| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843051 | 4 | M | CA | 05/28/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Fatigue, Injection site pain
Fatigue, Injection site pain
|
>12 year COVID vaccine administered. Mother reported that child had fatigue and soreness at injec...
>12 year COVID vaccine administered. Mother reported that child had fatigue and soreness at injection site.
More
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| 2843052 | 5 | F | OR | 05/28/2025 |
DTAPIPV |
SANOFI PASTEUR |
|
Inflammation, Product administered at inappropriate site
Inflammation, Product administered at inappropriate site
|
Patient developed localized inflammatory response. Vaccine was given more posterior on left vastus l...
Patient developed localized inflammatory response. Vaccine was given more posterior on left vastus lateralis.
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| 2843053 | 39 | M | NC | 05/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Fatigue, Myalgia
Fatigue, Myalgia
|
Myalgia. Pt came into our clinic after receiving the vaccine. He received the vaccine and within onl...
Myalgia. Pt came into our clinic after receiving the vaccine. He received the vaccine and within only a couple days showed symptoms of muscle aches and fatigue for multiple weeks following the vaccine.
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| 2843054 | 1.08 | M | CA | 05/28/2025 |
HEPA MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y015910 Z002989 |
Erythema, Swelling; Erythema, Swelling
Erythema, Swelling; Erythema, Swelling
|
REDNESS AND SWELLING
REDNESS AND SWELLING
|
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| 2843055 | 16 | F | PA | 05/28/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
U6521AB U8558BA |
Headache, Nausea, Paraesthesia; Headache, Nausea, Paraesthesia
Headache, Nausea, Paraesthesia; Headache, Nausea, Paraesthesia
|
Patient developed nausea, headache, and tingling legs over night after receiving the vaccine that da...
Patient developed nausea, headache, and tingling legs over night after receiving the vaccine that day.
More
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| 2843056 | 35 | M | ID | 05/28/2025 |
HEP |
MERCK & CO. INC. |
P-Y004552 |
No adverse event
No adverse event
|
No adverse reaction
No adverse reaction
|
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| 2843057 | 1.33 | F | KS | 05/28/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
232Z3 |
Breath sounds abnormal, Dermatitis diaper, Immunisation reaction, Skin swelling
Breath sounds abnormal, Dermatitis diaper, Immunisation reaction, Skin swelling
|
Mother reports that at approx. 10 pm she noticed a "rash" in patient's diaper area, t...
Mother reports that at approx. 10 pm she noticed a "rash" in patient's diaper area, that patient was "puffy" all over (child is normally very slim) and mom heard a "weird" sound in her airway, as if she was having trouble breathing therefore she took her to Hospital ER for evaluation.
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| 2843058 | 36 | M | MT | 05/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9532Y |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine's expiration date was 5/23/25, 4 days expired at the time of administration. No symptom...
Vaccine's expiration date was 5/23/25, 4 days expired at the time of administration. No symptoms at time of vaccination, no symptoms the following morning.
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| 2843059 | 8 | F | CA | 05/28/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Fatigue, Injection site pain
Fatigue, Injection site pain
|
>12 year old COVID vaccine given. Mother of child reported child had fatigue and soreness at site...
>12 year old COVID vaccine given. Mother of child reported child had fatigue and soreness at site after injection
More
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| 2843060 | 77 | M | GA | 05/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47N3Y |
Contusion
Contusion
|
patient came in and showed up a big bruise almost looked like a hematoma
patient came in and showed up a big bruise almost looked like a hematoma
|
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| 2843061 | 10 | F | NJ | 05/28/2025 |
COVID19 |
MODERNA |
3044211 |
Expired product administered
Expired product administered
|
At 15:06 on 5/27/25, the patient received Moderna covid vaccine in physician office during a routine...
At 15:06 on 5/27/25, the patient received Moderna covid vaccine in physician office during a routine wellness appointment. At 14:06 pm on 5/27/25, it was discovered that the best use by date of the Moderna covid vaccine administered was 5/25/25.
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| 2843062 | 71 | F | NJ | 05/28/2025 |
PNC21 PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
ZOo4301 ZOo4301 |
Erythema, Peripheral swelling, Pruritus, Rash; Headache, Injection site rash, In...
Erythema, Peripheral swelling, Pruritus, Rash; Headache, Injection site rash, Injection site swelling, Rash; Erythema, Peripheral swelling, Pruritus, Rash; Headache, Injection site rash, Injection site swelling, Rash
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Arm red swollen lasting 7 days still red. Both arms and ankles rash appeared. Skin itchy . No sign o...
Arm red swollen lasting 7 days still red. Both arms and ankles rash appeared. Skin itchy . No sign of infection.
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| 2843063 | M | ME | 05/28/2025 |
HEP |
MERCK & CO. INC. |
Y009551 |
Extra dose administered
Extra dose administered
|
Patient was administered a hep B vaccine on 5/22/25 in addition to vaccine administered on 5/11/25 a...
Patient was administered a hep B vaccine on 5/22/25 in addition to vaccine administered on 5/11/25 at hospital at birth. This was too soon and was not discovered as hospital created immunization record in the wrong name (incorrect spelling).
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| 2843064 | 18 | F | TX | 05/28/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
49M9N |
Head injury, Syncope
Head injury, Syncope
|
Notes: 1245 with syncopal event, post bexsero #2, Mom reported older brother had a similar reaction ...
Notes: 1245 with syncopal event, post bexsero #2, Mom reported older brother had a similar reaction to bexsero #2. no prior syncopal events, is fasting, hit head on the floor, but no overt headache. neuro exam within normal limits and given water and asked to rest for 15 minutes. wants to be pharmacist, alert oriented x 3. 1305 spoke with MD, blood sugar was checked and neuro exam WNL. feels better (Orange juice also provided)
More
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| 2843065 | 59 | F | AZ | 05/28/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
025L20A 025L20A 025L20A 025L20A 025L20A 025L20A 025L20A |
Asthenia, Atrial septal defect, Atrial septal defect repair, Autologous blood pa...
Asthenia, Atrial septal defect, Atrial septal defect repair, Autologous blood patching, Back pain; Blood gases abnormal, Blood test, Cardiac aneurysm, Cerebral atrophy, Cerebral small vessel ischaemic disease; Chest pain, Computerised tomogram head abnormal, Computerised tomogram normal, Computerised tomogram spine abnormal, Contusion; Demyelination, Diverticulitis, Echocardiogram, Echocardiogram abnormal, Encephalocele; Headache, Loss of employment, Lung assist device therapy, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal; Myocardial injury, Pulmonary function test, Right-to-left cardiac shunt, Scan with contrast abnormal, Spinal myelogram abnormal; Stress echocardiogram abnormal, Ultrasound head, Venogram, Vertigo, Vomiting
More
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Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on bo...
Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
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โ | |||||
| 2843066 | 59 | F | VA | 05/28/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
y011819 y011819 9l944 9l944 |
Chills, Erythema, Headache, Hypoaesthesia, Peripheral swelling; Pyrexia; Chills,...
Chills, Erythema, Headache, Hypoaesthesia, Peripheral swelling; Pyrexia; Chills, Erythema, Headache, Hypoaesthesia, Peripheral swelling; Pyrexia
More
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THE NEXT DAY, PT EXPERIENCED SEVERE HEADACHE, FEVER AND CHILLS. THEN SHE HAD REDNESS AND SWELLING I...
THE NEXT DAY, PT EXPERIENCED SEVERE HEADACHE, FEVER AND CHILLS. THEN SHE HAD REDNESS AND SWELLING IN BOTH ARMS. RIGHT ARM HAD REDNESS AND SWELLING THAT SPREAD DOWN ARM AND PT HAD TO GET RX FOR CEPHALEXIN. PT ALSO COMPLAINED ABOUT NUMBNESS IN HER ARM AND SHOOTING DOWN INTO HER HAND/FINGERS. HAS GOTTEN BETTER BUT STILL HAS NUMBNESS IN FINGERS OF LEFT HAND
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| 2843067 | 21 | F | OH | 05/28/2025 |
VARCEL |
MERCK & CO. INC. |
Y015559 |
Rash, Rash erythematous
Rash, Rash erythematous
|
Pt experienced small red bumps on both elbows after receiving vaccine.
Pt experienced small red bumps on both elbows after receiving vaccine.
|
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| 2843068 | 68 | F | NM | 05/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
K2BB7 |
Mobility decreased, Pain in extremity, Peripheral swelling, Sleep disorder, Tend...
Mobility decreased, Pain in extremity, Peripheral swelling, Sleep disorder, Tenderness
More
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PATIENT RETURNED TO PHARMACY TODAY 5/28 FOR 2ND DOSE OF SHINGRIX WITH HESITATION REGARDING HER FIRST...
PATIENT RETURNED TO PHARMACY TODAY 5/28 FOR 2ND DOSE OF SHINGRIX WITH HESITATION REGARDING HER FIRST DOSE, ADMINISTERED 2/21/25. SHORTLY AFTER HER SHOT ON HER DRIVE HOME SHE FELT HER ARM WAS MORE SORE THAN NORMAL. IT WAS DIFFICULT TO SLEEP ON THAT NIGHT AND THEN THE FOLLOWING DAY DID BECOME RATHER PAINFUL, SWOLLEN AND DIFFICULT TO RAISE HER ARM. IT IS NOW 3 MONTHS LATER AND STILL DIFFICULT TO RAISE HER ARM AND PAINFUL TO THE TOUCH, CANNOT SLEEP ON HER SIDE. HAS NOT SEEN A MEDICAL PROFESSIONAL REGARDING THIS ISSUE.
More
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| 2843069 | 53 | F | CA | 05/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Headache, Injection site pain, Nausea, Vomiting
Chills, Headache, Injection site pain, Nausea, Vomiting
|
Pain at the injection site, headache, nausea, vomiting, shivering.
Pain at the injection site, headache, nausea, vomiting, shivering.
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| 2843070 | 52 | F | RI | 05/28/2025 |
PNC20 |
PFIZER\WYETH |
LK6653 |
Injection site cellulitis
Injection site cellulitis
|
Cellulitis of the left upper arm extending down towards elbow with out systemic s/s. Treated with or...
Cellulitis of the left upper arm extending down towards elbow with out systemic s/s. Treated with oral doxycylcine BID for 7 days and f/u 5/30/25.
More
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| 2843071 | 31 | F | CA | 05/28/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
5JA57 |
No adverse event, Underdose
No adverse event, Underdose
|
Pediatric Hep A vaccine was given to an adult pt. No reaction afterwards.
Pediatric Hep A vaccine was given to an adult pt. No reaction afterwards.
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| 2843072 | 79 | F | WA | 05/28/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Asthenia, Dyspnoea, Mobility decreased, Pain in extremity
Asthenia, Dyspnoea, Mobility decreased, Pain in extremity
|
After i got my arm hurt like hell, and i did my normal things at night and i started to feel a littl...
After i got my arm hurt like hell, and i did my normal things at night and i started to feel a little bit out of breath. So i cut the evening short and went upstairs and i was having issues breathing all night and the next day i could not get my breath. I could not find enough oxygen to get into my lungs and i kept trying the breathe in and there was nothing to bring in. I kept using my inhaler every hour and it was the only thing that would allow me breathe. I was super weak and it was hard to get out of bed i was wondering what would happen if i fell out of bed. I couldnt do anything i couldnt think and i couldnt go anywhere. I thought about walking down the steps to feed my fish and i was so worried i would fall. And this last all day long and my dog was next to me the whole time.
More
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| 2843073 | 48 | M | WA | 05/28/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ew0153 ew0175 |
Vocal cord paralysis; Vocal cord paralysis
Vocal cord paralysis; Vocal cord paralysis
|
Paralyzed Vocal Cord, recurrent laryngeal nerve paralysis or vocal fold paralysis
Paralyzed Vocal Cord, recurrent laryngeal nerve paralysis or vocal fold paralysis
|
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| 2843074 | 72 | M | NC | 05/28/2025 |
CHIK CHIK HEPA HEPA TYP TYP |
VALNEVA USA, INC. VALNEVA USA, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
24B011 24B011 Z27PB Z27PB X2A411M X2A411M |
Feeling abnormal, Headache, Influenza virus test negative, Listless, Malaise; Py...
Feeling abnormal, Headache, Influenza virus test negative, Listless, Malaise; Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Feeling abnormal, Headache, Influenza virus test negative, Listless, Malaise; Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Feeling abnormal, Headache, Influenza virus test negative, Listless, Malaise; Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
More
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Thursday 3/13: He I felt slightly "off" but attributed it to other factors. Friday: He dev...
Thursday 3/13: He I felt slightly "off" but attributed it to other factors. Friday: He developed a headache and fever, prompting me to cancel an evening engagement. Saturday: He felt unwell and listless. My temperature rose to around 100?101๏ฟฝF, which is 2?3 degrees higher than his normal 98.1๏ฟฝF. Sunday: He spent most of the day in bed, experiencing intermittent fever cycles. Though he can?t recall all his symptoms, he just felt very unwell. Monday: With a flight scheduled for Wednesday, he thought I might be improving but decided to consult me(Dr. ). To ensure I could make an informed decision about traveling, he opted to get tested for other potential illnesses. I visited a clinic, where he was tested for COVID-19, flu, and RSV?all of which came back negative. Tuesday: The day before his flight, he started feeling better in the afternoon. Wednesday: Although he still had minor lingering symptoms, he flew. He improved shortly after.
More
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| 2843075 | 70 | F | MO | 05/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
74NC9 |
Formication, Injection site reaction, Pruritus
Formication, Injection site reaction, Pruritus
|
Initial reaction occurred approximately three days after injection which injection site reaction and...
Initial reaction occurred approximately three days after injection which injection site reaction and itching. 2 months later, patient is still reporting infrequent/occasional crawling up the left arm between elbow and shoulder.
More
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| 2843076 | 94 | F | CO | 05/28/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0592 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine expiration was 5/4/25. Medical assistant gave vaccine 2 days past exp date. No harm or injur...
Vaccine expiration was 5/4/25. Medical assistant gave vaccine 2 days past exp date. No harm or injury to the patient.
More
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| 2843077 | 24 | M | WA | 05/28/2025 |
COVID19 |
MODERNA |
|
Urticaria
Urticaria
|
Developed dermatographia within two weeks of second dose. Have consistently had this since then.
Developed dermatographia within two weeks of second dose. Have consistently had this since then.
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| 2843078 | 50 | F | 05/28/2025 |
COVID19 UNK |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
LM2210 388527 |
COVID-19; COVID-19
COVID-19; COVID-19
|
Tested positive for Covid, Experiencing mild symptoms; This spontaneous case, initially received on ...
Tested positive for Covid, Experiencing mild symptoms; This spontaneous case, initially received on 12-May-2025, was reported by a non health professional and concerns an adult female patient. Historical drug included unspecified product (reaction: allergy). Administration of company suspect drug: On 03-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Left arm, Lot number: 388527. Non-company suspect drugs: On 03-Oct-2024, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Deltoid, Lot number: LM2210. On 07-Apr-2025, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Not Reported, Lot number: LM2210. Adverse reactions/events and outcomes: On 09-May-2025, the patient experienced Tested positive for Covid, Experiencing mild symptoms (outcome: Recovering / Resolving). Intensity: Mild Additional information received as event started on 09-May-2025 as well. In other words, patient felt symptoms on 09-May-2025 and took a Covid test that same day, which was how patient became aware she had Covid. It was reported that this report that Tested positive for Covid. Experiencing mild symptoms, appeared to be related to efficacy of the drug which was not device related. As there was no issue reported with the device (Tozinameran), this would be closed as not device related. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the event Tested positive for Covid, Experiencing mild symptoms as non-serious and did not provide causality assessment. Follow up (19-May-2025) received from consumer: New reporter added (second), New dosing regimen added for co-suspect, event onset date updated to 09-May-2025. Upon internal review, race had been removed from patient tab and updated with other, narrative updated accordingly.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the event covid-19 is considered coincidental with no biological and temporal plausibility (7 months after vaccination) for Flucelvax to cause/contribute. Of note, there could be a lack of effect with non company COVID-19 vaccine (Tozinameran).
More
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| 2843086 | 66 | F | UT | 05/28/2025 |
MMRV |
MERCK & CO. INC. |
Z003310 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
No symptoms reported.; patient erroneously received a dose of PROQUAD instead of MMRII; This spontan...
No symptoms reported.; patient erroneously received a dose of PROQUAD instead of MMRII; This spontaneous report was received from a/an Nurse and refers to a(n) 66-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-May-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z003310, expiration date: 21-Jul-2026) 0.5 mL (0.5ML),. On 21-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). The patient started therapy with sterile diluent (MERCK STERILE DILUENT), for the treatment of prophylaxis. The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of Prophylaxis. On 21-May-2025, the patient experienced patient erroneously received a dose of PROQUAD instead of MMRII. On an unknown date, the patient experienced No symptoms reported. Lot # is being requested and will be submitted if received.
More
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| 2843087 | M | 05/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; son took the vaccine and still ended up with shingles; This serious c...
Suspected vaccination failure; son took the vaccine and still ended up with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: son took the vaccine and still ended up with shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient's parent via interactive digital media. The reporter stated that their son took the vaccine and still ended up with shingles. Between that and watching how many had covid two or three times after having a covid shot, they are very leary of vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843088 | 77 | F | 05/28/2025 |
FLU3 |
SANOFI PASTEUR |
UT8409CA |
Immediate post-injection reaction, Pain in extremity, Sleep disorder
Immediate post-injection reaction, Pain in extremity, Sleep disorder
|
Pt reported today, 5/28/2025, that her arm started hurting immediately after the vaccination on 1/16...
Pt reported today, 5/28/2025, that her arm started hurting immediately after the vaccination on 1/16/2025. She says it has progressively been getting worse since then. She's had to take pain meds (advil) at night to be able to sleep and as of today, she cannot lift her left arm to shoulder level without intense pain. She is going to see her doctor this week about this pain. I asked why she is just now reporting it and she said she's had a lot going on health wise that she is just now getting around to it.
More
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| 2843089 | 70 | F | NC | 05/28/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
DD72H U8361AA |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
|
Patient admitted to hospital for undisclosed reason and this was made aware when nurse called patien...
Patient admitted to hospital for undisclosed reason and this was made aware when nurse called patient to confirm her 3rd final Bexsero appt. We are unsure as to when her discharge date is. Last vaccine date was 01/22/25.
More
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| 2843090 | 48 | F | UT | 05/28/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3N2ND LG749 |
Underdose; Underdose
Underdose; Underdose
|
Was inadvertantly administered a pediatric dose
Was inadvertantly administered a pediatric dose
|
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| 2843091 | 15 | F | AZ | 05/28/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
x02668 x02668 |
Fall, Feeling abnormal, Head injury, Headache, Loss of consciousness; Rash, Rash...
Fall, Feeling abnormal, Head injury, Headache, Loss of consciousness; Rash, Rash erythematous
More
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15-year-old female was given the HPV #1 yesterday. 20 minutes after she left she reported that she ...
15-year-old female was given the HPV #1 yesterday. 20 minutes after she left she reported that she was starting to feel "a little funny". Patient did not say anything. Patient reports later in the day she was changing positions and going from a sitting to a standing position. Patient reportedly lost consciousness and fell back to the ground hitting the front of her head. Patient reports a headache today. Mother shows a picture of bilateral cheeks with a red raised rash. Skin intact on the head. No bruising. Patient does have a headache
More
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| 2843092 | 18 | F | GA | 05/28/2025 |
HPV9 MENB |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
Y014059 A5AD4 |
Hyperhidrosis, Hypotonia, Pain, Pallor, Unresponsive to stimuli; Hyperhidrosis, ...
Hyperhidrosis, Hypotonia, Pain, Pallor, Unresponsive to stimuli; Hyperhidrosis, Hypotonia, Pain, Pallor, Unresponsive to stimuli
More
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Patient received both vaccines and continued to site in chair beside mother. Mother stated patient d...
Patient received both vaccines and continued to site in chair beside mother. Mother stated patient does really well with shots, but just gets a little nervous about them ahead of time. Patient did state that HPV vaccine hurt more than men B. While paperwork was being printed, patient slumped over onto her mother's shoulder and was non-responsive. Nurses and mother eased patient from chair onto floor. Patient immediately became responsive upon laying flat. Pulse was strong and regular. Patient was pale and slightly diaphoretic. Upon regaining responsiveness, patient stated she was okay. Patient encouraged to lay flay. Cool, damp cloth applied to head. Patient became nauseated and was assisted to sit up and did vomit a small amount of emesis. A small scratch was bleeding noted to patient's upper left forehead at the hairline. Scratch cleaned with wet paper towel and did stop bleeding. Patient assisted up into chair and given water, a sucker and animal crackers. VS were stable and patient was able to ambulate to car with mother without further incident.
More
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| 2843093 | 1.25 | M | CT | 05/28/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMX8056A |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
No adverse reaction. Vaccine was mixed incorrectly with sterile water instead of the diluent that wa...
No adverse reaction. Vaccine was mixed incorrectly with sterile water instead of the diluent that was provided.
More
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| 2843094 | 97 | F | MD | 05/28/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Asthenia, Gait disturbance, Loss of personal independence in daily activities, M...
Asthenia, Gait disturbance, Loss of personal independence in daily activities, Muscular weakness
More
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Sudden weakness after covid vaccine. Lower limb weakness, difficulty walking / bathing.
Sudden weakness after covid vaccine. Lower limb weakness, difficulty walking / bathing.
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| 2843095 | 77 | M | MA | 05/28/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Erythema, Skin tightness, Swelling, Tenderness
Erythema, Skin tightness, Swelling, Tenderness
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Seen via video visit, area appeared erythematous and pt stated swollen, tight and tender. Pt sent to...
Seen via video visit, area appeared erythematous and pt stated swollen, tight and tender. Pt sent to ER for evaluation.
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| 2843104 | 0.33 | F | NC | 05/28/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
K25M5 Y005366 LK6655 2096663 |
Choking, Erythema, Infantile spitting up, Rash, Rash erythematous; Choking, Eryt...
Choking, Erythema, Infantile spitting up, Rash, Rash erythematous; Choking, Erythema, Infantile spitting up, Rash, Rash erythematous; Choking, Erythema, Infantile spitting up, Rash, Rash erythematous; Choking, Erythema, Infantile spitting up, Rash, Rash erythematous
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5 hours post vaccination, patient developed a red facial rash and had an episode of choking and smal...
5 hours post vaccination, patient developed a red facial rash and had an episode of choking and small spit up of formula. She was assessed in office 1 hour after reaction, 6 hours after vaccines, and facial rash had resolved to mild erythema to forehead. She had normal assessment with clear lungs.
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| 2843105 | 56 | F | KY | 05/28/2025 |
VARCEL |
MERCK & CO. INC. |
z003766 |
Rash, Rash erythematous
Rash, Rash erythematous
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A red rash on back of arm, she said she has been using ice and that it hasn't bothered her. I ...
A red rash on back of arm, she said she has been using ice and that it hasn't bothered her. I suggested that she see her primary care physician to have a look at it and see what the physician thinks of it and if she should get the second dose when appropriate.
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| 2843106 | 62 | M | OR | 05/28/2025 |
COVID19 |
MODERNA |
8081260 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient received a second Covid19 vaccine instead of a second Shingrix vaccine. Patient was informe...
Patient received a second Covid19 vaccine instead of a second Shingrix vaccine. Patient was informed and will be contacting pharmacy if there are any adverse reaction.
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| 2843107 | 62 | M | IN | 05/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Injection site mass, Injection site swelling
Injection site mass, Injection site swelling
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Swelling and feeling of a lump under the skin at injection site
Swelling and feeling of a lump under the skin at injection site
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| 2843108 | 27 | M | WA | 05/28/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
Covid-19 Vaccin Covid-19 Vaccin Covid-19 Vaccin |
Abdominal distension, Anxiety, Brain fog, Depression, Fatigue; Haemoglobin incre...
Abdominal distension, Anxiety, Brain fog, Depression, Fatigue; Haemoglobin increased, Hepatic enzyme increased, Hyperhidrosis, Influenza, Malaise; Mental impairment, Seizure, Swelling
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At 9:00 pm I started convulsing and sweating then I was flu like for days after, my legs got swollen...
At 9:00 pm I started convulsing and sweating then I was flu like for days after, my legs got swollen and I started bloating. The swelling came and went but my liver enzymes and hemoglobin have been elevated ever since. The brain fog has persisted and fatigue has persisted as well. With the diminished physical and mental capacity of become depressed and anxious.
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| 2843109 | 4 | F | CA | 05/28/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8209CB U8209CB Z002989 Z002989 |
Injection site cellulitis, Injection site erythema, Injection site pruritus, Inj...
Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling; Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling; Injection site warmth
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Patient received the following vaccines on Friday, May 23, 2025: Quadracel (Dtap & IPV), and Pro...
Patient received the following vaccines on Friday, May 23, 2025: Quadracel (Dtap & IPV), and ProQuad (MMRV). Per mom patient started complaining of itchiness on left thigh where Quadracel vaccine was administered. MOC noticed redness, swelling, and site felt warm to the touch. MOC applied ice. Per mom this helped with the swelling a little bit. MOC took patient to UC on Sunday where patient was diagnosed with a rash, Cellulitis of the left leg. Patient was placed on Clindamycin antibiotic 13.5 ml every 8 hours for 5 days.
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| 2843110 | 15 | M | OH | 05/28/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood test, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Myoca...
Blood test, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Myocarditis; X-ray
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Myocarditis
Myocarditis
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โ | โ | ||||
| 2843111 | 77 | F | CA | 05/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
3M9DS |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
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Redness, swelling, itchiness, heat and tenderness at the injection site
Redness, swelling, itchiness, heat and tenderness at the injection site
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| 2843112 | 1 | M | MD | 05/28/2025 |
MMR MMR PPV PPV VARCEL VARCEL MMR MMR PNC15 PNC15 VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
7975C 7975C Z003633 Z003633 Z003882 Z003882 7975C 7975C Z003633 Z003633 Z003882 Z003882 |
Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting; ...
Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting; Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting; Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting; Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting; Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting; Hypersensitivity, Lethargy, Nasal congestion, Vomiting; Pallor, Rash, Vomiting
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On May 28th 2025, my infant was scheduled to receive a vaccines at office. We arrived at 1:50 PM f...
On May 28th 2025, my infant was scheduled to receive a vaccines at office. We arrived at 1:50 PM for the appointment. The vaccines were administered at 2:40 PM by clinic staff. At the time of the incident, three vaccines were administered during the visit. Two of those vaccines Varicella and Pneumococcal Conjugate been given previously to my baby without any prior reactions.This was the first time the third vaccine MMR had been administered and Shortly after the injection with in minutes, my child began to show signs of a severe allergic reaction. At 2:47 PM, my baby started vomiting, became lethargic, and developed nasal congestion. I immediately informed the clinic staff of these symptoms. Despite the urgency of the situation and visible distress, no emergency action was taken by the clinic. No epinephrine was administered, and 911 was never called. As our child s condition worsened, my husband and I made the decision to leave the clinic and transport our baby ourselves to the Emergency Room. Upon arrival, ER staff immediately administered epinephrine, monitored our child, and stabilized the reaction. It is our firm belief that the delayed response by the clinic endangered our child s life and represents a serious breach of medical responsibility.
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| 2842715 | 05/27/2025 |
MEN |
UNKNOWN MANUFACTURER |
UNK |
Platelet count decreased, Platelet transfusion
Platelet count decreased, Platelet transfusion
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(plates tanked to zero after the Meningitis B shot).; This non-serious case was reported by a consum...
(plates tanked to zero after the Meningitis B shot).; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of platelet count decreased in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. The patient's past medical history included post herpetic neuralgia and hemoglobin decreased. Previously administered products included Soliris. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced platelet count decreased (Verbatim: (plates tanked to zero after the Meningitis B shot).). The outcome of the platelet count decreased was not reported. It was unknown if the reporter considered the platelet count decreased to be related to Meningococcal B vaccine. It was unknown if the company considered the platelet count decreased to be related to Meningococcal B vaccine. Additional Information: GSK Receipt ate:21-MAY-2025 The reporter was a patient with PNH. The reporter had hemoglobin counts of less than 5 a few times and dozens of blood transfusions, tried Soliris and Ultamiris, was injured by the vaccine required to take those treatments (plates tanked to zero after the Meningitis B shot). The patient then received platelet.
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| 2842716 | TX | 05/27/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Extra dose administered, Product prescribing error; Extra dose administered, Pro...
Extra dose administered, Product prescribing error; Extra dose administered, Product prescribing error
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Stem cell transplant after Shingrix series; Extra series prescribed; This serious case was reported ...
Stem cell transplant after Shingrix series; Extra series prescribed; This serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix and the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stem cell transplant (Verbatim: Stem cell transplant after Shingrix series) (serious criteria clinically significant/intervention required) and drug schedule prescribing error (Verbatim: Extra series prescribed). The outcome of the stem cell transplant was unknown and the outcome of the drug schedule prescribing error was not applicable. It was unknown if the reporter considered the stem cell transplant to be related to Shingrix. The company considered the stem cell transplant to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 20-MAY-2025 The pharmacist explained that an adult patient had received two doses of Shingrix in 2019 (specific dates were unknown). Since the patient had undergone a stem cell transplant, their healthcare provider had recommended administering another series of Shingrix, which led to Drug schedule prescribing error.; Sender's Comments: Stem cell transplant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2842718 | 11 | F | NC | 05/27/2025 |
COVID19 COVID19 HPV9 HPV9 MNQ MNQ TDAP TDAP |
MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3044143 3044143 Y010466 Y010466 U8369AA U8369AA 9YB46 9YB46 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling; Ultrasound scan normal, X-ray normal; Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling; Ultrasound scan normal, X-ray normal; Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling; Ultrasound scan normal, X-ray normal; Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling; Ultrasound scan normal, X-ray normal
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Redness, swollen itching - hard area underneath injection site Rt arm - reaction Swelling, warm &a...
Redness, swollen itching - hard area underneath injection site Rt arm - reaction Swelling, warm & tender to touch started on Friday 5-16-25
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