout my body. I took an antihistamine before sleep. On 10/07, I experienced symptoms including chills, headaches, itchiness, and hives all over my body except the chest and face. Symptoms were relieved with an antihistamine. On 10/08, I broke out in hives once again. Symptoms were relieved with an antihistamine.
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| 2864783 | 92 | M | AL | 10/09/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Given 2nd dose of RSV vaccine. No adverse reactions reported from patient.
Given 2nd dose of RSV vaccine. No adverse reactions reported from patient.
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| 2864784 | 77 | M | AL | 10/09/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Patient received 2nd dose of RSV vaccine
Patient received 2nd dose of RSV vaccine
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| 2864785 | 17 | M | IL | 10/09/2025 |
MNQ |
SANOFI PASTEUR |
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Seizure
Seizure
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seizure couple minutes after vaccine.
seizure couple minutes after vaccine.
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| 2864786 | 70 | F | CA | 10/09/2025 |
PNC20 |
PFIZER\WYETH |
LX4484 |
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
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Day after shot was given: Local reaction : Redness, swelling, hot to touch from shoulder to elbow, l...
Day after shot was given: Local reaction : Redness, swelling, hot to touch from shoulder to elbow, lump big as plum size then got smaller with time, swelling to arm and fingers had to remove her ring on Monday 10/06/2025. redness travelling to inner arm (biceps area ) causing a crease, this is happening today 10/09/2025, pt confirmed she is only having a local reaction and said she will report it to her doctor tomorrow morning and will try benadryl at night and zyrtec in the morning .
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| 2864787 | 61 | F | MN | 10/09/2025 |
COVID19 |
MODERNA |
8146367 |
Injection site discharge, Injection site erythema, Injection site pain, Injectio...
Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling
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MA that administered to vaccine to my left deltoid did not administer it IM after the injection cl...
MA that administered to vaccine to my left deltoid did not administer it IM after the injection clear fluid was running down the injection site. The MA swabbed up the liquid (clear) with the bandaid pad and put that same bandaid over my injection site. Site was sore with a bump that evening 10/8 and today the site is more sore and a red raised spot the size of a nickel is on injection site. I received the trivalent flu vaccine in my right arm and it was sore but not sore and red. The MA gave that injection using the proper technique.
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| 2864805 | 70 | F | OK | 10/09/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4ZS72 4ZS72 |
Headache, Injection site erythema, Injection site mass, Injection site pain, Inj...
Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling; Injection site warmth, Nausea
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Patient came in has large lump on Left arm where injection was given. Patient stated that shortly af...
Patient came in has large lump on Left arm where injection was given. Patient stated that shortly after receiving injection it was red, hot to the touch, swollen, very painful. Patient states she got a headache + felt nausa by the time she got to her car. Pt states it feels better today.
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| 2864806 | 80 | M | OH | 10/09/2025 |
COVID19 |
MODERNA |
3052583 |
Ageusia
Ageusia
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Gradual loss of taste still ongoing 3 wks later
Gradual loss of taste still ongoing 3 wks later
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| 2864807 | F | ME | 10/09/2025 |
UNK |
UNKNOWN MANUFACTURER |
AZ240065 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Pt is under 5kg, therefore should have received the 50mg dose instead of 100mg. Guardian was notifie...
Pt is under 5kg, therefore should have received the 50mg dose instead of 100mg. Guardian was notified of the error and reports pt has had no adverse effects of the vaccine thus far.
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| 2864808 | 54 | F | IA | 10/09/2025 |
FLU3 FLU3 PNC21 PNC21 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
J3T3B J3T3B Z009681 Z009681 |
Decreased appetite, Fatigue, Headache, Injection site cellulitis, Injection site...
Decreased appetite, Fatigue, Headache, Injection site cellulitis, Injection site erythema; Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Pyrexia; Decreased appetite, Fatigue, Headache, Injection site cellulitis, Injection site erythema; Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Pyrexia
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10/3 Patient developed swelling, redness, warmth, and pain of left arm at injection site. One felt f...
10/3 Patient developed swelling, redness, warmth, and pain of left arm at injection site. One felt feverish, reports a headache, muscle aches, fatigue, and loss of appetite. Seen for office visit 10/9- Cellulitis left upper arm. Prescribed cephalexin for skin infection.
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| 2865922 | 50 | F | NV | 10/09/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JS74H |
Headache, Pain, Rash
Headache, Pain, Rash
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Rash appeared on right forearm. Along with body ache and headache.
Rash appeared on right forearm. Along with body ache and headache.
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| 2864168 | M | NJ | 10/08/2025 |
PNC21 |
MERCK & CO. INC. |
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Chills, Pain, Pyrexia
Chills, Pain, Pyrexia
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fever; body aches; chills; This spontaneous report was received from a nurse prescriber and refers t...
fever; body aches; chills; This spontaneous report was received from a nurse prescriber and refers to an older male patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On approximately August 2025 (reported as about a month ago), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), administered as prophylaxis (dose, route of administration, lot #, and expiration date were not reported). On unknown date in 2025, the patient experienced fever, body aches, and chills. It was reported that the patient experienced an extended period of fever, body aches, and chills more so than they typically see. The patient sought medical attention, and treatment was given for the events. At the reporting time, the outcome of fever, body aches, and chills was unknown. The causal relationship between the reported events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown. Lot # is being requested and will be submitted if received.
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| 2864170 | 50 | F | MI | 10/08/2025 |
HPV9 |
MERCK & CO. INC. |
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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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No additional AE; patient received the first dose of GARDASIL9 at a different provider's office...
No additional AE; patient received the first dose of GARDASIL9 at a different provider's office on 07/25/2025 and the patient was 50 years old at that time; This spontaneous report was received from a nurse and refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-Jul-2025, at the age of 50-year-old, the patient was vaccinated at a different provider's office with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, anatomical site, lot # and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age). She went to nurse's office requesting a second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The nurse reported the second dose was not administered due to the patient's age. No additional adverse event reported (No adverse event). Batch/Lot number is being requested and will be submitted if received.
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| 2864171 | F | 10/08/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Abdominal discomfort, Chills, Decreased appetite, Fatigue, Headache; Musculoskel...
Abdominal discomfort, Chills, Decreased appetite, Fatigue, Headache; Musculoskeletal stiffness, Vaccination site pain
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chills started; she slowly developed a stiff neck; headache; little tenderness at the injection site...
chills started; she slowly developed a stiff neck; headache; little tenderness at the injection site; really fatigued; no appetite; a little of upset stomach; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 04Sep2025 as dose number unknown, single; BUPROPION; DOXYCYCLINE MONOHYDRATE; MULTIVITAMIN [VITAMINS NOS]; MAGNESIUM; CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "a little of upset stomach"; CHILLS (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "chills started"; HEADACHE (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025); VACCINATION SITE PAIN (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "little tenderness at the injection site"; DECREASED APPETITE (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "no appetite"; FATIGUE (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "really fatigued"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "she slowly developed a stiff neck". Therapeutic measures were taken as a result of chills, musculoskeletal stiffness, headache, vaccination site pain, fatigue, decreased appetite, abdominal discomfort. Additional information: Patient was vaccinated on Left arm/shoulder. Facility where vaccine was administered was reported as Pharmacy or Drug Store. Patient received other vaccines on the same date as the vaccine. The patient was taking other medications within 2 weeks of the event starting. 12 Hours after getting the shot, patient felt a little chilly, but they weren't chills. patient took 1000 mg Tylenol at 8:30 pm and kept a heating pad on and off her for a couple of hours. The heating pad did the trick and soon she had taken off the warm pjs and just slept in lightweight ones. She didn't use the heating pad anymore after that. When the vaguely chilly chills started, she slowly developed a stiff neck and headache that the Tylenol didn't cure. Just a little tenderness at the injection site. The next morning, she felt headachey, stiff necked, really fatigued and no appetite. She took 1000mg Tylenol at 8:15 am. patient took only 500 mg Tylenol at 4:15 pm and then at 5:00 pm she felt just about normal again. Still no appetite but still a little of upset stomach. She felt all better by 9:00 pm. So side effects lasted 36 hours. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2864172 | 55 | F | CA | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Vaccination failure
COVID-19, Vaccination failure
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This time I not only took paxlovid but had my most updated vaccine 05Sep2025 yet bought covid anyway...
This time I not only took paxlovid but had my most updated vaccine 05Sep2025 yet bought covid anyway; This time I not only took paxlovid but had my most updated vaccine 05Sep2025 yet bought covid anyway; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zithromax, reaction(s): "Allergies: Zithromax". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2025, outcome "unknown" and all described as "This time I not only took paxlovid but had my most updated vaccine 05Sep2025 yet bought covid anyway". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient did not take any other medications in two weeks. Patient stopped paxlovid felt better and tested negative Sunday then by Thursday experienced symptoms again such as headache and stuffy nose, clogged ears, diarrhea etc. took another Covid test Saturday and she was positive again and this time lost sense of smell. Exact same thing happened in 2022- when she took paxlovid. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2864173 | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
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I got the Pfizer booster at the beginning of Aug; I got the Pfizer booster at the beginning of Aug; ...
I got the Pfizer booster at the beginning of Aug; I got the Pfizer booster at the beginning of Aug; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Oct2025, outcome "unknown" and all described as "I got the Pfizer booster at the beginning of Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2025) Positive. Clinical course: The patient stated, had tested positive for COVID-19 and awaiting doctor's nurse to call in an order for Paxlovid. I got the Pfizer booster at the beginning of Aug obviously didn't really protect me because I'm positive today." When asked if there was any further assistance that can be provided, the patient stated, "No, I just wanted to get the drug, I guess I'm just going to have to weather the COVID without the drug. Hopefully won't have the poor results, had in the past when I didn't have it." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2864174 | CT | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood pressure increased, Blood pressure measurement, Headache
Blood pressure increased, Blood pressure measurement, Headache
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severe headaches / continuous frontal and back of head, headaches; BP shot up / Now I have 140-165/8...
severe headaches / continuous frontal and back of head, headaches; BP shot up / Now I have 140-165/80; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 13Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset Sep2025, outcome "unknown", described as "BP shot up / Now I have 140-165/80"; HEADACHE (non-serious) with onset Sep2025, outcome "not recovered", described as "severe headaches / continuous frontal and back of head, headaches". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient recently had the new covid vaccine. All their previous ones gave no problem except for a sore arm. About 2-3 days after the latest shot, the patient developed severe headaches and blood pressure shot up (prior were 118-120/60-70). Now, 140-165/80 and continuous frontal and back of head, headaches. The lot number for BNT162b2 omicron (lp.8.1), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500197828 Same reporter and patient, different dose and event ;
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| 2864197 | M | OR | 10/08/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Herpes zoster, Pain, Skin lesion, Vaccination failure; Herpes zoster, Pain, Skin...
Herpes zoster, Pain, Skin lesion, Vaccination failure; Herpes zoster, Pain, Skin lesion, Vaccination failure
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lack of vaccine effect/Suspected Vaccination failure; shingles/lesions that started on his right fla...
lack of vaccine effect/Suspected Vaccination failure; shingles/lesions that started on his right flank and spread to the right side of his back and his right abdomen along with stinging or burning pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. In NOV-2020, the patient received the 1st dose of Shingrix. On 15-SEP-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: lack of vaccine effect/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/lesions that started on his right flank and spread to the right side of his back and his right abdomen along with stinging or burning pain). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and shingles were not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 25-SEP-2025 The patient received his first Shingrix dose in NOV 2020 and the second Shingrix dose within six months, in APR 2021 or MAY 2021. The patient saw his health care professional (HCP) on 22 SEP 2025 and that day, he started valacyclovir 1 gram three times a day for seven days. The patient had not yet noticed an improvement, but the lesions and pain have not worsened. Nothing else was reported. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: A case of Vaccination failure and Herpes zoster, between 2 and 3 months after receiving 2nd dose of Shingrix and between 3 and 5 months after receiving 1st dose of Shingrix, in a 73-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2864200 | 45 | OH | 10/08/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
No adverse event, Product storage error
No adverse event, Product storage error
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temp. excursion due to a new refrigerator as their old one had multiple excursions, however, in the ...
temp. excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no ae; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA202579 (master case). This case involves a 45 years old and unknown gender patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Jun-2025, the patient received an unknown dose of diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- unknown, expiry date- 30-AUG-2026 and lot 3CA55C1) via unknown intramuscular route in unknown administration site for prophylactic vaccination (Immunization) post temperature excursion due to a new refrigerator as their old one had multiple excursions, however, in the new refrigerator, their Wi- Fi data loggers were not activated, and the USB data loggers were not engaged for 92.25 hours with no adverse event (product storage error) (latency- unknown). Reportedly, Max/low temperature reached: 21May2025-26Jun2025: 56๏ฟฝF for 4 hours, 25Jun2025: 32.2๏ฟฝF for 2.25 hours, 11Jul2025: 48.8๏ฟฝF for 0.75 hours, 10- 14Jul2025: 87.5 hours: no temperature data - total hours 92.25 hours ? included 87.5 hours if it was a hot excursion. ? excluding the cold excursion on 25Jun2025. ? excluding 87.5 hours it would only be 4.75 hours cumulatively (hot excursion). There was no previous excursion. Human error was involved. The extended stability data did not cover the excursion. 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-2025SA202579:master case
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| 2864202 | F | MN | 10/08/2025 |
FLU3 |
SANOFI PASTEUR |
U8847BA |
Pain, Swelling
Pain, Swelling
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experiencing side effects such as aching; experiencing side effects such as swelling; Initial inform...
experiencing side effects such as aching; experiencing side effects such as swelling; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an unknown age female patient who had side effects such as swelling and aching after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2025, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength) with lot U8847BA and expiry date 30-Jun-2026 via unknown route in unknown administration site for Immunization. On an unknown in 2025 the patient developed side effects such as swelling (swelling) and aching (pain) (unknown latency) following the administration of influenza USP trival A-B high dose subvirion vaccine. Action taken was not applicable. It was not reported if the patient received corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events.
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| 2864203 | 23 | F | ID | 10/08/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
NB3X7 NB3X7 |
Chills, Dizziness, Feeling cold, Hypoaesthesia, Nausea; Pain, Paraesthesia, Retc...
Chills, Dizziness, Feeling cold, Hypoaesthesia, Nausea; Pain, Paraesthesia, Retching, Vomiting
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I knew i would have side effects because I usually do. I took acetaminophen to help combat it early....
I knew i would have side effects because I usually do. I took acetaminophen to help combat it early. It did not work. About 8 hours after I received the flu shot, I started to get chills with the full body aches right after I left my boyfriend's house to go home. It came on very suddenly and then about 5 to 10 minutes into my drive I started to feel nauseous. I pulled over at the next exit but did not make it in time. I threw up all over the inside of my car. I pulled over to nearest parking lot and climbed out of my car. I threw up multiple times. From the time I started feeling nauseas and when I threw up was maybe a minute. That never happens. I usually know when I'm going to throw up. This was really weird. I tried to clean myself off with my car Tissues. Thought I was done throwing up so I stayed going again. After just another minute of driving I felt it coming again. There happened to be a (withheld name) across the bridge of the highway so I made my way there just in case. I threw up in my lap and it the window crossing the bridge. Made it to the (withheld) parking lot by the emergency entrance. I threw up some more out my door. And then my fingers started to get tingly and went completely numb for about a minute. I could bairly wiggle them. I called my mom, who is a nurse in education, and said I'll be fine and to just drive home. I became super dizzy. So I layed back in my car for about 5 minutes and then sat back up. Still super dizzy. Threw up some more. Still dizzy and my hands had then gone back to normal. I decided I was done vomiting and that I would not need to go inside to the emergency department. So I drove home. Dry heaved a bit in the shower and then when I got out I feel asleep on the bathroom floor for about an hour. Finally in bed. Still freezing from the chills and body aches.
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| 2864205 | 10/08/2025 |
RSV |
PFIZER\WYETH |
mm9159 |
Product preparation issue
Product preparation issue
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Describe Event, Problem, or Product Use Error: Abrysvo (RSV) vaccine product failed to reconstitute ...
Describe Event, Problem, or Product Use Error: Abrysvo (RSV) vaccine product failed to reconstitute upon activation. Replacement vial had to be obtained to administer to patient. Upon review of the vial the activation was performed correctly. The septum separating the diluent from lyophilized vaccine did not release.
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| 2864206 | F | 10/08/2025 |
FLUX HPV9 |
UNKNOWN MANUFACTURER MERCK & CO. INC. |
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Dysstasia, Incomplete course of vaccination, Pain, Speech disorder, Syncope; Dys...
Dysstasia, Incomplete course of vaccination, Pain, Speech disorder, Syncope; Dysstasia, Incomplete course of vaccination, Pain, Speech disorder, Syncope
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Got HPV vaccine Gardasil 9 and it was so painful I was fainted for the first time and cannot get up....
Got HPV vaccine Gardasil 9 and it was so painful I was fainted for the first time and cannot get up. I had to wait for 20 mins and actually try to get up since everyone was asking. Got flu shot on the same day and it's fine (got it first) and the gardasil was extremely painful to the point I cannot speak or stand up. Most of my patients were also fainted and asked to be sit for a while
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| 2864207 | F | 10/08/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5EF45 |
Chest pain, Dyspnoea, Hypoaesthesia
Chest pain, Dyspnoea, Hypoaesthesia
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Describe Event, Problem, or Product Use Error: Patient received seasonal flu vaccine as part of annu...
Describe Event, Problem, or Product Use Error: Patient received seasonal flu vaccine as part of annual flu vaccination series. She developed severe reaction initially presenting as chest pain, shortness of breath and bilateral hand numbness. Vitals were taken by clinic LVN. Patient initially refused to go to the emergency department and stated that this reaction sometimes happens with previous vaccines but goes away without any intervention. She opted to be taken to urgent care, which was in the same building. Urgent care decided to call emergency services and the patient was taken to the emergency department. Vaccine information data: MFT: Glaxo Smith Kline (Flulaval) Lot3 5EF45 Exp: 6/9/26 Drug dose: 0.5 mL Route: IM, L-deltoid
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| 2864208 | 28 | M | TX | 10/08/2025 |
FLU3 HEP |
GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER |
9FG5M |
Feeling abnormal, Mobility decreased, Pain, Seizure; Feeling abnormal, Mobility ...
Feeling abnormal, Mobility decreased, Pain, Seizure; Feeling abnormal, Mobility decreased, Pain, Seizure
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Had the influenza vaccine and the hepatitis b vaccine at 1130. Within minutes, a halo feeling follow...
Had the influenza vaccine and the hepatitis b vaccine at 1130. Within minutes, a halo feeling followed by immense pain that rapidly subsided. Ongoing full left arm mobility issues. Random complete convulsions of the full left arm and shoulder muscular system. On 2 occasions upon standing up, full body convulsions while fully lucid and coherent. These lasted approximately 10 minutes in length. Submitting same day, at 1828. Other medications being taken: Hydrochlorothiazide 10mg Concerta 75 mg Venlafaxine 150 mg
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| 2864209 | 52 | F | AZ | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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Pharmacy used a bandage that is clear on the middle when giving my 2nd Shingles vaccine and the phar...
Pharmacy used a bandage that is clear on the middle when giving my 2nd Shingles vaccine and the pharmacist did not explain what he was doing or why. When he placed the bandage on my arm I asked what is that, he answered it is a new bandage they are using and inserted the the needle. My arm was swollen red and warm for 5 days after the shot looked up what this barrier bandage was. I do believe they should have explained before proceeding. I called the pharmacy a week later explained my concern about possibly having an allergic reaction to this bandage I was talked to in a condescending manner. She said it was more likely from the shot. I explained I did not have this reaction from the 1st shot she said it is my body building up an immunization, I am a nurse and I believe these barrier bandages are bad practice. I read the report and it is possible for people to get foreign material inside their skin from this product and it can even migrate to other parts of the body.
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| 2864210 | 41 | M | 10/08/2025 |
COVID19 COVID19 COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Anhedonia, Anxiety, Aphasia, Bipolar disorder, Brain fog; Condition aggravated, ...
Anhedonia, Anxiety, Aphasia, Bipolar disorder, Brain fog; Condition aggravated, Decreased interest, Depressed mood, Depression, Fall; Feeling of despair, Insomnia, Memory impairment, Mental impairment, Mobility decreased; Multiple sclerosis relapse, Pain
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Patient reports after flare in July he is having mobility, memory issues, trouble finding words, bra...
Patient reports after flare in July he is having mobility, memory issues, trouble finding words, brain fog, thinking in general, sleeping and has pain all over (these are frequent and are unchanged over time). He was placed in the hospital, follow-up in 6 months (brain, neck, back will be scanned) - patient may need to change to an IV medication, he explained. His flare symptoms have gotten better, but hoping it will continue to get better, but things are the same. Patient reported getting a covid vaccine last year and it was not effective. Patient was recently diagnosed bipolar and anxiety - he has been placed on medication, it is helping, but his condition of multiple sclerosis effects how he feels over all mentally. He reported feeling little interest or pleasure in doing things and feeling down, depressed, or hopeless more than half the days - patient is seeing a psychiatrist and is on medication. In the last 90 days the patient reported a fall, ER visit, hospitalization and unplanned medical office visit - his doctor is aware and he is being followed by his Provider.
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| 2864211 | F | TN | 10/08/2025 |
HPV9 |
MERCK & CO. INC. |
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Arthralgia
Arthralgia
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The 24-48 hours after my vaccine I developed severe knee and joint pain. There was no change in my r...
The 24-48 hours after my vaccine I developed severe knee and joint pain. There was no change in my routine other than the vaccine. The pain has been severe everyday since. It's in both knees.
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| 2864212 | 67 | M | 10/08/2025 |
COVID19 |
MODERNA |
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Tinnitus
Tinnitus
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Received mNexspike Covid vaccine on 9/24. Next day noticed ringing in ears which I still have. I hav...
Received mNexspike Covid vaccine on 9/24. Next day noticed ringing in ears which I still have. I have gotten all covid vaccines in the past and this hasn't happened before. Just letting you know. Hopefully it will go away.
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| 2864214 | 43 | M | TX | 10/08/2025 |
FLU3 |
SEQIRUS, INC. |
AX4604A |
Fatigue, Flushing, Headache, Hypertension, Pruritus
Fatigue, Flushing, Headache, Hypertension, Pruritus
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Itching, high blood pressure, fatigue, flushed face, headache
Itching, high blood pressure, fatigue, flushed face, headache
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| 2864215 | 63 | F | IL | 10/08/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
NDC-70461-0655- NDC-70461-0655- |
Asthenia, Blood glucose increased, Chills, Condition aggravated, Malaise; Nausea...
Asthenia, Blood glucose increased, Chills, Condition aggravated, Malaise; Nausea, Product administered at inappropriate site, Pyrexia, Rash
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High Fever 102.9, rash spreading around my arm, feeling unwell, nauseous, weak, chills, sugar spikin...
High Fever 102.9, rash spreading around my arm, feeling unwell, nauseous, weak, chills, sugar spiking up to 240
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| 2864216 | 35 | F | FL | 10/08/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0161 EW0171 |
Antinuclear antibody positive, Arthralgia, Dyspnoea, Fatigue, Uterine leiomyoma;...
Antinuclear antibody positive, Arthralgia, Dyspnoea, Fatigue, Uterine leiomyoma; Antinuclear antibody positive, Arthralgia, Dyspnoea, Fatigue, Uterine leiomyoma
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I've developed chronic fatigue, joint pain , shortness of breath, positive ANA. I also develope...
I've developed chronic fatigue, joint pain , shortness of breath, positive ANA. I also developed multiple uterine fibroids. I have to take antiinflammatories, supplements and different medications for the pain
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| 2864217 | 61 | F | MI | 10/08/2025 |
PNC21 |
MERCK & CO. INC. |
Z006076 |
Injection site erythema, Injection site pruritus, Injection site warmth
Injection site erythema, Injection site pruritus, Injection site warmth
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Patient presented with a large pruritic erythematous area, warm to touch. The area measured about 80...
Patient presented with a large pruritic erythematous area, warm to touch. The area measured about 80 cm in diameter at the vaccine administration site. She was prescribed desoximetasone topical cream, 1 application twice a day to the affected skin. She was also advised to utilize a cool compress to reduce inflammation and puritus. Pt also instructed to f/u with PCP if symptoms are not improving or worsen.
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| 2864218 | 44 | F | CT | 10/08/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
407006 407006 |
Injection site pruritus, Injection site rash, Pruritus, Rash, Rash erythematous;...
Injection site pruritus, Injection site rash, Pruritus, Rash, Rash erythematous; Rash papular
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developed itchiness below breast area and at injection site then later afternoon noticed red small...
developed itchiness below breast area and at injection site then later afternoon noticed red small raise rash on breasts and below breast line on upper abdomen . 10/8/25 notified health nurse and examined patient and rash is noted on above site. suggested taking anti histamine and to monitor symptoms
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| 2864219 | 13 | F | MA | 10/08/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5XA2J |
Blood pressure decreased, Fatigue, Hyperhidrosis, Pallor, Syncope
Blood pressure decreased, Fatigue, Hyperhidrosis, Pallor, Syncope
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Syncopal episode. Patient became pale, fatigue, and sweating. Vital signs taken. BP low. Patient...
Syncopal episode. Patient became pale, fatigue, and sweating. Vital signs taken. BP low. Patient remained on the floor, sitting, with ice pack and cold water. She eventually recovered and moved to a chair. Vitals taken again and back to baseline
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| 2864220 | 27 | F | FL | 10/08/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
M2G3Z |
Exposure during pregnancy, No adverse event, Wrong product administered
Exposure during pregnancy, No adverse event, Wrong product administered
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No adverse events noted; Medication error - patient was 9weeks EGA at time of TDAP vaccine. Patient ...
No adverse events noted; Medication error - patient was 9weeks EGA at time of TDAP vaccine. Patient was inadvertently given TDAP instead of Flu vaccine as ordered.
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| 2864221 | 14 | M | VA | 10/08/2025 |
FLU3 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
ZE423 |
Inappropriate schedule of product administration, Wrong patient received product...
Inappropriate schedule of product administration, Wrong patient received product, Wrong product administered; Inappropriate schedule of product administration, Wrong patient received product, Wrong product administered; Inappropriate schedule of product administration, Wrong patient received product, Wrong product administered
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Patient was given siblings vaccines,. Tdap and Menquadfi administered off schedule as a result. Pati...
Patient was given siblings vaccines,. Tdap and Menquadfi administered off schedule as a result. Patient only needed flu vaccine at this visit.
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| 2864222 | 35 | F | MN | 10/08/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8146545 UT8817NA |
Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral; Hypoaesthesi...
Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral; Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
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Numbness and tingling in left side of face around lips, cheek and under left eye.
Numbness and tingling in left side of face around lips, cheek and under left eye.
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| 2864223 | 70 | M | CA | 10/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Eye pruritus, Eye swelling, Vision blurred
Eye pruritus, Eye swelling, Vision blurred
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Eye swelling (both eyes), blurry vision, itchy eyes, trouble focusing up close (never a problem prev...
Eye swelling (both eyes), blurry vision, itchy eyes, trouble focusing up close (never a problem previously.
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| 2864224 | 0.5 | M | VA | 10/08/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
80777-113-09 ZE423 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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Flu dose #2 was given too early- was given at 21 days from the first instead of 28 days.
Flu dose #2 was given too early- was given at 21 days from the first instead of 28 days.
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| 2864225 | 57 | F | NY | 10/08/2025 |
FLU3 |
SEQIRUS, INC. |
AX4143C |
Injection site erythema, Injection site pruritus, Rash, Rash macular
Injection site erythema, Injection site pruritus, Rash, Rash macular
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10/8/2025 900am Patient came to (withheld) County Health Department for employee flu shot clinic tod...
10/8/2025 900am Patient came to (withheld) County Health Department for employee flu shot clinic today. Patient was given the influenza vaccination in the left arm today. Within 5 mins of getting the influenza vaccination Patient said her arm was itchy. At the 15 min marker, Patient was still itchy at the injection site, site was reddened below the arm, and face was blotchy. 50mg of benadryl was given to patient. Patient is following up with PCP today.
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| 2864226 | 82 | F | TX | 10/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5a4xg |
Rash
Rash
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Patient has had rash, mostly on extremities, tried otc products and prescription betamethasone cream...
Patient has had rash, mostly on extremities, tried otc products and prescription betamethasone cream that gave little to no relief. Rash has persisted. If it does get better at all still returns to same severity
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