| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2820034 | 1.25 | M | FL | 01/08/2025 |
DTAP HIBV PNC20 |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH |
3CA11C1 UK148AA LJ5283 |
Injection site erythema, Injection site warmth, Lymphadenopathy, Skin irritation...
Injection site erythema, Injection site warmth, Lymphadenopathy, Skin irritation; Injection site erythema, Injection site warmth, Lymphadenopathy, Skin irritation; Injection site erythema, Injection site warmth, Lymphadenopathy, Skin irritation
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Mild red 5 x 6 cm on right thigh no breaking skin and no infection.
Mild red 5 x 6 cm on right thigh no breaking skin and no infection.
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| 2819679 | U | MA | 01/07/2025 |
MMRV |
MERCK & CO. INC. |
Y014436 |
No adverse event, Product storage error
No adverse event, Product storage error
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no AE; Inbound from nurse who reports product involved in temperature excursion administered to one ...
no AE; Inbound from nurse who reports product involved in temperature excursion administered to one patient. Excursion occurred last night, product administered to one patient this morning 12/12/2024. ? Names of vaccines involved (including lot/exp); This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 12-DEC-2024, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #Y014436, expiration date: 22-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 17 minutes (Product storage error). No additional AE reported.
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| 2819680 | F | 01/07/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
No batch number No batch number |
Aphasia, Dizziness, Hypoaesthesia, Impaired driving ability, Mental impairment; ...
Aphasia, Dizziness, Hypoaesthesia, Impaired driving ability, Mental impairment; Throat tightness
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Mental impairment; Dizziness; Hypoaesthesia; Impaired driving ability; Throat tightness; This sponta...
Mental impairment; Dizziness; Hypoaesthesia; Impaired driving ability; Throat tightness; This spontaneous case, initially received on 19-Dec-2024, was reported by a non-health professional and concerns an adult female patient. Past medical history included Gastroparesis, Celiac, GERD, RA, Sciatica, Acid Reflux, High Blood Pressure, Iron Deficiency Anemia, Barrett's Esophagitis, Chronic Nausea, Dysphasia, Fibromyalgia, Gastritis, Hemiplegic Migraine, Hypertension, Neuropathy, Near Syncope. Drug history included Bactrim (Reaction: Allergy), Ceftin (Reaction: Allergy), Ceftriaxone Sodium (Reaction: Allergy), Cipro (Reaction: Allergy), Doxycycline (Reaction: Allergy), Macrobid (Reaction: Allergy), Sulfa Topicals/Sufa Drugs (Reaction: Allergy), Morphine (Reaction: Allergy), Effexor (Reaction: Allergy), Lortab (Reaction: Allergy), Prednisone (Reaction: Allergy), Tramadol (Reaction: Allergy), Trazodone (Reaction: Allergy), Prednisone (Reaction: Allergy). At the time of the event the patient had Urinary tract infection, Wheat Allergy, Seafood Allergy, Fruit Allergy, Meat Allergy, Egg Yolk Allergy, Food Allergy. Concomitant medication: refer to appropriate report section. Administration of company suspect drug:: On 03-Oct-2024, the patient received Afluria (TIV) for Drug use for unknown indication, Route of administration: Intramuscular, Anatomical site: Unknown, Lot number: No batch number available and will be requested upon follow up. Non-company suspect drugs (captured as procedure in structured fields of medical history section due to limitations of WHO Drug Browser): Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (SARS-CoV-2 Spike protein (Omicron variant JN.1), Indication: COVID-19 immunization, 0.5 ml, Route of administration: Intramuscular, Anatomical site: Unknown, Lot number: No batch number available. Adverse reactions/events and outcomes: On 06-Oct-2024, the patient experienced Mental impairment (Medically Significant, outcome: Not recovered / Not resolved), Dizziness (outcome: Not recovered / Not resolved), Hypoaesthesia (outcome: Not recovered / Not resolved), Impaired driving ability (outcome: Not recovered / Not resolved), Throat tightness (outcome: Not recovered / Not resolved). Relevant Lab tests included Emergency Care Examination (Result: The patient went to the ER at to be for an and have had these occur Since then, worsening as goes on, Test date: Unknwon). Within 30 of the vaccines, the patient began to feel dizzy and numb in patient left Side. Started to her throat Close up and was hard to comprehend communicate. The doctor in the Clinic at the tine told her to sit in the waiting room which she did, for about an hour, because did not feel comfortable driving and felt like she was having an reaction. Afluria (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed the event Mental impairment as serious due to medically significant and other events as non-serious and did not provide the causality assessment for all the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Related for mental impairment, hypoesthesia, dizziness, impaired driving ability and throat tightness due to plausible temporal relationship. However, the medical history of hemiplegic migraine, hypertension, neuropathy and co-suspect Novavax COVID-19 Vaccine could have contributed to the events.
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| 2819682 | 65 | F | MD | 01/07/2025 |
RSV VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
HY1811 F9X4P |
Laboratory test, Postmenopausal haemorrhage, Vaginal haemorrhage; Laboratory tes...
Laboratory test, Postmenopausal haemorrhage, Vaginal haemorrhage; Laboratory test, Postmenopausal haemorrhage, Vaginal haemorrhage
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I started having heavy post-menopausal vaginal bleeding with clots on 11/22/24, which has continued ...
I started having heavy post-menopausal vaginal bleeding with clots on 11/22/24, which has continued into January 2025. I went to the emergency room in late December because of the heavy bleeding/clots and fear of anemia. I was started on a prescription that slowed the flow somewhat, but it has increased again in January. This bleeding has continued much too long.
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| 2819689 | 50 | F | SC | 01/07/2025 |
HEP HEPAB |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
|
Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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vaccine Interchangeability with Heplisav (second dose); This non-serious case was reported by a phar...
vaccine Interchangeability with Heplisav (second dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 30-JUL-2024, the patient received the 1st dose of Twinrix. On an unknown date, the patient received Heplisav b. On an unknown date, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: vaccine Interchangeability with Heplisav (second dose)). The outcome of the interchange of vaccine products was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-DEC-2024 Pharmacist reported that a fifty-year-old female patient received a first dose of Twinrix and then a second dose of Heplisav (Hepatitis B vaccine) which led to interchange of vaccine products. Pharmacist wanted to know about how to proceed, if they need to restart the series/schedule for the patient. Vaccination date (Twinrix) and patient demographics were retrieved during the call. No further information was obtained from the pharmacist๏ฟฝs end during the call.
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| 2819735 | 12 | F | 01/07/2025 |
HPV9 |
MERCK & CO. INC. |
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Biopsy cervix, Cervicectomy, Maternal exposure before pregnancy, Smear cervix ab...
Biopsy cervix, Cervicectomy, Maternal exposure before pregnancy, Smear cervix abnormal
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she had "an abnormal pap while pregnant; In June 2024 she had a Cervical Resection; This sponta...
she had "an abnormal pap while pregnant; In June 2024 she had a Cervical Resection; This spontaneous report was received from a Company Representative regarding a 28-year-old female patient. The patient's medical history, concurrent conditions, Concomitant therapies, past drug reactions and allergies were unknown by the reporter. On an unknown date, when the patient was 12 years old, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, lot number, expiration date, anatomical site of injection and route of administration were not provided). On an unknown date (also reported as years later), the patient had an abnormal pap while pregnant (Papanicolaou smear abnormal). When revisited a few years later, they did a cervical biopsy. On an unknown date in June 2024, the patient experienced a cervical resection (Cervicectomy). No additional details were available at the time of the call. The outcome of the events of Papanicolaou smear abnormal and Cervicectomy were not provided. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and both events was not reported. Upon internal review, the event of Cervicectomy was determined to be medically significant (OME).
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| 2819736 | U | KY | 01/07/2025 |
PNC15 |
MERCK & CO. INC. |
Y002643 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AEs were reported; The healthcare worker is reporting that a patient received improper...
No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643 10/4/2026) Temperature: 4; This spontaneous report was received from an other health care professional (healthcare worker) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 31-DEC-2024, the patient was vaccinated with 1 improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # Y002643, expiration date: 04-OCT-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature excursion of 46.6 degrees Fahrenheit for 1 hour and 55 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
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| 2819737 | U | KY | 01/07/2025 |
PNC15 |
MERCK & CO. INC. |
y002643 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional adverse event was reported; The healthcare worker is reporting that a patient received...
No additional adverse event was reported; The healthcare worker is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643 10/4/2026) Temperature: 4; This spontaneous report was received from healthcare worker and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date: 04-OCT-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 46.6 degree Farenheit for 1 hour 55 minutes (Product storage error). No additional adverse events were reported.
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| 2819738 | U | KY | 01/07/2025 |
PNC15 |
MERCK & CO. INC. |
y002643 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AEs were reported; The healthcare worker is reporting that a patient received improper...
No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date reported as and upon internal review confirmed to be 04-OCT-2026 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis. The patient received improperly stored vaccine (temperature: 46.6F; time frame: 1 hour 55 minutes) (product storage error). No previous temperature excursion was noted. No additional adverse events (AEs) were reported (no adverse event). No further information was provided.
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| 2819739 | 57 | F | MI | 01/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Underdose
No adverse event, Underdose
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The client had no adverse reaction. The appropriate vaccination was administered. The client was ina...
The client had no adverse reaction. The appropriate vaccination was administered. The client was inadvertently given a pediatric/adolescent dose instead of an adult dose.
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| 2819740 | 74 | M | AR | 01/07/2025 |
COVID19 |
MODERNA |
|
Coronary artery bypass, Death, Malaise
Coronary artery bypass, Death, Malaise
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Patient admitted 11/22 for CABG, wen to rehab on 12/26, re-admitted 12/29 with COVID symptoms, expir...
Patient admitted 11/22 for CABG, wen to rehab on 12/26, re-admitted 12/29 with COVID symptoms, expired 1/6/2025
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โ | โ | ||||
| 2819741 | 94 | M | 01/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a second dose of RSV after one year of a prior vaccination. Spoke with them and th...
Patient received a second dose of RSV after one year of a prior vaccination. Spoke with them and they are not experiencing any adverse reactions to the second dose.
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| 2819742 | 29 | M | IL | 01/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Inflammation, Injection site hypoaesthesia, Injection site pain, Laboratory test...
Inflammation, Injection site hypoaesthesia, Injection site pain, Laboratory test, Product administered at inappropriate site
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pt says after the 1st dose in the left arm he started having tingling in his bicep and pain into the...
pt says after the 1st dose in the left arm he started having tingling in his bicep and pain into the back of his arm and then moved into his chest wall as well as other areas. He saw a doctor for the pain but was told it was not unusual, take tylenol and thought it would go away. Then he received the 2nd dose in the left buttuck. It was numb for a couple of days and then it became it painful. He can still move his arm but the pain is still there and is now permanent never goes away and the pain on the buttock is still there and is also permanent. The left hand stays inflammed unless he takes anti-inflammitory or goes to sleep. His current PCP had him in therapy for treatment but that did not help with his symptoms. He continues to seek help for relief of these issues from the vaccines. He also received a 2nd opinion but also got an all clear for them also.
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| 2819743 | U | KY | 01/07/2025 |
PNC15 |
MERCK & CO. INC. |
y002643 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AEs were reported; The healthcare worker is reporting that a patient received improper...
No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date reported as and upon internal review confirmed to be 04-OCT-2026 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis. The patient received improperly stored vaccine (temperature: 46.6F; time frame: 1 hour 55 minutes) (product storage error). No previous temperature excursion was noted. No additional adverse events (AEs) were reported (no adverse event). No further information was provided.
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| 2819744 | 24 | F | MN | 01/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Eye swelling
Eye swelling
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Swelling of right eye when waking up at 6:00 AM 1/7/2025. Went to urgent care and was told to treat ...
Swelling of right eye when waking up at 6:00 AM 1/7/2025. Went to urgent care and was told to treat with Benadryl.
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| 2819745 | 37 | F | 01/07/2025 |
COVID19 FLU3 PPV |
PFIZER\BIONTECH SEQIRUS, INC. MERCK & CO. INC. |
lm2228 946620 x027348 |
Injection site erythema, Injection site reaction, Injection site swelling, Injec...
Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia; Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia; Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
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She had a fever start Sat evening and lasted all day Sunday, about 102F. Once the fever broke Sunday...
She had a fever start Sat evening and lasted all day Sunday, about 102F. Once the fever broke Sunday night she began to experience injection site reactions on her left arm. Red swollen, and slightly warm. No hives or itching.
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| 2819746 | 68 | M | MA | 01/07/2025 |
PNC20 |
PFIZER\WYETH |
LG5578 |
Inappropriate schedule of product administration, Pain in extremity
Inappropriate schedule of product administration, Pain in extremity
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VACCINE WAS GIVEN EARLIER THAN RECOMMENDED GUIDELINE; ACCORDING TO PFIZER GUIDELINE, A PERSON WHO HA...
VACCINE WAS GIVEN EARLIER THAN RECOMMENDED GUIDELINE; ACCORDING TO PFIZER GUIDELINE, A PERSON WHO HAD COMPLETED PREVNAR13 AND PNEUMOVAX23 VACCINES IS ELIGIBLE TO GET PREVNAR20 5 YEARS AFTER LAST PNEUMONIA SHOT. PREVNAR20 WAS GIVEN EARLIER THAN 5 YEARS. HIS DUE DATE WOULD HAVE BEEN 08/09/2027.
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| 2819748 | 4 | F | 01/07/2025 |
VARCEL |
MERCK & CO. INC. |
Y010045 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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swelling and tenderness at injection site
swelling and tenderness at injection site
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| 2819749 | 11 | M | TN | 01/07/2025 |
HPV9 HPV9 MNQ MNQ |
MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
Y000206 Y000206 3443E 3443E |
Injection site rash, Injection site warmth, Rash, Rash erythematous, Rash papula...
Injection site rash, Injection site warmth, Rash, Rash erythematous, Rash papular; Rash pruritic; Injection site rash, Injection site warmth, Rash, Rash erythematous, Rash papular; Rash pruritic
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On 12/25/2024 patient started with a localized rash around the site where he received his HPV vaccin...
On 12/25/2024 patient started with a localized rash around the site where he received his HPV vaccine in his right arm. It was raised and red and warm to the touch. Also itchy. On 12/28/2024 the rash spread around the arm, then to the feet, legs and cheeks. Afebrile. No joint pain. No other illness symptoms.
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| 2819750 | 15 | F | 01/07/2025 |
COVID19 |
MODERNA |
3043333 |
Syncope
Syncope
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vasovagal syncope
vasovagal syncope
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| 2819751 | 4 | F | TX | 01/07/2025 |
COVID19 |
PFIZER\BIONTECH |
HH3252 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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No adverse event occurred. Patient was accidently given 3 doses of vaccine at one time.
No adverse event occurred. Patient was accidently given 3 doses of vaccine at one time.
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| 2819752 | 16 | M | NC | 01/07/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
|
Blood glucose normal, Pallor, Syncope, Tremor; Blood glucose normal, Pallor, Syn...
Blood glucose normal, Pallor, Syncope, Tremor; Blood glucose normal, Pallor, Syncope, Tremor
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Patient had syncopal episode and fall off patient exam table after vaccination about 1-2 minutes aft...
Patient had syncopal episode and fall off patient exam table after vaccination about 1-2 minutes after injections. Syncope lasted less than 1 minute before patient was responding again. Had pallor and some shakiness for several minutes afterwards. Blood pressure was 90/48 and blood sugar 94. Blood pressure improved over the next 15 minutes and patient was able to leave office.
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| 2819753 | 17 | F | MA | 01/07/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
3L339 |
Ear discomfort, Throat tightness, Tinnitus
Ear discomfort, Throat tightness, Tinnitus
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mom states the next day after receiving the bexsero #1 vaccine she had ringing in both ears and the...
mom states the next day after receiving the bexsero #1 vaccine she had ringing in both ears and they felt clogged. Her throat felt like it was closing. After the 3rd day she started to feel better. No treatment was done.
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| 2819754 | 49 | F | SD | 01/07/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3A7CG 3A7CG |
Blood test normal, Computerised tomogram head normal, Head titubation, Magnetic ...
Blood test normal, Computerised tomogram head normal, Head titubation, Magnetic resonance imaging head normal, Movement disorder; Tremor
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Symptoms began on November 6, 2021 with a slight tremor in my right arm/hand. Within a week the trem...
Symptoms began on November 6, 2021 with a slight tremor in my right arm/hand. Within a week the tremors were affecting all of my limbs, neck and head. I went to my PCP who referred my to a neurologist. I was able to see him on December 22, 2021. He diagnosed me with Functional Movement Disorder.
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| 2819755 | 0.67 | F | ND | 01/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LN8272 U8523AA |
Cough, Nasal congestion, Viral upper respiratory tract infection, Vomiting; Coug...
Cough, Nasal congestion, Viral upper respiratory tract infection, Vomiting; Cough, Nasal congestion, Viral upper respiratory tract infection, Vomiting
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Cough, nasal congestion, vomiting overnight after an afternoon dose of vaccine. Continued cough and ...
Cough, nasal congestion, vomiting overnight after an afternoon dose of vaccine. Continued cough and congestion the next day. Symptomatic support. Likely viral URI.
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| 2819756 | 40 | F | WI | 01/07/2025 |
FLU3 |
SEQIRUS, INC. |
unknown |
Hypoaesthesia, Muscle spasms
Hypoaesthesia, Muscle spasms
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Received flu vaccine 12/10/24. On 12/24/24 was exercising (running) and noticed numbness in BLE'...
Received flu vaccine 12/10/24. On 12/24/24 was exercising (running) and noticed numbness in BLE's. Diminished sensation left side of face, BLE's and LUE for the next two weeks. Had whole body muscle spasms 12/27/24-12/30/24. Currently (01/07/25) improvement of symptoms, but still experiencing diminished sensation LUE, BLE's and some left side of face numbness. Saw psychiatrist 01/06/25 and he didn't know what was going on and offered neurologist consult.
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| 2819757 | 18 | M | SC | 01/07/2025 |
FLU3 |
SANOFI PASTEUR |
UT8434MA |
Extra dose administered
Extra dose administered
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Pt received 2 Flu vaccines accidentally- administered by medical assistants.
Pt received 2 Flu vaccines accidentally- administered by medical assistants.
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| 2819758 | 67 | M | FL | 01/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given a second Arexvy shot , He is fine. No side effects. We all thought it was the firs...
Patient was given a second Arexvy shot , He is fine. No side effects. We all thought it was the first one and so did he.
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| 2819760 | 1.5 | M | MO | 01/07/2025 |
DTAP HEPA PNC15 TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR |
5H773 22GP3 Y002643 3CA22C1 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered
More
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The nurse intended to administer ActHIB but accidentally administered Adacel.
The nurse intended to administer ActHIB but accidentally administered Adacel.
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| 2819761 | 17 | F | PA | 01/07/2025 |
MENB |
PFIZER\WYETH |
H66057 |
Rash
Rash
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Patient reported rash around the area
Patient reported rash around the area
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| 2819762 | 84 | F | CA | 01/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
94CC4 |
Injection site pruritus, Injection site rash, Pain in extremity, Rash erythemato...
Injection site pruritus, Injection site rash, Pain in extremity, Rash erythematous
More
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Pharmacist placed an adhesive sticker on the skin to assist with vaccine administration into the arm...
Pharmacist placed an adhesive sticker on the skin to assist with vaccine administration into the arm. Upon administration my arm was sore. About 2 days later I experienced 1/2 inch long by 1/8 inch wide red rash that was extremely itchy. The itching has finally resolved however the redness has persisted and is now pink color and slowly fading.
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| 2819763 | 11 | M | FL | 01/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
SKB235DC |
Injection site rash, Rash erythematous
Injection site rash, Rash erythematous
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At approximately 1:45PM, after the client was given the TDAP (Boostrix) vaccine, the nurse noticed a...
At approximately 1:45PM, after the client was given the TDAP (Boostrix) vaccine, the nurse noticed a slight red rash forming at the injection site. 25mL of Benadryl was administered orally less than 3 minutes later. Client was monitored for 20 minutes, and the slight rash was subsiding. No air way difficulties were noted.
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| 2819764 | U | KY | 01/07/2025 |
PNC15 |
MERCK & CO. INC. |
Y002643 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AEs were reported; The healthcare worker is reporting that a patient received improper...
No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643 10/4/2026) Temperature: 4; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided. On 30-DEC-2024 the patient was vaccinated with improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # Y002643 and expiration date 04-OCT-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lasted for 1 hour 55 minutes in temperature of 46.6 degrees Fahrenheit (product storage error). Bo additional adverse events were reported (no adverse event).
More
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| 2819765 | 26 | F | MO | 01/07/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y014510 Y014510 |
Blood glucose, Computerised tomogram, Electrocardiogram, Fall, Loss of conscious...
Blood glucose, Computerised tomogram, Electrocardiogram, Fall, Loss of consciousness; Skin laceration, Tooth fracture
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PATIENT LOST CONSCIOUSNESS SHORTLY AFTER RECEIVING THE VACCINE. SHE FELL ON HER WAY OUT OF THE CLINI...
PATIENT LOST CONSCIOUSNESS SHORTLY AFTER RECEIVING THE VACCINE. SHE FELL ON HER WAY OUT OF THE CLINIC AND BROKE HER TOOTH AND SUSTAINED LACERATIONS DUE TO THE FALL.
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| 2819766 | 20 | F | NY | 01/07/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
G334J |
Injected limb mobility decreased, Injection site pain, Injection site swelling, ...
Injected limb mobility decreased, Injection site pain, Injection site swelling, Ultrasound scan normal
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Patient developed left upper arm swelling and pain a few hours later after receiving Men B vaccine o...
Patient developed left upper arm swelling and pain a few hours later after receiving Men B vaccine on 12/17/24. Went to urgent care on 12/18, given one dose of cephalexin and Ibuprofen in office. Had significant pain, unable to abduct left shoulder on 12/19/24. Seen at ER on 12/19/24. Given acetaminophen, Ibuprofen and Lidocaine patch at ER. POCUS without cobble stoning or fluid collection. Pain improved with analgesia and able to actively range shoulder. Discharged home, Rxed Lidocaine 5% patch prn. Had follow up visit in PCP's office on 1/2/25 with condition resolved.
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| 2819767 | 16 | F | IL | 01/07/2025 |
FLU3 |
SEQIRUS, INC. |
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Dysphonia, Dyspnoea, Sensation of foreign body
Dysphonia, Dyspnoea, Sensation of foreign body
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felt like something was stuck in her throat, voice became hoarse, hard to take deep breaths
felt like something was stuck in her throat, voice became hoarse, hard to take deep breaths
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| 2819768 | 64 | F | MN | 01/07/2025 |
COVID19 |
MODERNA |
3043409 |
Injection site pain
Injection site pain
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Two days after injection of both Flucelvax and Spikevax, patient experienced "deep muscle pain&...
Two days after injection of both Flucelvax and Spikevax, patient experienced "deep muscle pain" at the injections site. Patient waited about 2 months to inform the pharmacy of this arm muscle pain. Talked to patient today and she said that the pain is worse.
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| 2819769 | 41 | F | AZ | 01/07/2025 |
PPV |
MERCK & CO. INC. |
X027348 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Medical assistant administered PCV 23 instead of PCV 20. Provider ordered PCV 20. Patient did not h...
Medical assistant administered PCV 23 instead of PCV 20. Provider ordered PCV 20. Patient did not have any reaction to vaccine administration in the clinic. Medical director spoke to patient about incident.
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| 2819770 | 75 | M | 01/07/2025 |
COVID19 FLU3 PNC20 |
PFIZER\BIONTECH SANOFI PASTEUR PFIZER\WYETH |
ln0588 |
Chest pain, Chills, Ocular hyperaemia, Vomiting; Chest pain, Chills, Ocular hype...
Chest pain, Chills, Ocular hyperaemia, Vomiting; Chest pain, Chills, Ocular hyperaemia, Vomiting; Chest pain, Chills, Ocular hyperaemia, Vomiting
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throwing up, chest pain, chills, eyes turned red
throwing up, chest pain, chills, eyes turned red
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| 2819771 | 21 | F | PA | 01/07/2025 |
YF YF |
SANOFI PASTEUR SANOFI PASTEUR |
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Back pain, Mobility decreased, Muscular weakness, Pain, Pain in extremity; Parae...
Back pain, Mobility decreased, Muscular weakness, Pain, Pain in extremity; Paraesthesia
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22 yr old female with no significant history who presented to the hospital on 9/10 with mid back pai...
22 yr old female with no significant history who presented to the hospital on 9/10 with mid back pain and paresthesias and pain shooting down legs and up toward neck and shoulders that started one day PTA. She went to urgent care and was given IM Toradol without relief. She subsequently developed progressive weakness in arms and legs to point that she could not move around in her bed. She then presented to the ED. She did receive a Yellow Fever Vaccine a few weeks ago in early August. No recent illnesses nor travel.
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| 2819772 | 74 | F | NM | 01/07/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
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Abdominal pain, Abdominal pain upper, Erythema, Fatigue, Headache; Muscle swelli...
Abdominal pain, Abdominal pain upper, Erythema, Fatigue, Headache; Muscle swelling, Myalgia, Pyrexia
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Redness and serious swelling of arm muscle; headache, fatigue, muscle aches and pain, fever, stomach...
Redness and serious swelling of arm muscle; headache, fatigue, muscle aches and pain, fever, stomach pain, abdominal pain
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| 2819773 | 0.5 | M | IN | 01/07/2025 |
DTAPIPVHIB HEP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UK107AA 4D333 |
Erythema, Peripheral swelling, Rash, Rash pruritic; Erythema, Peripheral swellin...
Erythema, Peripheral swelling, Rash, Rash pruritic; Erythema, Peripheral swelling, Rash, Rash pruritic
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itchy rash on both legs, thigh down to knees with redness and swelling. RX cetirizine 1mg/ml oral s...
itchy rash on both legs, thigh down to knees with redness and swelling. RX cetirizine 1mg/ml oral solution, take 2.5 ml PO every day. monitor patient for anaphylaxis, hives or angiodema and other symptoms.
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| 2819774 | 34 | M | KY | 01/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Arthralgia, Pain, Pain in extremity, Peripheral swelling
Arthralgia, Pain, Pain in extremity, Peripheral swelling
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Flu shot administered on 12/16/24. Soreness at the left shoulder with static positions and motions b...
Flu shot administered on 12/16/24. Soreness at the left shoulder with static positions and motions beginning the day following with progressive worsening over the subsequent 7-10 days. Swelling with pain and soreness eventually developed in forearm to wrist area as shoulder began to gradually improve. Currently beginning to gradually dissipate from forearm and wrist area.
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| 2819775 | 53 | M | KY | 01/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Peripheral swelling
Peripheral swelling
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Swelling of left forearm down to wrist, similar to a bee sting patient had gotten previously so he t...
Swelling of left forearm down to wrist, similar to a bee sting patient had gotten previously so he thought he should report as an ADR.
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| 2819776 | 1 | F | ID | 01/07/2025 |
FLU3 HEPA MMR MMRV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH |
5ZG92 Y011731 X014954 X021751 HN5980 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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None noted at this time
None noted at this time
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| 2819777 | 72 | M | FL | 01/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
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Patient recieved a 2nd Arexvy vaccine on 01/06/2025 when he previously recieved an Arexvy vaccine on...
Patient recieved a 2nd Arexvy vaccine on 01/06/2025 when he previously recieved an Arexvy vaccine on 10/20/2023. The CDC and manufacturer only currently recommends 1 dose of Arexvy per lifetime.
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| 2819778 | 16 | M | GA | 01/07/2025 |
HPV9 |
MERCK & CO. INC. |
y010656 |
Injection site rash, Rash, Rash pruritic
Injection site rash, Rash, Rash pruritic
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Itchy rash all over, starting on legs near injection site
Itchy rash all over, starting on legs near injection site
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| 2819779 | 46 | M | 01/07/2025 |
FLU3 |
SEQIRUS, INC. |
aw1696a |
Dizziness, Loss of consciousness, Syncope
Dizziness, Loss of consciousness, Syncope
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patient felt dizzy and fainted to the floor however was attended to and was conscious promptly
patient felt dizzy and fainted to the floor however was attended to and was conscious promptly
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| 2819780 | 72 | F | TX | 01/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2819781 | 0.5 | M | NC | 01/07/2025 |
DTAPIPV PNC15 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
3RT93 X026316 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Kinrix administered instead of Pediarix. Patient waited for 15 minutes and tolerated well
Kinrix administered instead of Pediarix. Patient waited for 15 minutes and tolerated well
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